National Institutes of Health

1. 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)

2. U. S. Department of Health and Human Services The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Care Financing Administration (HCFA) Agency for Health Care Policy and Research (AHCPR) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC)

3. NIH Extramural Awarding Components • National Cancer Institute (NCI) • National Heart, Lung, and Blood Institute (NHLBI) • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) • National Library of Medicine (NLM) • National Institute of Child Health and Human Development (NICHD) • National Institute of Deafness and Other Communication Disorders (NIDCD) • National Institute of Environmental Health Sciences (NIEHS) • National Institute of Neurological Disorders and Stroke (NINDS) • National Institute on Aging (NIA) • National Institute of Allergy and Infectious Diseases (NIAID) • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) • National Institute of Dental and Craniofacial Research (NIDCR) • National Eye Institute (NEI) • National Institute of General Medical Sciences (NIGMS) • National Institute of Mental Health (NIMH) • National Institute for Nursing Research (NINR) • National Institute on Alcohol Abuse and Alcoholism (NIAAA) • National Institute on Drug Abuse (NIDA) • National Center for Complementary and Alternative Medicine (NCCAM) • National Center for Research Resources (NCRR) • National Human Genome Research Institute (NHGRI) • National Institute of Biomedical Imaging and Bioengineering (NIBIB) • Fogarty International Center (FIC) • National Center on Minority Health and Health Disparities (NCMHD)

4. A Typical Institute/Center National Advisory Council Office of the IC Director Board of Scientific Counselors Extramural Intramural Scientific Programs Laboratory Studies Clinical Studies Grants Contracts

5. 22 Funding Mechanisms • R 01 Research Project To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his specific interest and competencies. • R 03 Small Research Grants To provide research support specifically limited in time and amount for studies in categorical program areas. Small grants provide flexibility for initiating studies which are generally for preliminary short-term projects and are non-renewable. • P 50 Center or Program Project Grants To support programmatic, sustained, multidisciplinary research on important problems.

6. 22 Finding Mechanisms • R 18 Research Demonstration and Dissemination Projects To provide support designed to develop, test, and evaluate health service activities, and to foster the application of existing knowledge for the control of categorical diseases. • R 21 Exploratory/Developmental Grants To encourage the development of new research activities in categorical program areas. (Support generally is restricted in level of support and in time.)

7. Research Career Programs • K 01 Research Scientist Development Award - Research & Training For support of a scientist, committed to research, in need of both advanced research training and additional experience. • K 02 Research Scientist Development Award - Research For support of a scientist, committed to research, in need of additional experience. • K 05 Research Scientist Award For the support of a research scientist qualified to pursue independent research which would extend the research program of the sponsoring institution, or to direct an essential part of this research program. • K 06(##) Research Career Awards To enable institutions to finance positions favorable to the intellectual growth and research productivity of established investigators of high competence for the duration of their careers.

8. Overall Peer Review Process

9. 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

10. Review Process for a Research Grant National Institutes of Health Research Grant Application School or Other Research Center Center for Scientific Review Assigns to IRG/Study Section & IC Study Section Initiates Research Idea Submits Application Evaluates for Scientific Merit Institute Evaluates for Program Relevance Advisory Councils and Boards Allocates Funds Conducts Research Recommends Action Institute Director Takes final action for NIH Director

11. Typical Timeline for a New Individual Research Project Grant Application (R01) • There are three overlapping cycles per year: • Submit in February (June, October) • Review in June(October, February) • Council in September (January, May) • Earliest award in December (April, July) • Cycle 1---- • Cycle 2---- • Cycle 3----

12. Center for Scientific Review • Serves as central receipt point for PHS Grant Applications • Assigns applications to CSR Integrated Review Groups/Study Sections or Institute Scientific Review Groups • Assigns applications to NIH Institute(s) as potential funding component(s) • Conducts initial scientific merit review of most research applications submitted to the NIH in more than 100 Study Sections

13. Grant Application Receipt and Assignment

14. Applications Submitted to NIH • Approximately 60,000 grant applications are submitted to NIH each year, of which 25-30% are funded • Competing grant applications are received for three review cycles per year

15. Applications are Assigned by Referral Officers: Professional scientists, most of whom also serve as scientific review administrators of CSR study sections

16. Applications are Assigned to: • Scientific review groups based on: • Specific review guidelines for each scientific review group • Institutes based on: • Overall mission of the Institute • Specific programmatic mandates and interests of the Institute

17. Assignment to CSR Study Sections (continued) • Within an IRG, applications are assigned for review to • Standing Study Sections when the subject matter of the application matches the referral guidelines for the study section • Ad Hoc Special Emphasis Panels (SEPs) when the subject matter does not fit into any study section, or when assignment of an application to the most appropriate study section would create a conflict of interest. Also used for special mechanisms (e.g., fellowships, SBIRs, AREAS)

18. Sample Application Number Individual Serial Amended Research Number Grant 1 R01 CA 12345 01 A1 New National Grant Application Cancer Support Institute Year

19. Initial Review in CSR

20. Peer Review in CSR • CSR Study Sections are managed by a Scientific Review Administrator (SRA) who is a professional, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section • Each CSR standing study section has 12 - 24 members who are primarily from academia • As many as 60 - 100 applications are reviewed at each study section meeting

21. Scientific Review Administrator • Performs administrative and technical review of applications • Selects reviewers • Manages study sections • Prepares summary statements • Provides requested information about study section recommendations to Institutes and National Advisory Councils/Boards

22. Criteria For Selection of Peer Reviewers • Demonstrated Scientific Expertise • Doctoral Degree or Equivalent • Mature Judgment • Work Effectively in a Group Context • Breadth of Perspective • Impartiality • Interest in Serving • Adequate Representation of Women and Minority Scientists

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

24. Action • Scored -- Scientific Merit Rating 1.0 to approximately 3.0 Based on the relevant review criteria, the application is judged to be in the upper half of applications reviewed by the study section or scientific review group. The recommendation can be for the requested time and amount or for an adjusted time and amount. A priority score is provided, and a summary statement prepared that incorporates the written critiques plus a resume and summary of the discussion.

25. Action • Unscored Application is unanimously judged to be in the lower half of applications reviewed by the study section or scientific review group. No priority score is assigned. The summary statement provided to the applicant is a compilation of reviewers’ comments prepared prior to the meeting.

26. Action • Deferral The study section cannot make a recommendation without additional information. This information may be obtained by a project site visit or by submission of additional material by the applicant.

27. Post Scientific Review Group Actions • Calculations of priority scores and percentile rankings • Preparation of summary statements • Removal of applications from National Advisory Council / Board consideration

28. Summary Statement • Once applications are reviewed, the results are documented by the SRA in a summary statement and forwarded to the Institute (and the PI) where a funding decision is made: • The summary statement contains: • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes

29. National Advisory Council or Board Review

30. Council Actions • Concurrence with study section action • Modification of study section action • Deferral for re-review

31. What Determines Which Awards Are Made? • Scientific merit • Program Considerations • Availability of funds