Peer Review of NIH Research Grant Applications Center for Scientific Review National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health
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)
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)
National Institutes of Health 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 Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Alternative Medicine National Library of Medicine National Center on Minority Health and Health Disparities Fogarty International Center National Center for Research Resources Clinical Center Center for Information Technology Center for Scientific Review
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
NIH Extramural Program Mission Manage a portfolio of investments to improve health through science Identify scientific opportunities Foster the best science Promote effective communication Ensure proper stewardship Exemplify and promote the highest level of scientific integrity, public accountability, and responsibility in the conduct of science Promote effective ways to communicate scientific information to scientists, health practitioners, and the public
NIH Extramural Program Grant patron (Assistance, encouragement) Cooperative partner Agreement (assistance but substantial Program involvement) Contract purchaser (Procurement)
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
Review Process for a Research Grant National Institutes of Health Research Grant Application Schoolor 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
Cycle 2 Receipt Council Review Award Referral Cycle 3 Receipt Council Review Award Referral Overall Timeframe From Submission to Award • There are three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL Cycle 1 Review Council Receipt Award Referral
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----
Types of Scientific Review GroupsWhere Are Applications Reviewed? GROUPS APPLICATIONS REVIEWED Research Projects CSR IRGs Academic Research Study Sections Enhancement Awards Postdoctoral Fellowships Special Emphasis Panels Small Business Innovation Research Shared Instrumentation INSTITUTES Program Projects Scientific Review Groups Centers Institutional Training Grants Conference Grants Career Awards Small Grants RFAs (R01, R21, R03, U01) Contract Review Committees Contracts
Peer Review of NIH Support Mechanisms CSR Institutes Research project grant (R01) Program Project grant (P01) Postdoctoral fellowship (F32) Center grant (P30, P50, P60) Senior fellowship (F32) Institutional fellowship (T32) Fogarty international center Academic career award (K07) Fellowship (F05, F06) Mentored clinical scientist Short-term training (T35) development award (K08) Small business grants (R41, R42 Conference grant (R13)* R43, R44) MARC fellowships (F34, F36, T34) Academic Research Enhancement Minority Biomedical Support Award (R15) Grant (S06) Biomedical Research Support Resource grant (P40, P41, R24, Shared Instrumentation R26, R28) Grant (S10)Contract *Reviewed by CSR upon request
Center for Scientific Review (CSR) • Focal point for initial review at NIH • Central receipt point for PHS applications • Referral to Institutes and to IRGs and Study Sections • Review of most research and research training applications ..for scientific merit
Applications Submitted to NIH • Approximately 46,000 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
CSR Receipt and Referral: Central Receipt Point for Applications Submitted to the Public Health Service National Institutes of Health Substance Abuse and Mental Health Services Administration CSR Receipt & Referral Agency for Health Care Policy & Research Centers for Disease Control Office of Assistant Secretary for Health Food & Drug
Competing Applications Reviewed By: NOTE: Starting in FY93, NIDA, NIAAA, and NIMH are included in NIH totals
Receipt Dates Depend on the Type of Application • Jan, May, Sept 10: institutional training grant applications • Jan, May, Sept 25: academic research enhancement award • Feb, June, Oct 1: new research applications • Mar, Jul, Nov 1: revised, competing continuations, and Supplemental Applications and Small Business Innovation Research Applications
Flowof a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Applications are Assigned by 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 Institutes • Applications are referred to an institute or center as the potential funding component: • This assignment is based on a match between the research proposed and the overall mission of the institute or center • Where applications are appropriate for more than one institute or center, multiple assignments are made
Sample Application Number Individual serial amended Research number Grant 1 R01 DK 12345 01 A1 New national grant Application cancer support Institute year
Assignment of Applications Review Group Institute AA Form Approved Through 9-30-97 OMB No. 0925 0001 Department of Health and Human Services Public Health Service GRANT APPLICATION Follow instructions carefully. Do not exceed character length restrictions indicated on sample. Leave Blank--for PHS Use Only Type 1ActivityR21 Number A154321-01 Review Group ZDK1 Formerly Council/Board (Month,Year) Date Received 09/01 07-26-01 1. Title of Project(Do not exceed 56 characters, including spaces and punctuation.)Planning Grant for Diabetes & Sc Ed in Tribal Schools 2. Response to Specific Request for Applications or Program Announcement Number: DK 01-033 Title: Planning Grant for Diabetes and Science Education … Yes (if “Yes” state number and title) X No x 3. Principal Investigator/Program Director 3a. Name (Last, first, middle) 3b. Degree(s) 3c. Social Security No.Smith, Brian E. Ph.D.
Assignment Notification Letter • Dear Dr. Smith: • Your grant application entitled “PLANNING GRANT FOR DIABETES AND SCIENCE EDUCATION IN TRIBAL SCHOOLS ” has been received by the National Institutes of Health and assigned to a scientific review group (SRG) for scientific merit evaluation and to an institute/center for funding consideration. Specific information about your assignment is given below. The initial peer review should be completed by AUGUST, 2001, and a funding decision made shortly after the appropriate National Advisory Group meets in SEPTEMBER, 2001. Questions about the assignment should be directed to the scientific review administrator (SRA) or the Division of Receipt and Referral, Center for Scientific Review (formerly Division of Research Grants) at (301) 435-0715. Other questions prior to review should be directed to the scientific review administrator and questions after the review to the program staff in the institute/center.
Assignment Notification Letter(continued) • Assignment Number:1 R01 DK12345 - 01 • Dual Assignment: NS • Scientific Review Group: • ZDK1 GRB-5 S1 S • Information about this IRG may be found on the NIDDK Home page (http://www.niddk.nih.gov) • Scientific Review Administrator: • DR. FRANCISCO CALVO, SRA • NATIONAL INSTITUTE OF DIABETES AND • DIGESTIVE AND KIDNEY DISEASES • 6707 DEMOCRACY BLVD, ROOM 752 • BETHESDA MD 20892-5452 • (301) 594-8885
Assignment Notification Letter(Continued) • Institute/Center: • NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES • DIV/EXTRAMURAL ACTIVITIES • 6707 DEMOCRACY BLVD, ROOM 752 • NATIONAL INSTITUTES OF HEALTH • BETHESDA, MD 20892 • (301) 594-8885
Peer Review • CSR and IC Study Sections are managed by a Scientific Review Administrator (SRA) who is a scientist, usually at the Ph.D. level, whose scientific background is close to the expertise of the study section • Each CSR/IC standing study section has 12-24 members who are primarily from academia • Institute review is also different in that Special Emphasis Panels are constituted specifically to review applications that have been received in response to an RFA or other Institute specific grant mechanisms • As many as 60-100 applications are reviewed at each study section meeting, again this depends on the complexity of the review
Scientific Review Administrator Designated Federal official with overall responsibility for the review process, including: • 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
Selection of Peer Reviewers Active and Productive Researchers Research Capability Non-Research Non-Doctoral Scientific Community
Criteria for Selection of Peer Reviewers Active & Productive Researchers Meet Internal Administrative Considerations • Geography Doctoral or Equivalent Degree Research Capability • Institutional Interest in Serving • Affiliation • Non-Federal • Employment Non-Research • Gender & Expertise in Discipline of Review Group and Specialization Needed Ethnic Status Non-Doctoral Scientific Community Active and Productive Researchers
Certification of No Conflict of Interest Thiswill 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. K185pp.46
Review of Research Grants REVIEW CRITERIA: • Significance • Approach • Innovation • Investigator • Environment • Overall Evaluation & Score Reflects Impact on Field
Review Criteria (Continued) • 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 scientificenvironment?
Specific Review Criteria RFA DK-01-033 • Administrative, leadership qualifications and experience of the Program Director. • Adequacy and availability of any necessary institutional facilities and resources. • Adequacy of the plan for developing a diabetes science education program, including use of existing resources, building partnerships with other institutions, use of consultants, and plans for critical review of the curriculum. • Documentation of potential participants for the science education program.
Research Involving Human Subjects Areas exempt from human subject review • Education research • Normal educational practices • Educational tests, survey or interview procedures, or observation of public behavior • Subjects not identified • Subjects’ privacy rights protected • Educational tests, survey or interview procedures, or observation of public behavior not exempt in previous category if: • Subjects are public officials or public office candidates • Federal statute requires confidentiality without exception
Research Involving Human Subjects (Continued) Areas exempt from human subject review • Collection or study of existing data, documents, records, pathological specimens • Information publicly available • Subjects not identified • Research and demonstration projects regarding certain public benefit or service programs • Taste and food quality evaluation and consumer acceptance studies using • Foods without additives • U.S. Government approved food ingredient
Research Involving Children Children must be considered for inclusion in all human subject research supported by NIH
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: • The summary statement contains: • Overall Resume and Summary of Review Discussion • Essentially Unedited Critiques • Priority Score and Percentile Ranking • Budget Recommendations • Administrative Notes