Office of the Director National Institute on Alcohol Abuse and Alcoholism National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute of Environmental Health Sciences National Institute on Aging National Institute on Aging National Institute of Child Health and Human Development National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute on Deafness and Other Communication Disorders National Eye Institute National Eye Institute National Human Genome Research Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of General Medical Sciences National Institute of Nursing Research National Institute of Nursing Research National Library of Medicine National Library of Medicine Center for Information Technology Center for Information Technology Center for Scientific Review Center for Scientific Review National Center for Complementary and Alternative Medicine National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases National Institute of Allergy and Infectious Diseases Fogarty International Center Fogarty International Center National Center for Research Resources National Center for Research Resources National Institutes of Health Clinical Center Clinical Center National Center on Minority Health and Health Disparities National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Institute of Biomedical Imaging and Bioengineering

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

NIH Extramural Awards GrantPatron (assistance, encouragement) (assistance, encouragement) CooperativePartner Agreement(assistance but substantial program involvement) program involvement) ContractPurchaser (procurement) (procurement)

NIH Funding in FY 2004: By Mechanism Total = $27B

Program Announcement (PA)  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

Request for Applications (RFA)  Invites grant applications in a defined research area for a one-time competition  Usually targets a perceived area of scientifically needed information for which the technology is available  Single receipt date designated  Specifies amount of funds set aside and expected number of awards  Applications reviewed by an Institute SEP

Request for Proposals (RFP)  Invites contract proposals in a given research area  Describes specific need(s) to be met by contractor and lists milestones for progress  Single receipt date designated  Projected costs are estimated and funds are set aside  Proposals are reviewed by Institute Contract Review Committee

Dual Review System for Grant Applications Second Level of Review Second Level of Review National Advisory Council National Advisory Council  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  Provides Initial Scientific Merit  Review of Grant Applications  Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award

GROUPS CSR IRGs Study Sections Special Emphasis Panels INSTITUTES INSTITUTES Scientific Review Groups Contract Review Committees APPLICATIONS REVIEWED Research Projects Academic Research Academic Research Enhancement Awards Postdoctoral Fellowships Small Business Innovation Research Shared Instrumentation Program Projects Centers Institutional Training Grants Conference Grants Career Awards Types of Scientific Review Groups Where are Applications Reviewed? Small Grants RFAs Contracts

Center for Scientific Review  Serves as central receipt point for most 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

Applications Submitted to NIH  Over 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

Competing Applications Reviewed By: NOTE: Starting in FY93, NIDA, NIAAA, and NIMH are included in NIH totals

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 Applications are assigned for review to 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)

Peer Review in CSR Study Sections  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   Performing administrative and technical review of applications to ensure completeness and accuracy   Selecting reviewers based on broad input   Managing study section meetings   Preparing summary statements   Providing any requested information about study section recommendations to Institutes and National Advisory Councils/Boards Designated Federal official with overall responsibility for the review process, including:

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

Certification of No Conflict of Interest This will certify that in the review of applications and proposals by (study section) on (date), I did not participate in the evaluation of any grant or fellowship applications from (1) any organization, institution or university system in which a financial interest exists to myself, spouse, parent,child, or collaborating investigators; (2) any organization in which I serve as officer, director, trustee, employee or collaborating investigator; or (3) any organization which I am negotiating or have any arrangements concerning prospective employment or other such associations. __________________ __________________ __________________ __________________ SIGNATURES

Confidentiality  Review materials and proceedings of review meetings represent privileged information to be used only by consultants and NIH staff.  At the conclusion of each meeting, consultants will be asked to destroy or return all review-related material.  Consultants should not discuss review proceedings with anyone except the SRA.  Questions concerning review proceedings should be referred to the SRA.

Review of Research Grants REVIEW CRITERIA: REVIEW CRITERIA:  Significance  Approach  Innovation  Investigator  Environment  Overall Evaluation

Review Criteria (defined)  Significance: Does the study address an important problem? How will scientific knowledge be advanced?  Approach: Are design and methods well-developed and appropriate? Are problem areas addressed?  Innovation: Are there novel concepts or approaches? Are the aims original and innovative?  Investigator: Is the investigator appropriately trained?  Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

Research Involving Human Subjects Important Considerations Important Considerations  Is the proposed study exempt from human subject review?  Are there any apparent risks* to the human subjects?  Are the protections adequate?  What are the potential benefits to the subjects and to mankind?  Are the inclusions of minorities and both genders adequately addressed? *”Risks” include the possibility of physical, psychological, or social injury resulting from research.

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

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

Calculation of Percentiles Based on the priority score, the percentile is the rank of an application relative to others reviewed over three cycles. It indicates the percentage of applications with better priority scores. Percentile = (relative rank – 0.5) x 100 # of applications # of applications__________ For Special Emphasis Panels, the percentile values are intercalated on a table of all-CSR review

Summary Statement Once applications have been reviewed, the results are documented by the SRA in a summary statement and released to the NIH Commons (available to Institutes and applicants) Once applications have been reviewed, the results are documented by the SRA in a summary statement and released to the NIH Commons (available to Institutes and applicants) The summary statement contains: The summary statement contains: Resume and Summary of Discussion Resume and Summary of Discussion Minimally-edited Critiques Minimally-edited Critiques Priority Score and Percentile Ranking Priority Score and Percentile Ranking Budget Recommendations Budget Recommendations Administrative Notes Administrative Notes

Dual Review System for Grant Applications Second Level of Review Second Level of Review National Advisory Council National Advisory Council  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  Provides Initial Scientific Merit  Review of Grant Applications  Rates Applications and Makes Recommendations for Appropriate Level of Support and Duration of Award

Extramural Program Mission Identify scientific opportunities Foster the best science Ensure proper stewardship Promote effective communication Manage a portfolio of investments to improve health through science

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