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Grants 101: NIH Structure

Grants 101: NIH Structure. Thomas Hawn July 28, 2011 Fellows Survival Course. Outline. July 28 I. NIH Structure 1. NIH Hx & Funding Trends 2. NIH Nuts & Bolts 3. Grant Mechanisms July 29 II. Writing a Grant Sheila Lukehart III. Behind the Scenes at Study Section

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Grants 101: NIH Structure

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  1. Grants 101: NIH Structure Thomas Hawn July 28, 2011 Fellows Survival Course

  2. Outline July 28 I. NIH Structure 1. NIH Hx & Funding Trends 2. NIH Nuts & Bolts 3. Grant Mechanisms July 29 II. Writing a Grant Sheila Lukehart III. Behind the Scenes at Study Section Bill Parks

  3. National Institutes of HealthUS Department of Health and Human Services Kathleen Sabelius - H&HS The Boss Director of NIH Francis Collins, MD PhD

  4. Responses toYellow Fever 1879 NIH History • Yellow fever destroyed the Mississippi Valley • A $30,000 bid (RFA) from the US Army for Universities • 1st peer-reviewed applications for research. • Marine Hospital Service established, NIH roots started • Director Joseph Kinyoun 1887 1930 • NIH officially named Adapted from slide From Toni Scarpa, head NIH CSR

  5. The Fundamental Tenets for NIH (1946) • 1. The only possible source for adequate support of our medical research is the taxing power of the federal government. • The federal government and politicians must assure complete freedom for individual scientists in developing and conducting their research work. • 3. Reviews should be conducted by outside experts essentially without compensation. • Program management and review functions should be separated. Surgeon General Thomas Parran, Jr. Slide From Toni Scarpa, head NIH CSR

  6. NIH Funding Stats Getting the Facts

  7. Department of Health and Human Services Total = $592 Billion Total = $52.6 Billion HRSA11% CDC 8% Medicare 58% FDA 3% Discretionary Programs 9% NIH54% Medicaid 33% Other 24 %

  8. The Bulk (~85%) of the NIH Budget Supports Extramural Research & Training Training 2.7% Research Mgmt. & Support 3.9% All Other 5.5% Research Project Grants 52.9% Other Research(Including K Awards) 5.9% Research Centers 9.9% R&D Contracts9.6% IntramuralResearch 9.7% *~4% of DOD budget

  9. FY 2011 NIH Budget -- $30.7 Billion Spending at NIH $4.5 B 2003:$27.1 billion 2004:$28.0 billion (+3.1%) 2005:$28.6 billion (+2.2%) 2006:$28.6 billion (-0.2%) 2007:$29.2 billion (+2.1%) 2008:$29.2 billion (0%) 2009:$30.4 billion (+4.1%) 2010:$30.8 billion (+1.4%) 2011:$30.7 billion (-0.3%) Spending Outside NIH $24.1 B 2007 data

  10. NIH Grew with Clinton and Fell with Bush C h a n g e i n N I H A p p r o p r i a t i o n s , F Y 1 9 9 5 - 2 0 0 7 0 3 0 1 8 % 1 6 % 2 5 1 4 % 2 0 1 2 % PercentChange Appropriations Billions $ 1 0 % 1 5 8 % 1 0 6 % 4 % 5 2 % 0 % 1 9 9 5 1 9 9 6 1 9 9 7 1 9 9 8 1 9 9 9 2 0 0 0 2 0 0 1 2 0 0 2 2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 * P r e - D o u b l i n g P e r i o d o f P o s t D o u b l i n g D o u b l i n g F i s c a l Y e a r

  11. Growth Wasn’t That Great Anyway Current Dollars Constant Dollars $30 $25 $20 Billions $15 $10 $5 $0 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

  12. More Applications + Flat Budget = Reduced Paylines

  13. Top Recipients of Taxpayers Largesse 2007 • 2816 institutions/companies/organizations ranked

  14. Source of Research Funds at UW~2/3 of Research Funds at UW Are Federal • Gold standard of extramural funding • Essential for advancement and promotion • Your salary support • Most important: • Indirect Costs: $1 = $0.54

  15. Source of Research Funds at UWDHHS is the predominant UW source of Federal Money

  16. Scenario—Who to Ask You are ready to apply for a grant and have many questions. Where do you get information? • Grants Management Specialist • Study Section Chairperson • NIH SRO/SRA • NIH PO

  17. Solicit Advice Broadly … Mentor Fellows Post-docs Colleagues NIH

  18. The SRO and the Program Officer • Scientific Review Officer (SRO) • 240 SROs in CSR • Legal Responsibility for Study Section Mtg • Selection of Study Section Members • Assignment of Applications • Follow the law, the rules and the regulations • Assisted by Grants Management Specialist • Program Officer • Role before and after review • Key “translator” of summary statements for investigator • Responsible for programmatic, scientific, and/or technical aspects of a grant.

  19. NIH Structure No funding authority Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities Center for Information Technology Clinical Center Center for Scientific Review NIH Institutes http://www.nih.gov/icd/

  20. Dual Review System for Grant Applications First Level of Review= CSR Scientific Review Group (SRG) • Second Level of Review • NIH Institute/Center Council

  21. The Basic Operating Principles of NIH Peer Review NIH has ownership of the review process • The Scientific Review Officer, a federal employee, nominates the review panel, assigns applications and is responsible for the meeting The study section has ownership of the science review • Is composed of the best and most experienced scientists in the field. • ~ 20 permanent members, serving 4 years 3 times/year; 10 ad hoc • Hundreds of study sections reviewing different fields Ownership of application: • - CSR from receipt to posting of Critiques • - IC after Critique posting

  22. 3 Funding Instruments for Extramural Research • Grant: Investigator decides the research to be designed or developed and the approach • ~ 84-88% of extramural grants • Contract: Government decides the research to fill their perceived need and establishes detailed requirements • ~ 8-10% • Cooperative Agreement: Similar to grants, but awarding Institute/Center (IC) and recipient have substantial involvement in carrying out the project’s activities • ~ 4-6%

  23. Major Grant Activities NIH Uses to Fund Extramural Research • Grants • Small Research Grant (R03) • Exploratory/Developmental Research Grant (R21/R33) • Traditional Research Project Grant (R01) • Program Project Grant (P01) • Scientific Meeting Support (R13) • Small Business Innovation Research Grant (SBIR: R43/R44) • Small Business Technology Transfer Grant (STTR: R41/R42) • Grants or Cooperative Agreements • Research Center Grant (P50/P60) • Contracts

  24. Mechanisms for NIH to Get Research Proposals • Investigator-Initiated Research • Unsolicited, from general institute extramural budget • R01, R21, R03 • ~ 80% of awards • Request for Applications (RFA) • Solicited; set-aside of funds for a certain number of awards • One-time competition to stimulate research in a priority area • R01, R21, R03, P01, Cooperative Agreement • ~ 10% of awards • Requests for Proposals (RFP) (contracts) • Solicited, with set-aside of funds for a certain number of awards • One-time competition

  25. Mechanisms for NIH to Get Research Proposals • Program Announcement and Special Review (PAR) • Solicited, but no set-aside of funds • Reviewed by special emphasis panel • Program Announcement (PA) • Solicited, but no set-aside of funds • Reviewed by standing study section

  26. New Investigator • A Principal Investigator (PI) who has not yet competed successfully for a substantial, competing NIH research grant (R01 or ‘higher’) is considered a New Investigator • http://grants1.nih.gov/grants/new_investigators/resources.htm

  27. Early Stage Investigator (ESI) • An individual who is classified as a New Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) Extension of ESI Eligibility • The 10-year period may be extended to accommodate special circumstances (e.g. medical concerns, disability, pressing family care responsibilities, or active military duty service)

  28. What Affects NI Status? • PI of an R03 or R21? No • PI of an NIH contract? No• PI of a grant with another Federal agency? No • PI of an SBIR/STTR? No • PI of a U01, specifically for a foreign investigator? Receipt of U01 removes NI status.• Inheriting an R01 from a PI who moved away or died? No

  29. Scenario I Scenario—What to Apply For You have just finished your 1st year of fellowship. What grant series should you apply for? • T • F • K • R, U, or P?

  30. NIH Award Mechanisms

  31. Training and Career Timetable Stage of Research Training / Career Awards Pre-Bac Pre-Bac Institutional Training Grant (T34) GRADUATE/ MEDICAL STUDENT Predoctoral Institutional Training Grant (T32) Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) POST DOCTORAL NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) EARLY Small Grant (R03) Research Project Grant (R01) Independent Scientist Award (K02) MIDDLE CAREER Midcareer Investigator Award in Patient-Oriented Research (K24) Exploratory/Develop-ment Grant (R21) SENIOR Senior Scientist Award (K05)

  32. Training Grant Awards—Clinical Track

  33. Training Grant Awards—PhD Track

  34. T & F Grants • Institutional Awards: T32 • Institution, not the individual, applies for the award • Not available at all schools, departments, divisions • Individual Awards: F32 • Mentored • Independent—can interact with other NIH Awards • Depending on the award, all doctorates or restricted to clinical doctorates • NIH support varies by Institute TOTAL YEARS of F and T NIH Grant Support=3 YEARS

  35. F32 NRSA Success Rates

  36. ‘Career’ Awards = ‘K’ Awards Purpose: To provide protected time for individuals to further develop their research expertise. • Individual Awards: • Mentored • Independent—can interact with other NIH Awards • Depending on the award, all doctorates or restricted to clinical doctorates • Institutional Awards: • Institution, not the individual, applies for the award • Curriculum/Program Development

  37. Mentored K Awards • K01: Mentored Research Scientist Development Award • K08: Mentored Clinical Scientist Development Award • K22: Research Career Award for Transition to Independence • K23: Mentored Patient-Oriented Research Development Award • K25: Mentored Quantitative Research Development Award • K99/R00: NIH Pathway to Independence (PI) Award • K12/KL2 Institutional Mentored Research Scientist Development Program

  38. K Career Awards—Clinical Track

  39. K08: For Health Professional Doctorate • Supervised research experience for individuals with health professional degree who are committed to a career in laboratory research • Phased award period • didactic experience • “hands-on” research experience • For individuals intending a career in basic or translational research

  40. K23: For Health Professional Degree • Supervised research for clinically trained professionals with a commitment to focus on patient-oriented research (POR) • POR is defined as research in which the investigator directly interacts with human subjects • Must have completed clinical training, including specialty/sub-specialty, if applicable, prior to award

  41. K Career Awards—PhD Track

  42. K01: For Research Doctorate • Provides an intensive, mentored research experience • Candidates normally must have a research doctorate and postdoctoral experience • Not an extension of postdoctoral training • Varied and limited NIH IC participation • Used for re-entry • Used for pursuit of new research area

  43. K22: For Research or Health Professional Doctorate • Assists transition to independence • May be activated after identifying a suitable position at a research institution • Might include mentored and independent phases • May support an NIH intramural and an extramural phase

  44. K99/R00: For Health Professional or Research Doctorates with Research Experience at the Postdoctoral Level • K99: Mentored research experience for up to 2 years • R00: Transition to research independence as junior faculty for up to 3 years • Applicants: no more than 5 years of postdoctoral research training at the time of initial application or resubmission • Non-U.S. citizens may apply, but institution must be domestic • Transition to R00 phase requires offer and acceptance of tenure-track, full-time assistant professor position (or equivalent)

  45. UW Institutional K Awards K12 Jan Abkowtiz, Hematology William Bremner, Male Reprod Health Res David Eschenbach, Women’s Reprod Health Res KL2 Nora Disis, ITHS

  46. K12: For Institutions • K12: Institutional Mentored Research Scientist Development Program • Enhance research career development for individuals, selected by the institution, who are training for careers in specified research areas • Provides institutions with the capacity for mentoring junior investigators through a programmatic approach

  47. UW’s MRHR/WRHR Programs • Institutional Career Development Award in Men’s and Women’s Reproductive Health Research • Open to MDs after completion of fellowship or residency in (Ob/Gyn, Medicine, Pediatrics or Urology) • 4-5 years of salary support (75% time), up to $100,000 yearly, with $25,000/yr. research funds • 5-6 Scholars in both programs (~1 new/year) • Contact: • MRHR, John Amory jamory@uw.edu • WRHR: Susan Reed reeds@uw.edu

  48. UW’s KL2 Program • Institutional Career Development Award in Clinical/Translational Research • Open to any MD/PhD after completion of fellowship or post-doc in clinical field • 4-5 years of salary support (75% time), up to $85,000 yearly, with $25,000/yr. research funds • 5-6 Scholars chosen yearly by December (28-24 total scholars). Applications due in fall. • Weekly research seminars and “works-in-progress” sessions • Details at http://old.iths.org/education/kl2

  49. Research Career Development AwardsNumber of entry-level awards

  50. Other Grant Sources To Consider NIH Loan Repayment Program • Ideal for individuals with clinical doctorate degrees working in specified areas of biomedical science, predominantly patient-oriented research • Examples of Sources of Non-Federal Grants American Hearth Association Infectious Diseases Society of America Cystic Fibrosis Foundation Parker B Francis Foundation

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