CORE RESOURCES NIH Office of Extramural Research (OER) Website http://grants1.nih.gov/grants/oer.htm NIH NIAID Website: All About Grants Tutorials http://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
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 RSA Proposal Guidelines Establish Timeline and Responsibilities PI Responsibilities RSA Responsibilities Complete Packet for Review Department of Medicine Review Chair to Sign Office of Sponsored Research Funding Agency indicate interest in submitting 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@example.com. Joseph Wilson can be reached by phone at (415) 514-1120 or e-mail at firstname.lastname@example.org.
DEPARTMENT OF MEDICINE TIMELINE Salaries are correct in relation to NIH cap F&A rate calculated correctly Correct MTDC rate, if applicable Indication of allowable funds for cost sharing CHR/CAR assurances with correct names and dates Complete financial disclosure forms Accurate Other Support Page Applicable Biosketches are included Academic title of PI require waiver Grant eligibility to be signed under RAP OSR form completed correctly DOM 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 DOM Space commitment is realistic Compliance with academic personnel issues NIH Proposals Department Review Assistant Director 1 Business Day Director 1 Business Day Chair 2 Business Days
DEPARTMENT OF MEDICINE TIMELINE Salaries are correct in relation to NIH cap Salaries include any funding restrictions, if applicable F&A rate calculated correctly Correct MTDC rate, if applicable Cost sharing calculated correctly and is allowable CHR and IACUC assurances with correct names and dates Complete financial disclosure forms Applicable Biosketches are included Accurate Other Support Page Academic title of PI requires waiver OSR form completely correctly DOM 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 Review Assistant Director 1 Business Day Director 1 Business Day Chair 2 Business Days Title is PI eligible within DOM Space commitment is realistic Compliance with academic personnel issues
DEPARTMENT OF MEDICINE TIMELINE Percent of effort has not decreased without justification F&A rate calculated correctly Cost sharing allowable and calculated correctly CHR and IACUC assurances with correct names and dates Complete financial disclosure forms Accurate Other Support Page Academic title of PI requires waiver OSR form completely correctly DOM 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 DOM Space commitment is realistic Compliance with academic personnel issues Fellowships, Non-competing continuations, No-cost extensions Department Review Assistant Director 1/2 Business Day Director 1/2 Business Day Chair 2 Business Days
BUILDING A BUDGET The budget may be comprised of the following: Salary and Benefits Consultant Costs Equipment Supplies Travel Patient Care Costs Other Expenses Subcontracts
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 costs Supplies Supplies that are required for the project e.g., Animals, Software, Reagents Travel Conferences Scientific Meetings Patient Care Costs Excluded from indirect costs Other 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.htmlhttp://or.ucsf.edu/osr/coi/forms.html for access to all COI forms.
COMMITTEE ON HUMAN RESEARCH (CHR) APPLICATIONS If 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.asp 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.
INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPLICATIONS Full 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 2 nd and 3 rd 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.
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
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.