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Office of Sponsored Program ll rights reserved GTRC Working with the NIH

Office of Sponsored Programs All rights reserved GTRC Working with the NIH

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Page 1: Office of Sponsored Programs All rights reserved GTRC Working with the NIH

Office of Sponsored ProgramsAll rights reserved GTRC

Working with the NIH

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Office of Sponsored ProgramsAll rights reserved GTRC

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Today’s TopicsIntroduction to the NIH– History– Mission & Organization– Funding Facts

Fundamentals of NIH Grants– Types of Grants– Roles & Responsibilities (handout)

Decoding the NIH Funding sourcesApplications & Scientific ReviewCurrent IssuesBudgets– Program & Grants Staff Actions– The Notice of Award (and after)

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Introduction to NIH

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Administration forChildren and Families

(ACF)

Administration forChildren and Families

(ACF)

Food and DrugAdministration

(FDA)

Food and DrugAdministration

(FDA)

Health Resourcesand Services

Administration(HRSA)

Health Resourcesand Services

Administration(HRSA)

Secretary of Health and Human Services

Secretary of Health and Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Centers for Disease Controland Prevention

(CDC)

Centers for Disease Controland Prevention

(CDC)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Substance Abuse andMental Health Services

Administration(SAMHSA)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)

U. S. Dept. of Health and Human Services

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NIH Founded in 1887One agency of 11 within U.S. Department of Health and Human Services (HHS)

Comprises 27 Institutes and Centers (IC)

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NIH Mission

NIH is the steward of medical and behavioral research for the Nation

Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability …

… from the rarest genetic disorder to the common cold

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NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director

No funding authority

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Fulfilling the Mission

Support research by non-Federal scientists across U.S. and abroad

Help train research investigators

Conduct research in our own labs

Foster communication of medical and health sciences information

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What Stays at NIH? What Goes Elsewhere?

$24.7

$4.7

Spending at NIH

Spending Outside

84% Outside NIH> 325,000 Scientists > 3,000 Organizations Worldwide

16% Inside NIH $2.9 B Intramural Research (10%)$1.2 B Staff & Buildings (4%)$0.6 B Other (2%)

Total FY 2008 Budget: $29.46 Billion

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Success Rates

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Fundamentals of NIH Grants

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PrincipalInvestigator

Authorized Organizational

Reps

ResearchAdministrator

Grantee Institution Team

Grants are awarded to institutions as represented by AORs.

PD/PIs manage and perform the science

Research Administrators support business aspects of the grant

Successful grants require close coordination between all members of the grantee team.

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The Grantee Institution

Actual recipient of awardLegally responsible for proper conduct and execution of grantProvides fiscal management Provides oversight on allocation decisionsAssures compliance with Federal, NIH, and organization-wide requirements

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Georgia Tech Source of Awards

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Decoding the NIH

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Sample Application Number

1 R01 GM 012345 10 A1/S1

Application Type

Activity Code

Institute/Center

Serial Number

Year of Support

Suffixes

http://grants.nih.gov/grants/funding/ac_search_results.htm

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Award MechanismsResearch Grants

Traditional – R01Exploratory/Development Grants – R03/R21/R33/R34Program Project – P01Research Center Grants – P50Small Business – R41, R42, R43, R44

Cooperative Agreements (U)Specialized Grant mechanismSubstantial NIH staff involvement in program and scienceTypically initiated by NIH

Research Training and Career Awards

Training Grants – T

Institutional

Pre-doctoral and Postdoctoral

Fellowships – F

Individual

Pre-doctoral – F31

Postdoctoral – F32

Career Development Award – K

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Mandatory Use of Cayuse424

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Cayuse424

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NIH Scientific Review

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NIH Organizational Structure

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacialResearch

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director

No funding authority

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The Division of Receipt and Referral (DRR) within the CSR

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Peer Review

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Initial Level of Review

Standing study section typically has 12-24 members

3 face-to-face meetings each year

Review 60 - 100 applications at each meeting

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Impact Score

The NIH grant application scoring system uses a 9-point scale This scale is used by all eligible (without conflict of interest)

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Peer Review

Priority Scores recorded

Summary Statements prepared– Overall Resume and Summary of Review Discussion

– Essentially Unedited Critiques

– Priority Score and Percentile Ranking

– Budget Recommendations

– Administrative Notes

Viewable 4-6 weeks after review meeting– Only available to the PI through the eRA Commons

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Summary Statement

Understanding the Percentile– A percentile is the approximate percentage of

applications that received a better overall impact/priority score from the study section during the past year.

– Only a subset of all applications receive percentiles. The types of applications that are percentiled vary across different NIH Institutes and Centers.

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Video

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Second Level of Review - Advisory Council or Board

NIH program staff members examine applications, their overall impact scores, percentile rankings (if applicable) and their summary statements and consider these against the IC's needs.Program staff provide a grant-funding plan to the Advisory Board/Council.The Advisory Board/Council also considers the IC’s goals and needs and advises the IC director.The IC director makes final funding decisions based on staff and Advisory Council/Board advice.

8th Month

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Second Level of Review - Advisory Council or Board

Beginning in September 2012, Council members will receive a list of competing applications that will be considered for funding from PD/PIs that meet the threshold for Special Council Review. These are investigators who currently receive $1 million or more in direct costs of NIH funding to support Research Project Grants. Council members will be asked to recommend consideration of funding for applications that afford a unique opportunity to advance research which is both highly promising and distinct from the other funded projects from the PD/PI. This does not represent a cap to NIH funding.

8th Month

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Timeline: New Applications

ReceiptDate

February 5June 5October 5

ScientificReview JulyOctoberMarch

CouncilReviewOctoberJanuaryMay

AwardDateDecember AprilJuly

Review& AwardCycle I Cycle IICycle III

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Do I Contact NIH Before Applying?

Mandatory:Application with budget >$500,000 direct costs for any single year

R13 Conference Grants

Optional:

When RFA’s request a Letter of Intent

Recommended:

When you think about applying for any grant

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Award Negotiation & Issuance

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Award Negotiation & IssuanceThere are still many steps after a funding decision is made before a grant is awarded.Grants management staff work closely with grantee and NIH program staff to complete this final process.

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Just-In-Time Information

Information not required to review the application but which is necessary to implement the grant.

Certification of Education on Human SubjectsInstitutional Review Board (IRB) approval – Required within 1 year and before any human subjects

research begins.Institutional Animal Care and Use Committee (IACUC) Approval – Required within 3 years and before animal research

begins.Information on “Other Support” received by Key Personnel

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Grants Management: Special Issues

For Example:

Is there a “foreign component” to the grant?– Includes grants to foreign organizations and

grants with activities or consortium partners in foreign countries.

– Require State Department Clearance prior to award.

Are there bars to the award?– Human subjects and animal subjects concerns– Are there research integrity issues?

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Award Process

Notice of Award (NoA)– The NoA is the legal document issued to notify the grantee that

an award has been made and that funds may be requested from the designated HHS payment system or office. An NoA is issued for the initial budget period. If subsequent budget periods are also approved, the NoA will include a reference to those budgetary commitments. Funding for subsequent budget periods are generally provided in annual

Accepting the Award– The grantee accepts an NIH award and its associated terms and

conditions by drawing or requesting funds from the Payment Management System, or upon the endorsement of a check from the US Treasury for foreign awardees.

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After the Award…

Administrative and Fiscal Monitoring Requirements– Annual Progress Report (SNAP)– Annual Financial Status Reports (FSR)– Invention Reporting– Yearly Audits (as applicable)– Final Closeout Reports

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Budget

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Budgetary IssuesCorrectly apply modular and categorical budgets– Modular budgets reduce burden by eliminating the need

for specific budget numbers– Available for grants at or below $250,000 per year– Grantees awarded grants in “modules” of $25,000

Budget Justification Adjustments may be applied to individual grant awards based on IC financial policies– Caps on certain types of costs specific to that funding

opportunity– Limits on overall grant funding due to NIH budget

constraints.

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Modular Budget

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Modular Budget Sections A&B: Personnel

Determine the amount of time (effort) that you will spend on this project.– Calendar, Academic, or Summer Months

Determine the number, qualifications and amount of time needed for other personnel– Technicians

– Postdoctoral Fellows

– Graduate Students

– Undergraduate Students

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There are no magic numbers regarding the qualifications and/or number of individuals needed for each aim.

Be realistic about what each individual can accomplish, and the time necessary to complete the work.Remember the current NIH Salary cap is $191,300

Modular Budget Sections A&B: Personnel

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Modular Budget Section C: Do you need new equipment?

If you need additional equipment, this is the time to consider it.Equipment should be project specific – be sure to include a written justification.Most equipment is requested during the first year of the grant.If you use a modular budget format, you may ask for extra module(s) to cover equipment.

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Modular Budget Section D: Travel funds

This amount is usually small: – $1,000 - 2,000 per meeting per individual

per year

Generally supports one meeting per year for 2-3 individuals

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Modular Budget Section E: Participant/Trainee Support Costs

Unless stated in the FOA, this section should be left blank for NIH applications

– Include tuition remission under Section F: Other Direct Costs

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Modular Budget Section F: Other Direct Costs

Estimate the materials and supplies needed for the personnel involved

It may be reasonable to estimate a supply budget of ~$12,000–15,000/year for each FTE

This number will vary depending on the nature of the research proposed.– Animal intensive studies and studies involving human

subjects tend to be more costly.– In silico studies tend to be less costly for supplies.

Consider stage of career of personnel involved

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Modular Budget Section F: Other Direct Costs

This category also includes funds needed for things such as:– Publication costs – Equipment maintenance– Consortium/subcontracts– Tuition remission.

Estimate these expenses realistically.

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Example Modular BudgetCal Req. Fringe FundsMon Salary BenefitsReq.

A. Senior/Key PersonPI 2 15,333 4,293 19,626

B. Other PersonnelPostdoc Assoc 12 38,976 10,913 49,889Grad Student 12 20,772 5,454 26,226Grad Student 12 20,772 5,454 26,226

C. Equipment – Microscope 19,000D. Travel - (2 meetings) 4,000E. Participant/Trainee usually left

blankF. Other Direct Costs

Materials/Supplies 25,533Publication Costs 1,500Subaward/Consortium/Contractual costs noneTuition Remission 7,000

G. Total Direct Costs 179,000

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Calculate the direct costs for the first year.– (for example, Year 1 budget = $179,000)

Calculate the direct costs for subsequent years taking into account salary increases and changes in funds requested for equipment.– Year 2 = $164,800– Year 3 = $169,744– Year 4 = $174,836– Year 5 = $180,081

Example Modular Budget

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Do I need to submit a modular budget?

Calculate the total direct costs for all years– Total direct costs for 5 years = $868,461

Divide total by the number of years requested– Average direct costs = $173,692/yr

Investigator-initiated R01s up to $250,000/yr must use modular format

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Convert Your Average Direct Costs to the Modular Format

Round up to the next module (number divisible by $25,000)– In the example, $173,692/yr rounds up to

$175,000/yr

No yearly increases for inflationFirst year may include additional modules for one-time expenses like equipment– In the example, add one additional module

to year 1 = $200,000

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Reminder for BudgetAll budget requests to NIH for R01

applications use:– the modular format when requesting direct

costs of $250,000 or less each year

– the non-modular format when requesting direct costs greater than $250,000 in any year

Consortium F&A costs are not factored into the modular direct cost limit

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R01 Budget with Consortium CostsPrepare an itemized budget for the parent

awardPrepare an itemized budget for

consortium/subcontract costs, including:Personnel – salary and benefits

Travel – professional or investigator meeting

Other Direct Costs– Materials and Supplies

Total Direct Costs = $38,300

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Total Consortium Costs

Consortium Direct Costs = $38,300

Consortium F&A– consortium institution (at 50%) = $19,150

Consortium Total Costs = $57,450Remember you may round to the nearest $1,000

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Should you request a modular budget?

Example Modular Budget

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R01 Grant with Consortium Budget

Submit as a modular budgetwhen requesting Direct Costs at or

below $250,000 per year…

… excluding Consortium F&A costs.

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Modular Grant with Consortium BudgetIn our example,

Year 1 – Itemized Total DC = $256,124minus Consortium F&A = $ 19,150

Year 1 – Itemized DC excluding F&A = $236,974

Year 2 – Itemized DC excluding F&A = $224,513Year 3 – Itemized DC excluding F&A = $231,249Year 4 – Itemized DC excluding F&A = $238,186Year 5 – Itemized DC excluding F&A = $245,332

Avg Direct Cost per yr (excluding F&A) = $235,251

Round up to the next module = $250,000

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Record Modular Budget with Consortium: PHS 398 Modular Budget, Period 1

A. Direct Costs Funds Requested ($)*Direct Cost less Consortium F&A $250,000

Consortium F&A $ 19,150 *Total Direct Costs $269,150

The total direct costs requested are allowed to exceed the modular maximum ($250,000) by the amount of F&A associated with the subcontract.

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eRA Will Check to Ensure…

Once NIH retrieves the application from Grants.gov, eRA systems check the application against NIH business rules.– Detailed check against the instructions in the

application guide– Validates against the instructions in the FOA– For a detailed list of NIH validations:

http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

Remember, the SF424 (R&R) forms are used by many agencies, so unfortunately NIH cannot build our specific rules into the forms.

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If You Receive Errors & Warnings from NIH…

Errors must be addressed for the application to move on to NIH Receipt & Referral.

– An application must be error-free in order for eRA systems to generate an image of the application for viewing.

Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on.

If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire ‘Changed/Corrected’ application again through Grants.gov.

– Use changed/corrected check box on SF424(R&R) form

NOTE: Reviewers/NIH Staff do not see notifications provided to applicants about errors/warnings.

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Submitting Changed/Corrected Application: Cover Letter

If submitting a changed/corrected application during the 2-business day error correction window after the receipt date, the cover letter must explain changes.

– If your original submission included a cover letter then you must include all previous cover letter text in the revised cover letter attachment.

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Check Status in Commons – PD/PI

Select Recent/Pending eSubmissions link

Or provide Grants.gov tracking number from email notification

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View Errors/Warnings

Check Status

Select to show errors/warnings

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Check Assembled Application

The AOR/SO has a 2-business day (excluding federal holidays) viewing window to reject an application that has system formatting errors. If the application is not rejected within the 2 business days it will automatically proceed to Receipt & Referral.

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Current Issues

Sequestration: NOT-OD-13-043

PRRP vs eSNAP

PubMed Central

GRA Salary Cap

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NIH Operation Plan in the Event of a Sequestration

The NIH continues to operate under a Continuing Resolution as described in NOT-OD-13-002, and therefore all non-competing continuation awards are currently being funded at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level)

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NIH Operation Plan in the Event of a Sequestration

Should a sequestration occur, NIH likely will reduce the final FY 2013 funding levels of non-competing continuation grants and expects to make fewer competing awards to  allow the agency to meet the available budget allocation.

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NIH Research Performance Progress Report

The RPPR will have separate screens for each of the following reporting components: Cover Page– Accomplishments– Products– Participants– Impact– Changes– Special [agency specific] Reporting Requirements– Budget [applicable only for non-SNAP awards]

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NIH Research Performance Progress Report

Specific location to report on competitive revisions/administrative supplements associated with the award.

Public Access compliance status will be displayed

Other support will only be required if there has been a change

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NIH Research Performance Progress Report

http://grants.nih.gov/grants/rppr/rppr_instruction_guide.pdf

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Deposit

PubMed Central http://www.pubmedcentral.nih.gov/

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Including PMCIDs in Citations

After May 25, 2008, “NIH applications, proposals, and progress reports must include the PubMed Central reference number when citing a paper that falls under the policy and is authored or co-authored by the investigator, or arose from the investigator’s NIH award. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.”

http://publicaccess.nih.gov/

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Publisher Deposit

Some publishers automatically deposit the published article in PMC http://publicaccess.nih.gov/submit_process_journals.htm

Some publishers deposit the final peer-reviewed manuscript in PMC– PIs must approve the submission in the NIH

Manuscript Submission System [NIHMS]). http://www.nihms.nih.gov/

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Library Services Offered

Answer questions related to the NIH Public Access Policy and how to comply. Offer NIH Public Access Policy informational sessions to departments, research groups, and individual faculty.Deposit manuscripts in PubMed Central and SMARTech on behalf of authors. Provide hands-on PubMed Central submission training. Suggest tools that help researchers retain rights to deposit in repositories like PubMed Central. Contact us at: [email protected]

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Closeout Final Report

Submit Closeout document electronically through the eRA Commons

Documents are due within 90 days of project period end date– Final Financial Status Report (Required electronically)– Final Invention Statement & Certification– Final Progress Report

Failure to submit timely reports may affect future funding to the organization

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Definition of Early Stage Definition of Early Stage InvestigatorInvestigator

A Program Director/Principal Investigator who qualifies as a New Investigator is considered an Early Stage Investigator (ESI) if he/she is  within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).