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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration
Maternal and Child Health BureauMaternal and Child Health Research Program
Combating Autism Act InitiativeR40: MCH Autism Intervention Research
Announcement Type: New Competition Announcement Number: HRSA 10-197
Catalog of Federal Domestic Assistance (CFDA) No. 93.110
FUNDING OPPORTUNITY ANNOUNCEMENT
Fiscal Year 2010
Application Due Date: June 7, 2010
Release Date: April 27, 2010Date of Issuance: April 27, 2010
Hae Young Park and Sue LinProgram OfficersDivision of Research, Training and EducationTelephone: (301) 443-2207Fax: (301) 443-4842
Legislative Authority: Section 399BB, Public Health Service Act, P.L. 109-416, as amended by the Combating Autism Act of 2006 (42 U.S.C. 280i-1)
EXECUTIVE SUMMARY
Maternal and Child Health Research Program (MCHR)
Thank you for your interest in the R40 MCH Autism Intervention Research Grant Competition. Grant support is available from the Division of Research, Training and Education (DRTE), part of the Maternal and Child Health Bureau (MCHB) of the Health Resources and Services Administration (HRSA) in the U.S. Department of Health and Human Services (DHHS). We are aware that preparation of this application will involve a considerable commitment of time and energy. Please read the guidance carefully before completing the application.
This funding opportunity announcement includes instructions for two separate grant competitions:
A) R40 MCH Autism Intervention Research Program supports research on evidence-based practices for interventions to improve the health and well-being of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities (DD).
B) R40 MCH Autism Intervention Secondary Data Analysis Studies (SDAS) Program supports research on evidence-based practices for interventions to improve the health and well-being of children and adolescents with autism spectrum disorders (ASD) and other developmental disabilities (DD), utilizing exclusively the analysis of existing secondary data.
Qualified Applicants: Public and nonprofit institutions of higher learning and public or private nonprofit agencies able to perform research relating to ASD and other developmental disabilities are eligible.
Number of Grants and MCH Autism Intervention Research-Subject to the availability Funds Available Per Year: of appropriations, approximately $1,200,000 will be available to
fund approximately 4 grants per year for up to 3 years (the ceiling amount of an individual award is $300,000 total cost per year). MCH Autism Intervention Secondary Data Analysis Studies -Subject to the availability of appropriations, approximately $500,000 is available to fund up to 5 grants for one year (the ceiling amount of an individual award is $100,000 total cost).
Application Due Date: MCH Autism Intervention Research – June 7, 2010
MCH Autism Intervention Secondary Data Analysis Studies – June 7, 2010
Project Period: MCH Autism Intervention Research -Approved projects will be funded effective September 1, 2010 and will be awarded project
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periods of up to three years based on availability of funding from Congress.
MCH Autism Intervention Secondary Data Analysis Studies - Approved projects will be funded effective September 1, 2010 and will be awarded a project period of one year.
Programmatic Assistance Additional information related to the overall program issues or technical assistance may be obtained by contacting:
Hae Young Park and Sue LinMaternal and Child Health BureauDivision of Research, Training and Education5600 Fishers Lane, Room 18A-55Rockville, MD 20857Telephone: (301) 443-2207Fax: (301) 443-4842E-Mail: [email protected], [email protected]
Business, Administrative and Fiscal InquiriesApplicants may obtain additional information regarding business, administrative, or fiscal issues related to this grant announcement by contacting:
Brad K. BarneyGrants Management SpecialistDHHS/HRSA/OFAMDivision of Grants Management OperationsResearch and Training Branch5600 Fishers Lane, Room 11A-02Rockville, MD 20857 Telephone: (301) 443-6916FAX: (301) 443-6343E-mail: [email protected]
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Table of Contents
I. FUNDING OPPORTUNITY DESCRIPTION..........................................................................................................1
PURPOSE.....................................................................................................................................................................1BACKGROUND.............................................................................................................................................................1
II. AWARD INFORMATION....................................................................................................................................3
1. TYPE OF AWARD...................................................................................................................................................32. SUMMARY OF FUNDING........................................................................................................................................4
III. ELIGIBILITY INFORMATION.........................................................................................................................4
1. ELIGIBLE APPLICANTS.........................................................................................................................................42. COST SHARING/MATCHING..................................................................................................................................43. OTHER...................................................................................................................................................................4
IV. APPLICATION AND SUBMISSION INFORMATION..................................................................................5
1. ADDRESS TO REQUEST APPLICATION PACKAGE................................................................................................52. CONTENT AND FORM OF APPLICATION SUBMISSION.........................................................................................6APPLICATION FORMAT REQUIREMENTS..................................................................................................................6APPLICATION FORMAT..............................................................................................................................................6
i. Application Face Page.................................................................................................................................10ii. Table of Contents.....................................................................................................................................10iii. Application Checklist...............................................................................................................................10iv. Budget.......................................................................................................................................................10v. Budget Justification.....................................................................................................................................10vi. Staffing Plan and Personnel Requirements............................................................................................12vii. Assurances................................................................................................................................................13viii. Certifications............................................................................................................................................13ix. Project Abstract........................................................................................................................................14x. Program Narrative.......................................................................................................................................14xi. Program Specific Forms..........................................................................................................................17xii. Attachments..............................................................................................................................................18
3. SUBMISSION DATES AND TIMES.........................................................................................................................184. INTERGOVERNMENTAL REVIEW........................................................................................................................195. FUNDING RESTRICTIONS....................................................................................................................................196. OTHER SUBMISSION REQUIREMENTS................................................................................................................19
V. APPLICATION REVIEW INFORMATION ...................................................................................................20
1. REVIEW CRITERIA..............................................................................................................................................202. REVIEW AND SELECTION PROCESS...................................................................................................................243. ANTICIPATED ANNOUNCEMENT AND AWARD DATES.......................................................................................24
VI. AWARD ADMINISTRATION INFORMATION...........................................................................................24
1. AWARD NOTICES................................................................................................................................................242. ADMINISTRATIVE AND NATIONAL POLICY REQUIREMENTS...........................................................................243. REPORTING..........................................................................................................................................................26
VII. AGENCY CONTACTS.....................................................................................................................................28
VIII. OTHER INFORMATION...............................................................................................................................29
APPENDIX A: HRSA ELECTRONIC SUBMISSION GUIDE...........................................................................30
APPENDIX B: MCHB ADMINISTRATIVE FORMS AND PERFORMANCE MEASURES...........................50
APPENDIX C: INSTRUCTIONS FOR THE SF424 R&R (RESEARCH AND RELATED)...................................66
I. Funding Opportunity Description
Purpose
MCH Autism Intervention Research Program
The current competition for R40 MCH Autism Intervention Research supports research on evidence-based practices for interventions to improve the health and well-being of children and adolescents with ASD and other developmental disabilities. Consistent with HRSA’s mission as the access agency to provide services to underserved populations, applicants are encouraged to propose research studies that address the unique and very important needs of underserved populations, including low-income, racial/ethnic minorities, immigrants, and individuals who are not already readily included in current research on children and adolescents with ASD and other developmental disabilities. Proposals that address the unique barriers to receipt of interventions for underserved populations and issues pertaining to the financing/reimbursement of services for children and adolescents with ASD and other developmental disabilities are also encouraged.
MCH Autism Intervention Secondary Data Analysis Studies (SDAS) Program
The current competition for R40 MCH Autism Intervention Secondary Data Analysis Studies supports research on evidence-based practices for interventions to improve the health and well-being of children and adolescents with ASD and other developmental disabilities, utilizing exclusively the analysis of existing secondary data. Consistent with HRSA’s mission as the access agency to provide services to underserved populations, applicants are encouraged to propose secondary data analysis studies that address the unique and very important needs of underserved populations, including low-income, racial/ethnic minorities, immigrants, and individuals not already readily included in current research on children and adolescents with ASD and other developmental disabilities. Proposals that address the unique barriers to receipt of interventions for underserved populations and issues pertaining to the financing/reimbursement of services for children and adolescents with ASD and other developmental disabilities are also encouraged.
The Maternal and Child Health Bureau’s intent is to ensure that project interventions are responsive to the cultural and linguistic needs of special populations, that services are family-centered and accessible to consumers, and that the broadest possible representation of culturally distinct and historically underrepresented groups is supported through programs and projects sponsored by the MCHB.
Background
Combating Autism Act of 2006: Enacted in December 2006, the Combating Autism Act of 2006 (Public Law 109-416) authorizes programs to combat autism through research, screening, intervention and education. Under this authority, HRSA/MCHB has developed the Combating Autism Act Initiative (CAAI), a $37 million initiative to address ASD and other developmental disabilities by:
Increasing awareness;
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Reducing barriers to screening and diagnosis; Supporting research on evidence-based interventions for children and adolescents with
ASD or other developmental disabilities; Promoting evidence-based guideline development for interventions; and Training professionals to utilize valid and reliable screening tools to diagnose or rule out
ASD and to provide evidence-based interventions.
Under the Combating Autism Act Initiative, the Maternal and Child Health Bureau initiated programs in 4 areas in Federal Fiscal Year 2008:
1) Combating Autism Training Programs Expansions of some existing Leadership Education in Neurodevelopmental Disabilities
(LEND) training programs; Four new LEND programs; Expansions to Developmental Behavioral Pediatrics (DBP) training programs; and An MCH Training Autism Resource Center cooperative agreement.
2) Autism Intervention Research Networks Program Two Autism Intervention Research Networks that focus on intervention research,
guideline development and information dissemination—one network focused on physical health interventions, and one network focused on behavioral, mental, social, and/or cognitive health interventions.
3) Combating Autism State Demonstration and Policy Programs State Autism Demonstration grants that will implement State autism plans and develop
models for how to develop systems of services for children and adolescents with ASD and other developmental disabilities.
A State Public Health Coordinating Center that will coordinate with the State Autism Demonstration grants and will develop and implement a strategy for defining, supporting, and monitoring the role of State public health agencies in assuring that children and adolescents with ASD receive early and appropriate identification, diagnosis, and intervention.
4) Combating Autism National Evaluation Information from this evaluation study will contribute to the HHS Secretary’s Report to
Congress on progress related to ASD and other developmental disabilities as required by the “Combating Autism Act of 2006.” The report is due within 4 years of the Act’s enactment.
In 2009, an additional $2 million was authorized under the Combating Autism Act of 2006 to support research on ASD and other developmental disabilities. With these additional funds, the Maternal and Child Health (MCH) Research Program initiated the MCH Autism Intervention Research and MCH Autism Intervention Secondary Data Analysis Studies Programs.
With an additional $2.2 million being authorized to support research activities under the Combating Autism Act of 2006 for Federal Fiscal Year 2010, the current competitions for the MCH Autism Intervention Research and MCH Autism Intervention SDAS Programs as well as other research activities are being competed.
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The Maternal and Child Health Research Program is located within MCHB’s Division of Research, Training and Education (DRTE). The MCH Research Program, with over 40 years of experience, has supported ground-breaking investigations that have significantly influenced clinical management, organization and delivery of health care services, preventive care and early intervention for the maternal and child health population, including children with special health care needs.
The MCH Research Program supports applied research and research networks relating to maternal and child health services including services for children with special health care needs, that show promise of substantial contribution to the advancement of the current knowledge pool, and when used in States and communities should result in improvements of health and health services. Research projects address critical MCH questions including public health systems and infrastructure, health disparities, quality of care, and promoting the health of MCH populations, that also support the goals of the Health Resources and Services Administration.
For more information about the MCH Research Program, visit our website: www.mchb.hrsa.gov/research .
Objectives of the MCH Autism Intervention Research and MCH Autism Intervention SDAS Programs
Funding associated with these awards is intended to support the conduct of research studies and secondary data analyses that will result in the following:
advancement of the current knowledge pool leading to improvements in interventions that address the physical and behavioral health needs of children and adolescents with ASD and other developmental disabilities; and
information dissemination to health professionals and the public, especially families impacted by ASD and other developmental disabilities.
Publication of DataPrompt and timely presentation and publication in the scientific literature of findings resulting from research and analyses undertaken is required. As per HHS guidelines, the Awardee agrees to acknowledge HRSA support in the publications and oral presentations resulting from research and/or activities conducted under this cooperative agreement. Peer-reviewed publications are the cardinal measure of success of the MCH Research Program. The number of publications resulting from each funded project contributes to the total number of publications by which the MCH Research Program is evaluated annually.
II. Award Information
1. Type of Award
Funding will be provided in the form of a grant for the R40 MCH Autism Intervention Research and the R40 MCH Autism Intervention SDAS Programs.
2. Summary of Funding
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MCH Autism Intervention Research Program This program will provide funding for Federal fiscal years 2010, 2011, and 2012. Projects will be awarded for up to three years. Approximately $1,200,000 is expected to be available annually to fund four (4) grantees (ceiling amount of an individual award is $300,000 total cost per year). Funding beyond the first year is dependent on the availability of appropriated funds for “MCH Autism Intervention Research Program” in subsequent fiscal years, grantee satisfactory performance, and a decision that continued funding is in the best interest of the Federal government.
MCH Autism Intervention Secondary Data Analysis Studies (SDAS)This program will provide funding for Federal fiscal year 2010. Projects will be awarded for one year. Approximately $500,000 is expected to be available to fund five (5) grantees (ceiling amount of an individual award is $100,000 total cost).
III. Eligibility Information
1. Eligible Applicants
The current competitions as part of the MCHB/HRSA Combating Autism Act Initiative are authorized under the Combating Autism Act of 2006, Public Law No. 109-416, §SEC.399BB, 120 Stat 2821, 2823-2827 (2006). Public and nonprofit institutions of higher learning and public or private nonprofit agencies able to perform research relating to ASD and other developmental disabilities are eligible.
2. Cost Sharing/Matching
There is no cost sharing or matching is requirement for these programs.
3. Other
MCH Autism Intervention ResearchApplications that exceed the ceiling amount of $300,000 or that request funding for more than three years will be considered non-responsive and will not be considered for funding under this announcement.
MCH Autism Intervention Secondary Data Analysis Studies (SDAS)Applications that exceed the ceiling amount of $100,000 or that request funding for more than one year will be considered non-responsive and will not be considered for funding under this announcement.
Any application that fails to satisfy the deadline requirements referenced in Section IV.3 will be considered non-responsive and will not be considered for funding under this announcement. Please see other limitations including page limit and font/margin requirements (Appendix A) that may deem application as non-responsive.
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Due to funding limitations and the need for a diversified portfolio, the following additional eligibility requirements apply for both the MCH Autism Intervention Research and MCH Autism Intervention SDAS Programs:
Applications that overlap in project period with a currently funded MCH Autism Intervention Research project by the same Principal Investigator (PI) will not be considered for funding (i.e., A Principal Investigator cannot have two R40 MCH Autism Intervention Research grants running simultaneously).
A current PI of an MCH Autism Intervention Research grant can serve for no more than 10% time on a new proposal in a capacity other than as Principal Investigator.
Analysis of secondary data previously collected by the applicant PI will not be considered for funding using the MCH Autism Intervention SDAS Program.
Secondary data analysis projects will not be considered for funding under the multi-year MCH Autism Intervention Research grant competition.
A Principal Investigator (PI) cannot apply to both the MCH Autism Intervention Research and MCH Autism SDAS Programs simultaneously. A PI cannot submit more than one application for any of these competitions.
IV. Application and Submission Information
1. Address to Request Application Package
Application Materials and Required Electronic Submission InformationHRSA is requires applicants for this funding opportunity to apply electronically through Grants.gov. All applicants must submit in this manner unless the applicant is granted a written exemption from this requirement in advance by the Director of HRSA’s Division of Grants Policy or designee. Applicants must request an exemption in writing from [email protected], and provide details as to why they are technologically unable to submit electronically though the Grants.gov portal. Your email must include the HRSA Announcement Number for which you are seeking relief, the name, address, and telephone number of the organization and the name and telephone number of the Project Director. Make sure you include specific information, including any tracking numbers or anecdotal information received from Grants.gov and/or the HRSA Call Center, in your justification request. HRSA and its Grants Application Center (GAC) will only accept paper applications from applicants that received prior written approval.
Refer to Appendix A for detailed application and submission instructions. Pay particular attention to Sections 2 and 5, which provide detailed information on the competitive application and submission process.
Applicants must submit proposals according to the instructions in Appendix A using this funding opportunity announcement in conjunction with Standard Form 424 Research and Related (SF-424 R&R). These forms contain additional general information and instructions for grant applications, proposal narratives, and budgets. These forms may be obtained from the following sites by:
(1) Downloading from http://www.hrsa.gov/grants/forms.htm
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Or
(2) Contacting the HRSA Grants Application Center at:910 Clopper RoadSuite 155 SouthGaithersburg, MD 20878Telephone: [email protected]
Instructions for preparing portions of the application that must accompany SF-424 R&R appear in the “Application Format” section below.
2. Content and Form of Application Submission
Application Format RequirementsThe total size of all uploaded files may not exceed the equivalent of 80 pages when printed by HRSA, or a total file size of 10 MB. This 80-page limit includes the abstract, project and budget narratives, attachments, and letters of commitment and support. Standard forms are NOT included in the page limit.
Applications that exceed the specified limits (approximately 10 MB, or that exceed 80 pages when printed by HRSA) will be deemed non-compliant. All non-compliant applications will not be considered under this funding opportunity announcement.
Application FormatApplications for funding must consist of the following documents in the following order:
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SF-424 R&R – Table of Contents
It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review.It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review. Failure to follow the instructions may make your application non-compliant. Non-compliant applications will not be given any consideration under this Failure to follow the instructions may make your application non-compliant. Non-compliant applications will not be given any consideration under this
funding opportunity announcement.funding opportunity announcement.
For electronic submissions, applicants only have to number the electronic attachment pages sequentially, resetting the numbering for each attachment,For electronic submissions, applicants only have to number the electronic attachment pages sequentially, resetting the numbering for each attachment, i.e., start at page 1 for each attachment. Do not attempt to number standard OMB approved form pages.i.e., start at page 1 for each attachment. Do not attempt to number standard OMB approved form pages.
For electronic submissions no table of contents is required for the entire application. HRSA will construct an electronic table of contents in the order For electronic submissions no table of contents is required for the entire application. HRSA will construct an electronic table of contents in the order specified.specified.
When providing any electronic attachment with several pages, add table of content page specific to the attachment. Such page will not be counted When providing any electronic attachment with several pages, add table of content page specific to the attachment. Such page will not be counted towards the page limit.towards the page limit.
Application Section Form Type Instruction HRSA/Program GuidelinesSF-424 R&R Cover Page Form Pages 1 & 2 of the R&R face page Not counted in the page limitPre-application Attachment Can be uploaded on page 2 of SF-424 R&R - Box 20 Not Applicable to HRSA; Do not use. HHS 5161 Checklist Form Also known as PHS-5161 checklist Not counted in the page limitSF-424 R&R Senior/Key Person Profile
Form Supports 8 structured profiles(PD + 7 additional)
Not counted in the page limit
Senior Key Personnel Biographical Sketches
Attachment Can be uploaded in SF-424 R&R Senior/Key Person Profile form. One per each senior/key person. The PD/PI biographical sketch should be the first biographical sketch. Up to 8 allowed.
Counted in the page limit.
Senior Key Personnel Current and Pending Support
Attachment Can be uploaded in SF-424 R&R Senior/Key Person Profile form.
Not Applicable to HRSA; Do not use.
Additional Senior/Key Person Profiles
Attachment Can be uploaded in SF-424 R&R Senior/Key Person Profile form. Single document with all additional profiles.
Not counted in the page limit
Additional Senior Key Personnel Biographical Sketches
Attachment Can be uploaded in the Senior/Key Person Profile form. Single document with all additional sketches.
Counted in the page limit
Additional Senior Key Personnel Current and Pending Support
Attachment Can be uploaded in the Senior/Key Person Profile form Not Applicable to HRSA; Do not use.
SF-424 R&R Performance Site Locations
Form Supports primary and 7 additional sites in structured form Not counted in the page limit
Additional Performance Site Location(s)
Attachment Can be uploaded in SF-424 R&R Performance Site Locations form. Single document with all additional site
Counted in the page limit
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Application Section Form Type Instruction HRSA/Program Guidelineslocations.
Project Summary/Abstract Attachment Can be uploaded in SF-424 R&R Other Project Information form, Box 6.
Required attachment. Counted in the page limit. Refer to the guidance for detailed instructions. Provide table of contents specific to this document only as the first page.
Project Narrative Attachment Can be uploaded in SF-424 R&R Other Project Information form, Box 7.
Required attachment. Counted in the page limit. Refer guidance for detailed instructions. Provide table of contents specific to this document only as the first page.
SF-424 R&R Budget Period (1-5) - Section A – B
Form Supports structured budget for up to 5 periods. Not counted in the page limit.
Additional Senior Key Persons Attachment SF-424 R&R Budget Period (1-5) - Section A - B, Box 9. One for each budget period.
Not counted in the page limit.
SF-424 R&R Budget Period (1-5) - Section C – E
Form Supports structured budget for up to 5 periods. Not counted in the page limit.
Additional Equipment Attachment SF-424 R&R Budget Period (1-5) - Section C – E, Box 11. One for each budget period.
Not counted in the page limit.
SF-424 R&R Budget Period (1-5) - Section F – J
Form Supports structured budget for up to 5 periods. Not counted in the page limit.
SF-424 R&R Cumulative Budget Form Total cumulative budget. Not counted in the page limit.Budget Narrative Attachment Can be uploaded in SF-424 R&R Budget Period (1-5) -
Section F - J form, Box K. Only one consolidated budget justification for the project period.
Required attachment. Counted in the page limit. Refer to the guidance for detailed instructions. Provide table of contents specific to this document only as the first page.
SF-424 R&R Subaward Budget Form Supports up to 10 budget attachments. This form only contains the attachment list.
Not counted in the page limit.
Subaward Budget Attachment 1-10 Attachment Can be uploaded in SF-424 R&R Subaward Budget form, Box 1 through 10. Extract the form from the SF-424RR Subaward Budget form and use it for each consortium/contractual/subaward budget as required by the program guidance. Supports up to 10
Filename should be the name of the organization and unique. Not counted in the page limit
SF-424B Assurances for Non- Form Assurances for the SF-424 R&R package. Not counted in the page limit.
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Application Section Form Type Instruction HRSA/Program GuidelinesConstruction ProgramsOther Project Information Form Allows additional information and attachments. Not counted in the page limit.Disclosure of Lobbying Activities (SF-LLL)
Form Supports structured data for lobbying activities. Not counted in the page limit.
Bibliography & References Attachment Can be uploaded in Other Project Information form, Box 8. Required; Counted in the page limit.Facilities & Other Resources Attachment Can be uploaded in Other Project Information form, Box 9. Required; Counted in the page limit. Equipment Attachment Can be uploaded in Other Project Information form, Box 10. Required; Counted in the page limit.Other Attachments Form Form Supports up to 15 numbered attachments. This form only
contains the attachment list.Not counted in the page limit.
Attachment 1-15 Attachment Can be uploaded in Other Attachments form 1-15. Refer to the attachment table provided below for specific sequence. Counted in the page limit.
Other Attachments Attachment Can be uploaded in SF-424 R&R Other Project Information form, Box 11. Supports multiple.
Not Applicable to HRSA; Do not use
To ensure that attachments are organized and printed in a consistent manner, follow the order provided below. Note that these instructions may vary To ensure that attachments are organized and printed in a consistent manner, follow the order provided below. Note that these instructions may vary across programs.across programs.
Evidence of Non Profit status and invention related documents, if applicable, must be provided in the other attachment form. Evidence of Non Profit status and invention related documents, if applicable, must be provided in the other attachment form. Additional supporting documents, if applicable, can be provided using the available rows. Do not use the rows assigned to a specific purpose in the Additional supporting documents, if applicable, can be provided using the available rows. Do not use the rows assigned to a specific purpose in the
program guidance.program guidance. Merge similar documents into a single document. Where several pages are expected in the attachment, ensure that you place a table of contents cover Merge similar documents into a single document. Where several pages are expected in the attachment, ensure that you place a table of contents cover
page specific to the attachment. Table of contents page will not be counted in the page limit.page specific to the attachment. Table of contents page will not be counted in the page limit.
Attachment Number Attachment Description (Program Guidelines)Attachment 1 Letters of Agreement/Letters of Support.Attachment 2 Key publications or condensed citations with abstracts. Attachment 3 Surveys, questionnaires, data collection instruments, clinical protocols. Attachment 4 Others, as needed
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Application Format
i. Application Face Page Use the SF-424 R&R provided with the application package. Prepare according to instructions provided in the form itself. For information pertaining to the Catalog of Federal Domestic Assistance, the Catalog of Federal Domestic Assistance Number is 93.110.
DUNS NumberAll applicant organizations are required to have a Data Universal Numbering System (DUNS) number in order to apply for a grant from the Federal Government. The DUNS number is a unique nine-character identification number provided by the commercial company, Dun and Bradstreet. There is no charge to obtain a DUNS number. Information about obtaining a DUNS number can be found at http://www.hrsa.gov/grants/dunsccr.htm or call 1-866-705-5711. Please include the DUNS number in item 5 on the application face page. Applications will not be reviewed without a DUNS number. Note: a missing or incorrect DUNS number is the primary reason for an application to be “Rejected for Errors” by Grants.gov.
Additionally, the applicant organization is required to register annually with the Federal Government’s Central Contractor Registry (CCR) in order to do electronic business with the Federal Government. It is extremely important to verify you’re your CCR registration is active. Information about registering with the CCR can be found at http://www.ccr.gov.
ii. Table of ContentsThe application should be presented in the order of the Table of Contents provided earlier. Again, for electronic applications no table of contents is necessary as it will be generated by the system. (Note: the Table of Contents will not be counted in the page limit.)
iii. Application Checklist Use HHS Checklist Form PHS-5161 provided with the application package.
iv. BudgetUse SF-424 R&R Budget pages provided with the application package. Please complete Section A - K and the Cumulative Budget for each project year. NOTE: The Cumulative Budget page for each project year will be automatically computed. The applicant does not need to calculate the figures for this page. Please complete the R&R Subaward Budget Attachment(s) Form for each contractual arrangement. NOTE: Subaward budget attachments DO NOT count toward the page limit. These forms will represent the full project period of Federal assistance requested. All budgets must be well justified, with explanations of each line item. NOTE: Contractual costs entered in the R&R Subaward Budget Attachment(s) Form do not automatically get included in the Cumulative Budget page for each budget period. Therefore, you must include the amount for contractual costs in Section F – K, #5 Subawards/Consortium/Contractual costs of each budget period. This will ensure that the cumulative budget page for each budget period will correctly reflect the entire cost for each budget period.
v. Budget JustificationProvide a narrative that explains the amounts requested for each line in the budget. The budget justification should specifically describe how each item will support the achievement
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of proposed objectives. Each budget period is for ONE year. However, the applicant must submit one-year budgets for each of the subsequent project period years (usually one to three years) at the time of application. Line item information must be provided to explain the costs entered the Standard Form 424 Research and Related Budget form. The budget justification must clearly describe each cost element and explain how each cost contributes to meeting the project’s objectives/goals for each year. Be very careful about showing how each item in the “other” category is justified. For subsequent budget years, the justification narrative should highlight the changes from year one or clearly indicate that there are no substantive budget changes during the project period. The budget justification MUST be concise. Do NOT use the justification to expand the project narrative. A budget justification for each subcontract organization must be included in the application.
Budget for Multi-Year Grant Award (N/A to Secondary Data Analysis Studies)This announcement is inviting applications for project periods up to three years. Awards, on a competitive basis, will be for a one-year budget period, although project periods may be for three years. Applications for continuation grants funded under these awards beyond the one-year budget period but within the multi- year project period will be entertained in subsequent years on a noncompetitive basis, subject to availability of funds, satisfactory progress of the grantee and a determination that continued funding would be in the best interest of the Federal government.
Caps on expenses: Applications for the MCH Autism Intervention Research competition must not exceed the $300,000 ceiling amount of an individual award. Applications for the MCH Autism Intervention Secondary Data Analysis Studies must not exceed the $100,000 ceiling amount of an individual award. These ceilings include both direct and indirect expenses. Applications which exceed the cap will be deemed non-responsive, and will not be considered in the current competition.
Include the following in the Budget Justification narrative:
Personnel Costs: Personnel costs should be explained by listing each staff member who will be supported from funds, name (if possible), position title, percent full time equivalency, and annual salary.
Fringe Benefits: List the components that comprise the fringe benefit rate, for example health insurance, taxes, unemployment insurance, life insurance, retirement plan, tuition reimbursement. The fringe benefits should be directly proportional to that portion of personnel costs that are allocated for the project.
Travel: List travel costs according to local and long distance travel. For local travel, the mileage rate, number of miles, reason for travel and staff member/consumers completing the travel should be outlined. The budget should also reflect the travel expenses associated with participating in meetings and other proposed trainings or workshops. Travel outside of the U.S. is not supported.
Equipment: List equipment costs and provide justification for the need of the equipment to carry out the program’s goals. Extensive justification and a detailed status of current equipment must be provided when requesting funds for the purchase of computers and
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furniture items that meet the definition of equipment (a unit cost of $5000 and a useful life of one or more years).
Supplies: List the items that the project will use. In this category, separate office supplies from medical and educational purchases. Office supplies could include paper, pencils, and the like; medical supplies are syringes, blood tubes, plastic gloves, etc., and educational supplies may be pamphlets and educational videotapes. Remember, they must be listed separately.
Contracts: Applicants and or grantees/awardees are responsible for ensuring that their organization and or institution has in place an established and adequate procurement system with fully developed written procedures for awarding and monitoring all contracts. Applicants and or grantees/awardees must provide a clear explanation as to the purpose of each contract, how the costs were estimated, and the specific contract deliverables.
Other: Put all costs that do not fit into any other category into this category and provide an explanation of each cost in this category. In some cases, grantee rent, utilities and insurance fall under this category if they are not included in an approved indirect cost rate.
Indirect Costs: Indirect costs are those costs incurred for common or joint objectives which cannot be readily identified but are necessary to the operations of the organization, e.g., the cost of operating and maintaining facilities, depreciation, and administrative salaries. For institutions subject to OMB Circular A-21, the term “facilities and administration” is used to denote indirect costs. If an organization applying for an assistance award does not have an indirect cost rate, the applicant may wish to obtain one through HHS’s Division of Cost Allocation (DCA). Visit DCA’s website at: http://rates.psc.gov/ to learn more about rate agreements, the process for applying for them, and the regional offices which negotiate them.
vi. Staffing Plan and Personnel RequirementsApplicants must present a staffing plan and provide a justification for the plan that includes education and experience qualifications and rationale for the amount of time being requested for each staff position. Position descriptions that include the roles, responsibilities, and qualifications of proposed project staff must be included in the “Budget Narrative” section that will be uploaded in SF-424 R&R Budget– Section F – K Form, Box K. Copies of biographical sketches for any key employed personnel that will be assigned to work on the proposed project must be included as an attached file to each SF-424 R&R Senior/Key Person Profile. NOTE: Use the sample Biosketch Form found in Appendix D. Recommended information includes: Education and Training, Research and Professional Experience, Collaborators and Affiliations (for conflicts of interest), Publications and Synergistic Activities. The Biographical Sketch may not exceed four pages per person. This 4-page limit includes the table at the top of the first page.
Biographical sketches should follow the format described below.
Complete the educational block at the top of the format page, and complete Sections A, B, C and D.
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A. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee.
B. Selected peer-reviewed publications or manuscripts in press (in chronological order). Do not include manuscripts submitted (but not yet accepted) for publication.
C. Research Support. List both selected ongoing and completed (during the last three years) research projects (Federal or non-Federal support). Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. You must also include percent effort on all ongoing research projects listed. The Research Support section highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual’s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team.
D. Additional Current and Pending Support(s). Provide a list of all current and pending support for the PD/PI and each Senior/Key Person (even if they receive no salary support from the project(s)) for ongoing projects and pending proposals. Show the total award amount for the entire award period (including indirect costs) as well as the percent effort to be devoted to the project by the senior/key person, regardless of source of support. If the applicant should receive support for any project listed under Pending Support at any time prior to receipt of an award or post-award by the MCH Research Program, the MCH Research Program must be notified.
vii. AssurancesA listing of the required assurances can be found in SF-424B – Assurances for Non Construction Programs included with the application kit. A description of applicable assurances can be found in Appendix C of this funding opportunity announcement.
The following are additional assurances pertinent to applying for both the MCH Autism Intervention Research and MCH Autism Intervention SDAS. Each application requires that the following assurances be verified by the Authorizing Official who electronically submits the application to HRSA through Grants.gov. In submitting the application to HRSA through Grants.gov, the duly authorized representative of the applicant organization certifies that the applicant organization will comply with the following assurances: Human Subjects, Research Using Human Pluripotent Stem Cells, Research on Transplantation of Human Fetal Tissue, Women and Minority Inclusion Policy, and Inclusion of Children Policy. viii. CertificationsA description of the required certifications can be found in Appendix C of this guidance Use the certifications and Disclosure of Lobbying Activities form provided with the application package. Any organization or individual that is indebted to the United States, and has a judgment lien filed against it for a debt to the United States, is ineligible to receive a Federal grant. By signing the SR-424 R&R, the applicant is certifying that they are not delinquent on Federal debt in accordance with OMB Circular A-129. (Examples of relevant debt include delinquent payroll or other taxes, audit disallowances, guaranteed and direct student loans, benefits that were overpaid, etc.) If an applicant is delinquent on Federal debt,
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they should attach an explanation that includes proof that satisfactory arrangements have been made with the Agency to which the debt is owed.
ix. Project AbstractProvide a summary of the application. Because the abstract is often distributed to provide information to the public and Congress, please prepare this so that it is clear, accurate, concise, and without reference to other parts of the application. It must include a brief description of the proposed grant project including the needs to be addressed, the proposed services, and the population group(s) to be served.
Please place the following at the top of the abstract: Project Title Applicant Name Address Contact Phone Numbers (Voice, Fax) E-Mail Address Web Site Address, if applicable
The project abstract must be single-spaced and limited to one page in length. In describing the research design and methods within the abstract, be careful to include data collection methods. Select a maximum of 8 significant key words from Appendix F: Menu of Suggested Key Words that describe the project, including proposed study population and include this at the end of your abstract. Briefly state the principal needs and problems that are addressed by the project. A complete and informative abstract is critical to the review of your application.
x. Program NarrativeThis section provides a comprehensive framework and description of all aspects of the proposed program. It should be succinct, self-explanatory and well organized so that reviewers can understand the proposed project.
Use the following section headers for the Narrative:
Sections A – D (specific aims, background and significance, preliminary studies/progress report, and research design and methods) may not exceed 25 pages total. You may use any page distribution within this overall limitation. For Secondary Data Analysis studies, these sections may not exceed 10 pages total.
A. Specific Aims: List the broad, long-term objectives and the goal of the specific research proposed, for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology.
Write a statement of the research problem, indicate the problem’s relevance to the health and well-being of children and adolescents with ASD and other developmental disabilities and identify the envisioned application of findings to the health care of this population and/or the ways that services are organized and delivered.
Hypothesis and Specification of Variables. Present the specific questions that are to be answered by the study. These should include not only predictions as to findings
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(hypotheses) but also justifications for the predictions. A summary table of the variables, classified as independent, intervening, mediating, and dependent, etc. should be presented, specifying the nature of the variables, the measures to be employed as indicators for these variables, and the units and levels of measurement of the indicators. If possible, construct and present a model or graphical representation of the set of relationships held to be operative among the variables. Make sure that there is congruence between the associations depicted by the graphic model, the table of variables, the statement of hypotheses, and the plan for data analysis.
B. Background and Significance: Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the importance and health relevance of the research described in this application by relating the specific aims to the broad, long-term objectives. If the aims of the application are achieved, state how specific knowledge or clinical practice will be advanced. Describe the effect of these studies on the concepts, methods, technologies, treatments, services or preventative interventions that drive this field.
C. Preliminary Studies: For new applications, use this section to provide an account of the PD/PI’s preliminary studies pertinent to this application, including his/her preliminary experience with and outreach to the proposed racial/ethnic group members. This information will also help to establish the experience and competence of the investigator to pursue the proposed project. Preliminary data often aid the reviewers in assessing the likelihood of the success of the proposed project.
D. Research Design and Methods: Describe the research design’s conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project. Include how the data will be collected, analyzed and interpreted as well as the data-sharing plan as appropriate. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed study. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. Provide assurance that the research team will conduct the study as designed. Due to the competitive nature of the MCH Research grant competition and limited availability of funding, it is important that applicants’ assess the feasibility of conducting and completing the study as proposed. Once funded, it is critical that the study is implemented and completed as proposed.
The Research Plan subsections A – D (specific aims, background and significance, preliminary studies, and research design and methods) should not exceed 25 pages total. For Secondary Data Analysis studies, these sections may not exceed 10 pages total.
E. Financing: State whether this proposal has been submitted or will be submitted to any other Federal agency or private foundation for consideration and review. Explain the amount of support available or expected for this project from other sources.
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NOTE: If there are going to be multiple sources of support, explain the amount of support promised or committed by the other prospective sources of support in addition to the proportion of overall costs being requested from the MCHB Research Program. Offer evidence of these commitment sources’ and certainty of support. This should give the reviewers and the awarding officials of HRSA an idea of how much the entire study will cost and what proportion of such overall cost the MCH Research Program is being asked to defray.
F. Protection of Human Subjects: Applicants must include information on the protection of human subjects for their research. Use the “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” (Appendix E).
You need to be aware that the involvement of human subjects in non-exempt research must be approved by your IRB prior to award. Some human subjects research is exempt from the HHS regulations. OHRP guidance states that exemptions should be independently determined. Institutions often designate their IRB to make this determination.
G. Targeted/Planned Enrollment Table: Complete the Targeted/Planned Enrollment Table (Appendix D).
The “Total Planned Enrollment” means the number of subjects that are expected to be enrolled during the entire period of the study and are needed to evaluate the research question. The “Total Planned Enrollment” will be reported in two ways in the table by: “Ethnic Category” and by “Racial Categories.”
List any proposed racial/ethnic subpopulations below the table.
Below the “Targeted/Planned Enrollment Table,” describe how the project will assure cultural competence. For R40 MCH Autism Intervention Research, describe how the project will assure cultural competence in terms of including individuals from the study population in the planning and implementation of the research project and in adapting the research methodology to reflect an understanding of and valuing the culture of the study population. For R40 Autism Intervention SDAS, describe how the analytic plan will reflect an understanding of and valuing the culture of the study population.
H. Dissemination Plan: Describe plans for dissemination of project results. State whether the project results are regional or national in scope or if replicable. It is expected that R40 MCH Autism Intervention Research grantees will produce at least 3 peer-reviewed publications and that R40 Autism Intervention Secondary Data Analysis Studies grantees will produce at least 2 peer-reviewed publications resulting from their MCH Research project. The dissemination plan should include information on how you will accomplish this minimum number of publications. Past MCH Research Program grantees are encouraged to demonstrate publication success from their previous MCH research grant. (NOTE: Peer-reviewed publications are the cardinal measure of success of the MCH Research Program. The number of publications resulting from each funded project contributes to the total number of publications by which the MCH Research Program is evaluated annually).
Please note the following requirements related to research misconduct:
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Research Misconduct
Each institution that applies for or receives Public Health Service (PHS) support for biomedical or behavioral research, research training or activities related to that research or research training must comply with 42 CFR Part 93, Public Health Service Policies on Research Misconduct. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with 42 CFR Part 93, satisfactory to the Secretary. HHS funding components may authorize funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with the Office of Research Integrity (ORI). The responsible institutional official must assure on behalf of the institution that the institution (1) Has written policies and procedures in compliance with Part 93 for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of Part 93. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.(a) Fabrication is making up data or results and recording or reporting them.(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.(c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.(d) Research misconduct does not include honest error or differences of opinion. For further information, please contact:U.S. Department of Health and Human ServicesOffice of Research Integrity1101 Wootton Parkway, Suite 750Rockville, MD [email protected]: (240) 453-8200Fax: (301) 443-5351
xi. Program Specific Forms
1) Performance Standards for Special Projects of Regional or National Significance (SPRANS) and Other MCHB Discretionary ProjectsThe Health Resources and Services Administration (HRSA) has modified its reporting requirements for SPRANS projects, CISS projects, and other grant programs administered by the Maternal and Child Health Bureau (MCHB) to include national performance measures that were developed in accordance with the requirements of the Government Performance and Results Act (GPRA) of 1993 (Public Law 103-62). This Act requires the establishment of measurable goals for Federal programs that can be reported as part of the budgetary process,
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thus linking funding decisions with performance. Performance measures for States have also been established under the Block Grant provisions of Title V of the Social Security Act, the MCHB’s authorizing legislation. Performance measures for other MCHB-funded grant programs have been approved by the Office of Management and Budget and are primarily based on existing or administrative data that projects should easily be able to access or collect. An electronic system for reporting these data elements has been developed and is now available.
2) Performance Measures for the MCH Research Program and Submission of Administrative DataTo prepare applicants for reporting requirements, administrative data collection requirements are presented in the appendices of this guidance.
xii. Attachments Please provide the following items to complete the content of the application. Please note that these are supplementary in nature, and are not intended to be a continuation of the project narrative. Be sure each attachment is clearly labeled. Up to 15 attachments can be uploaded in the “Other Attachments” form.
1) Attachment 1: Letters of agreement/Letters of SupportProvide any documents that describe working relationships between the applicant agency and other agencies and programs cited in the proposal. Documents that confirm actual or pending contractual agreements should clearly describe the roles of the subcontractors and any deliverable. Include only letters of support which specifically indicate a commitment to the project/program (in-kind services, dollars, staff, space, equipment, etc.). Letters of agreement and letters of support must be dated.
2) Attachment 2: Key publications or condensed citations with abstracts.
3) Attachment 3: Surveys, questionnaires, data collection instruments, clinical protocols.
3. Submission Dates and Times
Application Due Date The due date for applications under this grant announcement is June 7, 2010 at 8:00 P.M. ET.
The Chief Grants Management Officer (CGMO) or designee may authorize an extension of published deadlines when justified by circumstances such as natural disasters (e.g., floods or hurricanes) or other disruptions of services, such as a prolonged blackout. The CGMO or designee will determine the affected geographical area(s).
Applications will be considered as having been formally submitted and having met the deadline if the application has been successfully transmitted electronically by your organization's Authorized Organization Representative (AOR) through Grants.gov and it has been successfully validated by Grants.gov on or before the deadline date and time. It is incumbent on applicants to ensure that the AOR is available to submit the application to Grants.gov by the published date. HRSA will not accept submission or resubmission of incomplete, rejected, or otherwise delayed applications after the deadline. Therefore, you are urged to submit your application in advance of the deadline. If your application is rejected by Grants.gov due to
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errors, you must correct the application and resubmit it to Grants.gov before the deadline date and time.
Late applications: Applications which do not meet the criteria above are considered late applications and will not be considered in the current competition.
4. Intergovernmental Review
Executive Order 12372, “Intergovernmental Review of Federal Programs” allows States the option of setting up a system for reviewing applications from within their States for assistance under certain Federal Programs. Executive Order 12372, as implemented by 45 CFR 100, is not applicable to the R40 MCH Autism Intervention Research Program or R40 MCH Autism Intervention Secondary Data Analysis Studies.
5. Funding Restrictions
MCH Autism Intervention Research ProgramApplicants may request funding for a project period of up to 3 years. The ceiling amount of an individual award is $300,000 total cost (direct plus indirect expenses) per year.
Awards to support projects beyond the first budget year will be contingent upon Congressional appropriation, satisfactory progress in meeting the project’s objectives, and a determination that continued funding would be in the best interest of the Federal government. Funds under this announcement may not be used for the following purposes: foreign travel, tuition remission for graduate research assistants.
MCH Autism Intervention Secondary Data Analysis StudiesApplicants may request funding for a project period of 1 year. The ceiling amount of an individual award is $100,000 total cost (direct plus indirect expenses). Funds under this announcement may not be used for the following purposes: foreign travel, tuition remission for graduate research assistants.
6. Other Submission Requirements
As stated in Section IV.1, except in rare cases HRSA will no longer accept applications for grant opportunities in paper form. Applicants submitting for this funding opportunity are required to submit electronically through Grants.gov. To submit an application electronically, please use the http://www.Grants.gov apply site. When using Grants.gov, you will be able to download a copy of the application package, complete it off-line, and then upload and submit the application via the Grants.gov site.
It is essential that your organization immediately register in Grants.gov and become familiar with the Grants.gov site application process. If you do not complete the registration process you will be unable to submit an application. The registration process can take up to one month.
To be able to successfully register in Grants.gov, it is necessary that you complete all of the following required actions:
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• Obtain an organizational Data Universal Number System (DUNS) number• Register the organization with Central Contractor Registry (CCR)• Identify the organization’s E-Business Point of Contact (E-Biz POC)• Confirm the organization’s CCR “Marketing Partner ID Number (M-PIN)” password• Register an Authorized Organization Representative (AOR)• Obtain a username and password from the Grants.gov Credential Provider
Instructions on how to register, tutorials and FAQs are available on the Grants.gov web site at www.grants.gov. Assistance is also available 24 hours a day, seven days a week (excluding Federal holidays) from the Grants.gov help desk at [email protected] or by phone at 1-800-518-4726.
V. Application Review Information
1. Review Criteria
Procedures for assessing the technical merit of grant applications have been instituted to provide for an objective review of applications and to assist the applicant in understanding the standards against which each application will be judged. Critical indicators have been developed for each review criterion to assist the applicant in presenting pertinent information related to that criterion and to provide the reviewer with a standard for evaluation. Review criteria are outlined below with specific detail and scoring points.
Review Criteria are used to review and rank applications. The R40 MCH Autism Intervention Research and R40 MCH Autism Intervention Secondary Data Analysis Studies have seven review criteria:
Criterion 1. Need 10 pointsCriterion 2. Response 20 pointsCriterion 3. Evaluative Measures 30 pointsCriterion 4. Impact 10 pointsCriterion 5. Resources/Capabilities 10 pointsCriterion 6. Support Requested 10 pointsCriterion 7. Specific Program Criteria 10 points
TOTAL: 100 points
Criterion 1: NEED (10 points)The extent to which the application describes an important autism intervention research need and how the proposed study can address this issue.
Does the research project address an important problem on ASD and other developmental disabilities?
Criterion 2: RESPONSE (20 points)The extent to which the proposed project responds to the “Purpose” included in the program guidance. The clarity of the proposed hypotheses, goals and objectives and their relationship to
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the identified project. The extent to which the scientific activities described in the application are capable of addressing the problem and attaining the project objectives.
Is the overall scientific approach thoughtful, logical and original? Does the Principal Investigator (PI) demonstrate awareness of previous and current work
in the area of the project? Is the cited literature pertinent to the research problem and does it provide a rationale for the research?
Are the hypotheses logically derived from the literature and clearly stated? Are they related to the defined problem?
Are the goals and objectives clear, concise and appropriate? If the aims of the application are achieved, will scientific knowledge or clinical practice
be advanced? In terms of innovation, does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
CRITERION 3: EVALUATIVE MEASURES (30 points)The effectiveness of the methods proposed to conduct the research project. Measures must be able to assess to what extent the project objectives have been met.
Scientific and Technical Merit: Are the research plan and methodologies described appropriate? Is the research plan coherent as a whole?
Tests and Measurements: Are data gathering procedures described? If new data are to be collected, have instruments been selected or developed? Are
they adequate and appropriate? Is adequate attention given to reliability and validity (psychometric properties)? If secondary analysis of existing data is proposed, are the data available to the
investigator and are they appropriate for this study? Do the secondary data provide convincing validity for intended measurements, e.g., self-reported blood pressure, parent-reported anthropometric data?
Study Design: Is the study design appropriate to answer the research questions? Are proper controls included? Is the description of the design explicit enough to permit replication? Have all the significant threats to internal and external validity of the design been
adequately acknowledged and addressed? Is the method of randomization, if used, clearly described and are criteria for entering
the study well defined?
Population Description and Sampling Plan: Is the study population described? Is the sampling design described? Is it appropriate? Is the sample size adequate and justified in terms of statistical power? Are expected differences between groups defined in terms of statistical as well as
clinical significance?
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Is there a basis for anticipating the quality of sample estimates and is the quality adequate for the purpose of the study?
Plan for Data Analysis: Are plans for data analysis presented in detail? Do the plans describe the process of data analysis and the rationale for the sequence
of steps to be taken? Are plans appropriate to the nature of the data, design and samples? Are statistical methods appropriate? Is sufficient time allocated for data analysis and reporting?
CRITERION 4: IMPACT (10 points)The extent and effectiveness of plans for dissemination of project results and/or the extent to which project results may be regional or national in scope and/or degree to which the project activities are replicable.
Is there an effective publication and dissemination plan? Does the applicant have a sound plan for how they will meet the expectation to
produce the expected minimum number of peer-reviewed publications (i.e., 3 publications expected for R40 MCH Autism Intervention Research grantees and 2 publications expected for R40 MCH Autism Intervention SDAS grantees)?
Is the problem addressed by the proposed research unique to a community or region or is it one of national proportion?
Does the applicant convincingly argue for and support contentions of regional or national significance?
Will the findings be generalizable? Is the number of mothers or children affected by the problem or who will benefit
from the research significant?
CRITERION 5: RESOURCES/CAPABILITIES (10 points)The extent to which project personnel are qualified by training and/or experience to implement and carry out the research project. The capabilities of the applicant organization, and quality and availability of facilities and personnel to fulfill the needs and requirements of the proposed research project.
Are the PI and staff well qualified by training and/or expertise to conduct the research?
Is the work proposed appropriate to the experience level of the PI and other researchers (if any)?
Does the applicant have the existing resources/facilities to support the type of research that they describe in the proposal?
Is the organizational and physical environment supportive of the PI and the project? Have the key personnel indicated other current and pending support in their
biographical sketches? Does the applicant provide assurance that the research team will conduct and
complete the study as proposed? (It is expected that funded projects will demonstrate ongoing progress and completion as proposed).
Does the PI and other key personnel demonstrate current and/or past success in publishing the findings of their research?
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CRITERION 6: SUPPORT REQUESTED (10 points)The reasonableness of the proposed budget in relation to the objectives, the complexity of the research activities, and the anticipated results.
The extent to which costs as outlined in the budget and required resources sections are reasonable given the scope of work.
The extent to which budget line items are well described and justified in the budget justification.
The extent to which time allocated by key personnel is appropriate to achieve project objectives.
Does the application address other current and pending support for the current project?
CRITERION 7: SPECIFIC PROGRAM CRITERIA (10 points)
Human Subjects:The extent to which the proposal adequately addresses human subjects protections as appropriate.
Are there adequate protections afforded human subjects? Is the proposal in compliance with the Department of Health and Human Services
(HHS) regulations for protection of human subjects (45 CFR Part 46). See the Instructions in the Grants.gov Application Guide SF424 (R&R), Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan, found in Appendix E.
Does the applicant discuss plans to seek Institutional Review Board (IRB) approval? (IRB approval must be received prior to project start date but is not required at the time of application submission).
Cultural Competency:The extent to which the proposal assures cultural competence.
Does the proposal include individuals from the study population in the planning and implementation of the research project?
Does the proposal adequately adapt research methodology to reflect an understanding of and valuing the culture of the study population?
For SDAS, does the analytic plan reflect an understanding of and valuing the culture of the study population?
Healthy People 2010:The extent to which the proposal addresses Healthy People 2010 objectives.
Does the research project identify its relationship to specific Healthy People 2010 objectives? (See VI. Award Administration Information on Healthy People 2010).
2. Review and Selection Process
The Division of Independent Review is responsible for managing objective reviews within HRSA. Applications competing for federal funds receive an objective and independent review performed by a committee of experts qualified by training and experience in particular fields or
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disciplines related to the program being reviewed. In selecting review committee members, other factors in addition to training and experience may be considered to improve the balance of the committee, e.g., geographic distribution. Each reviewer is screened to avoid conflicts of interest and is responsible for providing an objective, unbiased evaluation based on the review criteria noted above. The committee provides expert advice on the merits of each application to program officials responsible for final selections for award.
Applications that pass the initial HRSA eligibility screening will be reviewed and rated by a panel based on the program elements and review criteria presented in relevant sections of this program announcement. The review criteria are designed to enable the review panel to assess the quality of a proposed project and determine the likelihood of its success. The criteria are closely related to each other and are considered as a whole in judging the overall quality of an application.
3. Anticipated Announcement and Award Dates
Anticipated award date is September 1, 2010.
VI. Award Administration Information
1. Award Notices
Each applicant will receive written notification of the outcome of the objective review process, including a summary of the expert committee’s assessment of the application’s merits and weaknesses, and whether the application was selected for funding. Applicants who are selected for funding may be required to respond in a satisfactory manner to conditions placed on their application before funding can proceed. Letters of notification do not provide authorization to begin performance.
The Notice of Award sets forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided (if applicable), and the total project period for which support is contemplated. Signed by the Grants Management Officer, it is sent to the applicant agency’s Authorized Representative, and reflects the only authorizing document. It will be sent prior to the start date of September 1, 2010.
2. Administrative and National Policy Requirements
Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 (non-governmental) or 45 CFR Part 92 (governmental), as appropriate.
HRSA grant awards are subject to the requirements of the HHS Grants Policy Statement (HHS GPS) that are applicable to the grant based on recipient type and purpose of award. This includes, as applicable, any requirements in Parts I and II of the HHS GPS that apply to the award. The HHS GPS is available at http://www.hrsa.gov/grants/. The general terms and conditions in the HHS GPS will apply as indicated unless there are statutory, regulatory, or award-specific requirements to the contrary (as specified in the Notice of Award).
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Cultural and Linguistic CompetenceHRSA is committed to ensuring access to quality health care for all. Quality care means access to services, information, materials delivered by competent providers in a manner that factors in the language needs, cultural richness, and diversity of populations served. Quality also means that, where appropriate, data collection instruments used should adhere to culturally competent and linguistically appropriate norms. For additional information and guidance, refer to the National Standards for Culturally and Linguistically Appropriate Services in Health Care published by HHS. This document is available online at http://www.omhrc.gov/CLAS.
Trafficking in PersonsAwards issued under this guidance are subject to the requirements of Section 106 (g) of the Trafficking Victims Protection Act of 2000, as amended (22 U.S.C. 7104). For the full text of the award term, go to http://www.hrsa.gov/grants/trafficking.htm. If you are unable to access this link, please contact the Grants Management Specialist identified in this guidance to obtain a copy of the Term.
HRSA Guidance on Preparations for the 2nd Phase of the Novel H1N1 InfluenzaHRSA has been working with HHS, other Federal agency partners, grantees and grantee associations to get ready for the upcoming flu season. “H1N1 Guidance for HRSA Grantees,” which can be found at www.hrsa.gov/h1n1/, is voluntary guidance intended primarily for HRSA-funded direct service grantees and their sub grantees and contractors, although other HRSA grantees may also find the information useful. This guidance may also be of interest to eligible 340B entities and HRSA’s cooperative agreement partners.
HRSA is providing this to help HRSA–funded programs plan how to best protect their workforce and serve their communities. HRSA will continue to monitor evolving pandemic preparedness efforts and work to provide guidance and information to grantees and grantee associations as it becomes available. Products and updates in support of H1N1 pandemic response efforts will be posted to www.hrsa.gov/h1n1/ as soon as they are released.
PUBLIC POLICY ISSUANCE
HEALTHY PEOPLE 2010 Healthy People 2010 is a national initiative led by HHS that sets priorities for all HRSA programs. The initiative has two major goals: (1) To increase the quality and years of a healthy life; and (2) Eliminate our country’s health disparities. The program consists of 28 focus areas and 467 objectives. HRSA has actively participated in the work groups of all the focus areas, and is committed to the achievement of the Healthy People 2010 goals.
Applicants must summarize the relationship of their projects and identify which of their programs objectives and/or sub-objectives relate to the goals of the Healthy People 2010 initiative.
Copies of the Healthy People 2010 may be obtained from the Superintendent of Documents or downloaded at the Healthy People 2010 website: http://www.health.gov/healthypeople/document/.
Smoke-Free Workplace
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The Public Health Service strongly encourages all award recipients to provide a smoke-free workplace and to promote the non-use of all tobacco products. Further, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children.
3. Reporting
The successful applicant under this guidance must comply with the following reporting and review activities:
a. Audit RequirementsComply with audit requirements of Office of Management and Budget (OMB) Circular A-133. Information on the scope, frequency, and other aspects of the audits can be found on the Internet at www.whitehouse.gov/omb/circulars;
b. Payment Management RequirementsSubmit a quarterly electronic Federal Financial Report (FFR) Cash Transaction Report via the Payment Management System. The report identifies cash expenditures against the authorized funds for the grant. The FFR Cash Transaction Reports must be filed within 30 days of the end of each quarter. Failure to submit the report may result in the inability to access award funds. Go to www.dpm.psc.gov for additional information.
c. Financial Reports1) Submit a Financial Report. A financial report is required within 90 days of the end of each budget period. The report is an accounting of expenditures under the project that year. More specific information will be included in the award notice;
2) For R40 MCH Autism Intervention Research, submit an Annual Continuation Application/Progress Report. Further information will be provided in the award notice.
3) Submit a Final Report. Further information will be provided in the award notice.
4) Submit Performance Standards for Special Projects of Regional or National Significance (SPRANS) and Other MCHB Discretionary Projects.
d. Performance Standards for Special Projects of Regional or National Significance (SPRANS) and Other MCHB Discretionary Projects
The Health Resources and Services Administration (HRSA) has modified its reporting requirements for SPRANS projects, CISS projects, and other grant programs administered by the Maternal and Child Health Bureau (MCHB) to include national performance measures that were developed in accordance with the requirements of the Government Performance and Results Act (GPRA) of 1993 (Public Law 103-62). This Act requires the establishment of measurable goals for Federal programs that can be reported as part of the budgetary process, thus linking funding decisions with performance. Performance measures for States have also been established under the Block Grant provisions of Title V of the Social Security Act, the MCHB’s authorizing legislation. Performance measures for other MCHB-funded grant programs have been
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approved by the Office of Management and Budget and are primarily based on existing or administrative data that projects should easily be able to access or collect.
1) Performance Measures and Program DataTo prepare applicants for these reporting requirements, the designated performance measures for this program and other program data collection are presented in the appendices of this guidance.
2) Performance ReportingSuccessful applicants receiving grant funds will be required, within 120 days of the Notice of Award (NOA), to register in HRSA’s Electronic Handbooks (EHBs) and electronically complete the program specific data forms that appear in the appendices of this guidance. This requirement entails the provision of budget breakdowns in the financial forms based on the grant award amount, the project abstract and other grant summary data as well as providing objectives for the performance measures.
Performance reporting is conducted for each grant year of the project period. Grantees will be required, within 120 days of the NOA, to enter HRSA’s EHBs and complete the program specific forms. This requirement includes providing expenditure data, finalizing the abstract and grant summary data as well as finalizing indicators/scores for the performance measures.
3) Project Period End Performance ReportingSuccessful applicants receiving grant funding will be required, within 90 days from the end of the project period, to electronically complete the program specific data forms that appear in the appendices of this guidance. The requirement includes providing expenditure data for the final year of the project period, the project abstract and grant summary data as well as final indicators/scores for the performance measures.
e. On-Site ReviewsThe Office of Regional Operations (ORO), formerly the Office of Performance Review (OPR), serves as the regional component of HRSA by providing leadership on HRSA’s mission, goals, priorities and initiatives in the regions, States and Territories. ORO will provide assistance to grant recipients in partnership with HRSA program leaders within the Bureaus/Offices in the conduct of site visits in addressing compliance with program requirements and evaluating performance against established Bureau/Office metrics. Bureaus/Office program leaders will determine which programs to visit and will enlist the assistance of ORO regional components in the pre-planning and conduct of those visits. As part of this effort, HRSA recipients may be asked to participate in an on-site visit to their HRSA funded program(s) by a review team from one of the ten ORO regional divisions and, if required, staff from the Bureau/Office making the award.
ORO works collaboratively with awardees and HRSA Bureaus/Offices to ensure that recipients are able to adequately address the identified performance measures based on the type of program(s). ORO will also seek to identify, collect, and disseminate leading/innovative practices.
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These visits will also provide an opportunity for HRSA recipients to offer direct feedback to the agency about the impact of HRSA policies on program implementation and performance within communities and states.
VII. Agency Contacts
Applicants may obtain additional information regarding business, administrative, or fiscal issues related to this funding opportunity announcement by contacting:
Brad K. Barney, Grants Management SpecialistAttn.: R40 MCH Autism Intervention Research Program OR R40 MCH Autism Intervention Secondary Data Analysis StudiesHRSA Division of Grants Management Operations, OFAMParklawn Building, Room 11A-025600 Fishers LaneRockville, MD 20857 Telephone: 301-443-6916Fax: 301-443-6343Email: [email protected]
Additional information related to the overall program issues and/or technical assistance regarding this funding opportunity announcement may be obtained by contacting:
Hae Young Park and Sue LinPublic Health Analysts, MCH Research ProgramAttn: R40 MCH Autism Intervention Research Program OR R40 MCHB Autism Intervention Secondary Data Analysis StudiesMaternal and Child Health Bureau, HRSAParklawn Building, Room 18A-555600 Fishers LaneRockville, MD 20857 Telephone: (301) 443-2207Fax: (301) 443-4842Email: [email protected] , [email protected]
Grantees may need assistance when working online to submit their application forms electronically. For assistance with submitting the application in Grants.gov, contact Grants.gov Contact Center, 24 hours a day, seven days a week, excluding Federal holidays:
Grants.gov Contact CenterPhone: 1-800-518-4726E-mail: [email protected]
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VIII. Other Information
MCH Research Web Sitewww.mchb.hrsa.gov/research
MCH Training Web Sitewww.mchb.hrsa.gov/training
Human Subjects Assuranceshttp://www.hhs.gov/ohrp http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
Standards for collecting and reporting data on race and ethnicityOMB Directive no.15www.whitehouse.gov/omb/fedreg/ombdir15.html
Inclusion of childrenhttp://grants.nih.gov/grants/funding/children/children.htm
Making Websites Accessible: Section 508 of the Rehabilitation Acthttp://www.section508.gov/
Healthy People 2010http://www.health.gov/healthypeople/ Surgeon General’s Health Reports http://www.surgeongeneral.gov/library/oralhealth/
Bright Futureshttp://www.brightfutures.aap.org/
Cultural Competencyhttp://nccc.georgetown.edu/
Medical Homehttp://www.aap.org
Institute of Medicinewww.iom.edu
IX. Tips for Writing a Strong Application
A concise resource offering tips for writing proposals for HHS grants and cooperative agreements can be accessed online at: http://www.hhs.gov/asrt/og/grantinformation/apptips.html.
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APPENDIX A: HRSA ELECTRONIC SUBMISSION GUIDE
Table of Contents
1.1. INTRODUCTIONINTRODUCTION.........................................................................................................................31
1.1. DOCUMENT PURPOSE AND SCOPE.........................................................................................311.2. DOCUMENT ORGANIZATION AND VERSION CONTROL............................................................31
2.2. PROCESS OVERVIEWPROCESS OVERVIEW..............................................................................................................32
2.1.. NEW COMPETING APPLICATIONS (ENTIRE SUBMISSION THROUGH GRANTS.GOV; NO VERIFICATION REQUIRED WITHIN HRSA EHBS)..............................................................................322.2.. NEW COMPETING, COMPETING CONTINUATION, AND COMPETING SUPPLEMENT APPLICATIONS (SUBMITTED USING BOTH GRANTS.GOV AND HRSA EHBS; VERIFICATION REQUIRED WITHIN HRSA EHBS)................................................................................................................................................322.3. NONCOMPETING CONTINUATION APPLICATION......................................................................33
3.3. REGISTERING AND APPLYING THROUGH GRANTS.GOVREGISTERING AND APPLYING THROUGH GRANTS.GOV...........................................33
3.1. REGISTER – APPLICANT/GRANTEE ORGANIZATIONS MUST REGISTER WITH GRANTS.GOV (IF NOT ALREADY REGISTERED).............................................................................................................343.2. APPLY - APPLY THROUGH GRANTS.GOV..............................................................................35
4.4. VALIDATING AND/OR COMPLETING AN APPLICATION IN THE HRSA ELECTRONIC VALIDATING AND/OR COMPLETING AN APPLICATION IN THE HRSA ELECTRONIC HANDBOOKSHANDBOOKS.....................................................................................................................................37
4.1. REGISTER - PROJECT DIRECTOR AND AUTHORIZING OFFICIAL MUST REGISTER WITH HRSA EHBS (IF NOT ALREADY REGISTERED).............................................................................................374.2. VERIFY STATUS OF APPLICATION...........................................................................................384.3. VALIDATE GRANTS.GOV APPLICATION IN THE HRSA EHBS................................................384.4. MANAGE ACCESS TO THE APPLICATION.................................................................................394.5. CHECK VALIDATION ERRORS..................................................................................................394.6. FIX ERRORS AND COMPLETE APPLICATION...........................................................................394.7. SUBMIT APPLICATION IN HRSA EHBS...................................................................................39
5.5. GENERAL INSTRUCTIONS FOR APPLICATION SUBMISSIONGENERAL INSTRUCTIONS FOR APPLICATION SUBMISSION.....................................40
5.1. NARRATIVE ATTACHMENT GUIDELINES...................................................................................405.2. APPLICATION CONTENT ORDER (TABLE OF CONTENTS).......................................................415.3. PAGE LIMIT...............................................................................................................................41
6.6. CUSTOMER SUPPORT INFORMATIONCUSTOMER SUPPORT INFORMATION...............................................................................42
6.1. GRANTS.GOV CUSTOMER SUPPORT.......................................................................................426.2. HRSA CALL CENTER..............................................................................................................426.3. HRSA PROGRAM SUPPORT....................................................................................................42
7.7. FAQSFAQS..............................................................................................................................................42
7.1. SOFTWARE...............................................................................................................................427.2. APPLICATION RECEIPT.............................................................................................................467.3. APPLICATION SUBMISSION.......................................................................................................487.4. GRANTS.GOV............................................................................................................................49
HRSA Electronic Submission Guide 30 Version 1.4 – August 2009
1.1.IntroductionIntroduction
1.1.1.1. Document Purpose and ScopeDocument Purpose and Scope
The purpose of this document is to provide detailed instructions to help applicants and grantees submit new competing, competing continuation, competing supplements, and most noncompeting continuation applications electronically to HRSA through Grants.gov (and HRSA EHBs, where applicable). All applicants must submit in this manner. This document is intended to be the comprehensive source of information related to the electronic grant submission processes and will be updated periodically. This document does not replace program guidance provided in funding opportunity announcements.
NOTE: In order to view, complete and submit an application package, you will need to download the NOTE: In order to view, complete and submit an application package, you will need to download the compatible version of Adobe Reader software. All applicants must use the Adobe Reader version 8.1.1 or compatible version of Adobe Reader software. All applicants must use the Adobe Reader version 8.1.1 or later version to successfully submit an application.later version to successfully submit an application.
1.2.1.2. Document Organization and Version ControlDocument Organization and Version Control
This document contains SEVEN (7) sections. Following is the summary:
Section Description
1. Introduction Describes the document’s purpose and scope.2.2. Process Overview-
- New Competing Application through Grants.gov only(no verification required within HRSA EHBs)
- New Competing, Competing Continuation, and Competing Supplement Applications (submitted using both Grants.gov and HRSA EHBs (with HRSA EHBs Verification)
- Noncompeting Continuation Application
Provides detailed instructions to applicant organizations and institutions submitting a new competing application using Grants.gov that does not require HRSA EHBs verification.
Provides detailed instructions for those grantees submitting new competing, competing continuation, and competing supplement applications through Grants.gov and HRSA EHBs that require HRSA EHBs verification.
Provides detailed instructions to existing HRSA Grantees on submitting a noncompeting continuation application through Grants.gov and HRSA EHBs; verification required within EHBs.
3.3. Registering and Applying through Grants.gov
Provides detailed instructions to enable applicants/grantees to register and apply electronically using Grants.gov in the submission of grant applications.
4.4. HRSA Electronic Handbooks Provides detailed instructions and important guidance on registering an individual and/or organization, verifying the status of applications, validating grants.gov application in the EHB, managing access to the application, checking and correcting validation errors, completing and submitting the application.
5 General Instructions for Application Submission
Provides instructions and important policy guidance regarding application format requirements and submission.
6. Customer Support Information
Provides contact information to address technical and programmatic questions.
7. Frequently Asked Questions (FAQs)
Provides answers to frequently asked questions by various categories
HRSA Electronic Submission Guide 31 Version 1.4 – August 2009
This document is under version control. Please visit http://www.hrsa.gov/grants to retrieve the latest published version.
2.2.Process OverviewProcess Overview
2.12.1 New Competing Applications (Entire Submission Through New Competing Applications (Entire Submission Through Grants.gov; no verification required within HRSA EHBs)Grants.gov; no verification required within HRSA EHBs)
NOTE: Use the program guidance to determine if verification in HRSA EHBs is required. NOTE: Use the program guidance to determine if verification in HRSA EHBs is required. If verification If verification is requiredis required, you should refer to , you should refer to Section 2.2Section 2.2. If verification is not required, continue reading this . If verification is not required, continue reading this section.section.
Following is the process for submitting a New Competing Application through Grants.gov:
1. HRSA will post all New Competing announcements on Grants.gov (http://www.grants.gov). 2. Once the program guidance is available, applicants should search for the announcement in
Grants.gov ‘Find Grant Opportunities.’ (http://www.grants.gov/applicants/find_grant_opportunities.jsp) or ‘Apply for Grants’ (http://www.grants.gov/Apply).
3. Download the application package and instructions from Grants.gov. The program guidance is also part of the instructions that must be downloaded.
4. Save a copy of the application package on your computer and complete all the forms based on the instructions provided in the program guidance.
5. Submit the application package through Grants.gov (requires registration).6. Track the status of your submitted application using Track My Status at Grants.gov until you receive
email notifications that your application has been received and validated by Grants.gov and received by HRSA.
2.22.2 New Competing, Competing Continuation, and Competing New Competing, Competing Continuation, and Competing Supplement Applications (Submitted Using Both Grants.gov Supplement Applications (Submitted Using Both Grants.gov and HRSA EHBs; verification required within HRSA EHBs)and HRSA EHBs; verification required within HRSA EHBs)
NOTE: You should review program guidance to determine if verification in HRSA EHBs is required. NOTE: You should review program guidance to determine if verification in HRSA EHBs is required. If verification is NOT requiredIf verification is NOT required, you should refer to , you should refer to Section 2.1 aboveSection 2.1 above. If verification is required, . If verification is required, continue reading this section.continue reading this section.
Following is the process for submitting a Competitive Application through Grants.gov with verification required within HRSA Electronic Handbooks (EHBs):
1. HRSA will post all Competing Continuation and Competing Supplemental announcements on Grants.gov (http://grants.gov/search). Announcements are typically posted at the beginning of the fiscal year. However, program guidances are not generally available until later. New Competing applications that require verification within EHBs are posted throughout the year. For more information, visit http://www.hrsa.gov/grants.
2. When a program guidance becomes available, applicants should search for the announcement in Grants.gov under ‘Apply for Grants’ (http://www.grants.gov/Apply). Since eligibility for Competing Continuation and Competing Supplemental funding is limited to current grantees, those announcements will not appear under Grants.gov ‘Find Grant Opportunities.’
3. Download the application package and instructions from Grants.gov. The program guidance is also part of the instructions that must be downloaded. Note the Announcement Number as it will be required later in the process.
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4. Save a copy of the application package on your computer and complete all the standard forms based on the instructions provided in the program guidance.
5. Submit the application package through Grants.gov (requires registration). Note the Grants.gov Tracking Number as it will be required later in the process.
6. Track the status of your submitted application using Track My Status at Grants.gov until you receive email notifications that your application has been received and validated by Grants.gov and received by HRSA.
7. HRSA EHBs software pulls the application information into EHBs and validates the data8. HRSA notifies the Project Director, Authorizing Official (AO), Business Official (BO) and application
point of contact (POC) by email to check HRSA EHBs for results of HRSA validations and enter supplemental information required to process the competing continuation or supplemental application. Note the HRSA EHBs tracking number from the email.
9. The application in HRSA EHBs is validated by a user from the grantee organization by providing three independent data elements--Announcement Number, Grants.gov Tracking Number and HRSA EHBs Tracking Number.
10. The AO verifies the pending application in HRSA EHBs, fixes any validation errors, and makes necessary corrections. Supplemental forms are completed. AO submits the application to HRSA.
2.3.2.3. Noncompeting Continuation ApplicationNoncompeting Continuation Application
The following is the process for submitting a Noncompeting Continuation application through Grants.gov and HRSA EHBs; verification required within HRSA EHBs:
1. HRSA will communicate the Noncompeting announcement number to the Project Director (PD) and authorizing official (AO) listed on the most recent Notice of Grant Award (NGA) via email. The announcement number will be required to search for the announcement/funding opportunity when applying in Grants.gov.
2. Search for the announcement/funding opportunity in Grants.gov under ‘Apply for Grants.’ Since eligibility is limited to current grantees, the announcement will not appear under Grants.gov ‘Find Grant Opportunities.’
3. Download the application package and instructions from Grants.gov. The program guidance is part of the instructions that must be downloaded.
4. Save a copy of the application package on your computer and complete all the forms based on the instructions provided in the program guidance.
5. Submit the application package through Grants.gov (requires registration).6. Track the status of your submitted application using Track My Status at Grants.gov until you receive
email notifications that your application has been received and validated by Grants.gov and received by HRSA.
7. The HRSA Electronic Handbooks (EHBs) software pulls the application information into EHBs and validates the data. HRSA sends an email to the PD, AO, business official (BO), and application point of contact (POC) to review the application in the HRSA EHBs for validation errors and enter additional information, including in some cases, performance measures, necessary to process the noncompeting continuation.
8. The PD logs into the HRSA EHBs to enter all additional information necessary to process the application. The PD must also provide the AO submission rights for the application.
9. The AO verifies the application in HRSA EHBs, fixes any remaining validation errors, makes necessary corrections, and submits the application to HRSA (requires registration in EHBs).
3.3.Registering and Applying Through Grants.govRegistering and Applying Through Grants.gov
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Grants.gov requires a one-time registration by the applicant organization and annual updating. If you do not complete the registration process and update it annually, you will not be able to submit an application.
The five-step registration process must be completed by every organization wishing to apply for a HRSA grant opportunity. The process will require some time (anywhere from five business days to a month). Therefore, first-time applicants or those considering applying at some point in the future should register immediately. Registration with Grants.gov provides the representatives from the organization the required credentials necessary to submit an application.
3.1.3.1. REGISTER – Applicant/Grantee Organizations Must Register REGISTER – Applicant/Grantee Organizations Must Register With Grants.gov (if not already registered)With Grants.gov (if not already registered)
If an applicant/grantee organization has already completed Grants.gov registration for HRSA or another Federal agency, skip to the next section.
For those applicant organizations still needing to register with Grants.gov, detailed registration information can be found on the Grants.gov “Get Registered” Web site (http://www.grants.gov/applicants/get_registered.jsp). These instructions will walk you through the following five basic registration steps:
Step 1: Obtain a Data Universal Number System (DUNS) numberA DUNS number is a unique number that identifies an organization. It has been adopted by the Federal government to help track how Federal grant money is distributed. Ask your grant administrator or chief financial officer to provide your organization’s DUNS number. If your organization does not have a DUNS number, you may request one online at http://fedgov.dnb.com/webform or call the special Dun & Bradstreet hotline at 1-800-705-5711 for the US and US Virgin Islands (1-800-234-3867 for Puerto Rico) to receive one free of charge. Note: A missing or incorrect DUNS number is the primary reason for applications being “Rejected for Errors” by Grants.gov.
Step 2: Register with the Central Contractor Registration (CCR)The CCR is the central government repository for organizations working with the Federal government. Check to see if your organization is already registered at the CCR Web site. If your organization is not registered, identify the primary contact who should register your organization. Visit the CCR Web site at http://www.ccr.gov to register online or call 1-888-227-2423 to register by phone. CCR Registration must be renewed annually.
- Designate the organization’s E-Business Point of Contact (E-BIZ POC) - Create the organization’s CCR “Marketing Partner ID Number (MPIN)” password. The E-BIZ
POC will use the MPIN to designate Authorized Organization Representatives (AORs) through Grants.gov
The CCR Registration must become active before you can proceed to step 3.
Step 3: Creating a Username & Password- AORs must create a short profile and obtain a username and password from the Grants.gov
Credential Provider- AORs will only be authorized for the DUNS number with which they registered in the Grants.gov
profile
Step 4: AOR Authorization- The E-Business POC uses the DUNS number and MPIN to authorize your AOR status- Only the E-BIZ POC may authorize AORs
Step 5: Track AOR Status
HRSA Electronic Submission Guide 34 Version 1.4 – August 2009
- Using your username and password from Step 3, go to Grants.gov’s ‘Applicant Login’ to check your AOR status at https://apply07.grants.gov/apply/loginhome.jsp.
In addition, allow for extra time if an applicant does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN). The CCR validates the EIN against Internal Revenue Service records, a step that will take an additional one to five business days.
Additional assistance regarding the complete registration process is available at Grants.gov at http://www.grants.gov/applicants/get_registered.jsp. Grants.gov provides a variety of support options through online Help including Context-Sensitive Help, Online Tutorials, FAQs, Training Demonstrations, User Guides (http://www.grants.gov/assets/ApplicantUserGuide.pdf), and Quick Reference Guides.
Please direct questions regarding Grants.gov registration to the Grants.gov Call Center at: 1-800-518-4726. Call Center hours of operation are 24 hours a day, 7 days a week, excluding Federal holidays.
NOTE: It is highly recommended that this registration process be completed at least two weeks prior to the NOTE: It is highly recommended that this registration process be completed at least two weeks prior to the submittal date of your organization’s first Grants.gov submission.submittal date of your organization’s first Grants.gov submission.
3.2.3.2. APPLY - Apply through Grants.govAPPLY - Apply through Grants.gov
The Grants.gov/Apply feature includes a simple, unified application process to enable applicants to apply for grants online. The information applicants need to understand and execute the steps can be found at Grants.gov Apply for Grants (http://www.grants.gov/applicants/apply_for_grants.jsp). Step 2 ‘Complete the Grant Application Package’ includes a narrated online tutorial on how to complete a grant application package using Adobe. The site also contains an Applicant User Guide at http://www.grants.gov/assets/ApplicantUserGuide.pdf.
3.2.1. Find Funding OpportunityIf you are submitting a new competing application, search for the announcement in Grants.gov Find Grant Opportunities (http://www.grants.gov/applicants/find_grant_opportunities.jsp) and select the announcement for which you wish to apply. Refer to the program guidance for eligibility criteria.
NOTE: All new competing announcements should be available in Grants.gov FIND! When funding NOTE: All new competing announcements should be available in Grants.gov FIND! When funding opportunities are released, announcements are made available in Grants.gov APPLY.opportunities are released, announcements are made available in Grants.gov APPLY.
If you are submitting a competing continuation, competing supplement, or noncompeting continuation application, search for the announcement in Apply For Grants (http://www.grants.gov/Apply). Enter the announcement number communicated to you in the field Funding Opportunity Number. (Example announcement number: 5-S45-10-001)
NOTE: Noncompeting continuations and announcements with restricted eligibility are NOTE: Noncompeting continuations and announcements with restricted eligibility are notnot available under available under the Find Grant Opportunities function in Grants.gov.the Find Grant Opportunities function in Grants.gov.
3.2.2. Download Application PackageDownload the application package and instructions. Application packages are posted in Adobe Reader format. To ensure that you can view the application package and instructions, you should download and install the Adobe Reader application.
For more information on using Adobe Reader, please refer to Section 7.1.2.
NOTE: Please review the system requirements for Adobe Reader at NOTE: Please review the system requirements for Adobe Reader at http://www.grants.gov/help/download_software.jsphttp://www.grants.gov/help/download_software.jsp..
HRSA Electronic Submission Guide 35 Version 1.4 – August 2009
3.2.3.Complete the Grant Application PackageComplete the application using both the built-in instructions and the instructions provided in the program guidance. Ensure that you save a copy of the application on your computer. For assistance with program guidance related questions, please contact the program officer listed on the program guidance.
NOTE: Competing continuations, competing supplements, and noncompeting continuations should provide NOTE: Competing continuations, competing supplements, and noncompeting continuations should provide their 10-digit grant number (box 4b from NGA) in the Federal Award Identifier field (box 5b in SF424 or box 4their 10-digit grant number (box 4b from NGA) in the Federal Award Identifier field (box 5b in SF424 or box 4 in SF424 R&R).in SF424 R&R). You may complete the application offline – you are not required to be connected to You may complete the application offline – you are not required to be connected to the Internet.the Internet.
3.2.4.Submit ApplicationOnce you have downloaded the application package, completed all required forms, and attached all required documents—click the “Check Package for Errors” button and make any necessary corrections.
In Adobe Reader, click on the ‘Save and Submit’ button when you have done all of the above and are ready to send your completed application to Grants.gov.
Review the provided application summary to confirm that the application will be submitted to the program for which you wish to apply. To submit, the AOR must login to Grants.gov and enter their user name and password. Note: the same DUNS number, AOR user name, and password must be used to complete and submit your application. Once you have logged in, your application package will automatically be uploaded to Grants.gov. A confirmation screen will appear once the upload is complete. Note that a Grants.gov Tracking Number will be provided on this screen (GRANTXXXXX). Please record this number so that you may refer to it for all subsequent help.
Please direct questions regarding application submission to the Grants.gov Call Center at: 1-800-518-4726. Call Center hours of operation are 24 hours a day, 7 days a week, excluding Federal holidays.
NOTE: The AOR must be connected to the Internet and must have a Grants.gov username and password NOTE: The AOR must be connected to the Internet and must have a Grants.gov username and password tied to the correct DUNS number in order to submit the application package.tied to the correct DUNS number in order to submit the application package.
3.2.5.Verify Status of Application in Grants.govOnce Grants.gov has received your submission, Grants.gov will send email messages to the PD, AO, and the POC listed in the application advising of the progress of the application through the system. You should receive up to four emails. The first will confirm receipt of your application by the Grants.gov system (“Received”), and the second will indicate that the application has either been successfully validated (“Validated”) by the system prior to transmission to the grantor agency or has been rejected due to errors (“Rejected with Errors”). An application for HRSA funding must be both received and validated by Grants.gov by the application deadline.
If your application has been rejected due to errors, you must correct the application and resubmit it to Grants.gov before the closing date. If you are unable to resubmit because the opportunity has since closed, you must contact the Director of the Division of Grants Policy, within five (5) business days from the closing date, via email at [email protected] and thoroughly explain the situation. Your email must include the HRSA Announcement Number, the name, address, and telephone number of your organization, and the name and telephone number of the project director, as well as the Grants.gov Tracking Number (GRANTXXXXXX) assigned to your submission, along with a copy of the “Rejected with Errors” notification you received from Grants.gov. HRSA is very strict in adhering to application deadlines and electronic submission requirements. Extensions for competitive funding opportunities are only granted in the rare event of a natural disaster or validated technical system problem on the side of either Grants.gov or the HRSA Electronic Handbooks (EHBS) that prevented a timely application submission.
HRSA Electronic Submission Guide 36 Version 1.4 – August 2009
You can check the status of your application(s) anytime after submission by logging into Grants.gov and clicking on the ‘Track My Application’ link on the left side of the page. This link will also be included in the confirmation email that you receive from Grants.gov.
If there are no errors, the application will be downloaded by HRSA. Upon successful download to HRSA, the status of the application will change to “Received by Agency” and the contacts listed in the application will receive a third email from Grants.gov. Once your application is received by HRSA, it will be processed to ensure that the application is submitted for the correct funding announcement, with the correct grant number (if applicable), and applicant/grantee organization. Upon this processing, which is expected to take up to two to three business days, HRSA will assign a unique tracking number to your application. This tracking number will be posted to Grants.gov and the status of your application will be changed to “Agency Tracking Number Assigned.” You will receive the fourth email in which Grants.gov will relay the Agency Tracking Number. Note the HRSA tracking number and use it for all correspondence with HRSA.
4.4. Validating and/or Completing an Application in the HRSA Validating and/or Completing an Application in the HRSA Electronic HandbooksElectronic Handbooks
Learn how to register, verify data, validate information, manage access to your application, fix errors, and complete your application in EHBs. For assistance in registering with, or using HRSA EHBs, call the HRSA Call Center at 1-877-464-4772 between 9:00 am to 5:30 p.m. ET or email [email protected].
4.1.4.1. Register - Project Director and Authorizing Official Must Register - Project Director and Authorizing Official Must Register with HRSA EHBs (if not already registered)Register with HRSA EHBs (if not already registered)
In order to access a noncompeting continuation, a competitive continuation, or a competitive supplement in HRSA EHBs, existing grantee organizations must register within the EHBs. The purpose of the registration process is to collect consistent information from all users, avoid collection of redundant information, and allow for the unique identification of each system user.
Note that registration within HRSA EHBs is required only once for each user. Note that HRSA EHBs now allow the user to use his/her single username and associate it with
more than one organization.
Registration within HRSA EHBs is a two-step process. In the first step, individual users from an organization who participate in the grants process must create individual system accounts. In the second step, the users must associate themselves with the appropriate grantee organization. To find your organization record, use the 10-digit grant number from the Notice of Grant Award (NGA) belonging to your grant. Note that since all existing grantee organization records are already in EHBs, there is no need to create a new one.
To complete the registration quickly and efficiently we recommend that you have the following information readily available:
1. Identify your role in the grants management process. HRSA EHBs offer the following three functional roles for individuals from applicant/grantee organizations:
Authorizing Official (AO), Business Official (BO), and Other Employee (for Project Directors, assistant staff, AO designees and others).
For more information on functional responsibilities, refer to the HRSA EHBs online help.
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2. Ensure you have the 10-digit grant number from the latest NGA belonging to your grant (Box 4b on NGA). You must use the grant number to find your organization during registration. All individuals from the organization working on the grant must use the same grant number to ensure correct registration.
In order to access a noncompeting continuation, competitive continuation, or a competitive supplement application, the Project Director and other participants must register the specific grant and add it to their respective portfolios. This step is required to ensure that only authorized individuals from the organization have access to grant data. Project Directors will need the latest Notice of Grant Award (NGA) in order to complete this additional step. Again, note that this is a one-time requirement.
The Project Director must give the necessary privileges to the AO and other individuals who will assist in the submission of grant applications using the administer feature in the grant handbook. The Project Director should also delegate the “Administer Grant Users” privilege to the AO.
Once you have access to your grant handbook, use the appropriate link under the deliverables section to access your application.
Note that registration with HRSA EHBs is independent of Grants.gov registration.
For assistance in registering with HRSA EHBs, call the HRSA Call Center at 1-877-464-4772 between 9:00 am to 5:30 p.m. ET or email [email protected].
IMPORTANT: You must use your HRSA EHBs Tracking Number or your 10-digit grant number (box 4b fromIMPORTANT: You must use your HRSA EHBs Tracking Number or your 10-digit grant number (box 4b from NGA) to identify your organization. NGA) to identify your organization.
4.2.4.2. Verify Status of ApplicationVerify Status of Application
HRSA will send an email to the PD, AO, POC, and the BO – all listed on the submitted application, to confirm that the application was successfully received. The PD listed on the most recent NGA, if different from the PD listed on the application will also receive an email notification. Therefore, it is important to ensure that email addresses are correct.
NOTE: Grantees should check HRSA EHBs within two to three business days from submission within NOTE: Grantees should check HRSA EHBs within two to three business days from submission within Grants.gov for availability of your application.Grants.gov for availability of your application.
4.3.4.3. Validate Grants.gov Application in the HRSA EHBsValidate Grants.gov Application in the HRSA EHBs
The HRSA EHBs include a validation process to ensure that only authorized individuals from an organization are able to access the organization’s competing applications. The first user who seeks access to any competing application needs to provide the following information:
Data Element Source ExampleAnnouncement Number From submitted Grants.gov application HRSA-10-061 or 10-016
Grants.gov Tracking Number
From submitted Grants.gov application GRANT00059900
HRSA EHBsApplication Tracking Number
From email notification sent to PD, AO, BO, and POC listed on application.
25328
Note that the source of each data element is different and knowledge of the three numbers together is considered sufficient to provide that individual access to the application.
HRSA Electronic Submission Guide 38 Version 1.4 – August 2009
To validate the grants.gov application, log in to the EHBs and click on the ‘View Applications’ link, then click on the ‘Add Grants.Gov Application’ link (this is only visible for grant applications that require supplemental forms).
At this point, you will be presented with a form, which will require the numbers specified in the table above in order to validate your grants.gov application.
NOTE: The first individual who completes this step should use the ‘Peer Access’ feature to share the NOTE: The first individual who completes this step should use the ‘Peer Access’ feature to share the application with other individuals from the organization. It is recommended that the AO complete this step.application with other individuals from the organization. It is recommended that the AO complete this step.
4.4.4.4. Manage Access to the ApplicationManage Access to the Application
You must be registered in HRSA EHBs in order to access the application. To ensure that only authorized individuals from the organization gain access to the application, you must follow the process described earlier.
The PD, using the Administer Users feature in the grant handbook, must give the necessary privileges to the AO and other individuals who will assist in the submission of applications. Project Directors must also delegate the ‘Administer Grant Users’ privilege to the AO so that future administration can be managed by the AO.
The individual who validated the application must use the ‘Peer Access’ feature to share this application with other individuals from the organization. This is required if you wish to allow multiple individuals to work on the application in HRSA EHBS.
Once you have access to your grant handbook, use the appropriate link under the deliverables section to access your grant application.
4.5.4.5. Check Validation ErrorsCheck Validation Errors
HRSA EHBs will validate the application received through Grants.gov. All validation errors are recorded and displayed to the applicant. To view the validation errors use the ‘Grants.gov Data Validation Comments’ link on the application status page in HRSA EHBs.
4.6.4.6. Fix Errors and Complete ApplicationFix Errors and Complete Application
Applicants must review the errors in HRSA EHBs and make necessary corrections. If so noted in the funding opportunity announcement, applicants must also complete the detailed budget and other required forms in HRSA EHBs and assign an AO who must be a registered user in the HRSA EHBs. HRSA EHBs will show the status of each form in the application package and the status of all forms must be “Complete” in the summary page before the HRSA EHBs will allow the application to be submitted.
4.7.4.7. Submit Application in HRSA EHBsSubmit Application in HRSA EHBs
4.7.1. Noncompeting Continuations - When completing and submitting a Noncompeting continuation, you must have the ‘Submit Noncompeting Continuation’ privilege. The Project Director must give this privilege to the AO or a designee. Once all forms are complete, the application must be submitted to HRSA.
HRSA Electronic Submission Guide 39 Version 1.4 – August 2009
NOTE: You will have two weeks from the date the application was due in Grants.gov for submission of the NOTE: You will have two weeks from the date the application was due in Grants.gov for submission of the remaining information in HRSA EHBs. The new due date will be listed in HRSA EHBs.remaining information in HRSA EHBs. The new due date will be listed in HRSA EHBs.
Performance Measures for Noncompeting Continuation Applications – For applications that require submittal of performance measures electronically through the completion of program specific data forms, instructions will be provided both in the program guidance and through an email notifying grantees of their responsibility to provide this information; and providing instruction on how to do so.
4.7.2. New Competing, Competing Continuation, and Competing Supplement Applications Submitted Using Both Grants.gov and HRSA EHBs - After the Grants.gov application is pulled into EHBs and validated, the AO verifies the pending application in HRSA EHBs, fixes any validation errors, and makes necessary corrections. Supplemental forms are completed. The application must then be submitted by the AO assigned to the application within HRSA EHBs. (The designee of the AO can also submit the application.) The completed application must be submitted to HRSA by the due dates listed within the program guidance.
NOTE: You must submit the application by the due date listed within the program guidance. There are two NOTE: You must submit the application by the due date listed within the program guidance. There are two deadlines within the guidance – one for submission within Grants.gov and the second for submission within deadlines within the guidance – one for submission within Grants.gov and the second for submission within HRSA EHBsHRSA EHBs..
Performance Measures for All Competitive Applications - Many HRSA guidances include specific data forms and require performance measure reporting. If the completion of performance measure information is indicated in this guidance, successful applicants receiving grant funds will be required, within 30 days of the Notice of Grant Award (NGA), to register in HRSA’s Electronic Handbooks (EHBs) and electronically complete the program specific data forms that appear in this guidance. This requires the provision of budget breakdowns in the financial forms based on the grant award amount, the project abstract and other grant summary data, and objectives for the performance measures.
5.5.General Instructions for Application SubmissionGeneral Instructions for Application Submission
The following guidelines are applicable to all submissions unless otherwise noted. Failure to follow the instructions may make your application non-compliant. Non-compliant applications will not be given any consideration and the particular applicants will be notified. It is mandatory to follow the instructions provided in this section to ensure that your application can be printed efficiently and consistently for review.
5.1.5.1. Narrative Attachment GuidelinesNarrative Attachment Guidelines
5.1.1. Font Please use an easily readable typeface, such as Times Roman, Arial, Courier, or CG Times. The text and table portions of the application must be submitted in not less than 12- point and 1.0 line spacing. Applications not adhering to 12-point font requirements may be returned. For charts, graphs, footnotes, and budget tables, applicants may use a different pitch or size font, not less than 10 pitch or size font. However, it is vital that when scanned and/or reproduced, the charts are still clear and readable.
Please do not submit organizational brochures or other promotional materials, slides, films, clips, etc.
5.1.2. Paper Size and MarginsFor duplication and scanning purposes, please ensure that the application can be printed on 8 ½” x 11” white paper. Margins must be at least one (1) inch at the top, bottom, left and right of the paper. Please left-align text.
HRSA Electronic Submission Guide 40 Version 1.4 – August 2009
5.1.3. NamesPlease include the name of the applicant and 10-digit grant number (if competing continuation, competing supplement, or noncompeting continuation) on each page.
5.1.4. Section HeadingsPlease put all section headings flush left in bold type.
5.1.5. Page NumberingDo not number the standard OMB approved forms. Please number each attachment page sequentially. Reset the numbering for each attachment. (Treat each attachment/document as a separate section.)
5.1.6. Allowable Attachment or Document TypesThe following attachment types are supported in HRSA EHBs. Even though grants.gov may allow you to upload various types of attachments, it is important to note that HRSA only accepts the following types of attachments. Files with unrecognizable extensions may not be accepted or may be corrupted, and will not be considered as part of the application:
.DOC - Microsoft Word
.RTF - Rich Text Format
.TXT - Text
.WPD - Word Perfect Document
.PDF - Adobe Portable Document Format
.XLS - Microsoft Excel
File Attachment Names o Limit File Attachment Name to Under 50 Characterso Do not use any Special Characters (e.g., -, %, /, #, ) or Spacing in the File Name or for Word
Separation -- The Exception is Underscore ( _ )Note- your application will be ‘rejected’ by Grants.gov if you use special characters or attachment names greater than 50 characters
5.2.5.2. Application Content Order (Table of Contents)Application Content Order (Table of Contents)
HRSA uses an automatic numbering approach that will ensure that all applications will look the same when printed for objective review.
HRSA uses two standard packages from Grants.gov. • SF 424 (otherwise known as 5161) – For service delivery programs• SF 424 R&R – For research and training programs
For each package, HRSA has defined a standard order of forms and that order is available within the program guidance. The program guidance also provides applicants with explicit instructions on where to upload specific documents.
HRSA Electronic Submission Guide 41 Version 1.4 – August 2009
5.3.5.3. Page LimitPage Limit
When your application is printed, the narrative documents may not exceed 80 pages in length unless otherwise stated in the funding opportunity announcement. These narrative documents include the abstract, project and budget narratives, and any other attachments such as letters of support required as a part of the guidance. This 80 page limit does not include the OMB approved forms. Note that some program guidances may require submission of OMB approved program specific forms as attachments. These attachments will not be included in the 80 page limit.
Applicants must follow the instructions provided in this section and ensure that they print out all attachments on paper and count the number of pages before submission.
NOTE: Applications that exceed the specified limits will be deemed non-compliant. Non-compliant NOTE: Applications that exceed the specified limits will be deemed non-compliant. Non-compliant competing applications will not be given any consideration and the particular applicants will be notified. Non-competing applications will not be given any consideration and the particular applicants will be notified. Non-compliant noncompeting applications will have to be resubmitted in order to comply with the page limits.compliant noncompeting applications will have to be resubmitted in order to comply with the page limits.
6.6.Customer Support InformationCustomer Support Information
6.1.6.1. Grants.gov Customer SupportGrants.gov Customer Support
Please direct ALL questions regarding Grants.gov to Grants.gov Call Center at: 1-800-518-4726. Call Center hours of operation are 24 hours a day, seven days a week, excluding Federal holidays.
Please visit the following URL for additional support on the Grants.gov Web site: http://www.grants.gov/help/help.jsp.
6.2.6.2. HRSA Call CenterHRSA Call Center
For assistance with or using HRSA EHBs, call 1-877-464-4772 between 9:00 am to 5:30 p.m. ET or email [email protected].
Please visit HRSA EHBs for online help. Go to: https://grants.hrsa.gov/webexternal/home.asp and click on ‘Help’
6.3.6.3. HRSA Program SupportHRSA Program Support
For assistance with program guidance related questions, please contact the program contact listed on the program guidance. Do not call the program contact for technical questions related to either Grants.gov or HRSA EHBs.
7.7.FAQsFAQs
7.1.7.1. SoftwareSoftware
7.1.1. What are the software requirements for using Grants.gov?Applicants will need to download Adobe Reader. For information on Adobe Reader, go to http://www.grants.gov/help/download_software.jsp#adobe811.
HRSA Electronic Submission Guide 42 Version 1.4 – August 2009
7.1.2. Adobe ReaderThe Adobe Reader screen is shown in Figure 1 below.
Figure 1: Adobe Reader Screen
Figure 2: The Adobe Reader Toolbar
1. Submit – Click to submit the application package to Grants.gov (not available until all mandatory documents have been completed and the application has been saved).
2. Save – Click to save the application package to your local computer.3. Print – Click to print the application package.4. Check Package for Errors – Click prior to submitting the application package to ensure there are no
errors.
Documents that you must include in your application package are listed under Mandatory Documents. Refer to Figure 3 below.
Figure 3: Working with Mandatory Documents (Adobe Reader)
HRSA Electronic Submission Guide 43 Version 1.4 – August 2009
Adobe Reader toolbar
Mandatory Documents
1 2 3 4
1 2
3
1. Under Mandatory Documents, select the document you want to work on.2. Click on the ‘Move Form to Complete’ button.3. Select the document under Mandatory Documents for Submission and click on the ‘Open Form’
button. (Note: depending on your version of Adobe Reader, the forms may open automatically when you click on the document name.)
When you open a document for viewing or editing, Adobe Reader opens the document at the bottom of the main application page. Refer to Figure 4 below.
Figure 4: An Open Form in Adobe Reader
Note that the buttons are attached to the top of the page and move with the page. Click on the ‘Close Form’ button to save and close the form.
Special Note: Working with Earlier Versions of Adobe ReaderIt is highly recommended that you remove all earlier versions of Adobe Reader prior to installing the latest version of Adobe Reader. Do this by using ‘Add or Remove Programs’ from Control Panel in Windows.
If it is necessary that you keep older versions of Adobe Reader on your computer, you should be aware that the program will unsuccessfully attempt to open application packages with the earlier, incompatible version. Use the following workaround to avoid this problem.
HRSA Electronic Submission Guide 44 Version 1.4 – August 2009
Adobe Reader opens documents at the bottom of the application
Close Form button
Required fields
Figure 5: Downloading from Grants.gov
1. From the Grants.gov download page, right-click on the Download Application Package link and select ‘Save Target As…’ from the menu.
2. Save the target on your computer (preferably to the Desktop) as an Adobe Acrobat Document.
Figure 6: Selecting Open with Adobe Reader
3. Right-click the icon.4. Select ‘Open With’ > ‘Adobe Reader 8.1’ from the menu.
7.1.3 Can I download Adobe Reader onto my computer?There are software applications that allow you to successfully navigate the Grants.gov pages and complete your application. These applications can be found at: http://www.grants.gov/help/download_software.jsp#811#adobe811. However, depending on your organization’s computer network and security protocols you may not have the necessary permissions to download software onto your workstation. Contact your IT department or system administrator to download the software for you or give you access to this function.
7.1.4. Is Grants.gov Macintosh compatible?Yes. For details, please visit http://www.grants.gov/help/general_faqs.jsp .
HRSA Electronic Submission Guide 45 Version 1.4 – August 2009
Right-click the download link.
Select Save Target As…
Right-click the icon and select Open With > Adobe Reader 8.1.
7.1.5. What are the software requirements for HRSA EHBs?HRSA EHBs can be accessed over the Internet using Internet Explorer (IE) v5.0 and above and Netscape 4.72 and above. IE 6.0 and above is the recommended browser. HRSA EHBs are 508 compliant.
HRSA EHBs use pop-up screens to allow users to view or work on multiple screens. Ensure that your browser settings allow for pop-ups.
In addition, to view attachments such as Word and PDF, you will need the appropriate viewers.
7.1.6.What are the system requirements for using HRSA EHBs on a Macintosh computer?
Mac users are requested to download the latest version of Netscape for their OS version. It is recommended that Safari v1.2.4 and above or Netscape v7.2 and above be used.
Note that Internet Explorer (IE) for Mac has known issues with SSL and Microsoft is no longer supporting IE for Mac. HRSA EHBs do not work on IE for Mac.
7.2.7.2. Application ReceiptApplication Receipt
7.2.1. When do I need to submit my application?
Competing Submissions:Applications must be submitted to Grants.gov by 8:00 p.m. ET on the due date. An application for HRSA funding must be both received and validated by Grants.gov by the application deadline.
For applications that require verification in HRSA EHBs (refer to program guidance), Verification must be completed and applications submitted in HRSA EHBs by 5:00 p.m. ET on the due date mentioned in the guidance. This supplemental due date is different from the Grants.gov due date.
Noncompeting Submissions:Applications must be submitted to Grants.gov by 8:00 p.m. ET on the due date. An application for HRSA funding must be both received and validated by Grants.gov by the application deadline.
7.2.2.What is the receipt date (the date the application is electronically received by Grants.gov or the date the data is received by HRSA)?
Competing Submissions:The submission/receipt date is the date the application is electronically received by Grants.gov. An application for HRSA funding must be both received and validated by Grants.gov by the application deadline.
For applications that require verification in HRSA EHBs (refer to program guidance), the submission/receipt date will be the date the application is submitted in HRSA EHBs.
Noncompeting Submissions:The submission/receipt date will be the date the application is submitted in HRSA EHBs.
Applications must be verified and submitted in HRSA EHBs by 5:00 p.m. ET on the due date. (Two (2) weeks after the due date in Grants.gov.) Refer to the program guidance for specific dates.
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7.2.3 Once my application is submitted, how can I track my application and what emails can I expect from Grants.gov and HRSA?
You can check the status of your application(s) anytime after submission by logging into Grants.gov and clicking on the 'Track My Application’ link on the left side of the page. This link will also be included in the confirmation email that you receive from Grants.gov.
When you submit your competing application in Grants.gov, it is first received and then validated by Grants.gov. Typically, this takes a few hours but it may take up to 48 hours during peak volumes. You should receive four emails from Grants.gov.
The first will confirm receipt of your application by the Grants.gov system (“Received”), and the second will indicate that the application has either been successfully validated (“Validated”) by the system prior to transmission to the grantor agency or has been rejected due to errors (“Rejected with Errors”). An application for HRSA funding must be both received and validated by Grants.gov by the application deadline.
Subsequently, the application will be downloaded by HRSA. This happens within minutes of when your application is successfully validated by Grants.gov and made available for HRSA to download. On successful download at HRSA, the status of the application will change to “Received by Agency” and you will receive a third email from Grants.gov.
After this, HRSA processes the application to ensure that it has been submitted for the correct funding announcement, with the correct grant number (if applicable) and grantee/applicant organization. This may take up to 3 business days. Upon this processing HRSA will assign a unique tracking number to your application. This tracking number will be posted to Grants.gov and the status of your application will be changed to “Agency Tracking Number Assigned;” you will receive a fourth email from Grants.gov.
For applications that require verification in HRSA EHBs, you will also receive an email from HRSA confirming the successful receipt of your application and asking the PD and AO to review and resubmit the application in HRSA EHBs.
If is suggested that you check the respective systems if you do not receive any emails within the specified timeframes.
NOTE: Refer to FAQ 7.2.5 below for a summary of emails.NOTE: Refer to FAQ 7.2.5 below for a summary of emails.
7.2.4. If a resubmission is required due to technological problems encountered using the Grants.gov system and the closing date has passed, what should I do?
You must contact the Director of the Division of Grants Policy, within five (5) business days from the closing date, via email at [email protected] and thoroughly explain the situation. Your email must include the HRSA Announcement Number, the Name, Address, and telephone number of the Organization, and the Name and telephone number of the Project Director, as well as the Grants.gov Tracking Number (GRANTXXXXXXXX) assigned to your submission, along with a copy of the “Rejected with Errors” notification you received from Grants.gov. Extensions for competitive funding opportunities are only granted in the rare event of a natural disaster or validated technical system problem on the side of either Grants.gov or the HRSA Electronic Handbooks (EHBS) that prevented a timely application submission. An application for HRSA funding must be both received and validated by the application deadline.
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7.2.5 Can you summarize the emails received from Grants.gov and HRSA EHBs and identify who will receive the emails?
Submission Type Subject Timeframe Sent By RecipientNoncompeting Continuation
“Submission Receipt” Within 48 hours
Grants.gov AOR
“Submission Validation Receipt” OR“Rejected with Errors”
Within 48 hours
Grants.gov AOR
“Grantor Agency RetrievalReceipt”
Within hours of second email
Grants.gov AOR
“Agency Tracking NumberAssignment”
Within 3 business days
Grants.gov AOR
“Application Ready for Verification”
Within 3 business days
HRSA AO, BO, SPOC, PD
Competing Application (without verification in HRSA EHBs)
“Submission Receipt” Within 48 hours
Grants.gov AOR
“Submission Validation Receipt” OR“Rejected with Errors”
Within 48 hours
Grants.gov AOR
“Grantor Agency Retrieval Receipt”
Within hours of second email
Grants.gov AOR
“Agency Tracking NumberAssignment”
Within 3 business days
Grants.gov AOR
Competing Application (with verification in HRSA EHBs)
“Submission Receipt” Within 48 hours
Grants.gov AOR
“Submission Validation Receipt” OR“Rejected with Errors”
Within 48 hours
Grants.gov AOR
“Grantor Agency Retrieval Receipt”
Within hours of second email
Grants.gov AOR
“Agency Tracking Number Assignment”
Within 3 business days
Grants.gov AOR
“Application Ready for Verification”
Within 3 business days
HRSA AO, BO, SPOC, PD
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7.3.7.3. Application SubmissionApplication Submission
7.3.1 How can I make sure that my electronic application is presented in the correct order for objective review?
Follow the instructions provided in Section 5 to ensure that your application is presented in the correct order and is compliant with all the requirements.
7.47.4 Grants.govGrants.gov
For a list of frequently asked questions and answers maintained by Grants.gov, please visit the following URL: http://www.grants.gov/applicants/applicant_faqs.jsp.
Grants.gov offers several tools and numerous user guides to assist applicants that are interested in applying for grant funds. To view the many applicant resources available through grants.gov please visit the following URL: http://www.grants.gov/applicants/app_help_reso.jsp.
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Appendix B: MCHB Administrative Forms and Performance Measures
On October 31, 2009, the Office of Management and Budget (OMB) approved revisions to the Maternal and Child Health Bureau (MCHB) Performance Measures for Discretionary Grants (OMB number 0915-0298; expiration date 10/31/2012).
A review of the Administrative Forms and Performance Measures for this discretionary grant program will be conducted and new Administrative Forms and Performance Measures will be assigned. The revised Administrative Forms and Performance Measures will be added to this guidance following the discretionary grant form review. If the review of the Administrative Forms and Performance Measures has not been conducted prior to the release of the guidance, the MCHB project officer will forward the new Administrative Forms and Performance Measures once the review is complete.
The following Administrative Forms and Performance Measures are assigned to this MCHB program.
Form 1, MCHB Project Budget Details
Form 2, Project Funding Profile
Form 4, Project Budget and Expenditures by Types of Services
Form 7, Discretionary Grant Project Summary Data
Form 8, Abstract for Research Projects
Performance Measures: To be inserted following review of the Administrative Forms and Performance Measures.
Data Elements: To be inserted following review of the Administrative Forms and Performance Measures.
HRSA-10-197 50
OMB # 0915-0298EXPIRATION DATE: 10/31/2012
FORM 1MCHB PROJECT BUDGET DETAILS FOR FY _______
1. MCHB GRANT AWARD AMOUNT $2. UNOBLIGATED BALANCE $3. MATCHING FUNDS
(Required: Yes [ ] No [ ] If yes, amount)$
A. Local funds$
B. State funds $C. Program Income $D. Applicant/Grantee Funds $E. Other funds: $
4. OTHER PROJECT FUNDS (Not included in 3 above) $A. Local funds $B. State funds $C. Program Income (Clinical or Other) $D. Applicant/Grantee Funds (includes in-kind) $E. Other funds (including private sector, e.g., Foundations) $
5. TOTAL PROJECT FUNDS (Total lines 1 through 4) $6. FEDERAL COLLABORATIVE FUNDS
(Source(s) of additional Federal funds contributing to the project)$
A. Other MCHB Funds (Do not repeat grant funds from Line 1)1) Special Projects of Regional and National Significance (SPRANS) $2) Community Integrated Service Systems (CISS) $3) State Systems Development Initiative (SSDI) $4) Healthy Start $5) Emergency Medical Services for Children (EMSC) $6) Traumatic Brain Injury $7) State Title V Block Grant $8) Other: $9) Other: $10) Other: $
B. Other HRSA Funds1) HIV/AIDS $2) Primary Care $3) Health Professions $4) Other: $5) Other: $6) Other: $
C. Other Federal Funds1) Center for Medicare and Medicaid Services (CMS) $2) Supplemental Security Income (SSI) $3) Agriculture (WIC/other) $4) Administration for Children and Families (ACF) $5) Centers for Disease Control and Prevention (CDC) $6) Substance Abuse and Mental Health Services Administration (SAMHSA) $7) National Institutes of Health (NIH) $8) Education $9) Bioterrorism10) Other: $11) Other: $12) Other $
7. TOTAL COLLABORATIVE FEDERAL FUNDS $
HRSA-10-197 51
OMB # 0915-0298EXPIRATION DATE: 10/31/2012
INSTRUCTIONS FOR COMPLETION OF FORM 1MCH BUDGET DETAILS FOR FY ____
Line 1. Enter the amount of the Federal MCHB grant award for this project.
Line 2. Enter the amount of carryover (e.g, unobligated balance) from the previous year’s award, if any. New awards do not enter data in this field, since new awards will not have a carryover balance.
Line 3. If matching funds are required for this grant program list the amounts by source on lines 3A through 3E as appropriate. Where appropriate, include the dollar value of in-kind contributions.
Line 4. Enter the amount of other funds received for the project, by source on Lines 4A through 4E, specifying amounts from each source. Also include the dollar value of in-kind contributions.
Line 5. Displays the sum of lines 1 through 4.
Line 6. Enter the amount of other Federal funds received on the appropriate lines (A.1 through C.12) other than the MCHB grant award for the project. Such funds would include those from other Departments, other components of the Department of Health and Human Services, or other MCHB grants or contracts.
Line 6C.1. Enter only project funds from the Center for Medicare and Medicaid Services. Exclude Medicaid reimbursement, which is considered Program Income and should be included on Line 3C or 4C.
If lines 6A.8-10, 6B .4-6, or 6C.10-12 are utilized, specify the source(s) of the funds in the order of the amount provided, starting with the source of the most funds. .
Line 7. Displays the sum of lines in 6A.1 through 6C.12.
HRSA-10-197 52
OMB # 0915-0298EXPIRATION DATE: 10/31/2012
FORM 2PROJECT FUNDING PROFILE
FY_____ FY_____ FY_____ FY_____ FY_____
Budgeted Expended Budgeted
Expended Budgeted
Expended Budgeted Expended Budgeted Expended
1 MCHB GrantAward AmountLine 1, Form 2 $ $ $ $ $ $ $ $ $ $
2 Unobligated Balance Line 2, Form 2 $ $ $ $ $ $ $ $ $ $
3 Matching Funds(If required) Line 3, Form 2 $ $ $ $ $ $ $ $ $ $
4 Other Project Funds Line 4, Form 2 $ $ $ $ $ $ $ $ $ $
5 Total Project Funds Line 5, Form 2 $ $ $ $ $ $ $ $ $ $
6 Total Federal Collaborative Funds Line 7, Form 2 $ $ $ $ $ $ $ $ $ $
HRSA-10-197 53
OMB # 0915-0298EXPIRATION DATE: 10/31/2012
INSTRUCTIONS FOR THE COMPLETION OF FORM 2PROJECT FUNDING PROFILE
Instructions:
Complete all required data cells. If an actual number is not available, use an estimate. Explain all estimates in a note.
The form is intended to provide funding data at a glance on the estimated budgeted amounts and actual expended amounts of an MCH project.
For each fiscal year, the data in the columns labeled Budgeted on this form are to contain the same figures that appear on the Application Face Sheet (for a non-competing continuation) or the Notice of Grant Award (for a performance report). The lines under the columns labeled Expended are to contain the actual amounts expended for each grant year that has been completed.
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FORM 4PROJECT BUDGET AND EXPENDITURES
By Types of Services
FY _____ FY _____TYPES OF SERVICES Budgeted Expended Budgeted Expended
I. Direct Health Care Services(Basic Health Services and Health Services for CSHCN.) $ $ $ $
II. Enabling Services(Transportation, Translation, Outreach, Respite Care, HealthEducation, Family Support Services, Purchase of Health Insurance, Case Management, and Coordination with Medicaid,WIC and Education.) $ $ $ $
III. Population-Based Services(Newborn Screening, Lead Screening, Immunization, SuddenInfant Death Syndrome Counseling, Oral Health,Injury Prevention, Nutrition, andOutreach/Public Education.) $ $ $ $
IV. Infrastructure Building Services(Needs Assessment, Evaluation, Planning, Policy Development, Coordination, Quality Assurance, Standards Development, Monitoring, Training, Applied Research, Systems of Care, and Information Systems.) $ $ $ $
V. TOTAL $ $ $ $
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INSTRUCTIONS FOR THE COMPLETION OF FORM 4PROJECT BUDGET AND EXPENDITURES BY TYPES OF SERVICES
Complete all required data cells for all years of the g rant. If an actual number is not available, make an estimate. Please explain all estimates in a note. Administrative dollars should be allocated to the appropriate level(s) of the pyramid on lines I, II, II or IV. If an estimate of administrative funds use is necessary, one method would be to allocate those dollars to Lines I, II, III and IV at the same percentage as program dollars are allocated to Lines I through IV.
Note: Lines I, II and II are for projects providing services. If grant funds are used to build the infrastructure for direct care delivery, enabling or population-based services, these amounts should be reported in Line IV (i.e., building data collection capacity for newborn hearing screening).
Line I Direct Health Care Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.
Direct Health Care Services are those services generally delivered one-on-one between a health professional and a patient in an office, clinic or emergency room which may include primary care physicians, registered dietitians, public health or visiting nurses, nurses certified for obstetric and pediatric primary care, medical social workers, nutritionists, dentists, sub-specialty physicians who serve children with special health care needs, audiologists, occupational therapists, physical therapists, speech and language therapists, specialty registered dietitians. Basic services include what most consider ordinary medical care, inpatient and outpatient medical services, allied health services, drugs, laboratory testing, x-ray services, dental care, and pharmaceutical products and services. State Title V programs support - by directly operating programs or by funding local providers - services such as prenatal care, child health including immunizations and treatment or referrals, school health and family planning. For CSHCN, these services include specialty and sub-specialty care for those with HIV/AIDS, hemophilia, birth defects, chronic illness, and other conditions requiring sophisticated technology, access to highly trained specialists, or an array of services not generally available in most communities.
Line II Enabling Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.
Enabling Services allow or provide for access to and the derivation of benefits from, the array of basic health care services and include such things as transportation, translation services, outreach, respite care, health education, family support services, purchase of health insurance, case management, coordination of with Medicaid, WIC and educations. These services are especially required for the low income, disadvantaged, geographically or culturally isolated, and those with special and complicated health needs. For many of these individuals, the enabling services are essential - for without them access is not possible. Enabling services most commonly provided by agencies for CSHCN include transportation, care coordination, translation services, home visiting, and family outreach. Family support activities include parent support groups, family training workshops, advocacy, nutrition and social work.
Line III Population-Based Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.
Population Based Services are preventive interventions and personal health services, developed and available for the entire MCH population of the State rather than for individuals in a one-on-one situation. Disease prevention, health promotion, and statewide outreach are major components. Common among these services are newborn screening, lead screening, immunization, Sudden Infant Death Syndrome counseling, oral health, injury prevention, nutrition and outreach/public education. These services are generally available whether the
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mother or child receives care in the private or public system, in a rural clinic or an HMO, and whether insured or not.
Line IV Infrastructure Building Services - enter the budgeted and expended amounts for the appropriate fiscal year completed and budget estimates only for all other years.
Infrastructure Building Services are the base of the MCH pyramid of health services and form its foundation. They are activities directed at improving and maintaining the health status of all women and children by providing support for development and maintenance of comprehensive health services systems and resources including development and maintenance of health services standards/guidelines, training, data and planning systems. Examples include needs assessment, evaluation, planning, policy development, coordination, quality assurance, standards development, monitoring, training, applied research, information systems and systems of care. In the development of systems of care it should be assured that the systems are family centered, community based and culturally competent.
Line V Total – Displays the total amounts for each column, budgeted for each year and expended for each year completed.
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FORM 7DISCRETIONARY GRANT PROJECT
SUMMARY DATA
1. Project Service Focus[ ] Urban/Central City [ ] Suburban [ ] Metropolitan Area (city & suburbs)[ ] Rural [ ] Frontier [ ] Border (US-Mexico)
2. Project Scope[ ] Local [ ] Multi-county [ ] State-wide[ ] Regional [ ] National
3. Grantee Organization Type[ ] State Agency[ ] Community Government Agency[ ] School District[ ] University/Institution Of Higher Learning (Non-Hospital Based)[ ] Academic Medical Center[ ] Community-Based Non-Governmental Organization (Health Care)[ ] Community-Based Non-Governmental Organization (Non-Health Care)[ ] Professional Membership Organization (Individuals Constitute Its Membership)[ ] National Organization (Other Organizations Constitute Its Membership)[ ] National Organization (Non-Membership Based)[ ] Independent Research/Planning/Policy Organization[ ] Other _________________________________________________________
4. Project Infrastructure Focus (from MCH Pyramid) if applicable[ ] Guidelines/Standards Development And Maintenance[ ] Policies And Programs Study And Analysis[ ] Synthesis Of Data And Information[ ] Translation Of Data And Information For Different Audiences[ ] Dissemination Of Information And Resources[ ] Quality Assurance[ ] Technical Assistance[ ] Training[ ] Systems Development[ ] Other
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5. Demographic Characteristics of Project Participants
Indicate the service level:
Direct Health Care Services Population-Based ServicesEnabling Services Infrastructure Building Services
RACE (Indicate all that apply) ETHNICITY
American Indian or Alaska Native
Asian Black or African
American
Native Hawaiian or Other Pacific Islander
White More than One Race
Unrecorded
Total Hispanic or
Latino
Not Hispanic or Latino
Unrecorded
Total
Pregnant Women (All Ages)Infants <1 yearChildren and Youth 1 to 25 yearsCSHCN Infants <1 yearCSHCN Children and Youth 1 to 25 yearsWomen25+ yearsOther
TOTALS
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6. Clients’ Primary Language(s)
______________________________________________________________________________________________________
7. Resource/TA and Training Centers ONLYAnswer all that apply.a. Characteristics of Primary Intended Audience(s)
[ ] Policy Makers/Public Servants[ ] Consumers
[ ] Providers/Professionalsb. Number of Requests Received/Answered: ___/____c. Number of Continuing Education credits provided: _______d. Number of Individuals/Participants Reached: _______e. Number of Organizations Assisted: _______f. Major Type of TA or Training Provided:
[ ] continuing education courses, [ ] workshops, [ ] on-site assistance, [ ] distance learning classes[ ] other
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INSTRUCTIONS FOR THE COMPLETION OF FORM 7PROJECT SUMMARY
Section 1 – Project Service FocusSelect all that apply
Section 2 – Project ScopeChoose the one that best applies to your project.
Section 3 – Grantee Organization TypeChoose the one that best applies to your organization.
Section 4 – Project Infrastructure FocusIf applicable, choose all that apply.
Section 5 – Demographic Characteristics of Project ParticipantsIndicate the service level for the grant program. Multiple selections may be made. Please fill in each of the cells as appropriate.
Direct Health Care Services are those services generally delivered one-on-one between a health professional and a patient in an office, clinic or emergency room which may include primary care physicians, registered dietitians, public health or visiting nurses, nurses certified for obstetric and pediatric primary care, medical social workers, nutritionists, dentists, sub-specialty physicians who serve children with special health care needs, audiologists, occupational therapists, physical therapists, speech and language therapists, specialty registered dietitians. Basic services include what most consider ordinary medical care, inpatient and outpatient medical services, allied health services, drugs, laboratory testing, x-ray services, dental care, and pharmaceutical products and services. State Title V programs support - by directly operating programs or by funding local providers - services such as prenatal care, child health including immunizations and treatment or referrals, school health and family planning. For CSHCN, these services include specialty and sub-specialty care for those with HIV/AIDS, hemophilia, birth defects, chronic illness, and other conditions requiring sophisticated technology, access to highly trained specialists, or an array of services not generally available in most communities.
Enabling Services allow or provide for access to and the derivation of benefits from, the array of basic health care services and include such things as transportation, translation services, outreach, respite care, health education, family support services, purchase of health insurance, case management, coordination of with Medicaid, WIC and educations. These services are especially required for the low income, disadvantaged, geographically or culturally isolated, and those with special and complicated health needs. For many of these individuals, the enabling services are essential - for without them access is not possible. Enabling services most commonly provided by agencies for CSHCN include transportation, care coordination, translation services, home visiting, and family outreach. Family support activities include parent support groups, family training workshops, advocacy, nutrition and social work.
Population Based Services are preventive interventions and personal health services, developed and available for the entire MCH population of the State rather than for individuals in a one-on-one situation. Disease prevention, health promotion, and statewide outreach are major components. Common among these services are newborn screening, lead screening, immunization, Sudden Infant Death Syndrome counseling, oral health, injury prevention, nutrition and outreach/public education. These services are generally available whether the mother or child receives care in the private or public system, in a rural clinic or an HMO, and whether insured or not.
Infrastructure Building Services are the base of the MCH pyramid of health services and form its foundation. They are activities directed at improving and maintaining the health status of all women and children by providing support for development and maintenance of comprehensive health services systems and resources including development and maintenance of health services standards/guidelines, training, data and planning systems. Examples include needs assessment, evaluation, planning, policy development, coordination, quality assurance,
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standards development, monitoring, training, applied research, information systems and systems of care. In the development of systems of care it should be assured that the systems are family centered, community based and culturally competent.
Section 6 – Clients Primary Language(s) Indicate which languages your clients speak as their primary language, other than English, for the data provided in Section 6. List up to three languages.
Section 7 – Resource/TA and Training Centers (Only)Answer all that apply.
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FORM 8(For Research Projects ONLY)
MATERNAL & CHILD HEALTH DISCRETIONARY GRANT PROJECT ABSTRACT
FOR FY____
I. PROJECT IDENTIFIER INFORMATION 1. Project Title:2. Project Number:3. Project Director:4. Principle Investigator(s), Discipline
II. BUDGET1. MCHB Grant Award $_____________
(Line 1, Form 2)2. Unobligated Balance $_____________
(Line 2, Form 2)3. Matching Funds (if applicable) $_____________
(Line 3, Form 2)4. Other Project Funds $_____________
(Line 4, Form 2)5. Total Project Funds $_____________
(Line 5, Form 2)
III.CARE EMPHASIS[ ] Interventional [ ] Non-interventional
IV.POPULATION FOCUS [ ] Neonates [ ] Pregnant Women[ ] Infants [ ] Postpartum Women[ ] Toddlers [ ] Parents/Mothers/Fathers [ ] Preschool Children [ ] Adolescent Parents[ ] School-Aged Children [ ] Grandparents[ ] Adolescents [ ] Physicians[ ] Adolescents (Pregnancy Related) [ ] Others[ ] Young Adults (>20)
V. STUDY DESIGN [ ] Experimental[ ] Quasi-Experimental[ ] Observational
VI. TIME DESIGN [ ] Cross-sectional[ ] Longitudinal[ ] Mixed
VII. PRIORITY RESEARCH ISSUES AND QUESTIONS OF FOCUSFrom the Maternal and Child Health Bureau (MCHB) Strategic Research Issues: Fiscal Years (FYs) 2004 – 2009.
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Primary area addressed by research:
Secondary area addressed by research:
VIII. ABSTRACT
IX.KEY WORDS
X. ANNOTATION
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INSTRUCTIONS FOR THE COMPLETION OF FORM 8MATERNAL & CHILD HEALTH RESEARCH PROJECT ABSTRACT
NOTE: All information provided should fit into the space provided in the form. Do not exceed the space provided.
Where information has previously been entered in forms 1 through 5, the information will automatically be transferred electronically to the appropriate place on this form.
Section I – Project Identifier Information
Project Title: Displays the title for the project.Project Number: Displays the number assigned to the project (e.g., the grant number).Project Director: Displays the name and degree(s) of the project director as listed on the grant
application.Principal Investigator: Enter the name(s) and discipline(s) of the principal investigator(s).
Section II – BudgetThe amounts for Lines 1 through 5 will be transferred from Form 1, Lines 1 through 5.
Section III – Care EmphasisIndicate whether the study is interventional or non-interventional.
Section IV – Population FocusIndicate which population(s) are the focus of the study. Check all that apply.
Section V – Study DesignIndicate which type of design the study uses.
Section VI – Time Design Indicate which type of design the study uses.
Section VII – Priority Research Issues and Questions of Focus (DO NOT EXCEED THE SPACE PROVIDED)Provide a brief statement of the primary and secondary (if applicable) areas to be addressed by the research. The topic(s) should be from those listed in the Maternal and Child Health Bureau (MCHB) Strategic Research Issues: Fiscal Years (FYs) 2004 – 2009).
Section VIII – Abstract
Section IX - -Key Words Provide up to 10 key words to describe the project, including populations served. A list of key words used to classify active projects is included. Choose keywords from this list when describing your project.
Section X – AnnotationProvide a three- to five-sentence description of your project that identifies the project’s purpose, the needs and problems, which are addressed, the goals and objectives of the project, the activities, which will be used to attain the goals, and the materials, which will be developed.
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APPENDIX C: INSTRUCTIONS FOR THE SF424 R&R (RESEARCH AND RELATED)
INSTRUCTIONS FOR THE APPLICATION FACE PAGES
Below are detailed instructions for the completion of the 424 R&R form:
Field Instructions
1. Select Type of Submission: Check the appropriate type from the submission options. Select Application for all HRSA grant programs
2. Date Submitted: Enter the date the application is submitted to the Federal agency.3. Date Received by State: State Use Only (if applicable)4. Federal Identifier: New Project Applications should leave this field blank. If this is a Continuation
application (competing or non-competing) or a Supplement, enter your grant number located on your Notice of Grant Award (NGA.
5. Applicant Information: All items in bold are required fields and must be completedEnter your Organization’s DUNS Number (received from Dun and Bradstreet), Enter the Legal Name, Applicant Department (if applicable) and Division (if applicable) who will undertake the assistance activity. In Street 1 enter the first line of the street address of your organization. In Street2 enter the second line of your organization, if applicable. Enter the City, County and State, Zip Code and Country where your organization is located. Enter the Person to be Contacted on Matters Involving the Application:
This is the POINT OF CONTACT, the person to be contacted for the matters pertaining to this specific application (i.e. principle investigator, project director, other). Enter the Prefix, First Name, Middle Name and Last Name and Suffix (if applicable) of the person to be contacted on matters relating to this application. Enter the Phone and Fax number as well as the E-MAIL address of this person. These are all required fields.
6. Employer Identification (EIN)/ (TIN) Enter the 9 Digit Employer Identification Number as Assigned by the Internal Revenue Services.
7. Type of Applicant : Select the appropriate letter from one of the following: A. State GovernmentB. County GovernmentC. City or Township GovernmentD. Special District GovernmentE. Independent School DistrictF. State Controlled Institution of Higher Education G. Native American Tribal Government (Federally Recognized) H. Public/Indian Housing AuthorityI. Native American Tribal Organization (other than Federally recognized)J. Nonprofit with 501C3 IRS status (other than Institute of Higher Education)K. Nonprofit without 501C3 IRS status (other than Institute of Higher EducationL. Private Institution of Higher EducationM. Individual N. For Profit Organization(other than small business) O. Small BusinessP. Other (specify)
Women Owned: Check if you are a woman owned small business( 51% owned/controlled and operated by a woman/women)Socially and Economically Disadvantaged: Check if you are a socially and economically disadvantaged small business, as determined by the U.S. SBA pursuant to Section 8(a) of the SBA U.S.C.637(a).
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8. Type of Application: Select the Type from the following list :- New: A new assistance award- Resubmission ( not applicable to HRSA)- Renewal – An application for a competing continuation – this is a request for an extension for an additional funding/budget period for a project with a projected completion.-Continuation: A non-competing application for an additional funding/budget period for a project within a previously approved projected period - Revision: Any change in the Federal Governments financial obligation or contingent liability from an existing obligation. Indicate the Type of Revision by checking the appropriate box: A. Increase in Award (supplement, competing supplement)B. Decrease AwardC. Increase DurationD. Decrease DurationE. Other (Enter text to Explain) Is Application being submitted to Other Agencies: Indicate by checking YES or NO if the application is being submitted to HRSA only.What other Agencies: Enter Agency Name ( if applicable)
9. Name of Federal Agency: Enter the Name of the Federal Agency from which assistance is being requested
10. Catalogue of Federal Domestic Assistance Number (CFDA): Use the CFDA Number found on the front pea of the program guidance and associated Title of the CFDA (if available).
11. Descriptive Title of Applicant’s Project: Enter a brief descriptive title of the project. A continuation or revision must use the same title as the currently funded project.
12.12. Proposed Project: Enter the project Start Date of the project in the Start Date Field and the
project Ending Date in the Ending Date Field. ( ex.11/01/2005 to 10/31/2008)13. Congressional District Applicant and Congressional District Project: Enter your Congressional
District(s) in Applicant Field. Enter the Congressional District (s) of Project, the primary site where the project will be performed. (http://www.gpoaccess.gov/cdirectory/browse-cd-05.html)
14. Project Director/Principal Investigator Contact Information : All items in bold are required fields and must be completedEnter the Prefix, First Name, Middle Name and Last Name and Suffix (if applicable) of the Project Director/Principle Investigator (PD/PI) for the project. Enter the Title of the PD/PI and the name of the organization of the PD/PI. Enter the name of the primary organization Department and Division of the PD/PI. In Street 1 enter the first line of the street address of the PD/PI for the project. In Street2 enter the second line of the street address for the PD/PI, if applicable. Enter the City, County and State, Zip Code and Country of the PD/PI. Enter the Phone and Fax number as well as the E-MAIL address of this person. These are all required fields.
15. Estimated Project Funding: a. Total Estimated Project Funding Enter the total Federal Funds requested for the BUDGET PERIOD for which you are applying. Enter only the amount for the year you are applying, NOT the amount for the entire project period. b. Total Federal and Non-Federal Funds: Enter the total Federal and non-Federal funds for the BUDGET PERIOD for which you are applying. c. Estimated Program Income: Identify any Program Income for the BUDGET PERIOD.
16. Is Application Subject to Review by State Executive Order 12372 Process:If YES: Check the YES box if the announcement indicates that the program is covered under State Executive Order 12372. If NO: Place a check in the NO box.
17. Complete CertificationCheck the “I agree” box to attest to acceptance of required certifications and assurances listed at the end of the Application.
18. Authorized Representative (Authorizing Official - This is the person who has the authority to sign the application for the organization ) All items in bold are required fields and must be completed
Enter the name of Authorized Representative/Authorizing Official. Enter the Prefix, First Name,
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Middle Name and Last Name and Suffix (if applicable) of the Authorized Representative (AR) or Authorizing Official (AO). Enter the Title of the Authorized Representative and the organization of the AR/AO. Enter the name of the primary organization Department and Division of the AO. In Street1 enter the first line of the street address of the AR/AO for the project. In Street2 enter the second line of the street address for the AR/AO, if applicable. Enter the City, County and State, Zip Code and Country of the AR/AO. Enter the Phone and Fax number as well as the E-MAIL address of AR/AO this person. These are all required fields .
Note: Applicants applying in paper must send their entire grant application with the signed face/cover pages to the GAC
19. Pre-ApplicationThis is Not applicable to HRSA. A limited number of HRSA programs require a Letter of Intent which is different from a preapplication. Information required and the process for submitting such a Letter of Intent is outlined in the funding opportunity announcements for those programs with such a requirement.
INSTRUCTIONS FOR 5161 CHECKLIST (This is used for the 424 R&R as well)
Field Instructions Type of Application Check one of the boxes corresponding to one of the following types:
- New: A new application is a request for financial assistance for a project or program not currently receiving DHHS support.-Non competing Continuation: A non-competing application for an additional funding/budget period for a project within a previously approved project period - Competing Continuation ( same as Renewal from 424R&R face page)–this is a request for an extension of support for an additional funding/budget period for a project with a projected completion.- Supplemental (same as Revision from 424 R&R face page) An application requesting a change in the Federal Governments financial obligation or contingent liability from an existing obligation.
Part A Leave this Section Blank Part B Leave this Section Blank Part C In the Space Provided below, please provide the requested informationBusiness Official to be notified if an award is to be made
Enter the name of Business Official to be notified if an award is to be made. Enter the Prefix, First Name, Middle Name and Last Name and Suffix (if applicable) of the Business Official and the organization. Enter the Address Street1 enter the first line of the street address of the Business Official. In Street2 enter the second line of the street address for the AR/AO, if applicable. Enter the City, County and State, Zip Code and Country of the business official. Enter the Telephone and Fax number as well as the E-MAIL address of Business Official. Enter the Applicant Organizations 12 Digit DHHS EIN ( if already assigned) – This should be the same information as supplied in file number 5 of the 424 R&R face page .
Project Director/Principle Investigator designated to direct the proposed project
Enter the name of Project Director/Principle Investigator (PD/PI) – this should be the same information as supplied on the 424 R & R face page field number 15. Enter the Prefix, First Name, Middle Name and Last Name and Suffix (if applicable). Enter the name of the primary organization and Address: Street1 enter the first line of the street address of the AR/AO for the project. In Street2 enter the second line of the street address for the AR/AO, if applicable. Enter the City, County and State, Zip Code and Country of the PD/PI. Enter the Telephone Number, E-Mail and Fax number. DO NOT enter the social security number. Enter the highest degree earned for the PD/PI.
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INSTRUCTIONS FOR R&R SENIOR/KEY PERSON PROFILE
Starting with the PD/PI, provide a profile for each senior/key person proposed. Unless otherwise specified in an agency announcement senior key personnel are defined as all individuals who contribute in a substantive, measurable way to the execution of the project or activity whether or not salaries are requested. Consultants should be included if they meet this definition. For each of these individuals a Biosketch should be attached which lists the individual’s credentials/degrees.
Field InstructionPrefix Ex. Mr., Ms. Mrs. Rev. Enter the Prefix for the Individual identified as a key person for the
project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the prefix for the project director identified on the face page of the 424 R&R.
First Name This is the first (given) name of the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the name of the project director identified on the face page of the 424 R&R.
Middle Name This is the middle name of the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the name of the project director identified on the face page of the 424 R&R.
Last Name This is the last name of the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the last name of the project director identified on the face page of the 424 R&R.
Suffix Enter the Suffix (Ex. Jr., Sr., PhD.,) for the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the prefix for the project director identified on the face page of the 424 R&R.
Position/Title Enter the Title for the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the Title for the project director identified on the face page of the 424 R&R.
Department This is the name of the primary organizational department, service, laboratory, or equivalent level within the organization for the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the Department for the project director identified on the face page of the 424 R&R.
Organization Name
This is the name of the organizational for the Individual identified as a key person for the project. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the Organization Name for the project director identified on the face page of the 424 R&R.
Division This is the primary organizational division, office, or major subdivision of the individual. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the Division for the project director identified on the face page of the 424 R&R.
Street1 This is the first line of the street address for the individual identified as a key/senior person. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the Street address for the project director identified on the face page of the 424 R&R.
Street 2 This is the second line of the street address (if applicable) for the individual identified. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated with the second line of the Street address ( if applicable) for the project director identified on the face page of the 424 R&R
City Enter the city where the key/senior person is located. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated.
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County Enter the County where the key/senior person is located. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated.
State Enter the state where the key/senior person is located. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated
ZIP Code Enter the Zip Code where the key/senior person is located. If this is the entry for the Project Director and you are submitting electronically this field will be prepopulated
Phone Number Enter the daytime phone number for the senior/key person. If this is the entry for the Project Director and you are submitting electronically this filed will be prepopulated
Fax Number Enter the fax number for the senior/key person. If this is the entry for the Project Director and you are submitting electronically this filed will be prepopulated
Email address Enter the email address for the senior/key person. If this is the entry for the Project Director and you are submitting electronically this filed will be prepopulated- This is a required field
Credential e.g. agency login
Leave this field blank
Project Role Enter the project role from the list below1. Project Director (PD)/Principle Investigator(PI) 2. Co- PD/Co- PI3.Faculty 4. Post Doctoral5. Post Doctoral Associate6. Other Professional7. Graduate Student8. Undergraduate Student 9. Technician 10. Consultant11. Other (Specify)
Other Project Role Category
Complete if you selected “Other “as a project role. For example, Engineer, social worker.
Attach Biographical Sketch
Provide a biographical sketch for the PD/PI or Senior Key Person identified. For each of these individuals a Biosketch should be attached which lists the individual’s credentials/degrees. Recommended information includes: education and training, research and professional and synergistic activities. Save the information in a single file and attach by clicking Add attachment –if applying electronically
Attach Current & Pending Support
Follow the individual program guidance pertaining to this issue. If current and pending support on level of effort documentation is required, please attach accordingly.
INSTRUCTIONS FOR R&R PROJECT PERFORMANCE SITE LOCATION(S) FORM
Indicate the primary site/sites where the work or activity will occur. If a portion of the project is at any other location(s), identify it in the section provided. If more than eight project/performance site locations are proposed, provide the information in a separate file and attach these in a file in the space provided at the bottom of the form. If applying in paper add this information as part of the appendix.
Enter the Primary Performance Site first. Add all other performance sites in the space provided.
Field name InstructionsOrganization Name
Enter the Name of the Performance Site/Organization
Street 1 Enter the first line of the street address of the performance site locationStreet 2 Enter the second line of the street address of the performance site location, if applicable City Enter the city of the performance site.County Enter the county where the performance site is located.State Select from the list of States or enter the State/province in which the performance site is
located
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Zip Code Enter the zip code of the performance sit locationCountry Enter the country of the performance site from the list
INSTRUCTIONS FOR R&R BUDGET
SECTION AField Name InstructionsOrganizational DUNS
Enter the DUNS or DUNS +4 number of your organization. For applicants applying electronically, this field is pre-populated from the R&R SF424 Cover Page.
Budget Type Check the appropriate block. Check Project if the budget requested is for the primary applicant organization. Check Subaward/consortium organizations (if applicable). Separate budgets are usually required only for Subaward Budgets and are not allowed by HRSA unless legislatively authorized or requested in the program application guidance. Use the R&R Subaward Budget Attachment and attach as a separate file on the R&R Budget Attachment(s) form..
Enter Name of Organization
Enter the name of your organization
Start Date Enter the requested Start Date of Budget Period End Date Enter the requested End Date of the Budget Period ( these should cover 1 full year/12
months) Budget Period Identify the specific budget period (1 for first year of the grant, 2 for second year of
the grant, 3 for third etc.) A. Senior/Key Person
Enter the Prefix, First/(Given) name, Middle name (if applicable), Last Name and Suffix of the senior/key person
Project Role Enter the project role of the Senior/Key person. Base Salary ($) Enter the annual compensation paid by the employer for each Senior/Key person.
This includes all activities such as research, teaching, patient care. etc.Cal. Months Enter the number of Calendar months devoted to the project in the applicable box for
each project role categoryAcad. Months Enter the number of academic year months devoted to the project in the applicable
box for each project role category ( If your institution does not use a 9 month academic period, indicate your institution’s definition of academic year in the budget justification)
Sum. Months Enter the number of summer months devoted to the project in the applicable box for each project role category ( If your institution does not use a 3 month summer period, indicate your institution’s definition of summer period in the budget justification)
Requested Salary ($)
Regardless of the number of months being devoted to the project, indicate only the funds being requested to cover the amount of salary/wages for each senior/key person for this budget period
Fringe Benefits ($)
Enter applicable fringe benefits, if any, for each senior/key person
Funds Requested ($)
Enter federal funds requested for salary/wages & fringe benefits for each senior/key person for this budget period for this project.
Line 9. Total Funds Requested for all Senior Key Persons in the attached Files
Enter the total federal funds requested for all senior/key persons listed in the attached file (these requested funds would be for key persons over and above those listed in the preceding rows/fields of section A). If applicants are applying in hardcopy please attach a table listing the key personnel over and above the 8 persons listed on the budget page using the same format appearing in the budget table and enter the total funds requested for these additional by people in row 9.
Additional Senior Key Persons (attach file)
If applying electronically attach a file here detailing the funds requested for key personnel over and above the 8 senior/key persons already listed in this section; include all pertinent budget information. The total funds requested in this file should
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be entered in “the total funds requested for all additional senior/key persons in line 9 of Section A . If applying in hardcopy please be certain to provide detailed information on the key personnel as well as funds requested in the same format appearing in the budget table. Be certain to include the total funds for these additional key persons in the total funds requested for all additional senior/key persons in line 9 of Section A.
SECTION B. Other Personnel
Field Name InstructionsNumber of Personnel
For each project role/category identify the number of personnel proposed.
Project Role If project role is other than Post-Doctoral Associates, Graduate Students, Undergraduate students, or Secretarial/Clerical, enter the appropriate project role ( for example, Engineer, Statistician, IT Professional etc. ) in the blanks.
Cal. Months Enter the number of Calendar months devoted to the project in the applicable box for each project role category/stipend category
Acad. Months Enter the number of academic year months devoted to the project in the applicable box for each project role category ( If your institute does not use a 9 month academic period , indicate your institution’s definition of academic year in the budget justification)
Sum. Months Enter the number of summer months devoted to the project in the applicable box for each project role category ( If your institute does not use a 3 month summer period , indicate your institution’s definition of summer period in the budget justification)
Requested Salary ($)
Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages/stipend amount being requested for each project role
Fringe Benefits ($)
Enter applicable fringe benefits, if any, for each project role category
Funds Requested ($)
Enter requested salary/wages & fringe benefits for each project role category
Total Number Other Personnel
Enter the total number of other personnel and related funds requested for this project
Total Salary, Wages and Fringe Benefits (A &B)
Enter the total funds requested for all senior key persons, stipends and all other personnel- If applying electronically this will be computed based on detailed information provided. If applying through hard copy please enter this number, ensuring that the total is equal to the detailed information provided
SECTION C: Equipment Description Field Name InstructionsOrganizational DUNS
Enter the DUNS or DUNS +4 number of your organization. For Project applicants and those applying electronically, this field is pre-populated from the R&R SF424 Cover Page.
Budget Type Check the appropriate block. Check Project if the budget requested is for the primary applicant organization. Check Subaward/consortium organizations (if applicable). Separate budgets are usually required only for Subaward Budgets and are not allowed by HRSA unless legislatively authorized or requested in the program application guidance. Use the R&R Subaward Budget Attachment and attach as a separate file on the R&R Budget Attachment(s) form)
Enter Name of Organization
Enter the name of your organization
Start Date Enter the requested Start Date of Budget Period End Date Enter the requested/proposed End Date of the Budget Period ( these should cover 1
full year/12 months)
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Budget Period Identify the specific budget period (1 for first year of the grant, 2 for second year of the grant, 3 for third etc. )
Equipment Item Equipment is identified as an item of property that has an acquisition cost of $5,000 or more (unless the organization has established lower levels) and an expected service life of more than 1 year. List each item of equipment separately and justify each in the budget justification section. Ordinarily allowable items are limited to those which will be used primarily or exclusively in the actual conduct or performance of grant activities.
Funds Requested Enter the estimated cost of each item of equipment, including shipping and any maintenance costs and agreements.
Total Funds Requested for all equipment listed in the attached files
Enter the estimated cost of all equipment listed in any attached documents/files.
Additional Equipment
If the space provided can not accommodate all the equipment proposed, attach a file or document delineating the equipment proposed. If applying in hardcopy please provide this information on a separate/attached sheet. List the total funds requested on line 11 of this section.
SECTION D. Travel Field Name InstructionsDomestic Travel Costs (Incl. Canada, Mexico, and US Possessions)
Enter the total funds requested for domestic travel. Domestic travel includes Canada, Mexico and US possessions. In the budget justifications section, include the purpose , destinations, dates of travel (if known) , and number of individuals for each trip. If the dates of travel are known, specify estimated length of trip (for example, 3 days)
Foreign Travel Costs
Enter the total funds to be used for foreign travel. Foreign travel includes any travel outside of the United States, Canada, Mexico and or the U.S. Possessions. In the budget justification section, include the purpose, destination, travel dates (if known), and number of individuals for each trip. If the dates of travel are not known , specify estimated length of trip ( ex. 3 days)
Total Travel Costs The total funds requested for all travel related to this project– this should equal the total of all domestic and foreign and may be computed if applying electronically. If applying in hardcopy please enter this amount
SECTION E: Participant/Trainee Support Costs
Field Name InstructionsTuition/Fees/Health Insurance
Enter the total amount of funds requested for participant /trainee tuition, fees, and /or health insurance. (if applicable)
Stipends Enter the total amount of funds requested for participant /trainee stipends. Travel Enter the total funds requested for participant/trainee travel associated with this
project (if applicable)Subsistence Enter the total funds requested for participant/trainee subsistence (if applicable) Other Describe and enter the total funds requested for any other participant/trainee
costs/institutional allowances, scholarships etc. Please identify these in the space provided.
Number of Participants Enter the total number of proposed participants/trainees (those receiving stipends, scholarships, etc.)
Trainee Costs Enter the total costs associated with the above categories (i.e.
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participants/trainees- items 1-5). If applying electronically this total will be calculated for you.
SECTION F-K Budget Period
Field Name InstructionsOrganizational DUNS
Enter the DUNS or DUNS +4 number of your organization. For Project applicants and those applying electronically, this field is pre-populated from the R&R SF424 Cover Page.
Budget Type Check the appropriate block. Check Project if the budget requested is for the primary applicant organization. Check Subaward/consortium organizations (if applicable). Separate budgets are usually required only for Subaward Budgets and are not allowed by HRSA unless legislatively authorized or requested in the program application guidance. Use the R&R Subaward Budget Attachment and attach as a separate file on the R&R Budget Attachment(s) form.
Enter Name of Organization
Enter the name of your organization
Start Date Enter the requested Start Date of the Budget Period End Date Enter the requested/proposed End Date of the Budget Period (these should cover 1
full year/12 months) Budget Period Identify the specific budget period (1 for first year of the grant, 2 for second year of
the grant, 3 for third etc. )
SECTION F Other Direct Cost
Field Name Instructions1. Materials and Supplies Enter the total funds requested for materials and supplies. In the
budget justification attachment please itemize all categories for which costs exceed $1,000. Categories less than $1,000 do not have to be itemized.
2. Publication Costs Enter the total publication funds requested. The budget may request funds for the cost of documenting, preparing, publishing or otherwise disseminating the findings of this project to others. In the budget justification include supporting information.
3. Consultant Services Enter the total funds requested for consultant services. In the budget justification identify each consultant, the services to be performed, travel related to this project and the total estimated costs.
4. ADP/Computer Services Enter total funds requested for ADP/computer services. In the budget justification include the established computer service rates at the proposed organization (if applicable)
5. Subawards/Consortia/ Contractual Costs
Enter total funds requested for subaward, consortium and/or contractual costs proposed for this project.
6. Equipment/Facility Rental/ User Fees
Enter total funds requested for equipment or facility rental or users fees. In the budget justification please identify and justify these fees.
7. Alterations and Renovations (not applicable to training program grants)
Enter the total funds requested for alterations and renovations. In the budget justification itemize by category and justify the costs including repairs, painting, removal or installation of partitions. Where applicable provide square footage and costs.
Items 8-10 In items 8-10 please describe any “other” direct costs not requested above. Use the Budget Justification attachment to further itemize and justify these costs. If line space is inadequate
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please use line 10 to combine all remaining “other direct costs” and include details of these costs in the budget justification.
Total Other Costs The total funds requested for all Other Direct Costs
SECTION G: Direct Costs
If applying electronically, this item will be computed as the sum of sections A-F . If applying in paper please enter the sum of sections A-F in this field
SECTION H: Indirect Costs
Field Name InstructionsIndirect Cost Type Indicate the type of indirect cost. Also indicate if this is off-site. If more than one
rate/base is involved, use separate lines for each. If you do not have a current indirect cost rate (s) approved by a Federal Agency indicate “None—will negotiate” and include information for proposed rate. Use the budget justification if additional space is needed.
Indirect Cost Rate (%) Indicate the most recent indirect cost rate(s), also known as Facilities and Administrative Costs {F&A} established with a cognizant Federal office or, in the case of for–profit organizations, the rate(s) established with the appropriate agency. If you do not have a cognizant oversight agency and are selected for an award, you must submit your requested indirect cost rate documentation to the awarding department. For HHS this would be the Division of Cost Allocation in DHHS.
Indirect Cost Base ($) Enter amount of the base for each indirect cost type.Funds Requested Enter the total funds requested for each indirect cost type. Cognizant Federal Agency
Enter the name of the cognizant Federal Agency, name and telephone number of the individual responsible for negotiating your rate. If no cognizant agency is known, enter None.
SECTION I: Total Direct and Indirect Institutional Costs (Section G+ Section H)Enter the total funds requested for direct and indirect costs. If applying electronically this field will be calculated for you.
SECTION J: FeeGenerally, a fee is not allowed on a grant or cooperative agreement. Do not include a fee in your budget, unless the program announcement specifically allows the inclusion of a fee. If a fee is allowable, enter the fee requested in this field.
SECTION K: Budget Justification Detailed instructions for information to include in this section will be provided in the program application guidance. Use the budget justification to provide the additional information in each budget category and any other information necessary to support your budget request. Please use this attachment/section to provide the information requested/required in the program guidance. Please refer to the guidance to determine the need for and placement of (ex. in Appendix section) any other required budget tables stipulated in the guidance.
RESEARCH AND RELATED BUDGET –CUMULATIVE BUDGET
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If applying electronically, all of the values on this form will be calculated based on the amounts that were entered previously under sections A through K for each of the individual budget periods. Therefore, if this application is being submitted electronically no data entry is allowed or required in order to complete this Cumulative Budget section.
If any amounts displayed on this form appear to be incorrect you may correct the value by adjusting one or more of the values that contributed to the total from the previous sections. To make such an adjustment you will need to revisit the appropriate budget period form(s) to enter corrected values.
If applying in paper form please ensure that entries in the cumulative budget are consistent with those entered in Sections A-K. Field Name InstructionsSection A: Senior/Key Person
The cumulative total funds requested for all Senior/Key personnel.
Section B: Other Personnel
The cumulative total funds requested for all other personnel.
Total Number Other Personnel
The cumulative total number of other personnel.
Total Salary, Wages, and Fringe Benefits (Section A + Section B)
The cumulative total funds requested for all Senior/Key personnel and all other personnel.
Section C: Equipment The cumulative total funds requested for all equipment.
Section D:Travel
The cumulative total funds requested for all travel.
1. Domestic The cumulative total funds requested for all domestic travel. 2. Foreign The cumulative total funds requested for all foreign travel. Section E: Participant/Trainee Support Costs
The cumulative total funds requested for all participant/trainee costs.
1. Tuition/Fees/Health Insurance
Enter the number of Calendar months devoted to the project in the applicable box for each project role category.
2. Stipends Enter the cumulative total funds requested for participants/trainee stipends. 3. Travel The cumulative total funds requested for Trainee /Participant travel.4. Subsistence The cumulative total funds requested for Trainee/Participant subsistence.5. Other The cumulative total funds requested for any Other participant trainee costs
including scholarships. 6. Number of participants/trainees
The cumulative total number of proposed participants/trainees.
Section F: Other Direct Costs
The cumulative total funds requested for all other direct costs.
1. Materials and Supplies The cumulative total funds requested for Materials and Supplies.
2. Publication Costs The cumulative total funds requested for Publications.3. Consultant Services The cumulative total funds requested for Consultant Services.4. ADP/Computer Services
The cumulative total funds requested for ADP/Computer Services.
5. Subawards/ Consortium/ Contractual Costs
The cumulative total funds requested for 1) all subaward/ consortium organization(s) proposed for the project, and 2) any other contractual costs proposed for the project.
6. Equipment or Facility Rental/User Fees
The cumulative total funds requested for Equipment or Facility Rental/ User Fees.
7. Alterations and The cumulative total funds requested for Alterations and Renovations.
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Renovations8. Other 1 The cumulative total funds requested in line 8 or the first Other Direct Costs
category. 9. Other 2 The cumulative total funds requested in line 9or the second Other Direct Costs
category. 10. Other 3 The cumulative total funds requested in line 10 or the third Other Direct Costs
category. Section G: Direct Costs A-F
The cumulative total funds requested for all direct costs.
Section H: Indirect Costs
The cumulative total funds requested for all indirect costs.
Section I : Total Direct and Indirect Costs
The cumulative total funds requested for direct and indirect costs.
Section J: Fee The cumulative funds requested for Fees (if applicable).
INSTRUCTIONS FOR R&R SUBAWARD BUDGET ATTACHMENT(s) FORM
Subawards are not allowed by HRSA unless legislatively authorized or requested in the Program Application Guidance. Please click on the subaward budget attachment to obtain the required budget forms. Attach all budget information by attaching the files in line items 1-10. Please do not attach any files to the subaward documents as they will not be transferred to HRSA. All justification for expenditures should be added to the budget justification for the project in section K of the project budget.
SF 424 R&R OTHER PROJECT INFORMATION COMPONENT
If this is an application for a Research Grant Please Respond to All of the Questions on this page.
If this is an application for a Training Grant Please Respond to Items 1 and Items 6-11.
Field Name Instructions1. Are Human Subjects Involved
If activities involving human subjects are planned at any time during proposed project check YES. Check this box even if the proposed project is exempt from Regulations for the protection of Human Subjects. Check NO if this is a training grant or if no activities involving human subjects are planned and skip to step 2.
1.a If YES to Human Subjects Involved
Skip this section if the answer to the previous question was NO. If the answer was YES, indicate if the IRB review is pending. If IRB has been approved enter the approval date. If exempt from IRB approval enter the exemption numbers corresponding to one or more of the exemption categories. See: http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm for a list of the six categories of research that qualify for exemption from coverage by the regulations are defined in the Common Rule for the Protection of Human Subjects.
For Human Subject Assurance Number enter the IRB approval number OR the approved Federal Wide Assurance ( FWA) , multiple project assurance (MPA) , Single Project Assurance(SPA) Number or Cooperative Project Assurance Number that the applicant has on file with the Office of Human Research Protections, if available.
2. Are Vertebrae Animals Used
If activities using vertebrae animals are planned at any time during the proposed project at any performance site check the YES box; otherwise check NO and proceed to step 3.
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2 a. If YES to Vertebrae animals
Indicate if the IACUC review is pending by checking YES in this field otherwise check NO. Enter the IACUC approval Date in the approval date field leave blank if approval is pending.For Animal Welfare Assurance Number , enter the Federally approved assurance number if available
3. Is Proprietary /Privileged Information Included in the Application
Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosure of which may harm the applicant, should be included in the application only when such information is necessary to convey an understanding of the proposed project. If the application includes such information, check the YES box and clearly mark each line or paragraph of the pages containing proprietary/privileged information with a legend similar to: “the following contains proprietary /privileged information that (name of applicant) requests not be released to persons outside the Government, except for purposes of review and evaluation.
4a. Does this project have an actual or potential impact on the environment?
If your project will have an actual or potential impact on the environment check the YES box and explain in the box provided in 4b. Otherwise check NO and proceed to question 5a.
4.b. If yes, please explain
If you checked the YES box indicating an actual or potential impact on the environment, enter the explanation or the actual or potential impact on the environment here.
4c. If this project has an actual or potential impact on the environment has an exemption been authorized or an Environmental Assessment (EA) or an Environmental Impact Statement (EIS) been performed?
If an exemption has been authorized or an EA or EIS has been performed check the YES box in 4d. Otherwise check the NO box.
4d. If yes please explain
If you checked the YES box indicating an exemption has been authorized or an EA or EIS has been performed, enter the explanation.
5a. Does the project involve activities outside of the U.S. or partnership with international collaborators?
If your project involves activities outside of the U.S. or partnerships with international collaborators check the YES box and list the countries in the box provided in 5b and an optional explanation in box 5c. Otherwise check NO and proceed to item 6.
5b. If yes Identify Countries
If the answer to 5a is YES – identify the countries with which international cooperative activities are involved.
5c. Optional explanation
Use this box to provide any supplemental information, if necessary. If necessary you can provide the information as an attachment by clicking “Add Attachment” to the right of Item 11 below.
6. Project Summary/ Abstract
Please refer to the guidance for instructions regarding the information to include in the project summary/abstract. The project summary must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of the objectives and methods employed. The summary must NOT include any proprietary/confidential information.
If applying electronically attach the summary/abstract by clicking on “Add Attachment” and browse to where you saved the file on your computer and attach.
7. Project Narrative Provide the project narrative in accordance with the program
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guidance/announcement and/or agency/program specific instructions. If you are applying electronically, to attach project narrative click “Add Attachment,” browse to where you saved the file, select the file, and click to attach. .
8. Bibliography and References Cited
Provide a bibliography of any references cited in the Project Narrative. Each reference must include the names of all authors (in the sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers and year of publication. Include only bibliographic citations. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of this application. If applying electronically – attach the bibliography by clicking “Add Attachment” on line 8.
9. Facilities and Other Resources
This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their pertinent capabilities, relative proximity and extent of availability to the project (e.g. machine shop, electronic shop), and the extent to which they would be available to the project.
To attach a Facilities and Other Resources file, click Add Attachment, browse to where you saved the file, select the file and then click open.
10. Equipment List major items of equipment already available for this project and if appropriate identify location pertinent capabilities. To attach an Equipment file click “Add Attachment “ and select the file to be attached.
11. Other Attachments Attach a file to provide any program specific forms or requirements not provided elsewhere in the application in accordance with the agency or program specific guidance. Click “Add Attachment” and select the file for attachment from where you saved the file.
ATTACHMENTS FORM
Use this form to add files/attachments required in the program guidance whose location has not been specified elsewhere in the application package. Use the first line item to attach the file with information on your organization’s Business Official. Name this file BUSINESS OFFICIAL INFORMATION. Attach other files as required in the program guidance.
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Appendix D: Sample Forms
Biographical Sketch Targeted/Planned Enrollment Table Additional Senior/Key Person Profile(s) Additional Location(s) for the Project/Performance Site Locations
BIOGRAPHICAL SKETCHProvide the following information for the key personnel and other significant contributors.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME POSITION TITLE
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eRA COMMONS USER NAME
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION DEGREE(if applicable) YEAR(s) FIELD OF STUDY
Please refer to the application instructions in order to complete sections A, B, and C of the Biographical Sketch
Targeted/Planned Enrollment Table
This report format should NOT be used for data collection from study participants.
Study Title: __________________________________________________________________
Total Planned Enrollment: ______________________________________________________
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TARGETED/PLANNED ENROLLMENT: Number of Subjects
Ethnic Category Sex/GenderFemales Males Total
Hispanic or Latino
Not Hispanic or Latino
Ethnic Category: Total of All Subjects *
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
Racial Categories: Total of All Subjects *
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”
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To list Additional Senior/Key Person Profile(s) for the Senior/Key Person Profile(s) Component, use the format provided below. You can copy the informational table as many times as needed, or delete tables that are not needed. Follow the instructions provided for Senior/Key Person [n] Profile, indicating the number of the profile. You must enter the Prefix, Suffix, State, Country, and Project Role, rather than selecting from a list.
Please delete these instructions before attaching this file to your Senior/Key Person Profile(s) Component.
PROFILE – Senior/Key PersonPrefix *First Name Middle Name *Last Name Suffi
x
Position/Title: Department:Organization Name:Division:*Street1: Street2:*City: County:*State: *Zip Code: *Country:*Phone Number: Fax Number:*E-Mail:Credential, e.g., agency login:*Project Role: Other Project Role Category:
PROFILE – Senior/Key PersonPrefix *First Name Middle Name *Last Name Suffi
x
Position/Title: Department:Organization Name:Division:*Street1: Street2:*City: County:*State: *Zip Code: *Country:*Phone Number: Fax Number:*E-Mail:Credential, e.g., agency login:*Project Role: Other Project Role Category:
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To list Additional Location(s) for the Project/Performance Site Locations Component, use the format provided below. You can copy the informational table as many times as needed, or delete tables that are not needed. Follow the instructions provided for Project/Performance Site Locations, except you must enter the Site Location number, and enter the State and Country rather than selecting from a list.
Please delete these instructions before attaching this file to your Project/Performance Site Locations Component.
Project/Performance Site LocationOrganization Name:*Street1:Street2:*City: County:*State: *ZIP Code: *Country:
Project/Performance Site LocationOrganization Name:*Street1:Street2:*City: County:*State: *ZIP Code: *Country:
Project/Performance Site LocationOrganization Name:*Street1:Street2:*City: County:*State: *ZIP Code: *Country:
Project/Performance Site LocationOrganization Name:*Street1:Street2:*City: County:*State: *ZIP Code: *Country:
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Appendix E: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan
Preparing the Human Subjects Research Section of the Research PlanIn the Human Subjects Research section of the Research Plan, you must provide sufficient information for reviewers to determine that the proposed research meets (1) the requirements of the HHS regulations to protect human subjects from research risks (45 CFR Part 46), (2) the requirements of NIH policies for data and safety monitoring of clinical trials, and (3) the requirements of NIH policies on inclusion of women, minorities, and children. See Instructions Pertaining to Non-Exempt Human Subjects Research.
If the research is exempt from the requirements in the Federal regulations, you must provide a justification for the exemption with sufficient information about the involvement of the human subjects to allow a determination by peer reviewers and NIH staff that claimed exemption(s) is/are appropriate. See Exempt Human Subjects Research.
Applications must comply with this requirement; if not, application processing may be delayed or the application may be returned to the applicant without review.
For all research involving human subjects, a part of the peer review process will include careful consideration of protections from research risks, as well as the appropriate inclusion of women, minorities, and children. The Scientific Review Group (SRG) will assess the adequacy of safeguards of the rights and welfare of research participants, and the appropriate inclusion of women, minorities, and children, based on the information in the application.
To assist you in completing the Research Plan (Human Subjects Research), we have provided six possible scenarios. All research will fall into one of these six scenarios. Determining which scenario best matches your proposed research depends on your answers to the following five questions:
Question 1: Does your proposed research involve human subjects?
Question 2: Does your proposed human subjects research meet the criteria for one or more of the exemptions in the HHS regulations (45 CFR Part 46)?
Question 3: Does your proposed research meet the definition of clinical research?
Question 4: Does your proposed research include a Clinical Trial?
Question 5: Does your proposed research meet criteria for an NIH-Defined Phase III Clinical Trial?
Click on the questions and when you can answer the five questions, select the scenario that best matches your responses, and then follow the instructions provided for the scenario you choose.
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Decision Table for Human Subjects Research, Protection and the Inclusion of Women, Minorities, and Children
Criteria and Answers to Questions 1 thru 5
Scenarios with linked instructions
1. Human Subjects Research
2. Exempt from HHS Human Subjects Regulations
3. Clinical Research
4. Clinical Trial
5. NIH-Defined Phase III Clinical Trial
ANo Human Subjects
No N/A N/A N/A N/A
Requirements for Scenario A: If Human Subjects is “Yes,” see Scenarios B-F below.BHuman Subjects/E-4
Yes Yes Exemption: 4 No N/A N/A
Requirements for Scenario B:- Indicate Exemption 4 (E-4) and include justification that E-4 is appropriate.CHuman Subjects/ Other Exemptions
YesYes Exemptions:
1, 2, 3, 5, 6Yes N/A N/A
Requirements for Scenario C:- Indicate Exemption number(s) and include justification that the designated exemption(s) is appropriate.- Address “Inclusion of Women and Minorities”- Address “Inclusion of Children”DClinical Research
Yes No Yes No N/A
Requirements for Scenario D:- Address Protection of Human Subjects- Address “Inclusion of Women and Minorities”- Address “Inclusion of Children”“Targeted/Planned Enrollment Table(s)” for each new study/ protocol (New applications; Competing Renewal applications; Competing Revisions (Supplements))- “Inclusion Enrollment Report Table(s)” (Competing Renewals; Competing Revisions (Supplements))EClinical Trials
Yes No Yes Yes No
Requirements for Scenario E:- All requirements in Scenario D- Data and Safety Monitoring Plan- Note: Some trials may require a Data and Safety Monitoring Board, based on risk
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Criteria and Answers to Questions 1 thru 5
Scenarios with linked instructions
1. Human Subjects Research
2. Exempt from HHS Human Subjects Regulations
3. Clinical Research
4. Clinical Trial
5. NIH-Defined Phase III Clinical Trial
FNIH-Defined Phase III Clinical Trial
Yes No Yes Yes Yes
Requirements for Scenario F:- All requirements in Scenario EIncreased requirements for Inclusion of Women and Minorities in Clinical Research
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HUMAN SUBJECTS RESEARCH
Question 1: Does your proposed research involve human subjects? The first thing you must determine is whether or not your research involves human subjects, either at the applicant organization or at any other performance site or collaborating institution (e.g., subcontractors, consultants).
The research described in your application may include more than one research project; thus the application may include individual projects that meet the requirements for non-exempt or exempt human subjects research, or are not defined as human subjects research.
If research activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution, then your answer is “Yes” even if the research is exempt from regulations for the protection of human subjects.
The HHS regulations “Protection of Human Subjects” (45 CFR Part 46, administered by OHRP) define a human subject as a living individual about whom an investigator conducting research obtains:
data through intervention or interaction with the individual or
identifiable private information
Research that involves obtaining private information or human biological specimens (such as blood and tissue samples) that can be linked by the investigator(s) to living individuals is considered human subjects research.
Research that involves only coded private information/data or coded human biological specimens may or may not constitute human subjects research under the HHS human subjects regulations (45 CFR 46).
Investigator: The OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. However, if the individuals who provide coded information or specimens also collaborate on other activities related to the conduct of the research with the investigators who receive such information or specimens, they will be considered to be involved in the conduct of the research. [OHRP’s Coded Specimen Guidance]
Research: HHS regulations define research at 45 CFR 46.102(d) as follows:Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Obtains: In its guidance for use of coded specimens, OHRP has determined that under the definition of human subject at 45 CFR 46.102(f), obtaining identifiable private information or identifiable specimens for research purposes constitutes human subjects research. Obtaining means receiving or accessing identifiable private information or identifiable specimens for research purposes. OHRP interprets obtaining to include an investigator’s use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the investigator.
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Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. (45 CFR 46.102(f))
Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102(f))
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102(f))
Individually Identifiable Private Information: According to its guidance for use of coded specimens, OHRP generally considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Conversely, OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Research Using Human Specimens or Data: Regulatory requirements (Federal and state) to protect human subjects apply to a much broader range of research than many investigators realize, and researchers using human specimens and/or data are often unsure about how regulations apply to their research. Regulatory obligations to protect human subjects would apply, for example, to research that uses –
Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, from living individuals who are individually identifiable to the investigator(s), even if these materials were collected by others;
Residual diagnostic specimens from living individuals that are individually identifiable to the investigator(s), including specimens obtained for routine patient care that would have been discarded if not used for research;
Private information, such as medical information, about living individuals that is individually identifiable to the investigator(s), even if the information was not specifically collected for the study in question. This includes research on genetic information that can be readily associated by the investigator(s) with identifiable living individuals.
The definition of “human subject” includes, but is not limited to, human organs, tissues, and body fluids from living individuals, well as private graphic, written, or recorded information about living individuals, if (1) there is interaction or intervention with a living individual to obtain the specimens or data for research purposes, or (2) the identity of the subjects can be readily ascertained by the investigator or other members of the research team.
Research that involves only coded private information/data or coded human biological specimens may not constitute human subjects research under the HHS human subjects regulations (45 CFR Part 46) if:
the specimens and/or private information were not collected specifically for the currently proposed research project through an interaction/intervention with living individuals AND
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the investigator(s) (including collaborators) on the proposed research cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (e.g., the researcher’s access to subject identities is prohibited by written repository procedures and policies and/or through an agreement signed between the recipient researcher and the repository providing the specimens and/or data). [See definitions below and the following guidance from the Office for Human Research Protections (OHRP) for additional information and examples: http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf.]
Individuals who provide coded information or specimens for proposed research and who also collaborate on the research involving such information or specimens are considered to be involved in the conduct of human subjects research.
Coded: With respect to private information or human biological specimens, coded means that:
1. Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof (i.e., the code); and
2. A key to decipher the code exists, enabling linkage of the identifying information with the private information or specimens.
You may find it helpful to consult the following guidance from OHRP:
OHRP Decision Charts: http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
OHRP Policy on Coded Specimens and Data: http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf
OHRP Guidance on Repositories: http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm; http://www.hhs.gov/ohrp/humansubjects/guidance/guid1223.pdf
With regard to the engagement of performance sites in proposed human subjects research, you may find it helpful to consult the following:
OHRP Memo on Engagement: http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm
The decisions about when research involving human specimens and/or data from subjects is considered human subjects research are complex. The OHRP recommends that institutions have policies in place that designate the individual or entity authorized to determine whether proposed research is exempt from regulatory requirements to protect human subjects and that determinations should be made by someone other than the investigator.
You need to be aware that the involvement of human subjects in non-exempt research must be approved by your IRB prior to award.
The NIH Office of Extramural Research Human Subjects website contains additional information and Frequently Asked Questions that may help investigators understand how these regulations and Guidance documents apply to their research. See http://grants.nih.gov/grants/policy/hs/index.htm.
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How can you determine whether research that involves only the use of specimens and/or data from pathology archives or a specimen bank and/or data repository is human subjects research?
The research described in your application may include more than one research project; thus the application may include separate projects that meet the requirements for either human subjects research, exempt human subjects research, or are not defined as human subjects research. Examples are provided below:
If the specimens and/or data were obtained specifically for the currently proposed research project through intervention or interaction with a living individual, then your research is human subjects research.
If you receive or have access to individually identifiable specimens or data from living individuals (e.g., pathology or medical records), your proposed research is human subjects research.
If you receive or have access to existing individually identifiable private information or identifiable specimens from living individuals (e.g., pathology or medical records), but you as the investigator or your collaborator record the information in such a manner that you cannot subsequently access or obtain direct or indirect identifiers that are linked to the subjects the research project that you conduct using data recorded in this manner meets the requirements of Exemption 4. If you will retain or can access any identifiers, the research project is not exempt under Exemption 4.
If you are using specimens and/or data and neither you nor your collaborators can identify the subjects from whom the specimens and/or data were obtained either directly or indirectly through coding systems, the HHS human subjects regulations (45 CFR Part 46) do not apply at all.
If your research involves only coded private information/data or coded specimens, OHRP does not consider this research to involve human subjects as defined under the HHS Protection of Human Subjects Regulations (45 CFR Part 46.102(f)) if the following conditions are both met:
o the private information/data or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
o the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
(a) the key to decipher the code is destroyed before the research begins; (b) the investigators and the holder of the key enter into an agreement prohibiting the
release of the key to the investigators under any circumstances, until the individuals are deceased;
(c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
(d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
What is not human subjects research under HHS regulations at 45 CFR Part 46?
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Research that does not involve intervention or interaction with living individuals, or identifiable private information is not human subjects research (see definitions),
Research that only proposes the use of cadaver specimens is not human subjects research, because human subjects are defined as “living individuals.” The use of cadaver specimens is not regulated by 45 CFR Part 46, but may be governed by other Federal, state and local laws.
Guidance and Additional Instructions If you answered “No” to Question 1, then proceed to Scenario A.
If you answered “Yes” to Question 1, then you may need to determine whether your research meets the criteria for an exemption from the Human Subjects Protection requirements. Proceed to Question 2.
If you need to consider an alternative scenario, return to the Decision Table.
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EXEMPT HUMAN SUBJECTS RESEARCH
Question 2: Does your proposed human subjects research meet the criteria for one or more of the exemptions in the HHS regulations (45 CFR Part 46)? Some human subjects research is exempt from the HHS regulations (45 CFR Part 46). OHRP guidance states that Exemptions should be independently determined (http://www.hhs.gov/ohrp/humansubjects/guidance/irb71102.pdf). Institutions often designate their IRB to make this determination. Because NIH does not require IRB approval at time of application, the exemptions designated in Item 1a of the Other Project Information Component often represent the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is evaluated during peer review.
The research described in your application may include more than one research project; thus the application may include individual projects that meet the requirements for non-exempt or exempt human subjects research, or are not defined as human subjects research.
If research activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution, then your answer is “Yes” to Question 1 “Does your proposed research involve human subjects” even if the research is exempt from regulations for the protection of human subjects.
Research involving individuals who are or who become prisoners cannot be exempt under any exemption categories (see 45 CFR Part 46 Subpart C).
Your human subjects research is exempt if all of the proposed research meets the criteria for one or more of the following six exemptions.
Exemption 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exemption 2: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
Exemption 2 for research involving survey or interview procedures or observation of public behavior, does not apply to research with children (see 45 CFR Part 46, Subpart D), except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
Exemption 3: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
Exemption 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the
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information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
The humans subjects regulations decision charts (http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm) from the Office of Human Research Protection (OHRP) will help you to see whether your research falls under the human subjects regulations and if so, whether it meets the criteria for Exemption 4. See also the information contained at: Exemption 4 Guidance and Information.
The NIH Office of Extramural Research website also contains information that is helpful for determining whether your human subjects research meets the criteria for Exemption 4. See http://grants.nih.gov/grants/policy/hs/index.htm.
Research that meets the criteria for Exemption 4 is not considered “clinical research” as defined by NIH. Therefore the NIH policies for inclusion of women, minorities and children in clinical research do not apply to research projects covered by Exemption 4.
Exemption 5: Research and demonstration projects that are conducted by or subject to the approval of Department or Agency heads and that are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs (ii) procedures for obtaining benefits or services under those programs (iii) possible changes in or alternatives to those programs or procedures or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Exemption 6: Taste and food quality evaluation and consumer acceptance studies (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical, or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
Guidance and Additional Instructions If you answered “Yes” to Question 2, then your research meets the criteria for an exemption.
If your research meets the criteria for Exemption 4, then follow the instructions for Scenario B and read the information contained in Exemption 4 Guidance and Information.
If your research meets the criteria for any of the other five exemptions, follow the instructions for Scenario C.
Remember that you need to identify which exemption(s) you believe is applicable to your research, and provide a justification for the exemption(s) with sufficient information about the involvement of human subjects to allow a determination by peer reviewers and NIH staff that the claimed exemption(s) is appropriate.
If you answered “No” to Question 2, then your research does not qualify for one of the exemptions, and your research is not exempt from full IRB review. Proceed to Question 3.
If you need to consider an alternative scenario, return to the Decision Table.
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CLINICAL RESEARCH
Question 3: Does your proposed research meet the definition of clinical research? The NIH defines Clinical Research as:
(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
(2) Epidemiologic and behavioral studies.
(3) Outcomes research and health services research.
Clinical research that does not meet the criteria for a clinical trial or an NIH-defined Phase III clinical trial must follow the instructions in Scenario D.
Research projects that meet the criteria for Exemption 4 are not considered “clinical research.” Investigators who propose research that meets the criteria for Exemption 4 must follow the instructions provided in Scenario B.
Guidance and Additional Instructions If you answered “Yes” to Question 3, then proceed to Question 4 and Question 5 to determine whether your research meets the criteria for a clinical trial or an NIH-defined Phase III clinical trial.
If you answered “No,” then you need to consider an alternative Scenario. Return to the Decision Table.
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CLINICAL TRIAL
Question 4: Does your proposed research include a clinical trial? The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits these criteria of a clinical trial.
Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision-making for the subject or the test itself imposes more than minimal risk for subjects.
Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:
Phase I clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range, and to identify side effects).
Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
Guidance and Additional Instructions If you answered “Yes” to Question 4, then you will need to provide a general description of a Data and Safety Monitoring Plan. See Scenario E.
Also continue to Question 5 to determine whether your research meets the criteria for an NIH-defined Phase III clinical trial.
If you answered “Yes” to Question 3 (Clinical Research) and “No” to Question 4 (Clinical Trial), then follow the instructions for Scenario D.
If you answered “No” to Question 4, you will need to consider an alternative scenario. Return to the Decision Table.
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NIH-DEFINED PHASE III CLINICAL TRIAL
Question 5: Does your proposed research meet criteria for an NIH-Defined Phase III Clinical Trial? An NIH-Defined Phase III Clinical Trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of either evaluating an experimental intervention in comparison with a standard or control intervention or of comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
If your research meets the above criteria, then in addition to providing a Data and Safety Monitoring Plan, you will be expected to address whether you expect to find clinically important sex/gender and/or race/ethnicity differences in the intervention effect. The discussion may include supporting evidence and/or data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology, and other relevant studies.
You will be expected to provide a Research Plan that must include one of the following plans:
Plans to conduct valid analyses to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR
Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender and racial/ethnic groups is not required as subject selection criteria, but inclusion is encouraged.), OR
Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.
Guidance and Additional Instructions If you answered “Yes” to Question 5, then follow the instructions for Scenario F.
If you answered “No,” then you need to consider an alternative Scenario. Return to the Decision Table.
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EXEMPTION 4 GUIDANCE AND INFORMATION
Research that meets the criteria for Exemption 4 is Human Subjects Research, but it is not considered clinical research.
Exemption 4 includes research projects involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
What is meant by “existing” data or specimens? Exemption 4 applies to retrospective studies of specimens and/or data that have already been collected. The materials must be “on the shelf” (or in the freezer) at the time the protocol is submitted to the IRB or other designated officials at your institution to determine whether the research is indeed exempt. Research that involves the ongoing collection of specimens and/or data does not meet the criteria for Exemption 4.
What is meant by “publicly available sources”? This language in the regulation was intended to apply to public sources of data, such as census data. Its meaning with respect to human tissue specimens is widely debated. Although there are organizations that make human cells and tissues broadly accessible to the research community, these materials are not usually available to the public at large and are not generally considered to be publicly available.
What is meant by “identifiers linked to the subjects”? Identifiers, such as names, social security numbers, medical record numbers, or pathology accession numbers, or other codes that permit specimens to be linked to living individuals and perhaps also to associated medical information.
How can I determine whether my research meets the criteria for Exemption 4? The humans subjects regulations decision charts (http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm) from the Office of Human Research Protection (OHRP) will help you to see whether your research falls under the human subjects regulations and if so, whether a research project meets the criteria for Exemption 4.
OHRP advises that investigators should not have the authority to make an independent determination that research involving human subjects is exempt. OHRP guidance states that Exemptions should be independently determined (http://www.hhs.gov/ohrp/humansubjects/guidance/irb71102.pdf). Institutions often designate their IRB to make this determination. Because NIH does not require IRB approval at time of application, the exemptions designated in Item 1a of the Other Project Information Component often represent the opinion of the PD/PI, and the justification(s) provided by the PD/PI for the exemption(s) is/are evaluated during peer review.
Information is also available on the NIH Office of Extramural Research website at http://grants.nih.gov/grants/policy/hs/index.htm.
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How can you determine whether research that involves only the use of specimens and/or data from pathology archives or a specimen bank and/or data repository is human subjects research?The research described in your application may include more than one research project; thus the application may include separate projects that meet the requirements for either human subjects research, exempt human subjects research, or are not defined as human subjects research. Examples are provided below:
If the specimens and/or data were obtained specifically for the currently proposed research project through intervention or interaction with a living individual, then your research is human subjects research.
If you receive or have access to individually identifiable specimens or data from living individuals (e.g., pathology or medical records), your proposed research is human subjects research.
If you receive or have access to existing individually identifiable private information or identifiable specimens from living individuals (e.g., pathology or medical records), but you as the investigator or your collaborator record the information in such a manner that you cannot subsequently access or obtain direct or indirect identifiers that are linked to the subjects the research project that you conduct using data recorded in this manner meets the requirements of Exemption 4. If you will retain or can access any identifiers, the research project is not exempt under Exemption 4.
If you are using specimens and/or data and neither you nor your collaborators can identify the subjects from whom the specimens and/or data were obtained either directly or indirectly through coding systems, the HHS human subjects regulations (45 CFR Part 46) do not apply at all.
If your research involves only coded private information/data or coded specimens, OHRP does not consider this research to involve human subjects as defined under the HHS Protection of Human Subjects Regulations (45 CFR Part 46.102(f)) if the following conditions are both met:
o the private information/data or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
o the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
(a) the key to decipher the code is destroyed before the research begins; (b) the investigators and the holder of the key enter into an agreement prohibiting the
release of the key to the investigators under any circumstances, until the individuals are deceased;
(c) there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
(d) there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
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Guidance and Additional Instructions If your research meets the criteria for Exemption 4, refer to Scenario B.
If you need to consider an alternative scenario, return to the Decision Table.
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INSTRUCTIONS PERTAINING TO NON-EXEMPT HUMAN SUBJECTS RESEARCH
In your PHS398 Research Plan Component, include attachments for Items 8 through 11, if required. Although no specific page limitation applies to this section of the application, be succinct. Scientific Review Groups will assess each application as being “acceptable” or “unacceptable” with regard to the protection of human subjects.
In the attachment for Item 8, include a heading entitled “Protection of Human Subjects.” Use subheadings to address the issues listed under items 1- 5 below.
Protection of Human Subjects
1. RISKS TO THE SUBJECTS
a. Human Subjects Involvement and Characteristics
Describe the proposed involvement of human subjects in the work outlined in the Research Design and Methods section.
Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
Identify the criteria for inclusion or exclusion of any subpopulation.
Explain the rationale for the involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. Note that ‘prisoners’ includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins.
List any collaborating sites where human subjects research will be performed, and describe the role of those sites in performing the proposed research.
b. Sources of Materials
Describe the research material obtained from living human subjects in the form of specimens, records, or data.
Describe any data that will be recorded on the human subjects involved in the project.
Describe the linkages to subjects, and indicate who will have access to subject identities.
Provide information about how the specimens, records, or data are collected and whether material or data will be collected specifically for your proposed research project.
c. Potential Risks
Describe the potential risks to subjects (physical, psychological, social, legal, or other), and assess their likelihood and seriousness to the subjects.
Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed research.
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2. ADEQUACY OF PROTECTION AGAINST RISKS
a. Recruitment and Informed Consent
Describe plans for the recruitment of subjects (where appropriate) and the process for obtaining informed consent. If the proposed studies will include children, describe the process for meeting requirements for parental permission and child assent.
Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent. Informed consent document(s) need not be submitted to the PHS agencies unless requested.
b. Protection Against Risk
Describe planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and assess their likely effectiveness.
Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects.
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS
Discuss the potential benefits of the research to the subjects and others.
Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and others.
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED
Discuss the importance of the knowledge gained or to be gained as a result of the proposed research.
Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.
NOTE: Test articles (investigational new drugs, devices, or biologicals) including test articles that will be used for purposes or administered by routes that have not been approved for general use by the Food and Drug Administration (FDA) must be named. State whether the 30-day interval between submission of applicant certification to the FDA and its response has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration, and/or the status of requests for an IND or IDE covering the proposed use of the test article in the Research Plan.
5. DATA AND SAFETY MONITORING PLAN
If your research includes a clinical trial, create a subheading entitled “Data and Safety Monitoring Plan.”
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Provide a general description of a monitoring plan that you plan to establish as the overall framework for data and safety monitoring. Describe the entity that will be responsible for monitoring and the process by which Adverse Events (AEs) will be reported to the Institutional Review Board (IRB), the funding I/C, the NIH Office of Biotechnology Activities (OBA), and the Food and Drug Administration (FDA) in accordance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) regulations. Be succinct. Contact the FDA (http://www.fda.gov/) and also see the following websites for more information related to IND and IDE requirements:http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr312_01.html (IND)http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr812_01.html (IDE)
The frequency of monitoring will depend on potential risks, complexity, and the nature of the trial; therefore, a number of options for monitoring trials are available. These can include, but are not limited to, monitoring by a:
a. PD/PI (required)
b. Independent individual/Safety Officer
c. Designated medical monitor
d. Internal Committee or Board with explicit guidelines
e. Data and Safety Monitoring Board (DSMB). NIH specifically requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trails. Although Phase I and Phase II clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.
f. Institutional Review Board (IRB - required)
A detailed Data and Safety Monitoring Plan must be submitted to the applicant’s IRB and subsequently to the funding IC for approval prior to the accrual of human subjects (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html). For additional guidance on creating this Plan, see the above reference.
Guidance and Additional Instructions Proceed to Inclusion of Women and Minorities.
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INCLUSION OF WOMEN AND MINORITIES
In the attachment for Item 9, include a heading entitled “Inclusion of Women and Minorities.” Although no specific page limitation applies to this section of the application, be succinct.
Scientific Review Groups will assess each application as being “acceptable” or “unacceptable” with regard to the protection of human subjects.
In this section of the Research Plan, address, at a minimum, the following four points:
1. The targeted/planned distribution of subjects by sex/gender and racial/ethnic groups for each proposed study or protocol using the format in the Targeted/Planned Enrollment Table. (Instructions for completing this table are provided below.) If you are using existing specimens and/or data that does not meet the criteria for Exemption 4 and you do not have access to information on the distribution of women and minorities, so state and explain the impact on the goals of the research as part of the rationale that inclusion is inappropriate (item 3 below). Alternatively, you may describe the women and minority composition of the population base from whom the specimens and/or data will be obtained. Include the Targeted/Planned Enrollment Table in Item 10.
2. A description of the subject selection criteria and rationale for selection of sex/gender and racial/ethnic group members in terms of the scientific objectives and proposed study design. The description may include, but is not limited to, information on the population characteristics of the disease or condition under study.
3. A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group (see examples below).
4. A description of proposed outreach programs for recruiting sex/gender and racial/ethnic group members as subjects.
Examples of acceptable justifications for exclusion of:
A. One gender:
1. One gender is excluded from the study because:
inclusion of these individuals would be inappropriate with respect to their health;
the research question addressed is relevant to only one gender;
evidence from prior research strongly demonstrates no difference between genders;
sufficient data already exist with regard to the outcome of comparable studies in the excluded gender, and duplication is not needed in this study.
2. One gender is excluded or severely limited because the purpose of the research constrains the applicant’s selection of study subjects by gender (e.g., uniquely valuable stored specimens or existing datasets are single gender; very small numbers of subjects are involved; or overriding factors dictate selection of subjects, such as matching of transplant recipients, or availability of rare surgical specimens).
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3. Gender representation of specimens or existing datasets cannot be accurately determined (e.g., pooled blood samples, stored specimens, or data-sets with incomplete gender documentation are used), and this does not compromise the scientific objectives of the research.
B. Minority groups or subgroups:
1. Some or all minority groups or subgroups are excluded from the study because:
Inclusion of these individuals would be inappropriate with respect to their health;
The research question addressed is relevant to only one racial or ethnic group;
Evidence from prior research strongly demonstrates no differences between racial or ethnic groups on the outcome variables;
A single minority group study is proposed to fill a research gap;
Sufficient data already exists with regard to the outcome of comparable studies in the excluded racial or ethnic groups and duplication is not needed in this study.
2. Some minority groups or subgroups are excluded or poorly represented because the geographical location of the study has only limited numbers of these minority groups who would be eligible for the study, and the investigator has satisfactorily addressed this issue in terms of:
The size of the study;
The relevant characteristics of the disease, disorder or condition;
The feasibility of making a collaboration or consortium or other arrangements to include representation.
Some minority groups or subgroups are excluded or poorly represented because the purpose of the research constrains the applicant’s selection of study subjects by race or ethnicity (e.g., uniquely valuable cohorts, stored specimens or existing datasets are of limited minority representation, very small numbers of subjects are involved, or overriding factors dictate selection of subjects, such as matching of transplant recipients or availability of rare surgical specimens).
3. Racial or ethnic origin of specimens or existing datasets cannot be accurately determined (e.g., pooled blood samples, stored specimens or data sets with incomplete racial or ethnic documentation are used) and this does not compromise the scientific objectives of the research.
Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are ProposedIf your proposed research includes an NIH-Defined Phase III Clinical Trial, the section on Inclusion of Women and Minorities also must address whether you expect to find clinically important sex/gender and/or race/ethnicity differences in the intervention effect. The discussion may include supporting evidence and/or data derived from prior animal studies, clinical observations, metabolic studies, genetic studies, pharmacology studies, and observational, natural history, epidemiology and other relevant studies. Your discussion of expected sex/gender and/or race/ethnicity differences in intervention effect must include selection and discussion of one of the following analysis plans:
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Plans to conduct valid analyses to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, or
Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender and racial/ethnic groups is not required as subject selection criteria, but inclusion is encouraged.), or
Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.
Instructions for Completing the Targeted/Planned Enrollment Tables for Reporting Race and Ethnicity Data for Subjects in Clinical Research If your application includes Targeted/Planned Enrollment tables, save all as a single PDF file and attach them using section 10. Targeted/Planned Enrollment of the PHS 398 Research Plan Component.
A. New Applications and Clinical Research Studies begun after January 10, 2002:
All new clinical research studies should collect and report information on participants with respect to two categories of ethnicity and five categories of race. The new Inclusion Enrollment Report Table (http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc) for reporting summary data on participants to NIH includes two categories of ethnicity and five categories of race and is based on recent changes by the Office of Management and Budget (OMB) regarding standards for data on race and ethnicity. Investigators should review the instructions and Frequently Asked Questions about using the new Enrollment Table format at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
When reporting these data in the aggregate, investigators should report: (a) the number of respondents in each ethnic category; (b) the number of respondents who selected only one category for each of the five racial categories; (c) the total number of respondents who selected multiple racial categories reported as the “number selecting more than one race,” and (d) the number of respondents in each racial category who are Hispanic or Latino. Investigators may provide the detailed distributions, including all possible combinations, of multiple responses to the racial designations as additional information. However, more detailed items should be designed in a way that they can be aggregated into the required categories for reporting purposes.
For new applications and clinical research studies begun after January 10, 2002, complete the Targeted/Planned Enrollment Table (http://grants.nih.gov/grants/funding/424/SF424R-R_enrollment.doc) and attach as Item 10.
Provide the study title.
The “Total Planned Enrollment” means the number of subjects that are expected to be enrolled during the entire period of the study and are needed to evaluate the research question The “Total Planned Enrollment” will be reported in two ways in the table: by “Ethnic Category” and by “Racial Categories.”
“Ethnic Category”: Provide the numeric distribution of the Total Planned Enrollment according to ethnicity and sex/gender in the top part of the table.
“Racial Categories”: Provide the numeric distribution of the Total Planned Enrollment, this time by racial categories and sex/gender, in the bottom part of the table. Note that Hispanic is not a racial category.
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If there is more than one study/protocol, provide a separate table for each.
List any proposed racial/ethnic subpopulations below the table.
How should I report race and ethnicity data when my research involves a foreign population?
Investigators are encouraged to design their data collection instruments in ways that allow respondent self-identification of their racial and ethnic affiliation. However, these items should be designed in a way that they can be aggregated into the required categories. Also, the investigator can report on any racial/ethnic subpopulations by listing this information in an attachment to the required table. This may be particularly useful when distinctive subpopulations are relevant to the scientific hypotheses being studied.
When completing the tables, investigators should asterisk and footnote the table indicating that data includes foreign participants. If the aggregated data only includes foreign participants, the investigator should provide information in one table with an asterisk and footnote. However, if the study includes both domestic and foreign participants, the investigator should complete two separate tables – one for domestic data and one for foreign data, with an asterisk and footnote accompanying the table with foreign data.
B. Clinical Research Studies begun before January 10, 2002:
If the proposed research uses existing data, then use the formats below for competing continuations (now known as “Renewals”) and competing supplements (now known as “Revisions”). Investigators should review the instructions and Frequently Asked Questions about using the new Enrollment Table format at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
Competing Continuations (now known as “Renewals”): For renewal applications involving the collection of new/additional clinical data, use the “Targeted/Planned Enrollment Table” and the instructions above. Note: If you choose to report information with the new Targeted/Planned Enrollment Table, you must continue to use this format for the remaining years of the project.
For renewal applications involving studies begun before January 10, 2002 that do not involve the collection of new/additional clinical data, the data on ethnicity/race and sex/gender may be presented in EITHER the Targeted/Planned Enrollment Table OR the 4/98 Version of the Inclusion Table. If data were originally collected from study subjects using two questions (one about ethnicity and one about race) and subjects were given the option of selecting more than one race, then use the Targeted/Planned Enrollment Table. Otherwise, use the 4/98 Version of the Inclusion Table, which uses a combined race/ethnicity format with five categories.
Competing Supplements (now known as “Revisions”): For revision applications involving studies begun before January 10, 2002, investigators may report ethnicity/race and sex/gender composition using EITHER the Inclusion Enrollment Report OR the 4/98 Version of the Inclusion Table. If data are being collected using two questions (one about ethnicity and one about race) and subjects were given the option of selecting more than one race, then use the Targeted/Planned Enrollment Table. Note: If you choose to report information with the new Targeted/Planned Enrollment Table, you must continue to use this format for the remaining years of the project.
If data are being collected using one question that combines ethnicity and race, use the 4/98 Version of the Inclusion Table. For previously funded studies that used the 4/98 Version of the Inclusion Table the earlier reporting format is NOT directly transferable to the format.
C. What Inclusion/Enrollment Table Should PDs/PIs Use for Reporting Accrual Data to NIH? (New versus Old Table)
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The following instructions apply to progress reports, whether submitted as part of a non-competing or competing application.
Guidelines for choosing the new Inclusion Enrollment Report Table versus the old Inclusion Table are as follows:
New Inclusion Enrollment Report (http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc)
Studies begun after January 10, 2002, must be designed to ask participants two questions, one about their ethnicity and one about their race, and investigators must use the new Inclusion Enrollment Report table format for reporting summary data to NIH.
Project Directors/Principal Investigators (PDs/PIs) who started a study prior to January 10, 2002 using the old Inclusion Table format for reporting summary data to NIH may switch to the new Inclusion Enrollment Report format if they choose to do so, but they must also change their data collection methods to ask two questions (one about ethnicity and another about race) rather than one question (that combined race and ethnicity) for all participants enrolled in the study from that point on.
For studies that began prior to January 10, 2002: When the study is submitted for renewal and plans to collect new/additional data, the PD/PI is required to change to the new standards for collecting data and use the new Inclusion Enrollment Report format for reporting data to NIH. In some cases, this will mean that PDs/PIs will need to re-ask study participants about their race and ethnicity using the new two-question format. Note: PDs/PIs should not ask again about race and ethnicity if the subjects are no longer participating in the study.
Old Inclusion Table (4/98 Version) (http://grants.nih.gov/grants/funding/424/SF424R-R_Inclusion498version.doc)
Studies begun prior to January 10, 2002 (and now in their non-competing Type 5 period) that were structured with one question about race and ethnicity may continue to report enrollment/accrual data to NIH based on the old form, i.e., using five categories of race/ethnicity. However, when they come in for competitive renewal (Type 2), they will need to change to the new standards/new form for any additional data collection.
PDs/PIs should not switch to the new form if only one question about race and ethnicity is used in data collection.
Investigators who have questions about these choices should contact NIH program staff for advice.
Guidance and Additional InstructionsAfter you have completed the Inclusion of Women and Minorities section, proceed to Inclusion of Children.
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INCLUSION OF CHILDREN
In the attachment for Item 11, include a heading entitled “Inclusion of Children.”
For the purpose of implementing these guidelines, a child is defined as an individual under the age of 21 years (for additional information see http://grants.nih.gov/grants/funding/children/children.htm and http://grants.nih.gov/grants/guide/notice-files/not98-024.html).
Provide either a description of the plans to include children or, if children will be excluded from the proposed research, application, or proposal, then you must present an acceptable justification (see below) for the exclusion.
If children are included, the description of the plan should include a rationale for selecting a specific age range of children. The plan also must include a description of the expertise of the investigative team for dealing with children at the ages included, of the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis relative to the purpose of the study.
Scientific Review Groups will assess each application as being “acceptable” or “unacceptable” with regard to the age-appropriate inclusion or exclusion of children in the research project.
When children are involved in research, the Additional Protections for Children Involved as Subjects in Research (45 CFR Part 46 Subpart D) apply and must be addressed in the “Human Subjects Research and Protection from Risks” subheading.
Justifications for Exclusion of Children
For the purposes of this policy, all individuals under 21 are considered children; however, exclusion of any specific age group, such as individuals under 18, should be justified in this section.
It is expected that children will be included in all clinical research unless one or more of the following exclusionary circumstances can be fully justified:
1. The research topic to be studied is not relevant to children.
2. There are laws or regulations barring the inclusion of children in the research.
3. The knowledge being sought in the research is already available for children or will be obtained from another ongoing study, and an additional study will be needlessly redundant. Documentation of other studies justifying the exclusions should be provided. NIH program staff can be contacted for guidance on this issue if the information is not readily available.
4. A separate, age-specific study in children is warranted and preferable. Examples include:
a. The condition is relatively rare in children, as compared to adults (in that extraordinary effort would be needed to include children, although in rare diseases or disorders where the applicant has made a particular effort to assemble an adult population, the same effort would be expected to assemble a similar child population with the rare condition); or
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b. The number of children is limited because the majority are already accessed by a nationwide pediatric disease research network; or
c. Issues of study design preclude direct applicability of hypotheses and/or interventions to both adults and children (including different cognitive, developmental, or disease stages or different age-related metabolic processes). While this situation may represent a justification for excluding children in some instances, consideration should be given to taking these differences into account in the study design and expanding the hypotheses tested, or the interventions planned, to allow inclusion of children rather than excluding them.
5. Insufficient data are available in adults to judge potential risk in children (in which case one of the research objectives could be to obtain sufficient adult data to make this judgment). Although children usually should not be the initial group to be involved in research studies, in some instances, the nature and seriousness of the illness may warrant their participation earlier based on careful risk and benefit analysis.
6. Study designs are aimed at collecting additional data on pre-enrolled adult study subjects (e.g., longitudinal follow-up studies that did not include data on children).
7. Other special cases can be justified by the investigator and found acceptable to the review group and the Institute Director.
Guidance and Additional Instructions After you have completed this section of the application, proceed to Vertebrate Animals.
See Policy on Inclusion of Children.
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SCENARIO A: NO HUMAN SUBJECTS RESEARCH PROPOSED
CriterionIf you are uncertain as to whether your research involves Human Subjects please read: Question 1: Does your proposed research involve human subjects?
InstructionsCheck the box marked “No” on the Other Project Information Component, Item 1.
If your proposed research involves human specimens and/or data from subjects, please provide a justification for your claim that no human subjects are involved by creating a heading labeled “Human Subjects Research” and attach it in Item 8 of the PHS 398 Research Plan Component. (See guidance under Question 1. Does your proposed research involve human subjects?)
Unless you are providing a special justification, no attachment is necessary in Item 8, if no human subjects are involved.
Guidance and Additional Instructions The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research.
Do not follow the instructions for Scenario A if research activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution. You will need to consider an alternative scenario.
If you need to consider an alternative scenario return to the Decision Table.
or
After you have completed this section of the application, proceed to Vertebrate Animals.
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SCENARIO B: HUMAN SUBJECTS RESEARCH CLAIMING EXEMPTION 4
Criteria Human Subjects Research Yes
Exemption 4
Clinical Research No
Clinical Trial N/A
NIH-Defined Phase III Clinical Trial N/A
Instructions and Required InformationAlthough no specific page limitation applies to this section of the application, be succinct in your responses.
Check the box marked “Yes” on the Other Project Information Component, Item 1. Check “Yes” if activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other performance site or collaborating institution. “Yes” should be checked even if the research is exempt from requirements in the Federal regulations for the protection of human subjects (45 CFR Part 46).
Indicate that you are claiming Exemption 4 in Item 1a and enter “NA” for the Human Subject Assurance Number, since no assurance is needed.
In the PHS 398 Research Plan Component attachment for Item 8, Protection of Human Subjects, include a heading entitled “Protection of Human Subjects.” Include the statement “This Human Subjects Research falls under Exemption 4” after the heading. Use subheadings to address the following three items in this attachment.
1. Human Subjects Involvement and Characteristics:
a. Describe the proposed involvement of human subjects in the work outlined in the Research Design and Methods section.
b. Describe the characteristics of the subject population, including their anticipated number, age range, and health status. If the characteristics of the population are not available, then the applicant should indicate that the information is unknown.
c. Identify the criteria for inclusion or exclusion of any subpopulation.
d. Explain the rationale for the involvement of vulnerable populations, such as fetuses, neonates, pregnant women, children, institutionalized individuals, or others who may be considered vulnerable populations. Exemptions 1-6 do not apply to research involving prisoners or subjects who become prisoners (see 45 CFR Part 46 Subpart C). Although Exemptions 1 and 3-6 apply to research involving children (see 45 CFR Part 46 Subpart D), Exemption 2 can only be used for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
e. List any collaborating sites where human subjects research will be performed and describe the role of those sites in performing the proposed research.
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2. Sources of Materials:
a. Describe the research material obtained from living human subjects in the form of specimens, records, or data.
b. Describe any data that will be recorded on the human subjects involved in the project.
c. Describe the linkages to subjects, and indicate who will have access to subject identities.
d. Provide information about when the specimens, records, or data were collected and whether new material or data will need to be collected specifically for your proposed research project.
3. Justification for Exemption:
a. Indicate that you are claiming Exemption 4.
b. Provide a justification for why your research meets the criteria for Exemption 4.
Guidance and Additional Instructions The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research.
What types of research meet the criteria for Exemption 4? Research projects involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Determining the appropriateness of Exemption 4 for research using specimens and data can be complex.
Note: Prospective collection of additional specimens does not meet the criteria for Exemption 4.
If you are uncertain as to whether your research meets the criteria for Exemption 4, refer to Exemption 4 Guidance and Information.
If you need to consider an alternative scenario, return to the Decision Table.
After you have completed this section of the application, proceed to Vertebrate Animals.
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SCENARIO C: HUMAN SUBJECTS RESEARCH CLAIMING EXEMPTION 1, 2, 3, 5, OR 6
CriteriaHuman Subjects Research Yes
Exemption Claimed 1, 2, 3, 5, 6
Clinical Research Yes
Clinical Trial N/A
NIH-Defined Phase III Clinical Trial N/A
Instructions and Required Information Although no specific page limitation applies to this section of the application, be succinct.
Check the box marked “Yes” on the Other Project Information Component, Item 1, enter the exemption number that you are claiming in Item 1a. Enter “NA” for the Human Subject Assurance Number, since no OHRP assurance number is needed for exempt research.
Although your research may be exempt from the IRB oversight provisions, it is still human subjects research, and you need to follow the instructions that are identified for each of the following topics and provide the information that is requested.
In the PHS 398 Research Plan Component, follow the instructions that are identified for each of the following topics and attach the information that is requested:
In the attachment for Item 8, Protection of Human Subjects, include a heading entitled “Protection of Human Subjects.” Include the statement “This Human Subjects Research falls under Exemption(s) …” after the heading. Use subheadings to address the following three items in this attachment.
1. Human Subjects Involvement and Characteristics:
a. Describe the proposed involvement of human subjects in the work outlined in the Research Design and Methods section.
b. Describe the characteristics of the subject population, including their anticipated number, age range, and health status.
c. Identify the criteria for inclusion or exclusion of any subpopulation (e.g., men, women, children).
d. Explain the rationale for the involvement of vulnerable populations, such as fetuses, neonates, pregnant women, children, institutionalized individuals. Please note that research involving prisoners is not exempt under any category (see 45 CFR Part 46 Subpart C).
e. List any collaborating sites where human subjects research will be performed and describe the role of those sites in performing the proposed research.
2. Sources of Materials:
a. Describe the sources of the research material obtained from living human subjects in the form of specimens, records, or data.
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b. Describe any data that will be recorded on the human subjects involved in the project.
c. Describe the linkages to subjects and indicate who will have access to subject identities.
d. Provide information about when the specimens, records, or data were collected and whether new material or data will need to be collected specifically for your proposed research project.
3. Justification for Exemption(s):
In this section, identify which exemption(s) (1, 2, 3, 5, or 6) you are claiming. (If you are claiming Exemption 4 please refer to Scenario B and the appropriate instructions.) Justify why your research is appropriate for the exemption(s) that you have claimed.
Inclusion of Women and Minorities (click and follow instructions)
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study.
Create a section entitled “Inclusion of Women and Minorities” and attach it as Item 9 of the PHS 398 Research Plan Component.
Describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. See http://grants.nih.gov/grants/funding/women_min/women_min.htm.
Targeted/Planned Enrollment Table, attach the completed table as Item 10.
Inclusion of Children ( click and follow instructions )
For the purpose of implementing these guidelines, a child is defined as an individual under the age of 21 years. (For additional information see http://grants.nih.gov/grants/funding/children/children.htm and http://grants.nih.gov/grants/guide/notice-files/not98-024.html.)
Inclusion of Children information should be addressed separately as Item 11 of the PHS 398 Research Plan Component.
Guidance and Additional Instructions The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research.
If you are uncertain as to whether your research meets the criteria for an exemption please read: Question 2: Does your proposed human subjects research meet the criteria for one or more of the exemptions in the HHS regulations?
If you need to consider an alternative Scenario, return to the Decision Table.
After you have completed this section of the application, proceed to Vertebrate Animals.
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SCENARIO D: CLINICAL RESEARCH
CriteriaHuman Subjects Research Yes
Exemption No
Clinical Research Yes
Clinical Trial No
NIH-Defined Phase III Clinical Trial No
Instructions and Required InformationAlthough no specific page limitation applies to this section of the application, be succinct.
Check the box marked “Yes” on the Other Project Information Component, Item 1, and enter your OHRP assurance number in Item 1a.
In the PHS 398 Research Plan Component, follow the instructions that are identified for each of the following topics and attach the information that is requested:
Protection of Human Subjects ( click and follow instructions for Item 8) . Include the statement “This Human Subjects Research meets the definition of Clinical Research” after the heading.
Inclusion of Women and Minorities (click and follow instructions for Item 9)
Targeted/Planned Enrollment Table, attach the completed table as Item 10.
Inclusion of Children (click and follow instructions for Item 11)
If your application involves collaborating sites, provide the information identified above for each participating site.
Guidance and Additional Instructions Research that meets the criteria for Exemption 4 is not considered clinical research.
Research that uses existing (archived) specimens or data that can be linked to living individuals must address the inclusion of women, minorities and children as identified above, unless the investigator does not have access to the information.
The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research.
If you are uncertain as to whether your research meets the criteria for clinical research, read: Question 3: Does your proposed research meet the definition of Clinical Research?
If you need to consider an alternative scenario, return to the Decision Table.
After you have completed this section of the application, proceed to Vertebrate Animals.
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SCENARIO E. CLINICAL TRIALS
CriteriaHuman Subjects Research Yes
Exemption No
Clinical Research Yes
Clinical Trial Yes
NIH-Defined Phase III Clinical Trial No
Instructions and Required InformationCheck the box marked “Yes” on the Other Project Information Component, and enter your OHRP assurance number for Item 1a.
In the PHS 398 Research Plan Component, follow the instructions that are identified for each of the following topics and attach the information that is requested:
Protection of Human Subjects ( click and follow instructions for Item 8) . Include the statement “This Human Subjects Research meets the definition of a clinical trial” after the heading. Address the Data and Safety Monitoring Plan (click and follow instructions).
Inclusion of Women and Minorities (click and follow instructions for item 9)
Targeted/Planned Enrollment Table, attach the completed table as Item 10.
Inclusion of Children (click and follow instructions for item 11)
If your application involves collaborating sites, provide information for each of the issues identified above for each participating site.
Guidance and Additional Instructions The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research. If you are uncertain as to whether your research includes a clinical trial please read: Question 4: Does your proposed research include a clinical trial?
If you need to consider an alternative scenario, return to the Decision Table.
After you have completed this section of the application, proceed to Vertebrate Animals.
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SCENARIO F. NIH DEFINED PHASE III CLINICAL TRIAL
CriteriaHuman Subjects Research: Yes
Exempt: No
Clinical Research: Yes
Clinical Trial: Yes
NIH-Defined Phase III Clinical Trial: Yes
Instructions and Required InformationCheck the box marked “Yes” on the Other Project Information Component, and enter your OHRP assurance number for Item 1a.
In the PHS 398 Research Plan Component, follow the instructions that are identified for each of the following topics and attach the information that is requested:
Protection of Human Subjects ( click and follow instructions for item 8) . Include the statement “This Human Subjects Research is an NIH-Defined Phase III Clinical Trial” after the heading. Address the Data and Safety Monitoring Plan (click and follow instructions).
Inclusion of Women and Minorities (click and follow instructions for item 9)
Targeted/Planned Enrollment Table, attach the completed table as Item 10.
Inclusion of Children (click and follow instructions for item 11)
If your application involves collaborating sites, provide the information identified above for each participating site.
Guidance and Additional Instructions The material that you provide will be used by reviewers as part of their evaluations on the research design and methods of your proposed research. If you are uncertain as to whether your research includes clinical research, read Question 5: Does your proposed research meet criteria for an NIH-Defined Phase III Clinical Trial?
If you need to consider an alternative scenario, return to the Decision Table.
After you have completed this section of the application, proceed to Vertebrate Animals.
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HUMAN SUBJECTS RESEARCH DEFINITIONS
Autopsy Materials. The use of autopsy materials is governed by applicable Federal, state and local law and is not directly regulated by 45 CFR Part 46.
Child. The NIH Policy on Inclusion of Children defines a child as an individual under the age of 21 years. The intent of the NIH policy is to provide the opportunity for children to participate in research studies when there is a sound scientific rationale for including them, and their participation benefits children and is appropriate under existing Federal guidelines. Thus, children must be included in NIH conducted or supported clinical research unless there are scientific and ethical reasons not to include them.
HHS Regulations (45 CFR Part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: “Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted.” Generally, state laws define what constitutes a “child.” Consequently, the age at which a child’s own consent is required and sufficient to participate in research will vary according to state law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.
Clinical Research. NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.
Clinical Trial. The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective.
Behavioral human subjects research involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fits this definition of a clinical trial.
Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects.
Biomedical clinical trials of experimental drug, treatment, device or behavioral intervention may proceed through four phases:
Phase I clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).
Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.
Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
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Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
NIH-Defined Phase III Clinical Trial. For the purpose of the Guidelines an NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
Data and Safety Monitoring Plan. NIH requires a data and safety monitoring plan for each clinical trial that will provide oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. A detailed data and safety monitoring plan must be submitted to the applicant’s IRB and subsequently to the funding IC for approval prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR Part 46.
Data and Safety Monitoring Board (DSMB). NIH requires the establishment of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials.
Gender. Refers to the classification of research subjects into either or both of two categories: women and men. In some cases, representation is unknown, because gender composition cannot be accurately determined (e.g., pooled blood samples or stored specimens without gender designation).
Human Subjects. The HHS regulations “Protection of Human Subjects” (45 CFR 46, administered by OHRP) define a human subject as a living individual about whom an investigator conducting research obtains:
data through intervention or interaction with the individual or identifiable private information
Investigator. The OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. However, if the individuals who provide coded information or specimens also collaborate on other activities related to the conduct of the research with the investigators who receive such information or specimens, they will be considered to be involved in the conduct of the research. [OHRP’s Coded Specimen Guidance]
Research. HHS regulations define research at 45 CFR 46.102(d) as follows:Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Obtains. In its guidance for use of coded specimens, OHRP has determined that under the definition of human subject at 45 CFR 46.102(f), obtaining identifiable private information or identifiable specimens
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for research purposes constitutes human subjects research. Obtaining means receiving or accessing identifiable private information or identifiable specimens for research purposes. OHRP interprets obtaining to include an investigator’s use, study, or analysis for research purposes of identifiable private information or identifiable specimens already in the possession of the investigator.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. (45 CFR 46.102(f))
Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102(f))
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102(f))
Individually Identifiable Private Information. According to its guidance for use of coded specimens, OHRP generally considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Conversely, OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.
Coded. With respect to private information or human biological specimens, coded means that:
(1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof (i.e., the code); and
(2) a key to decipher the code exists, enabling linkage of the identifying information with the private information or specimens.
Research that involves only coded private information/data or coded human biological specimens may not constitute human subjects research under the HHS human subjects regulations (45 CFR 46) if:
o the specimens and/or information/data are not obtained from an interaction/intervention with the subject specifically for the research; and
o the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (e.g., the researcher’s access to subject identities is prohibited).
(See the following guidance from the Office for Human Research Protections (OHRP) for additional information and examples: http://www.hhs.gov/ohrp/humansubjects/guidance/cdeiol.pdf.)
Significant Difference. For purposes of NIH policy, a “significant difference” is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used “statistically significant difference,” which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little
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clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.
Valid Analysis. This term means an unbiased assessment. Such an assessment will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for both small and large studies. A valid analysis does not need to have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are: allocation of study participants of both sexes/genders (males and females) and from different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization; unbiased evaluation of the outcome(s) of study participants; and use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups.
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HUMAN SUBJECTS RESEARCH POLICY
Human Subjects Research Policy includes Federal regulations for the protection of human subjects and the following NIH policies related to human subjects research.
Protection of Human SubjectsThe Department of Health and Human Services (HHS) regulations for the protection of human subjects provide a systematic means, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities supported or conducted by the HHS. The regulations stipulate that an applicant organization, whether domestic or foreign, bears responsibility for safeguarding the rights and welfare of human subjects in HHS-supported research activities. The regulations require that applicant organizations proposing to involve human subjects in nonexempt research, provide written Assurance of Compliance with the Office for Human Research Protections (OHRP), that they will comply with requirements set forth in the HHS regulations to protect human subjects. These regulations, 45 CFR Part 46, Protection of Human Subjects, are available from OHRP, Department of Health and Human Services, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852 or by contacting OHRP at [email protected]; Telephone: 1-866-447-4777 or (301) 496-7005.
Under HHS regulations to protect human subjects from research risks, certain research areas are exempt. However, if an applicant makes inappropriate designations of the noninvolvement of human subjects or of exempt categories of research, this may result in delays in the review of an application or the return of the application without review. The PHS will make a final determination as to whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the Research Plan. When in doubt, consult with the Office for Human Research Protections (OHRP), Department of Health and Human Services by accessing their website http://www.hhs.gov/ohrp/ for guidance and further information.
No non-exempt research involving human subjects can be conducted under a HHS award unless that organization is operating in accord with an approved Assurance of Compliance and provides verification that an Institutional Review Board (IRB) that is registered under the specific Assurance has reviewed and approved the proposed activity in accordance with the HHS regulations. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the HHS regulations. Foreign applicant organizations must also comply with the provisions of the regulations.
In addition to the HHS human subjects regulations, FDA regulations (21 CFR part 50; 21 CFR part 56) may also apply to your research. FDA regulations generally apply to biomedical research involving an unapproved drug, device or biologic and may apply to certain studies of approved products. Researchers proposing such research should consult with their IRB and the FDA to determine whether and how the FDA regulations may apply. Additional information on FDA regulations is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.
Studies that involve the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into human research participants (known as “human gene transfer” or “gene therapy”) are subject to the oversight and biosafety requirements outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) when these studies are conducted at, or sponsored by, an institution that receives any NIH support for recombinant DNA research. These requirements, which include review by an Institutional Biosafety Committee and submission to the NIH for review by the Recombinant DNA Advisory Committee, are described in Section III-C-1 and Appendix M of the NIH Guidelines (accessible at: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). Additional information on the special
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requirements that pertain to human gene transfer can be found in a series of Frequently Asked Questions at: http://www4.od.nih.gov/oba/RAC/RAC_FAQs.htm.
Federal requirements to protect human subjects apply to most research on human specimens (such as cells, blood, and urine), residual diagnostic specimens and medical information. Research involving the collection or study of existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable is considered “research involving human subjects.” The NIH Office of Extramural Research Human Subjects website contains additional information and Frequently Asked Questions that is available to help investigators understand how these Federal requirements apply to their research. See http://grants.nih.gov/grants/policy/hs/index.htm.
The HHS regulations also require “Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency” (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.120). This independent evaluation is conducted at the NIH through the peer review system and NIH staff review, and, as required, will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. On the basis of this evaluation, the NIH may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
Vulnerable PopulationsInvestigators who conduct research involving pregnant women, human fetuses and neonates, prisoners, or children must follow the provisions of the regulations in Subparts B, C, and D of 45 CFR Part 46, respectively, which describe the additional protections required for these populations. Note that ‘prisoners’ includes all subjects involuntarily incarcerated (for example, in detention centers) as well as subjects who become incarcerated after the study begins. Relevant information may be obtained at the OHRP website (http://www.hhs.gov/ohrp/policy/index.html).
REMINDER: HHS regulations at 45 CFR Part 46, subpart C describe requirements for additional protections for research involving prisoners as subjects or individuals who become prisoners after the research has started. Refer to: http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm for complete instructions.
Exemptions 1-6 do not apply to research involving prisoners or subjects who become prisoners (see Subpart C). Although Exemptions 1 and 3-6 apply to research involving children (see Subpart D), Exemption 2 can only be used for educational tests or research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.
Data and Safety Monitoring Plans for Clinical Trials For each proposed clinical trial, NIH requires a data and safety monitoring plan that describes oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. A detailed data and safety monitoring plan must be submitted to the applicant’s IRB and subsequently to the funding IC for approval prior to the accrual of human subjects. The reporting of Adverse Events must be reported to the IRB, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR Part 46. NIH requires the establishment of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials.
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Research on Transplantation of Human Fetal TissueWhen verifying the submitted application in the eRA Commons, the duly authorized representative of the applicant organization certifies that if research on the transplantation of human fetal tissue is conducted, the applicant organization will make available, for audit by the Secretary, HHS, the physician statements and informed consents required by section 498A (b)(2) and (c) of the Public Health Service Act, 42 U.S.C. 289g (b)(2) and (c), or ensure HHS access to those records, if maintained by an entity other than the applicant organization.
Research Using Human Embryonic Stem Cellshttp://stemcells.nih.gov/index.asp When verifying the submitted application in the eRA Commons, the duly authorized representative of the applicant organization certifies that if research using human embryonic stem cells is proposed, the applicant organization will be in compliance with the “Notice of Extended Receipt Date and Supplemental Information Guidance for Applications Requesting Funding that Proposes Research with Human Embryonic Stem Cells” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html).
IRB ApprovalNIH does not require certification of IRB approval of the proposed research prior to NIH peer review of an application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html .
Following NIH peer review, applicants and their institutions will be notified of the need for review and approval of the proposed research by an OHRP-registered IRB. See http://www.hhs.gov/ohrp/ to register an IRB. Documentation of IRB approval must be sent to the Grants Management Office identified in the notice requesting certification. This IRB certification must include: the PHS application number, title of the project, name of the Project Director/Principal Investigator (PD/PI), date of IRB approval, and appropriate signatures. You may also use the optional form “Protection of Human Subjects - Assurance Identification/IRB Certification/Declaration of Exemption (Common Rule) (OMB Form No. 0990-0263) to meet this requirement: http://www.hhs.gov/ohrp/humansubjects/assurance/OF310.rtf
An institution is automatically considered to be engaged in human subjects research when it receives an NIH award to support nonexempt human subjects research. All institutions engaged in human subjects research must obtain a Federal Wide Assurance (FWA) from OHRP. Instructions for applying for a Federal Wide Assurance (FWA) are available from the OHRP website at http://www.hhs.gov/ohrp/assurances/assurances_index.html.
Any modifications in the Research Plan section of the application, required by either NIH or by the IRB must be submitted with the follow-up certification of IRB approval to the NIH before the competing award is made. It is the responsibility of the PD/PI and the applicant organization to submit the follow-up certification.
If more than a year will have elapsed between the initial IRB review date and the anticipated award date, the awarding unit staff shall require re-review by the IRB prior to award.
Required Education in the Protection of Human Research ParticipantsNIH requires education on the protection of human research participants for all individuals identified as Key Personnel before funds are awarded for applications or contract proposals involving human subjects. For information relating to this requirement, see the following see the following notices (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html and http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-061.html), and Frequently Asked Questions
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found at: http://grants.nih.gov/grants/policy/hs_educ_faq.htm. Prior to award, applicants will be required to provide a description of education completed in the protection of human subjects for all Key Personnel involved in human subjects research. Although NIH does not endorse programs, there are curricula available that can provide guidance or that can be modified to provide training in this area. See http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp for computer-based training developed for NIH that can be downloaded at no charge. For information on facilitating education and developing curricula, see http://www.nih.gov/sigs/bioethics.
Relevant Policies and Information
PROCEDURES FOR SUBMISSION OF COMPLIANCE DOCUMENTS TO THE HUMAN PLURIPOTENT STEM CELL REVIEW GROUP FOR THE RESEARCH USE OF HUMAN EMBRYONIC GERM CELLS
NOTICE: NOT-OD-02-049 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html
GUIDANCE FOR INVESTIGATORS AND INSTITUTIONAL REVIEW BOARDS REGARDING RESEARCH INVOLVING HUMAN EMBRYONIC STEM CELLS, GERM CELLS AND STEM CELL-DERIVED TEST ARTICLES
NOTICE: NOT-OD-02-044 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-044.html
IMPLEMENTATION ISSUES FOR HUMAN EMBRYONIC STEM CELL RESEARCH - FREQUENTLY ASKED QUESTIONS
NOTICE: NOT-OD-02-014 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-014.html
FEDERAL GOVERNMENT CLEARANCES FOR RECEIPT OF INTERNATIONAL SHIPMENT OF HUMAN EMBRYONIC STEM CELLS
NOTICE: NOT-OD-02-013 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-013.html
NOTICE OF EXTENDED RECEIPT DATE AND SUPPLEMENTAL INFORMATION GUIDANCE FOR APPLICATIONS REQUESTING FUNDING THAT PROPOSES RESEARCH WITH HUMAN EMBRYONIC STEM CELLS
NOTICE: NOT-OD-02-006 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-006.html
NOTICE OF CRITERIA FOR FEDERAL FUNDING OF RESEARCH ON EXISTING HUMAN EMBRYONIC STEM CELLS AND ESTABLISHMENT OF NIH HUMAN EMBRYONIC STEM CELL REGISTRY
NOTICE: NOT-OD-02-005 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html
NIH FUNDING OF RESEARCH USING SPECIFIED EXISTING HUMAN EMBRYONIC STEM CELLS
NOTICE: NOT-OD-01-058 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-059.html
NIH Policy on the Inclusion of Women and Minorities in Clinical Research It is the policy of NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving clinical research unless a clear and compelling rationale and justification establishes to the satisfaction of the relevant Institute/Center Director that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. Exclusion under other circumstances may be made by the Director, NIH, upon the recommendation of an Institute/Center Director based on a compelling rationale and justification. Cost is not an acceptable reason for exclusion except when the study would duplicate data from other
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sources. Women of childbearing potential should not be routinely excluded from participation in clinical research. All NIH-supported biomedical and behavioral research involving human subjects is defined as clinical research. This policy applies to research subjects of all ages.
The inclusion of women and members of minority groups and their subpopulations must be addressed in developing a research design appropriate to the scientific objectives of the study. The Research Plan should describe the composition of the proposed study population in terms of sex/gender and racial/ethnic group, and provide a rationale for selection of such subjects. Such a plan should contain a description of the proposed outreach programs for recruiting women and minorities as participants. See http://grants.nih.gov/grants/funding/women_min/women_min.htm.
NIH Policy on Inclusion of Children (See Definition of “child.”)
Research involving children must comply with the NIH Policy and Guidelines on the Inclusion of Children in Clinical Research. The following excerpts provide the key policy statements. Investigators should obtain full copies of the Policy and Guidelines from NIH staff, or from the NIH grants Web site under http://grants.nih.gov/grants/funding/children/children.htm.
NIH policy requires that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH unless there are clear and compelling reasons not to include them. Therefore, proposals for clinical research must include a description of plans for including children. If children will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.
In addition, the involvement of children as subjects in research must be in compliance with all applicable subparts of 45 CFR Part 46 as well as with other pertinent Federal laws and regulations.
Additionally, IRBs have special review requirements to protect the well-being of children who participate in research. These requirements relate to risk, benefit, parental/guardian consent, and assent by children, and to research involving children who are wards of the state or of another institution. The local IRB approves research that satisfies the conditions set forth in the regulations.
NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
The Office of Management and Budget (OMB) (http://www.whitehouse.gov/omb/fedreg/ombdir15.html) defines minimum standards for maintaining, collecting and presenting data on race and ethnicity for all Federal reporting agencies (including NIH). The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. The standards were revised in 1997 and now include two ethnic categories, “Hispanic or Latino” and “Not Hispanic or Latino.” There are five racial categories: American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White. Reports of data on race and ethnicity shall use these categories. NIH is required to use these definitions to allow comparisons to other Federal databases, especially the census and national health databases. The following definitions apply to the minimum standards for the ethnic and racial categories.
Ethnic Categories:
Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin,” can be used in addition to “Hispanic or Latino.”
Not Hispanic or Latino
Racial Categories:
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American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliation or community attachment.
Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.)
Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”
Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.
Ethnic/Racial Subpopulations: In addition to OMB ethnic and racial categories, NIH uses the following definition for ethnic/racial subpopulations:
Subpopulations: Each ethnic/racial group contains subpopulations that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self identify with more than one race. These ethnic/racial combinations may have biomedical, behavioral, and/or social-cultural implications related to the scientific question under study. (http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm).
Guidance on Collecting Race and Ethnicity Data from Study Subjects
When an investigator is planning to collect data on ethnicity and race, the categories identified above should be used. The collection of greater detail is encouraged, for example on ethnic/racial subpopulations. However, any collection that uses more detail must be designed in a way that data can be aggregated into these minimally required categories. Use self-report or self-identification to collect this information by asking two separate questions – one on ethnicity and one on race. Collect ethnicity information first followed by the question on race and provide subjects with the option to select more than one racial category.
See NIH Policy on Inclusion of Women and Minorities.
Collecting Data on Foreign Populations: If you are conducting clinical research outside of the US, you should design culturally sensitive and appropriate data collection items and instruments that allow subjects to self-identify their ethnic and racial affiliation in a culturally appropriate manner. These items, however, should be designed in a way that allow you, the investigator, to aggregate the information into the OMB minimally required ethnic and racial categories when reporting the information to NIH.
Submitting Applications or Proposals Using Existing Data in Clinical Research with No Plans for Collecting New/Additional Data:
Investigators are instructed to provide plans for the total number of subjects proposed for the study and to provide the distribution by ethnic/racial categories and sex/gender. Under these circumstances, investigators are not required to re-contact subjects solely to comply with the newly revised categories. If the existing data on ethnicity and race allow accurate correspondence with the new categories, the investigator can use the format in the Targeted/Planned Enrollment table. However, if the existing data do not allow accurate correspondence with the new categories, information may be reported using the former categories and according to the format in the 4/98 Version of the Inclusion Table.
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Annual Progress Reports (Type 5 applications) and Competing Supplement Applications
In annual Progress Reports, investigators conducting clinical research are required to provide the cumulative total enrollment of subjects to-date, showing the distribution by ethnic/racial categories and sex/gender on EITHER the new Inclusion Enrollment Report OR the format in the former 4/98 Version of the Inclusion Table.
For competing supplement applications, any proposed additions to the Targeted/Planned Enrollment Table should be provided, in addition to the current Inclusion Enrollment Table.
If Data Collection is Ongoing, Such that New Subjects Will be Enrolled and/or Additional Data Will be Collected from Human Subjects:
Investigators may choose to report ethnicity/race and sex/gender sample composition using EITHER the new Inclusion Enrollment Report OR the format in the former 4/98 Version of the Inclusion Table.
[Note: If investigators with on-going data collection choose to report information using the new Inclusion Enrollment Report, they must continue to use this format for the remaining years of the project.]
If Data Collection is Complete, Such that No New/Additional Subject Contact is Planned:
Investigators may EITHER continue to report using the former categories and according to the 4/98 Version of the Inclusion Table, OR, if data allow accurate correspondence with the new categories, use the format in the new Inclusion Enrollment Report.
Additional Information
Additional information on NIH policy regarding the Inclusion of Women and Minorities in Clinical Research can be found at the website http://grants.nih.gov/grants/funding/women_min/women_min.htm.
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Appendix F: Menu of Suggested Key Words for Project Abstracts
A list of keywords used to describe MCHB-funded projects follows. Please choose from this list when selecting terms to classify your project.
If no term on this list adequately describes a concept that you would like to convey, please select a term which you think is appropriate and include it in your list of keywords.
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Access to Health CareAdolescent Health ProgramsAdolescent NutritionAdolescent ParentsAdolescent PregnancyAdolescent Pregnancy PreventionAdolescent Risk Behavior PreventionAdolescentsAdolescents with DisabilitiesAdvocacyAfrican AmericansAgricultural SafetyAIDSAIDS PreventionAlaska NativesAlcoholAmerican Academy of PediatricsAmerican College of Obstetricians and GynecologistsAmerican Public Health AssociationAmniocentesisAnemiaAnticipatory GuidanceAppalachiansArthritisAsian Language MaterialsAsiansAsthmaAttachmentAttachment BehaviorAttention Deficit DisorderAudiologyAudiometryAudiovisual MaterialsBaby Bottle Tooth DecayBattered WomenBehavior DisordersBehavioral PediatricsBereavementBicycle HelmetsBicycle SafetyBilingual ServicesBiochemical GeneticsBlindnessBlood Pressure DeterminationBody CompositionBondingBrain InjuriesBreast PumpsBreastfeedingBronchopulmonary DysplasiaBurnsCambodiansCaregiversCase ManagementCerebral PalsyChelation TherapyChild AbuseChild Abuse PreventionChild CareChild Care CentersChild Care WorkersChild MortalityChild Neglect
Child NutritionChild Sexual AbuseChildhood CancerChildren with Special Health NeedsChild Death ReviewChronic Illnesses and DisabilitiesCleft LipCleft PalateClinical GeneticsClinicsCocaineCollaborative Office RoundsCommunicable DiseasesCommunication DisordersCommunication SystemsCommunity Based Health EducationCommunity Based Health ServicesCommunity Based Preventive HealthCommunity DevelopmentCommunity Health CentersCommunity Integrated Service SystemCommunity ParticipationComplianceComprehensive Primary CareComputer LinkageComputer SystemsConferencesCongenital AbnormalitiesConsortiaContinuing EducationContinuity of CareCost EffectivenessCounselingCounty Health AgenciesCraniofacial AbnormalitiesCultural DiversityCultural SensitivityCurriculaCystic FibrosisCytogeneticsData AnalysisData CollectionData SystemsDatabasesDeafnessDecision Making SkillsDelayed DevelopmentDental SealantsDental Treatment of Children with DisabilitiesDepressionDevelopmental DisabilitiesDevelopmental EvaluationDevelopmental ScreeningDiagnosisDiarrheaDietitiansDispute ResolutionDisseminationDistance EducationDivorceDNA AnalysisDown SyndromeDrowning
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Early Childhood DevelopmentEarly InterventionElectronic Bulletin BoardsElectronic MailEligibility DeterminationEmergency Medical Services for ChildrenEmergency Medical TechniciansEmergency Room PersonnelEmotional DisordersEmotional HealthEmployersEnabling ServicesEnteral NutritionEPSDTErythrocyte ProtoporphyrinEthicsEvoked Otoacoustic EmissionsFailure to ThriveFamiliesFamily Centered Health CareFamily Centered Health EducationFamily CharacteristicsFamily EnvironmentFamily MedicineFamily PlanningFamily Professional CollaborationFamily RelationsFamily Support ProgramsFamily Support ServicesFamily Violence PreventionFarm WorkersFathersFeeding DisordersFetal and Infant Mortality ReviewFetal Alcohol EffectsFetal Alcohol SyndromeFinancingFood Preparation in Child CareFormulaFoster CareFoster ChildrenFoster HomesFoster ParentsFragile X SyndromeGenetic CounselingGenetic DisordersGenetic ScreeningGenetic ServicesGenetics EducationGestational Weight GainGlucose IntoleranceGovernorsGriefGynecologistsHawaiiansHead StartHealth Care FinancingHealth Care ReformHealth care utilizationHealth EducationHealth InsuranceHealth Maintenance OrganizationsHealth Professionals
Health PromotionHealth SupervisionHealthy Mothers Healthy Babies CoalitionHealthy Start InitiativeHealthy Tomorrows Partnership for ChildrenHearing DisordersHearing LossHearing ScreeningHearing TestsHemoglobinopathiesHemophiliaHepatitis BHispanicsHIVHmongHome Health ServicesHome Visiting for At Risk FamiliesHome Visiting ProgramsHome Visiting ServicesHomeless PersonsHospitalsHygieneHyperactivityHypertensionIllnesses in Child CareImmigrantsImmunizationIncarcerated WomenIncarcerated YouthIndian Health ServiceIndigenceIndividualized Family Service PlansInfant Health CareInfant MorbidityInfant MortalityInfant Mortality Review ProgramsInfant NutritionInfant ScreeningInfant TemperamentInfantsInformation NetworksInformation ServicesInformation SourcesInformation SystemsInjuriesInjury PreventionIntensive CareInteragency CooperationInterdisciplinary TeamsInternship and ResidencyIntubationIron Deficiency AnemiaIron SupplementsJewsJuvenile Rheumatoid ArthritisLaboratoriesLactose IntoleranceLanguage BarriersLanguage DisordersLaotiansLead PoisoningLead Poisoning PreventionLead Poisoning Screening
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Leadership TrainingLearning DisabilitiesLegal IssuesLife Support CareLiteracyLocal Health AgenciesLocal MCH ProgramsLow BirthweightLow Income PopulationLower BirthweightMalesManaged CareManaged CompetitionMarijuanaMarital ConflictMaternal and Child Health BureauMaternal NutritionMCH ResearchMedia CampaignsMedicaidMedicaid Managed CareMedical GeneticsMedical HistoryMedical HomeMental HealthMental Health ServicesMental RetardationMetabolic DisordersMexicansMicronesiansMigrant Health CentersMigrantsMinority GroupsMinority Health ProfessionalsMobile Health UnitsMolecular GeneticsMorbidityMortalityMotor Vehicle CrashesMultiple BirthsMyelodysplasiaNational Information Resource CentersNational ProgramsNative AmericansNeeds AssessmentNeonatal Intensive CareNeonatal Intensive Care UnitsNeonatal MortalityNeonatesNetworkingNeurological DisordersNewborn ScreeningNurse MidwivesNursesNutritionObstetriciansOccupational TherapyOne Stop ShoppingOnline DatabasesOnline SystemsOral HealthOrganic AcidemiaOtitis Media
OutreachP. L. 99-457Pacific IslandersPainParaprofessional EducationParent EducationParent Education ProgramsParent NetworksParent Professional CommunicationParent Support GroupsParent Support ServicesParental VisitsParenteral NutritionParenting SkillsParentsPatient EducationPatient Education MaterialsPediatric Advanced Life Support ProgramsPediatric DentistryPediatric Intensive Care UnitsPediatric Nurse PractitionersPediatriciansPeer CounselingPeer Support ProgramsPerinatal HealthPhenylketonuriaPhysical DisabilitiesPhysical TherapyPneumococcal InfectionsPoisonsPreconception CarePregnant AdolescentsPregnant WomenPrematurityPrenatal CarePrenatal DiagnosisPrenatal ScreeningPreschool ChildrenPreterm BirthPreventive Health CarePreventive Health Care EducationPrimary CareProfessional Education in Adolescent HealthProfessional Education in Behavioral PediatricsProfessional Education in BreastfeedingProfessional Education in Chronic Illnesses and DisabilitiesProfessional Education in Communication DisordersProfessional Education in CSHNProfessional Education in Cultural SensitivityProfessional Education in DentistryProfessional Education in Developmental DisabilitiesProfessional Education in EMSCProfessional Education in Family MedicineProfessional Education in GeneticsProfessional Education in Lead PoisoningProfessional Education in MCHProfessional Education in Metabolic DisordersProfessional Education in Nurse MidwiferyProfessional Education in NursingProfessional Education in NutritionProfessional Education in Occupational TherapyProfessional Education in Physical TherapyProfessional Education in Primary Care
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Professional Education in Psychological EvaluationProfessional Education in Pulmonary DiseaseProfessional Education in Social WorkProfessional Education in Violence PreventionProvider ParticipationPsychological EvaluationPsychological ProblemsPsychosocial ServicesPublic Health Academic ProgramsPublic Health EducationPublic Health NursesPublic PolicyPublic Private PartnershipPuerto RicansPulmonary DiseaseQuality AssuranceRecombinant DNA TechnologyReferralsRegional ProgramsRegionalized CareRegulatory DisordersRehabilitationReimbursementRepeat pregnancy preventionResearchResidential CareRespiratory IllnessesRetinitis PigmentosaRheumatic DiseasesRNA AnalysisRobert Wood Johnson FoundationRunawaysRural PopulationRussian JewsSafety in Child CareSafety SeatsSanitation in Child CareSchool Age ChildrenSchool DropoutsSchool Health ProgramsSchool Health ServicesSchool NursesSchoolsScreeningSeat BeltsSelf EsteemSensory ImpairmentsService CoordinationSex RolesSexual BehaviorSexuality EducationSexually Transmitted DiseasesShaken Infant SyndromeSiblingsSickle Cell DiseaseSleep DisordersSmoking during PregnancySocial WorkSoutheast AsiansSpanish Language MaterialsSpecial Education ProgramsSpecialized CareSpecialized Child Care Services
Speech DisordersSpeech PathologySpina BifidaSpouse AbuseStandards of CareState Health AgenciesState Health OfficialsState LegislationState ProgramsState Staff DevelopmentState Systems Development InitiativeStressSubstance AbuseSubstance Abuse PreventionSubstance Abuse TreatmentSubstance Abusing MothersSubstance Abusing Pregnant WomenSubstance Exposed ChildrenSubstance Exposed InfantsSudden Infant Death SyndromeSuicideSupplemental Security Income ProgramSupport GroupsSurveysTay Sachs DiseaseTechnology DependenceTeleconferencesTelevisionTeratogensTerminally Ill ChildrenTertiary Care CentersThalassemiasThird Party PayersTitle V ProgramsToddlersTrainingTransportationTraumaTuberculosisTwinsUninsuredUnintentional InjuriesUniversity Affiliated ProgramsUrban PopulationUrinary Tract InfectionsUsher SyndromeVietnameseViolenceViolence PreventionVision ScreeningVocational TrainingWaiver 1115Well Baby CareWell Child CareWICYouth in Transition
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