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

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

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)

A Typical Institute/Center Office of the IC DirectorNationalAdvisoryCouncil Board of ScientificCounselors Extramural ScientificPrograms GrantsContracts Intramural LaboratoryStudiesClinicalStudies

Overall Peer Review Process

Dual Review System for Grant Applications Second Level of Review Second Level of ReviewCouncil  Assesses Quality of SRG  Review of Grant Applications  Makes Recommendation to  Institute Staff on Funding  Evaluates Program Priorities  and Relevance  Advises on Policy 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

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

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

NIH Grant Receipt, Review, and Award Schedule Jan-May May-SeptReceipt Dates Sept-JanJune-July Oct-NovReview Dates Feb-MarSept-Oct Jan-FebNational Advisory Council Board Dates May-June Dec 1 Apr 1Earliest Possible Beginning Date July 1

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

Grant Application Receipt and Assignment

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

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

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

Assignment to CSR Study Sections (continued) Within an IRG, applications are assigned for review to 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)

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

Initial Review in CSR

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 members who are primarily from academia  As many as applications are reviewed at each study section meeting

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

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

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

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.

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.

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.

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

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: 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: The summary statement contains:  Overall Resume and Summary of Review Discussion  Essentially Unedited Critiques  Priority Score and Percentile Ranking  Budget Recommendations  Administrative Notes

National Advisory Council or Board Review

Council Actions  Concurrence with study section action  Modification of study section action  Deferral for re-review

What Determines Which Awards Are Made?  Scientific merit  Program Considerations  Availability of funds

Preparation of an Application

PHS Research Grant Application Kit (form PHS 398) 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

When Preparing an Application  Read instructions  Never assume that reviewers “will know what you mean”  Refer to literature thoroughly  State rationale of proposed investigation  Include well-designed tables and figures  Present an organized, lucid write-up  Obtain pre-review from faculty at your institution

Common Problems in Applications  Lack of new or original ideas  Absence of an acceptable scientific rationale  Lack of experience in the essential methodology  Questionable reasoning in experimental approach  Uncritical approach  Diffuse, superficial, or unfocused research plan  Lack of sufficient experimental detail  Lack of knowledge of published relevant work  Unrealistically large amount of work  Uncertainty concerning future directions