NIH and the Grant Review Process

1. NIH and the Grant Review Process Dawn M Elliott, PhD

2. Outline • What’s up with the NIH? • What happens to my grant after it is submitted? • What happens at a study section?

3. National Institutes of Health (NIH) • The steward of medical and behavioral research for the nation. • Composed of 27 Institutes and Centers (ICs) • Provideleadership and financial support • NIH Public Health Mission: To enable discovery of new knowledge that leads to better health for the nation • Support peer-reviewed scientific research at universities, medical schools, hospitals, and research institutions • Train research investigators. • Develop and disseminate credible health information based on scientific discovery.

4. NIH = National Institutes of Health NCI – National Cancer Institute NEI – National Eye Institute NHGRI - National Human Genome Research Institute NHLBI - National Heart, Lung, and Blood Institute NIA - National Institute on Aging NIAAA - National Institute on Alcohol Abuse and Alcoholism NIAID - National Institute of Allergy and Infectious Diseases NIAMS - National Institute of Arthritis and Musculoskeletal and Skin Diseases NIBIB - National Institute of Biomedical Imaging and Bioengineering NICHD - National Institute of Child Health and Human Development NIDA - National Institute on Drug Abuse NIDCD - National Institute of Deafness and Other Communication Disorders NIDDK - National Institute of Diabetes and Digestive and Kidney Diseases NIDCR - National Institute of Dental and Craniofacial Research NIEHS - National Institute of Environmental Health Sciences NIGMS - National Institute of General Medical Sciences NIMH - National Institute of Mental Health NINDS - National Institute of Neurological Disorders and Stroke NINR - National Institute for Nursing Research

5. A Simple View of the NIH For help with the business aspects – Listed on the eRA Commons link to your submitted application For questions during the review – Listed on the eRA Commons link to your submitted application Grants Management (GMS) Scientific Review (SRO) Extramural Research Program Intramural Research Program Scientific Program (PD/PO) About the scientific and technical aspects – Listed in FOA and IC’s programmatic descriptions

6. Program Director/Officer (PD/PO)Roles and Responsibilities • Scientific Public Face of the Government • Pre-application and post-review scientific contact; • Responsible Steward of Public Funds • Monitor award and progress; ensure proper use of public fund • Scientific Portfolio Builder • Help to set/implement IC priorities; design/execute specific initiatives; make funding recommendations

7. Scientific Review Officer (SRO) • Federal Official responsible for implementing review policies and procedures and a fair, unbiased and competent review • Primary NIH contact with PIs during review phase • Manager of all aspects of the review process: • Analyze applications for completeness, scientific content and determines who will review them • Manage and oversee scientific peer review meetings to ensure the fairness and consistency;legally responsible for ensuring NIH regulations and policies are followed • Prepare summary statements reflecting recommendations from the review meeting

8. Grants Management Specialist (GMS) • Provide advice on all business-related aspects of NIH grants such as budgets • Monitor the business management practices of grantee organization to assure awarded funds are spent properly • Assure grantees fulfill requirements regarding laws, regulations and administrative grant policies • Pre-Award Steps: Just-in-time (JIT) information • Eligibility verification statement • Human and Animal subjects training and approvals • Other support for key personnel • Consortium/subcontract information • Post-Award Advice/Guidance • Annual Progress Reports • Financial Status Reports • Closeout activities GMS issues the Notice of Award!

9. Who to Contact When? Application in Contact your grants office, or grant.gov, or NIH eRA Help for issues related to submission. Contact SRO for any review related issues such as changing IRG, sending in supplements, indicating conflicts etc. Pre-Review Pre-Submission Contact PD/PO for IC scientific mission relevance of your research, and advice on grant mechanism, IRG selection and/or revision; and GMS for budget related issues. Peer Review Contact PD/PO for revision and funding. Post-Review Once funded, contact PD/PO for scientific relevant issues and GMS for process and/or policy issues.

10. Finding NIH Grant Opportunities • All applications must be submitted in response to a Funding Opportunity Announcement (FOA) • FOAs are posted online in the NIH Guide for Grants & Contracts and at www.Grants.gov(under “Find Grant Opportunities”) • All of the NIH FOAs (unsolicited and solicited) found at the NIH Guide http://grants.nih.gov/grants/guide/index.html • Weekly NIH Funding Opportunities and Notices published • Sign up athttp://grants.nih.gov/grants/guide/listserv.htm

11. Types of NIH Applications • “Unsolicited” or “investigator-initiated” • Majority of NIH funded applications • Research ideas come from PIs • “Solicited” – NIH publishes Funding Opportunity Announcement (FOA) to solicit specific research topics or types Program Announcement (PA) Request for Applications (RFA)

12. Some NIH Funding Mechanisms • Research Project Grants – RPG (R01) • Requires high likelihood of success and strong preliminary data • Under $500,000/year , up to 5 years • >$500K direct cost requires permission to apply • NIAMS Small Research Grants (R03) • New Investigators only, limited to 2 R03 awards/career • $50,000/yr direct costs, 3 year maximum, not renewable • Developmental/Exploratory Grants (R21) • Ground breaking, potentially high yield research • $275K direct costs over two years, not renewable • not recommended for New PIs to obtain preliminary data

13. NIH New Investigator Policy • New Investigator (NI): Principal Investigator (PD/PI) who has not previously competed successfully as PD/PI for a significant NIH independent research award; but may have received the following: fellowships (F), career awards (K), R00, R03, R15, R21, R34, R36, R41, R43 • NIH expects to support NIs at success rates equivalent to that of established investigators • This policy applies only to the R01 mechanism • The NIH strongly encourages Nis to apply for R01 grants when seeking first-time NIH funding • Advantage at Review – clustered together to be reviewed • Advantage at Funding – higher percentile for funding • All PIs on a Multi-PI application must be NIs

14. Outline • What’s up with the NIH? • What happens to my grant after it is submitted? • What happens at a study section?

15. Review Process for a Grant

16. NIH Dual Level Review System First Level – Peer Review • Scientific Review Group (SRG) • Independent outside review • Evaluate scientific merit, significance • Recommend length and level of funding Output: Priority Score and Summary Statement Second Level – Council Review • Scientific Advisory Council • Assesses Quality of SRG Review of Grant Applications • Makes Recommendations to the Institute/Center (IC) on Funding • Evaluates Program Priorities and Relevance 3-7 months 1-3 months Output:Funding Recommendations • NIH IC Director Output: Awards or Resubmission

17. Two Level Review Process • Center for Scientific Review (CSR) Receipt, Referral, & Review • Receives all grant applications • Assigns (“Refers”) to • study sections for review • ICs for potential funding • Reviews most of the NIH grant applications • CSR does not fund grants • NIH Institutes and Centers (ICs): Secondary Review, Funding Decisions, Management, & Oversight • Program Directors, Grants Management Specialists, and IC specific Scientific Review Officers • Fund and manage grants and contracts

18. Who Makes Final Funding Decisions? The Institute or Center Director Taking the recommendations from the Council and Program Directors, consider the following factors: • Scientific Merit • Contribution to Institute Mission • Program Balance • Availability of Funds

19. NIH Grant Application Process – Summary • Grant application in the CSR; is logged in and givena unique ID number • application assigned to an integrated review groups (IRG) and to a Study Section for initial peer review. • application also assigned to NIH IC based on research topic • PI can log in to the eRA Commons to get assignment information within 6 weeks after the CSR receives application • SRO sends applications to reviewers 1 month prior to the Study Section meeting for their review and preliminary scores • Application is either discussed(if score is in top ~50%) or not discussed (if scores is in bottom ~50%) at the Study Section meeting (View mock study section at http://www.csr.nih.gov/Video/Video.asp)

20. NIH Grant Application Process – Summary • 2 days after review meeting, PI can see priority score or determine that application was not discussed in the Commons • Roughly 4 weeks after review, summary statementwill be posted on the NIH Commons, or 1-2 weeks for new PI • Applications undergo second-level reviewby the Institute advisory Council • IC will request “Just In Time“(JIT) materials if application is within an IC’s pay line or close to it • All the administrative issues raised in the summary statement must be addressed prior to funding • For most to-be-funded applications, you will receive Notice of Award (NoA or NGA) within 6 to 8 weeks of Council meeting • First time applications that are not funded can be revised based on feedback from the review and resubmitted for reconsideration

21. Relevant Scientific Review Groups One of the five divisions – the Division of Translational and Clinical Sciences includes: Musculoskeletal, Oral & Skin Sciences (MOSS) IRG reviews applications on structural systems prerequisite for physical form, mechanical function, movement, & integrity of the body. Some study sections are: • Oral, Dental and Craniofacial Sciences Study Section [ODCS] • Skeletal Biology Development and Disease Study Section [SBDD] • Skeletal Biology Structure and Regeneration Study Section [SBSR] • Skeletal Muscle Biology and Exercise Physiology Study Section [SMEP] • Musculoskeletal Rehabilitation Sciences Study Section [MRS] • Arthritis, Connective Tissue and Skin Study Section [ACTS] • Musculoskeletal Tissue Engineering Study Section [MTE] • Surgical Sciences, Biomedical Imaging, and Bioengineering (SBIB) IRG review applications for research grants that address topics in a variety of areas at the interface between a physical science or engineering and biomedical or clinical research. Some study sections are: • Bioengineering, Technology, and Surgical Sciences [BTSS] • Medical Imaging Study Section [MEDI]

22. Center for Scientific Review • The CSR study section rosters are public • You can request that your proposal be reviewed by a particular study section • Often, program officers from several institutes attend each study section • A few grants are not reviewed by CSR, but are reviewed by institute-run subcommittes • Examples: training grants, K-awards, some R03s, and special initiatives

23. Outline • What’s up with the NIH? • What happens to my grant after it is submitted? • What happens at a study section?

24. NIH Study Section Meeting • Each Study Section has 12-23 members • university, government, industry scientists • “regular” and “ad hoc” • One regular member is chair • Scientific Review Administrator (SRA) is NIH’s overseer and works for CSR • Up to 60-100 proposals reviewed in a session

25. NIH study section meeting

26. NIH Study Section Meeting • Each proposal is assigned to • a primary reviewer • a secondary & usually a tertiary reviewer • can have 1-3 “readers” • Each reviewer has about 10 reviews to write and several proposals to read • Everyone is free to discuss/comment • Everyone scores every proposal

27. Review Formats Overall Impact Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria. Scored Review Criteria Reviewers will consider each of the five review criteria in the determination of scientific and technical merit, and give a separate score for each. Strengths and weaknesses will be identified for each of the five review criteria 1. Significance 2. Investigator(s) 3. Innovation 4. Approach 5. Environment

28. NIH Scoring System Minor weakness: Easily addressable weakness that does not substantially lessen impact. Moderate Weakness:Impact lessened. Major Weakness: Impact severely limited. Overall Impact Score = Panel Average x 10

29. Reviewers • Reviewers are not blinded to the applicants • because they must assess their qualifications • The applicants will be told who was on the review panel • Reviewers leave the room during the discussion if they • work at the applicant’s institution • are otherwise close to the applicant

30. NIH study section meeting • “Streamlining” or triage • at start reviewers provide list of proposals they reviewed that were in bottom half • if assigned reviewers agree and no one objects, proposal not scored or discussed • anyone can object, no argument necessary • Usually < half streamlined • Norm is ~10-20 min. per discussed proposal

31. NIH study section meeting • Initial level of enthusiasm (score) • Primary reviewer presents the proposal • description • positive and negative aspects • Secondary & tertiary reviews follow • detail depends on extent of agreement • Readers comment, general discussion • Reviewers give final scores (often change) • Everyone writes down their own score (must be within range OR write down why scoring outside the range)

32. Ethics, Etiquette, and Politics • The SRA, chair are ethics watchdogs • no conflicts of interest, real or perceived • no discussions of application between reviewer and applicant, before or afterward • all discussions of applications between reviewers must occur in session • The mood of the room is professional • Other NIH administrators present

33. Summary Statement • Review results are documented by the Scientific Review Officers (SROs) in a summary statement and made available to the PI and NIH Institute/Center where a funding decision is made. A priority score and, in some cases, a percentile will be posted on Commons account if application is discussed. • Proposals will receive a summary statement that contains: • Impact/Priority Score and possibly a Percentile Ranking and overall Resume and Summary of Discussion (if discussed) • Essentially Unedited Critiques from individual reviewers (2-4) • Budget Recommendations • Administrative Notes (animal, human, overlap, etc.) For questions on the summary statement, applicants should contact the Program Director, NOT Scientific Review Officer!

34. Final thoughts • Thanks to Tom Buchanan (UD) and Gayle Lester (NIH) for providing slides • Good luck! • Grant writing can be the most intellectually engaged part of your job • The review process is not perfect, but it is pretty good and quite fair