U.S. Department of Health and Human Services

1. James P. Kiley, Ph.D. National Heart, Lung, and Blood Institute U.S. Department of Health and Human Services Orientation to NIH National Institutes of Health May 21, 2005 National Heart, Lung, and Blood Institute

2. National Institutes of Health • Much of the biomedical research in the United States is supported by the Federal Government, primarily the National Institutes of Health (NIH)

3. NIH Mission • Acquire new knowledge that will lead to better health for everyone • Support research • Train young investigators • Communicate research results to the medical community and the public

4. FY 2005 Funding By Mechanism(dollars in billions) 16% NIH In-House 6,000 Scientists $2.8 Intramural = 10% $1.0 RM&S = 4% $0.9 Other (NLM, OD, et al.) = 3% Spending at NIH $4.7 TOTAL BUDGET $28.8 Billion 84% Outside NIH (Supports over 212,000 Scientists & Other Personnel) (Supports over 3,000 Institutions Nationwide) Spending Outside NIH $24.1 NIH comprises 27 Institutes and Centers

5. National Institutes of Health Office of the Director National Cancer Institute National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute on Aging National Eye Institute National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Biomedical Imaging and Bioengineering National Institute of Child Health and Human Development National Institute on Alcohol Abuse and Alcoholism 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 Institute of General Medical Sciences National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research

6. NIH Home Page - www.nih.gov • NIH Guide • Grant Policy • Applications • Additional Program Information • Staff Contacts

7. NIH Extramural Programs Grant Patron (assistance, encouragement) Cooperative Partner Agreement (assistance but substantial program involvement) Contract Purchaser (procurement)

8. Investigator-Initiated Research and Research Training Opportunities • R01: Regular Research • P01: Program Project • SBIR: Small Business Innovative Research • K-series: Career Awards • NRSA: Fellowships and Training Grants

9. Opportunities for “Young” Investigators • National Research Service Individual Fellowship (F32) • Mentored Research Scientist Development Award (K01) • Independent Scientist Award (K02) • Mentored Clinical Scientist Development Award (K08) • Small Grant (R03) • Academic Research Enhancement Award (R15) • Exploratory/Developmental Grant (R21) • Loan Repayment Program (L30 and L40)

10. NIH Grant Process Identifies Career Goal and Training and Prepares Application Research Investigator Grantee Submit Application Manages Funds Institution National Institutes of Health Center for Scientific Review IRG Institute makes Institute assigns application to evaluates funding decision Advisory Council Initial Review Group (IRG) scientific and issues recommendation and Institute merit Award

11. PHS Research Grant Application Kit (form PHS 398) Mail Completed Forms To: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH ROCKLEDGE II ROOM 1040 MSC-7710 BETHESDA MD 20892-7710 http://grants.nih.gov/grants/funding/phs398/phs398.html

12. Dual Review System for Grant Applications • First Level of Review • Scientific Review Group (SRG) • Provides Initial Scientific Merit • Review of Grant Applications • Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review Council • Assesses Quality of SRG • Review of Grant Applications • Makes Recommendation to • Institute Staff on Funding • Evaluates Program Priorities • and Relevance • Advises on Policy

13. Receipt and Review • Standard Receipt Dates for Competing Applications (http://grants2.nih.gov/grants/funding/submissionschedule.htm) • Review Guidelines of Research Grants (http://www.csr.nih.gov/cdg/cd%20guidelines/r01_Research_Grants.pdf) • NIH Grant Review Process Video (http://www.csr.nih.gov/video/video.asp)

14. Applications are Assigned to: • Scientific review groups based on: • Specific review guidelines for each scientific review group • Applicants may indicate preference as to Institute and SRG assignment in cover letter • Institutes based on: • Overall mission of the Institute and referral guidelines • Specific programmatic mandates and interests of the Institute

15. Review of Research Grants Review Criteria: • Significance • Approach • Innovation • Investigator • Environment • Overall Evaluation & Score Reflects Impact on Field

16. Scientific Review Group Actions • Scored, Scientific Merit Rating (priority scores and percentiles) • Unscored (lower half) • Deferral

17. STUDY SECTIONS DO NOT FUND INSTITUTES FUND!

18. Research Training and Career Development

19. Research Training and DevelopmentGraduate Student Pre-doctoral Training Support (T32) Research Project Grant (R01) Senior Fellowship (F33) Postdoctoral Training Support (T32, F32) Graduate Student Mid- Career Change Post- Doc. Career Stages of Research Training and Development

20. Research Training and DevelopmentMedical Student Mentored Clinical Scientist Development Award (K08) Short-term Training of Health Professional Students (T35) (K23) (K24) Research Project Grant (R01) Senior Fellowship (F33) Postdoctoral Training Support (T32, F32) Medical Student Mid- Career Change Internship Residency Post- Doc. Stages of Research Training and Development Career

21. Institute-Initiated Research • Targeted (<25% of extramural funds) • Usually time-limited (4 yrs) unless re- announced • Institute Specifies: • Area of Research, Research Goals, Funds Allocated, Research Design, and Length of program (Program Announcements; Requests for Applications or Proposals)

22. Program Announcements (PAs) • Invites grant applications in a given research area • May describe new or expanded interest in a particular extramural program • May be a reminder of a continuing interest in a particular extramural program • Generally has no funds set aside • Applications reviewed in CSR along with unsolicited grant applications

23. Requests for Applications (RFAs) • Announcement describing an institute initiative in a well-defined scientific area • Invitation to the field to submit research grant applications for a one-time competition • Set-aside of funds for a certain number of awards • Applications generally reviewed within the issuing institute

24. NIH Guide for Grants and Contracts

25. NHLBI Home Page – www.nhlbi.nih.gov