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 ssutton@medicine.ucsf.edu. Joseph Wilson can be reached by phone at (415) 514-1120 or e-mail at jwilson@medicine.ucsf.edu.

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.