PI’S GUIDE TO CONTRACTS AND GRANTS BASICS
CORE RESOURCES
NIH Office of Extramural Research (OER) Website http://grants1.nih.gov/grants/oer.htm
NIH NIAID Website: All About Grants Tutorialshttp://www.niaid.nih.gov/ncn/grants/default.htm
NIH Funding Opportunities, Peer Review and Grant Writing, Presented by Anthony Coelho, Ph.D. Review Policy Officer, NIH
National Institutes of Health http://ora.stanford.edu/ora/ratd/nih_04.asp
IN PREPARING YOUR GRANT
Allow ample time Review instructions carefully Explore the NIH CRISP Database: Historical database of
funded grants from NIH and other federal agencies Communicate early with the Institutes and Program
Officers Write a cover letter suggesting Institutes and Centers and
review section targets Secure collaborators for areas in which you lack expertise Have the application reviewed for both clarity and
scientific merit
ORGANIZE YOUR APPLICATION
Use major and minor section headings
Stay within page limitations Make it easy for reviewers to
navigate through your proposal
UNDERSTAND NIH REVIEW CRITERIA
Significance Approach Innovation Investigator Environment
FOR REVIEWERS
Never assume that the reviewers will know what you mean
Always be explicit about what you want the reviewers to know
REVISING APPLICATIONS
Update preliminary results
Address all criticisms completely
Think like a reviewer
BASIC REQUIREMENT FOR SUBMITTTING PROPOSALS
All extramural proposals must be signed by the chairperson and must be submitted by the University for consideration. No Principal Investigator (PI) is allowed to submit on their own behalf.
PI STATUS ELIGIBILITY
University policy defines Principal Investigator (PI) Status as the eligibility to submit proposals for research, training, or public service contracts or grants to extramural agencies, subject to approval of the appropriate department chair/Organized Research Unit (ORU) director and dean.
Academic appointees in the following title groups are eligible to submit proposals for extramural support provided that the appointments are at 50% or more and they have received the approvals mentioned above:
Professor, Associate Professor, Assistant Professor, and Instructor Professor In Residence series Professor of Clinical X series Adjunct Professor series Clinical Professor series Professional Research series Librarian series
HOW TO GET PI STATUS
Individuals who are not eligible for PI status by virtue of their appointments must be approved for PI status to submit contract and grant proposals and/or applications to the Committee on Human Research (CHR) and Institutional Animal Care and Use Committee (IACUC).
Complete the Principal Investigator Status Request Form. The completed form must be submitted with the contract or grant proposal and/or with the application to the Committee on Human Research (CHR) and Institutional Animal Care and Use Committee (IACUC).
The Principal Investigator Status Request Form is available at http://or.ucsf.edu/cg/cg/forms.html
PI
RSAProposal
Guidelines
EstablishTimeline and
Responsibilities
PI Responsibilities
RSAResponsibilities
Complete Packetfor Review
Department of MedicineReview
Chair toSign
Office of SponsoredResearch
FundingAgency
indicate interest in submittin
g proposal
decision regarding funding or
review
START
HOW TO SUBMIT A PROPOSAL
RESEARCH SERVICES ANALYST (RSA)The RSA is responsible for all pre- and post-award contract and grants management. The RSA is the primary contact for the Principal Investigator (PI) in preparing, coordinating, and completing contract and grant submissions. The RSA also manages the contract and grants that are awarded, including generating monthly Budget Status Reports (BSRs), managing correct expenditures, overseeing the resolution of overdrafts, and preparing all necessary documents to close out accounts.
PIs should plan to contact their RSA at least 3 months before a planned submission to allow an error free submission to increase the chances of being funded.
If the Principal Investigator (PI) does not know who the assigned RSA is, please contact either the Division Administrator, Suzanne Sutton, or Joseph Wilson. Suzanne Sutton can be reached by phone at (415) 502-4896 or e-mail at [email protected]. Joseph Wilson can be reached by phone at (415) 514-1120 or e-mail at [email protected].
DEPARTMENT OF MEDICINE (DOM) FORMS
Responsibility of PI PI Staff
RSA PI Signature Required
Division Chief’s Cover Letter to Chair of the Department
X
Waiver of PI Status (if applicable) X X X
CAMPUS FORMS
Responsibility of PI PI Staff
RSA PI Signature Required
Office of Sponsored Research (OSR) Approval Form
X X
Provide Copies of IACUC and/or CHR Approval Letter(s)
X X
PI Certification for Clinical Studies X X
Disclosure of Financial Interests Form X X
Human Subjects Protection Training – Certification Form (Each Key Personnel)
X X
Human Subjects Protection Training – Certification Letter to NIH
X X
DEPARTMENT OF MEDICINE TIMELINE
Salaries are correct in relation to NIH capF&A rate calculated correctlyCorrect MTDC rate, if applicableIndication of allowable funds for cost sharingCHR/CAR assurances with correct names and datesComplete financial disclosure formsAccurate Other Support PageApplicable Biosketches are includedAcademic title of PI require waiverGrant eligibility to be signed under RAPOSR form completed correctlyDOM checklist completed correctly
Direct and indirect cost rates match throughout proposalCHR and IACUC assurances with correct names and datesPI effort and salary matchCost sharing from allowable fundsTitle is PI eligible within DOMSpace commitment is accurate
Title is PI eligible within DOMSpace commitment is realisticCompliance with academic personnel issues
NIH Proposals
Department ReviewAssistant Director
1 Business Day
Director
1 Business Day
Chair
2 Business Days
DEPARTMENT OF MEDICINE TIMELINE
Salaries are correct in relation to NIH capSalaries include any funding restrictions, if applicableF&A rate calculated correctlyCorrect MTDC rate, if applicableCost sharing calculated correctly and is allowableCHR and IACUC assurances with correct names and datesComplete financial disclosure formsApplicable Biosketches are includedAccurate Other Support PageAcademic title of PI requires waiverOSR form completely correctlyDOM checklist completed correctly
Direct and indirect cost rates match throughout proposal
CHR and IACUC assurances with correct names and dates
PI effort and salary match
Cost sharing from allowable funds
Title is PI eligible within DOM
Space commitment is accurate
Government contracts, Private contracts and grants,New subcontracts, Renewals
Department ReviewAssistant Director
1 Business Day
Director
1 Business Day
Chair
2 Business Days
Title is PI eligible within DOMSpace commitment is realisticCompliance with academic personnel issues
DEPARTMENT OF MEDICINE TIMELINE
Percent of effort has not decreased without justificationF&A rate calculated correctlyCost sharing allowable and calculated correctlyCHR and IACUC assurances with correct names and datesComplete financial disclosure formsAccurate Other Support PageAcademic title of PI requires waiverOSR form completely correctlyDOM checklist completed correctly
Direct and indirect cost rates match throughout proposal
CHR and IACUC assurances with correct names and dates
PI effort and salary match
Cost sharing from allowable funds
Title is PI eligible within DOM
Space commitment is accurate
Title is PI eligible within DOMSpace commitment is realisticCompliance with academic personnel issues
Fellowships, Non-competing continuations,No-cost extensions
Department ReviewAssistant Director1/2 Business Day
Director
1/2 Business Day
Chair
2 Business Days
BUILDING A BUDGET
The budget may be comprised of the following:
Salary and BenefitsConsultant CostsEquipmentSuppliesTravelPatient Care CostsOther ExpensesSubcontracts
SALARIES AND BENEFITS
The PI provides the following to the RSA: Name Role on Project Percent of Effort on Project
The RSA will complete the following: Type of Appointment Institutional Base Salary Salary Requested Fringe Benefits (fixed percentage of salary based on appointment type) Total
NIH SALARY CAP
National Institutes of Health (NIH), Substance Abuse and Mental Health Services Administration (SAMHSA), and Agency for Healthcare Research and Quality (AHRQ) have instituted new Salary Cap Rates for fiscal year 2010.
All competitive grant proposals (new, renewal, and revisions) as well as supplements must use the new salary cap rate of $199,700 as of January 1, 2010.
More information on the NIH salary cap is available at http://or.ucsf.edu/cg/6121-DSY.html.
FELLOW STIPEND SCALE
These are the minimum stipends paid to predoctoral and postdoctoral scholars based on years of experience after graduation when paid from federal sponsored awards.http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-047.html
Stipend as of FY 2010 Predoctoral $21,180
Postdoctoral Years of Experience after Graduation: 0 $37,740 1 $39,756 2 $42,624 3 $44,304 4 $45,960 5 $47,940 6 $49,836 7 or more $52,068
NON-PAYROLL EXPENSES
Equipment Anything greater than $5,000 per item Excluded from indirect costsSupplies Supplies that are required for the project e.g., Animals, Software, ReagentsTravel Conferences Scientific MeetingsPatient Care Costs Excluded from indirect costsOther Expenses e.g., Equipment maintenance, Animal care, Patient
reimbursement, Transcription, Publication costs
DISCLOSURE OF FINANCIAL INTERESTS
Financial Interest Disclosures are required for every proposal.
For proposals to NIH, PHS, NSF, UC Discovery Grants, UCOP Special Program, AHA, and ACS, complete the Federal Principal Investigator Certification Form.
For all other and/or private grants, complete the 700-U Form.
For industry sponsored clinical studies, in addition to the 700-U, complete the COIAC Compliance with UCSF Policy #11 form.
http://or.ucsf.edu/osr/coi/forms.html for access to all COI forms.
COMMITTEE ON HUMAN RESEARCH (CHR) APPLICATIONSIf an investigator on a study (not just PI) is paid 50% or more full time. Regardless of source of funding or even if there is no funding, and
regardless of study site or location. The investigator must submit to the UCSF CHR
Types of CHR Applications: Full Committee Application: Allow about 6-8 weeks for approval Expedited Review Application: Allow about 2-6 weeks for approval Exempt Certification Form: Allow about 1-2 weeks for approval
Federal proposals that involve human subjects require Human Subjects Protection Training Certification for each key personnel and a Certification Letter to the NIH must be included in the proposal packet.
Training is provided at www.research.ucsf.edu/chr/train/chrtrain.aspUnless otherwise stated, both CHR and IACUC approvals are valid for one year.Approvals may be given for less than a year for more difficult studies.
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPLICATIONSFull Committee
Allow about 6 to 8 weeks for approval For new applications and some modifications
Annual Review Allow about 4 to 6 weeks for approval For 2nd and 3rd year renewals
Minor Modifications Allow about 3 weeks for approval
All of these are now online applications through Research Information Online (RIO) at
https://www.researchapps.ucsf.edu/rio.
Unless otherwise stated, both CHR and IACUC approvals are valid for one year.Approvals may be given for less than a year for more difficult studies.
CLINICAL TRIALS COORDINATION
The Clinical Research Coordinator (CRC) is responsible for pre- and post-award clinical trial management. The CRC manages the research study, study start-up, regulatory activities, and data; oversees the daily operations of the clinical trial; and oversees complicated research protocols. The CRC may also assist with budget preparation, submission of Committee on Human Research (CHR) proposals and consent forms, and developing and maintaining data gathering forms, databases, and record systems according to the local and federal compliance policies and procedures. The CRC is expected to work closely with the RSA to ensure compliance with clinical billing of study services provided.
For clinical studies, the responsibilities of the Research Services Analyst (RSA) and Clinical Research Coordinator (CRC) are depicted in the chart below. It is important that the RSA and CRC work collaboratively to ensure the completion of the following tasks. The RSA and CRC should ensure that an effective communication system is in place to facilitate a smooth process. RSA Responsibilities CRC Responsibilities Pre- Award
Preparing the proposal packet for review and internal approval
Completing the OSR Form Preparing assurances Submitting to OSR for review and
approval
Working with PI to negotiate protocol
Developing budget Submitting for CHR approval
Post-award continued next slide
RSA Responsibilities CRC Responsibilities Post- Award
Setting up the Account/ Fund number
Obtaining a Speedchart number for purchasing supplies that will be charged to the study
Submitting budget to UCSF Medical Center for correct billing
Reconciling expenses against Account/ Fund
Balancing accounts by moving expenses to appropriate funds
Creating Budget Status Reports (BSRs)
Invoicing for services provided Creating any Financial Status
Reports (FSRs) required
Obtaining the discounted research patient care rates
Setting up the Clinical Trial Accounts (ZZ Number)
Obtaining the NCT# and registering the trial at ClinicalTrial.gov
Registering Research Subjects for inpatient services
Ordering tests and procedures Using correct QV modifier and
ICD-9 V70.7 code on billable services to Medicare
Reconciling the Medical Center ledger against provided services and visits and initialing and dating after completion
Deactivating the ZZ Medical Record Number after the Clinical Trial Accounts closes
Destroying all unused labels and forms with the deactivated ZZ Medical Record Number
EXTERNAL REVIEW PROCESS
When a proposal arrives at an agency, it is subject to the scrutiny of review boards before a grant is awarded or withheld. Each review process is different according to the specific agency and the type of grant the PI is applying for. DOM applies for 4 main categories of grants which include federal funding, foundational/private funding, city funding, and state funding. Following are some examples of the review processes of major agencies under each category.
FEDERAL FUNDING
For a list of the study sections and members, go to http://www.drg.nih.gov/committees/rosterindex.asp
FEDERAL FUNDING
FEDERAL FUNDING
FEDERAL FUNDING
PRIVATE AGENCIES AND FOUNDATIONS
PRIVATE AGENCIES AND FOUNDATIONS
PRIVATE AGENCIES AND FOUNDATIONS
CITY CONTRACTS AND GRANTS
STATE CONTRACTS AND GRANTS
AWARD SET-UP AND MANAGEMENT
If a proposal is approved by the funding agency, the UCSF Office of Research will be notified via an award notice or signed contract from the agency. They will then communicate to the Accounting Department to set-up a new fund for the award. The RSA monitors this process. Once funds are appropriated, the RSA manages the funds for appropriate and allowable expenditures, creates financial projections based on actual expenses, and helps the PI close out the project.
NIH awards may require just in time (JIT) documents such as updated Other Support before they will issue the notice of grant award (NGA). The RSA will help the PI to submit these materials through the Office of Sponsored Research to the NIH.