Presentation is loading. Please wait.

Presentation is loading. Please wait.

The NIH Peer Review Process and Grant Writing

Similar presentations


Presentation on theme: "The NIH Peer Review Process and Grant Writing"— Presentation transcript:

1 The NIH Peer Review Process and Grant Writing
Denise Wiesch, Ph.D. Scientific Review Administrator Epidemiology of Cancer SRG Health of the Population IRG Center for Scientific Review NIH/DHHS

2 Outline NIH Infrastructure From Submission to Funding Grant Mechanisms
Electronic submission Grant Mechanisms Reviewers Study Section Meeting Role of NIH Program vs. Review staff NIH Advisory Councils Grant Writing

3 NIH The Big Picture

4 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)

5 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 Fogarty International Center National Center for Research Resources National Library of Medicine National Center on Minority Health and Health Disparities Clinical Center Center for Information Technology Center for Scientific Review

6 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)

7 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

8 FY 2005 NIH Funding (dollars in billions)
TOTAL BUDGET $28.8 Billion Spending at NIH $4.7 16% NIH In-House 6,000 Scientists 84% Outside NIH - Supports over 212,000 Scientists & Other Personnel - Supports over 3,000 Institutions Nationwide Spending Outside NIH $24.1

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

10 NIH Referral and Review Process
Program and Policy Considerations NIGMS NINDS NIA NIAID NIAAA NIDCR Referral NEI NIAMS NINR CSR NIMH NIEHS NHLBI NCHGR NIDCD Funding Decisions Review NLM NICHD NCRR NIDDK Scientific NCCAM FIC NIDA Management

11 Receipt of Grant Applications at CSR

12 CSR Referral Applications Are Assigned to:
Scientific Review Groups based on: Specific referral guidelines for each scientific review group NIH Institutes or Centers based on: Overall mission of the Institute or Center Specific programmatic mandates and interests of the Institute or Center

13 Number of Applications Reviewed by NIH

14 Where are Applications Reviewed?
CSR Research Projects Academic Research Enhancement Awards SBIR & STTR Shared Instrumentation Career Awards Small Grants Fellowships RFAs Institutes/Centers Contracts Program Projects (most) Institutional Training Grants Conference Grants Centers Career Awards Small Grants Fellowships RFAs

15 Division of Molecular and Division of Physiology
CSR Review Divisions Division of Biologic Basis of Disease Elliot Postow, Ph.D. Division of Molecular and Cellular Mechanisms Donald Schneider, Ph.D. Division of Physiology and Pathology Michael Martin, Ph.D. Division of Clinical and Population-Based Studies Anita Miller Sostek, Ph.D Surgical Sciences, Biomedical Imaging and Bioengineering IRG (SBIB) Eileen Bradley, D. Sc. Health of the Population IRG (HOP) Robert Weller, Ph.D. Risk, Prevention, and Health Behavior IRG (RPHB) Michael Micklin, Ph.D. Brain Disorders and Clinical Neuroscience IRG (BDCN) David Armstrong, Ph.D. Behavioral & Biobehavioral Processes IRG (BBBP) Karen Sirocco, Ph.D. Bioengineering Sciences and Technologies IRG (BST) Sally Amero, Ph.D. AIDS and Related Research IRG (AARR) Ranga V. Srinivas, Ph.D. Cardiovascular Sciences IRG (CVS) Joyce Gibson, D.Sc. Biology of Development and and Aging IRG (BDA) Sherry Dupere, Ph.D. Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG (EMNR) Sooja Kim, Ph.D. Digestive Sciences IRG (DIG) Mushtaq Khan, Ph.D. Biological Chemistry and Macromolecular Biophysics IRG (BCMB) John Bowers, Ph.D. Hematology IRG (HEME) Joyce Gibson, D.Sc. Immunology IRG (IMM) Calbert Laing, Ph.D. Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Christine Melchior, Ph.D. Cell Biology IRG (CB) Marcia Steinberg, Ph.D. Infectious Diseases and Microbiology IRG (IDM) Alex Politis, Ph.D. Genes, Genomes and Genetics IRG (GGG) Richard Panniers, Ph.D Oncological Sciences IRG (ONC) Syed Quadri, Ph.D. Musculoskeletal, Oral, and Skin Sciences IRG (MOSS) Daniel McDonald, Ph.D. Molecular, Cellular and Developmental Neuroscience IRG (MDCN) Carole Jelsema, Ph.D. Renal and Urological Sciences IRG (RUS) Daniel McDonald, Ph.D. Respiratory Sciences IRG (RES) Mushtaq Khan, Ph.D.

16 Health of the Population (HOP) IRG Population-Based Studies
Community-Level Health Promotion Community Influences on Health Behavior Division of Clinical & Population-Based Studies Behavioral Genetics and Epidemiology Social Sciences and Population Studies Behavioral & Biobehavioral Processes Health Services Organization and Delivery Biostatistical Methods and Research Development Brain Disorders & Clinical Neuroscience Epidemiology of Cancer Cardiovascular and Sleep Epidemiology Health of the Population Kidney, Nutrition, Obesity, & Diabetes Epi Risk, Prevention & Health Behavior Infectious Diseases, Reproductive Health, Asthma and Pulmonary Epidemiology Neurological, Aging and Musculoskeletal Epi Surgical Sciences, Biomedical Imaging & Bioengineering Nursing Science: Children & Families Nursing Science: Adults & Older Adults

17 From Submission to Funding

18 From Submission to Funding: THE PROCESS FOR A RESEARCH GRANT
NIH Principal Investigator School or Other Research Center Center for Scientific Review Assign to IRG and IC Initiates Research Idea Submits application Review Group Institute Review for scientific merit Evaluate for relevance Advisory Council or Board Recommend Action Allocates Funds Conducts Research Institute Director

19 Timeline for Submission to Potential Award
New RO1 Application Feb. 1 March 15 May 10 June 24-25 July 8 August 1 September Dec. 1 Send Appl. to CSR New Assignment Notification Sent to PI Mail to Reviewers Study Section Meeting Review Notification Sent Summary Statement Sent Council Meets Earliest Award Date Revised/Competing Continuation/ Supplemental RO1 Application March 1 April 15 May 10 June July 8 August 1 September Dec. 1 Send Appl. To CSR Revised or Continuation Assignment Notification Sent to PI Mail to Reviewers Study Section Meeting Review Notification Sent Summary Statement Released Council Meets Earliest Award Date

20 Who / What Determines which Study Section Reviews your Application?
Grant Mechanism CSR Referral Staff – determine broad scientific area Scientists, most of whom also serve as Scientific Review Administrators (SRAs) of CSR Study Sections. Initial Review Group (IRG) Chiefs and SRAs IRGs: Clusters of scientifically related study sections IRG Chiefs are also SRAs with own Study Section(s) Past review history (if any) of application Principal Investigator Letter attached to application; self-referral

21 Cover Letter Request study section (optional)
Be familiar with the study sections and what they review CSR website with study section descriptions and rosters ( Ask peers Contact SRA Do not recommend specific reviewers (expertise required is OK). Request an NIH Institute (optional)

22 Assignment Notification
Study Section or Special Emphasis Panel Scientific Review Administrator Address, telephone number, etc. Institute Assignment Primary and any dual General contact number Unique Identifier (1 R01 CA A1) Request change if assignment is wrong Contact SRA if assigned to the wrong study section Contact Referral office if grant # is wrong (is it really a new application or competing continuation). Is the NIH Institute assignment correct. more efficient to include a request in cover letter at submission.

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

24 Receipt Dates Depend on the Type of Application
Jan 10, May 10, Sept. 10: Institutional Training Grant Applications Feb 25, June 25, Oct 25: Academic Research Enhancement awards Feb 1, June 1, Oct 1: New Research Grant Applications Mar 1, July 1, Nov 1: Revised, Competing Continuations, Supplemental April 1, Aug 1, Dec 1: Small Business (sbir/sttr) April 5, Aug 5, Dec 5: Fellowship applications May 1, Sept 1, Jan 1: AIDS applications

25 Electronic Grant Submission!
Soon will be REQUIRED Phased in dates by grant mechanism Grant opportunities will be posted on Grants.gov download and begin working on application package after grant mechanism transition - SF424(R&R) form Until a grant mechanism is transitioned - submit on paper PHS 398 forms. As mechanisms are transitioned, Funding Opportunity Announcements (PAs, RFAs etc.) will be issued in the NIH Guide for Grants and Contracts ( and posted in Grants.gov.

26 Electronic Submission Transition Dates
GRANT TYPE Submission DATE Small Business (SBIR/STTR) R41, R42, R43, R44 Dec. 1 ‘05 Conferences & Scientific Meetings R13 Dec.15 ‘05 Academic Research Enhancement Award (AREA) R15 Feb. 25 ‘06 Small Grant Programs; Exploratory/Developmental Research Grant Awards R03, R21 June 1 ‘06 Research Project Grant Program R01 Oct. 1 ‘06 Remaining grant mechanisms May 2007

27 Where to go for Help General information on Electronic Submission and the SF424 (R&R): Forms transition and questions on NIH’s overall plan for electronic receipt NIH GrantsInfo.gov Phone: eRA Commons registration and post submission questions on Commons functionality Support Page: Help Desk Phone: OR Grants.gov registration and submission questions Visit: Grants.gov Customer Service Phone:

28 Grant Mechanisms

29 Unsolicited vs. Solicited Applications
Unsolicited R01s – Investigator initiated Program Announcement (PA): Funding announcement for grants relating to areas of increased priority and/or emphasis on particular funding mechanisms for a specific area of science. Applications are usually accepted on standard receipt dates on an on-going basis. PAR: A PA for which special referral guidelines apply (usually special receipt date), as described in the PAR announcement. PAS: A PA that includes specific set-aside funds, as described in the PAS announcement. Request for Applications (RFA): Funding announcement for grants that identifies a more narrowly defined area for which one or more NIH institutes have set aside funds for awarding grants. An RFA usually has a single receipt date, as specified in RFA announcement. Request for Proposals (RFP): Solicits contract proposals. An RFP usually has one receipt date, as specified in RFP solicitation. Request for Applications (RFAs) PARs (program announcements with special receipt dates) Success Rates

30 R01 Can submit without PA etc. Need preliminary/pilot data
Up to 5 years of funding Need to obtain approval from program staff prior to submission of proposal costing $500,000 or more in direct costs in any one year

31 Mechanisms for Preliminary Studies
R21 - Exploratory/Developmental Grants Feasibility/New Technology/ Innovative High Risk Pilot studies Preliminary data for a R01 2 years with a maximum of $275K total Need Program Announcement specific to appropriate funding Institute

32 Mechanisms for Preliminary Studies
R03: Small Grants Feasibility (for those without preliminary data) Development of pilot / preliminary data 2 years with a maximum of $50,000 per year Need Program Announcement specific to appropriate funding Institute

33 Other Grant Mechanisms
Grant mechanisms supported by different NIH Institutes: General information about different grant mechanisms:

34 for Grants NIH GUIDE and Contracts U. S
for Grants NIH GUIDE and Contracts U.S. Department of Health and Human Services Announces NIH Scientific Initiatives Provides NIH Policy and Administrative Information Available on the NIH Web Site (can search for grant mechanism and specific NIH Institute using ‘Advance Search’)

35 Reviewers

36 Criteria for Selection of Peer Reviewers
Scientific Community Active and Productive Researchers Non-Doctoral Non-Research Active & Productive Researchers Research Capability Doctoral or Equivalent Degree Interest in Serving Expertise in Discipline of Review Group and Specialization Needed Meet Internal Administrative Considerations Geography Institutional Affiliation Gender & Ethnic Status

37 Criteria for Selection of Peer Reviewers
Active and productive researchers Demonstrated scientific expertise Mature and impartial judgment Work effectively in a group context Breadth of perspective Interest in serving Adequate representation of women and minority scientists

38 Process for Nominating Chartered Study Section Members
SRAs solicit names from ICs, societies, former and current members Try out potential nominees as temporary members Contact potential members to see if they are willing to serve if nomination is approved SRA drafts nomination package Submission to IRG Chief and Division Director CSR CMO sends copies to ICs for concurrence (3-week hold) CSR Director’s approval NIH Director’s approval New members start July 1 and typically serve a four-year term

39 Study Section Meeting

40 CSR Study Sections Each CSR standing study section has regular members who are primarily from academia Ad Hoc members CSR standing study sections convene face-to-face meetings As many as applications are reviewed by each study section

41 Pre-Meeting Activities
Reviewers receive applications and assignments 4-6 weeks prior to meeting Identify conflicts of interest Generally assigned between 8-14 applications Write critiques prior to the meeting Post preliminary scores and critiques on secure meeting website Read written critiques of other reviewers a few days before the meeting

42 What Happens at the Study Section Meeting
Closed Meeting Orientation Conflict of Interest Confidentiality Developments of interest to the study section Changes in policy or procedure Roles of the persons present Chair and other Reviewers Program Officers (Observers) SRA Streamlining Application by Application review

43 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

44 Confidentiality Review materials and proceedings of review meetings represent privileged information to be used only by reviewers and NIH staff. At the conclusion of each meeting, reviewers will be asked to destroy or return all review-related material. reviewers should not discuss review proceedings with anyone except the SRA. Questions concerning review proceedings should be referred to the SRA. K185pp.46

45 Streamlining The process by which applications judged by the reviewers to be in the worse half are not discussed at the the study section meeting (identification of “unscored”) Purpose is to allow more time for discussion of more meritorious applications Shortens meeting time from 3 days to 1.5 days Pre-meeting - identification of unscoreds Meeting – unanimous voting of unscoreds (any member can object to streamlining an application) Unscored applications receive written critiques Unscored vs. NRFC

46 Review of Each Application
Reviewers with conflicts leave room Assigned reviewers state preliminary scores Discussion of scientific and technical merit Based on the 5 review criteria Assigned reviewers first then open discussion to whole committee Discussion of Protection of Human Subjects and Inclusion criteria Assigned reviewers state final score – range of scores is set Every member scores each application Budget and Administrative concerns Ideal time for each application - 15 to 20 minutes

47 Review Criteria SIGNIFICANCE: Does the study address an important problem? How will scientific knowledge be advanced by the proposed project? APPROACH: Are design and methods well-developed, appropriate, and feasible? Are problem areas addressed? INNOVATION: Are there novel concepts or approaches? Are the aims original and innovative? INVESTIGATORS: Is the investigator appropriately trained? Is the investigative team strong in necessary areas? ENVIRONMENT: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment?

48 Inside the NIH Grant Review Process Video
CSR has developed a video of a mock study section meeting to show how NIH grant applications are reviewed.

49 Post Meeting: Results of Review
Unscored (approximately bottom half) Score (generally between 100 and 300) Percentile ranking (if scored) Deferral (rare) NRFC - Not Recommended for Further Consideration (very rare; serious concerns) Notification of Principal Investigator NIH Commons Summary Statement

50 Summary Statement Study Section Recommendation – Score, Unscored
Resume and Summary of Discussion (if scored) Description (Abstract) Essentially unedited comments of reviewers Organized by review criteria Administrative notes Budget Recommendations Coding for human subjects, animals, gender, minorities, children Institute/Center contact information – Program Director

51 Role of Program vs. Review Staff

52 Separation of Funding and Review
Program Staff: Identify and promote research priorities Recommend projects for funding (based on score, budget, priorities) Manage portfolio of projects Work with applicants up to review and after review Review Staff: Manage study section meetings to evaluate scientific and technical merit Provide a fair, thorough and competent review for each application Work with applicants before review

53 Review Process for a Research Grant
Study Section Meeting Not Funded N I H Application Grant Referral Review Program Principal Investigator

54 Review Staff – Scientific Review Administrators (SRA)
Designated federal official responsible for ensuring that the grant applications are reviewed in an impartial environment. Responsible for overseeing the scientific peer review of applications Managing study section meetings Prepare summary statements Communicate with program staff on review issues Discuss review issues and policies with applicants

55 Program Officers (PO) Interface between NIH funding Institute and the extramural research community Serve as a resource and advocate Monitor research progress via annual reports Discuss other research opportunities (e.g. competing supplements, minority supplements)

56 PO Assistance: Pre-Application
Point of contact for investigators Assist with identifying appropriate mechanism of support Clarify policy requirements Discuss budget plans

57 PO Assistance - After the Review Meeting
Review summary statement with PI Obtain additional information regarding: gender / minorities / children human subjects budget Explore funding opportunities with other Institutes / Centers Work with grants management to make award

58 Role of Program vs. Review
Program Officers Contact for scores and other funding issues after SS meeting Advocate at Council meetings - Funding for borderline applications in some ICs Observe study section meetings Help with revised application Contact after grant is funded Progress reports Oversight of funded grants Review – SRAs Contact for review issues – before SS meeting (e.g. study section assignment, supplemental review material) Unbiased treatment for all PIs – Assure a fair, thorough, competent review of all applications Supplemental data for applications

59 NIH Institute Advisory Councils

60 Dual Review System for Grant Applications
First Level of Review Scientific Review Group (SRG) Provides Initial Scientific Merit Review of Grant Applications Scores Applications and Makes Recommendations for Appropriate Level of Budget 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

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

62 STUDY SECTIONS DO NOT FUND
INSTITUTES FUND! Study sections judge application’s scientific and technical merit Institutes take these evaluations very seriously Institutes also consider relevance of application to the Institute’s research priorities

63 What Determines Which Awards Are Made?
Scientific merit (score) Program considerations Availability of funds

64 Grant Writing

65 When Preparing an Application
Read PHS398 instructions Consider the review criteria Consider your primary audience - Reviewers Never assume that reviewers “will know what you mean” Refer to literature thoroughly and update when submitting revised application Clearly state rationale of proposed investigation Include well-designed tables and figures Present an organized, lucid write-up Obtain pre-review from other faculty at your institution

66 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

67 Additional Considerations
Research involving human subjects Protection from risks Inclusion of women, minorities, children Animal Welfare Biohazards Data Sharing Plans Appropriateness of Budget

68 Revised Applications 2 amendment limitation (no time limit any more)
Must have received summary statement Cycle designed to submit every other round (this may change- see NIH Guide notice on pilot study to shorten cycle for New PIs ) Be calm and respectful of reviewers Be responsive to reviewer’s specific critiques Need to include Introduction and clearly mark text to show changes Next review usually the same study section. Continuity of review is goal. Don’t give up!

69 Other Grant Writing Tips
Follow format rules (don’t squeeze, don’t cheat!) At least 11 pt font smallest allowed No more than 15 characters per inch and 6 lines per inch At least ½” margins Take time avoid sloppy errors Give to colleagues for feedback Write clearly for whole review committee (they are your main audience as well as judge and jury) Well-written applications are noticed and appreciated You are not anonymous – don’t embarrass yourself with a sloppy application.

70 Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications
To qualify for this expedited resubmission all of the following conditions must all be met: The PI must meet the NIH definition of a new investigator (see webiste below). A new or first resubmission of an R01 application must be submitted for the February 1 or March 1, 2006 date. The application must be reviewed in one of the participating Study Sections listed in the Notice at website below. The Summary Statement must have the special note indicating eligibility to participate in the pilot. The Principal Investigator must determine that it is reasonable to prepare a resubmission application in a short time. The Principal Investigator must agree that the resubmitted application be assigned to the same Study Section; no change in review venue is permitted for the resubmission. The July 20, 2006 receipt date must be met; late applications will not be considered.

71 Volunteer To Review! Junior Investigators Senior Investigators
Ad hoc reviewer Learn process – do’s and don’ts Senior Investigators Contribution is vital to peer review process Consider the debt to the scientific community Be constructive instead of complaining You are the “Peer” in Peer Review!

72 The NIH Commons https://commons.era.nih.gov/commons/
Register in the Commons Individual Profile Obtain priority score, summary statement, notice of grant award Reviewer can post critiques

73 Websites WWW.NIH.GOV NIH homepage; directories; information;
gateway to parts of NIH Information about Institutes Application forms, rosters, policies Information about HOP IRG


Download ppt "The NIH Peer Review Process and Grant Writing"

Similar presentations


Ads by Google