Grants 101: An Introduction to NIH Grants Lynn Clemow, Ph.D.

    

Overview Outline the organization of the National Institutes of Health Program Announcements and RFAs Describe commonly-used grant mechanisms Application and Review Process

Structure of the NIH Intramural Research Research done onsite by NIH scientists 9% of the NIH budget Extramural Research – 82% of budget Research grants Training R& D contracts Research Management & Support

NIH Budget Intramural Grants & Contracts

Offices of: Women’s Health AIDS Research - Disease Prevention Behavioral & Social Science Research (OBSSR)

Institutes and Annual Budgets - 2007 National Cancer Institute – (NCI) $4.8 billion National Institute of Allergy & Infectious Disease (NIAID) - $4.5 billion National Heart, Lung & Blood Institute (NHLBI) $2.9 billion National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - $1.85 billion

Institutes and Budgets - 2007 National Institute of Neurological Diseases and Stroke (NINDS) - $1.5 billion National Institute of Mental Health (NIMH)- $1.4 billion National Institute on Aging (NIA)- $1.04 billion National Institute of Drug Abuse (NIDA) - $1.0 billion

Centers and Budgets NCCAM - Complementary and Alternative Medicine - $121 million NCMHD – Minority Health & Health Disparities - $190 million NINR – Nursing Research - $135 million

Other Federal Entities Agency for Healthcare Research & Quality (AHRQ) Centers for Disease Control & Prevention (CDC) Health Resources and Services Administration (HRSA)

Grant Application Overview 3 regular grant submission cycles every year February 1 (+/- 2 weeks) June 1 (+/- 2 weeks) October 1 (+/- 2 weeks) If a resubmission, due 1 month later (Mar, July, Nov). Also special one-shot grant opportunities come up (Requests for Applications or RFAs) with very little notice.

Grant Submission Rules Prior to January, 2009, many grant mechanisms could be re-submitted twice (i.e., total of 3 submissions), and that rule still applies to grants submitted prior to 1/09 As of January, 2009, new grants can only be re-submitted once (for a total of 2 submissions)

Grant Budgets Budgets include: DIRECT COSTS: (GO TO THE PROJECT) Personnel costs (salary + ~36% fringe benefits rate) – specifying % effort for each person Equipment Supplies Subject payments/ incentives Travel (local mileage and conference travel) Each person and item needs to be justified in budget justification section of grant

Grant Budgets INDIRECT COSTS: (GO TO INSTITUTION) Money goes to the institution to provide facilities and administrative support to researchers Rate calculated by periodic negotiations between each institution and the Federal Government – at UMDNJ currently 56% . For every dollar of direct costs (excluding large equipment purchases) UMDNJ gets an additional $.56. Usually indirect costs are given OVER AND ABOVE budget limits…. Usually ceilings apply only to direct costs. How that money gets divided up within the institution varies a great deal from place to place. For many medical schools, the dean/central admin. gets half, the department gets half (in large depts., shared with the division and investigator in some way for resources).

NIH Grant Mechanisms T - Institutional Research Training Grants (granted to institutions – grad students and post-docs appointed by institution) (e.g., NRSA) F – Fellowships – Individual post-doc fellowships for research training in biomedical or behavioral science K – Research Career Development Awards – to develop research scientists with clear potential (can be early or later career, mentored or to support mentoring)

Grant Mechanisms R – Research grants – Awarded to fund a specific objective or study in the area of the principal investigator’s interest & competence P - Program Grants – awarded to more senior investigators only, funds a broad-based long-term program of research, interacting projects with groups of investigators, often 3 or 4 projects and shared cores for stats, admin, training, instrumentation, etc. Tend to focus on mechanisms of disease. P- Center Grants – Senior investigators, research likely to have a more clinical focus, in response to I/C priorities. (MUPS center grant)

Grant Mechanisms SBIR – Grants made to small business concerns that have expertise to contribute to scientific mission of NIH Small Business Technology Transfer (STTR) – to facilitate research between small businesses and research institutions. Conference Grants

Career Development Grants Many K-award mechanisms: Great career step, at whatever level. Must devote >75% effort to research in most Covers 75% base salary for up to 5 years For mentored mechanisms often want people to be with 5 years of end of training, though some career transition awards exist For early-career researchers, this kind of award is the “Holy Grail”. Protects the time and space to develop research skills, ideas The project is usually of fairly limited scope Can’t take any other NIH money for duration of award Develops a track record with NIH funding. The mentors and institutional resources are often key elements for success

Career Development Award Some K grants are more basic-science focused K01 – Mentored research scientist award K02 – Independent scientist award K05 – Senior scientist award K07 – Academic career award - curriculum development focus Some with more clinical scientist focus: K08 – Mentored clinical scientist award K23 – Mentored patient-oriented research career development award K24 - Mid-career investigator award in patient-oriented research (must spend 25-50 % effort on pt-oriented research There are many others…Important to note that each I/C uses these mechanisms differently – important to check

R-Series Grants SMALLER/ DEVELOPMENTAL GRANTS: Used in different ways by different I/Cs R03 – Small grant program: May request up to 2 years of funding @$50,000 / year. Great for pilot data for larger study. R21 – Exploratory/developmental grant: May request up to 2 years for project, with TOTAL of $275,000. Often used to develop and pilot test an intervention.

R-Series Grants SMALLER / DEVELOPMENTAL GRANTS R34 – Clinical Trial Planning grant- project to prepare for a larger clinical trial, (often R-18 or large R01) which generally is used to translate established scientific findings into clinical practice. Total of $100,000 / year, 1 or 2 years

R-Series Grants R01 – Research Project Grant Program To support a discrete, specific project Need to have pilot & feasibility data and a team with necessary expertise (preferably some of whom have worked together before) Budget: <$500,000 direct costs per year, up to 5 years Supplements and amendments are allowed.

P-Series Large program-projects or center grants Led by senior investigators (supported by collaborative interdisciplinary group) Usually made up of 3-4 interacting projects and several shared core functions (biostatistics/ data management, administration, training, instrumentation, laboratories, etc.) Budgets usually $1.5 million/year for 5 years, goes up for competitive renewal every 5 years

Minority Supplements Trainees and junior investigators who are members of under-represented minorities are eligible for special minority supplements grants. Generally propose a relatively simple additional measure or research question to be added to the parent grant… covers time at designated stipend levels. Benefit to applicant: Great opportunity to get research experience and funding for that time Benefit to project: an extra pair of hands that are free to the project, sponsoring minority trainees viewed positively by NIH No specific deadlines for applications (usually ~ 5 pages and admin. paperwork) – quick turnaround – 2 months. Issues in working with institutional HR, etc.

Stimulus Plan (ARRA) Funding Whole bunch of RFAs, used differently by I/Cs. Challenge Grants (RC-1) – Each I/C defines specific research aims. 12-page application format, $500,000 per year x 2 years. Administrative Supplements – Again, each I/C defines use of these supplements, many institutes gave these primarily to new investigators Announcements still emerging Very high level of special reporting and tracking of funds

GRANT DEVELOPMENT PROCESS Get an idea, discuss with colleagues, mentors Think about appropriate grant mechanisms Adequate pilot data? Scope of project? NIH grant deadline to shoot for? Develop sample size estimates & project timeline – and budget flows from those Develop budget and budget justification, consult with administrator regarding budget details, has to be in early. Develop grant application

New NIH Grant Scoring Domains OVERALL IMPACT (Summary score) SCORED REVIEW CRITERIA: Significance Investigators Innovation Approach Environment

Grant Outline / Formatting For R01 – 12 pages of science for the project. For R21 and some other mechanisms – shorter format (6 pages)

Grant Outline Introduction (for resubmission only, 1 page) Specific Aims (1 page) Research Strategy Significance Innovation Approach Preliminary Studies for New Applications Progress Report for Renewal and Revision Applications References Human Subjects issues, Environment, etc Page limits apply to these sections

Grant Outline Also need to include: Budget/ budget justification Any subcontract paperwork, if including co-investigators from other institution Biosketches (4-page limit) for investigators and main staff people Letters of support Administrative pages with info on PI, investigators, and institution

Grant Submission Have to get internal sign-offs Financial disclosure from each investigator Grants office, financial review of budgets. Admin. sign-off from departments, facilities Submissions done electronically in almost all cases at this time… to grants.gov via grants office

Grant Review Process Sent to Center for Scientific Review, directed to an I/C Assigned to a Study Section (can request specific assignment) Can submit 3 pages of supplemental data/ info prior to review. Reviewed ~ 4 months later when Study Section meets After study section meets (usually a few days) get score, summary statement follows within 30 days.

Scoring Approximately half of grants don’t get scored and are not discussed at the study section meeting. So you get reviews, but no discussion and no overall priority score. New scoring system gives reviewers’ ratings of each scoring criteria Scored grants (and grant elements) are rated from 1 - 9: 1 = perfect score; 9 = worst possible score

NEW SCORING CRITERIA Score Descriptor Additional Guidance on Strengths/Weaknesses 1 Exceptional Exceptionally strong with essentially no weaknesses 2 Outstanding Extremely strong with negligible weaknesses 3 Excellent Very strong with only some minor weaknesses 4 Very Good Strong but with numerous minor weaknesses 5 Good Strong but with at least one moderate weakness 6 Satisfactory Some strengths but also some moderate weaknesses 7 Fair Some strengths but with at least one major weakness 8 Marginal A few strengths and a few major weaknesses 9 Poor Very few strengths and numerous major weaknesses Minor Weakness: An easily addressable weakness that does not substantially lessen impact Moderate Weakness: A weakness that lessens impact Major Weakness: A weakness that severely limits impact The final overall impact/priority score: Average of OVERALL IMPACT/PRIORITY SCORES OF REVIEW PANEL MEMBERS to one decimal point and multiplying by ten. Thus, the new scores range from 10-90 in whole numbers.

PERCENTILES Also get a percentile rank Percentile lets you compare your grant’s score to the likely payline (cutoff percentile score). The lower the percentile and the score, the better. Fundable % scores generally published every year by the I/C Example: Score : 21, 11% Payline: 15% - grant is nearly sure to be funded Can’t be absolutely sure until the Council meets (3 times/year) and confirms payline. Later: Notice of Grant Award is issued (that’s the actual money)

Paylines Differ Year by year, given level of NIH budget Institute by Institute – depends on budget level and their long-term commitments Depending on the Investigator – Advantage given to new investigators (sometimes get extra 5% points). People who have had K awards or small R grants are still considered “new” At some I/Cs, if you get close to the payline, can submit a 5-page response to the reviewers and undergoes administrative review

Resubmission Need to carefully digest the reviews and decide how best to respond. May need to strengthen background, study rationale, details of methods, statistical analysis plan, adjust budget, or collect additional pilot data May just need to highlight things you originally wrote, but didn’t emphasize Always best to be clear that you are being responsive to feedback Great to get advice from Program Officer assigned to your grant once you get score – they were generally in the room when it was discussed

Resubmission You have up to 2 years to resubmit…. Most often done sooner. Deadline usually a month later than regular intervals, but check about special mechanisms Sooner rather than later is the general rule, but totally worth it to wait a cycle and collect pilot data if feasibility is questioned. You have 1 additional page up front to respond directly to the reviewers’ comments, and mark other revisions in body of grant Generally goes back to the same study section Especially important to get the response right when only 1 resubmission is allowed