1. B IOMEDICAL E NGINEERING NIH and the Grant Review Process Dawn M Elliott, PhD

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

3. B IOMEDICAL E NGINEERING National Institutes of Health (NIH)  The steward of medical and behavioral research for the nation  Composed of 27 Institutes and Centers (ICs)  Provides leadership 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. B IOMEDICAL E NGINEERING 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. B IOMEDICAL E NGINEERING A Simple View of the NIH Grants Management (GMS) Scientific Program (PD/PO) Scientific Review (SRO) Intramural Research Program About the scientific and technical aspects – Listed in FOA and IC’s programmatic descriptions For questions during the review – Listed on the eRA Commons link to your submitted application For help with the business aspects – Listed on the eRA Commons link to your submitted application Extramural Research Program

6. B IOMEDICAL E NGINEERING Program Director/Officer (PD/PO)  Scientific Portfolio Builder Help to set/implement IC priorities Design/execute specific initiatives Make funding recommendations  Responsible Steward of Public Funds Monitor award and progress Ensure proper use of public fund  Scientific Public Face of the Government Pre-application and post-review scientific contact

7. B IOMEDICAL E NGINEERING Scientific Review Officer (SRO)  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. B IOMEDICAL E NGINEERING Grants Management Specialist (GMS)  Provide advice on business-related aspects of 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. B IOMEDICAL E NGINEERING Who to Contact When? Pre-Review Post-Review Pre-Submission 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. 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. Contact PD/PO for revision and funding. Once funded, contact PD/PO for scientific relevant issues and GMS for process and/or policy issues. Application in Peer Review

10. B IOMEDICAL E NGINEERING 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

11. B IOMEDICAL E NGINEERING 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”) www.Grants.gov –All of the NIH FOAs (unsolicited and solicited) found at the NIH Guide http://grants.nih.gov/grants/guide/index.html http://grants.nih.gov/grants/guide/index.html –Weekly NIH Funding Opportunities and Notices published –Sign up at http://grants.nih.gov/grants/guide/listserv.htm http://grants.nih.gov/grants/guide/listserv.htm

12. B IOMEDICAL E NGINEERING 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)

13. B IOMEDICAL E NGINEERING 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 max, 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 prelim data

14. B IOMEDICAL E NGINEERING Pathway to Independence (K99/K00) Goal of the Pathway to Independence Award program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators. The program is designed to facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm

15. B IOMEDICAL E NGINEERING NIH Director’s New Innovator Award 15 CONFIDENTIAL Open to exceptionally creative Early Stage Investigators Early stage investigator – New Investigator within 10 years of terminal degree Goal is to fund bold and highly innovative research with potential to have significant impact on a broad area of biomedical or behavioral research Up to $1.5 million in direct costs over 5 years (300K/yr) 537 applications submitted for 2014, 50 awards (9.3%) 490 applications submitted for 2015 Expect to fund ~33 awards in 2015 (6.7%) https://commonfund.nih.gov/newinnovator/index

16. B IOMEDICAL E NGINEERING New Innovator Award Application Applications are shorter than R01s (10 pg) and Research Strategy includes:  Project description: scientific problem, significance, and potential impact; suitability of planned research for New Innovator Award rather than a traditional mechanism  Innovativeness: what makes project exceptionally innovative; risks and challenges, alternatives if approaches not successful  Investigator Qualifications: evidence to support claim of creativity and innovativeness Biographical Sketch – 2 pages List of current and pending research support CONFIDENTIAL16

17. B IOMEDICAL E NGINEERING New Innovator Award Application Applicant must be an Early Stage Investigator (no multiple PI) Must propose bold highly innovative new approaches to high impact problem Innovation and impact expected to be significantly greater than in typical R01 Preliminary data not required but allowed CONFIDENTIAL17

18. B IOMEDICAL E NGINEERING New Innovator Award Review Process Phase 1 -- mail review (January)  Assignments made by broad scientific area:  Instrumentation and Engineering; Behavioral and Social Sciences; Chemical Biology; Clinical and Translational Research; Immunology; Molecular and Cellular Biology; Neuroscience; High Throughput and Integrative Biology; Quantitative and Computational Biology Phase 2 – on-site review meeting (April)  Different reviewers

19. B IOMEDICAL E NGINEERING New Innovator Award Review Criteria Scientific Problem (Significance): Does the project address an important scientific problem or critical barrier in the field? How will scientific knowledge, technical capability and or clinical practice be improved? If the proposed research is completed, will the project have a major impact on a broad area of biomedical or behavioral research? CONFIDENTIAL19

20. B IOMEDICAL E NGINEERING New Innovator Award Review Criteria Innovativeness of the research proposed: Does the application challenge or seek to shift current research or clinical practice? Are the proposed scientific problem, concepts, approaches or instrumentation or interventions significantly more innovative, bold and creative than would normally be expected from an early stage investigator? Is it evident from research strategy that the investigator has considered and addressed the potential risks and challenges? Is the proposed project unusually innovative?

21. B IOMEDICAL E NGINEERING New Innovator Award Review Criteria Investigator Qualifications Is the investigator well suited to the project? Is the investigator appropriately trained to independently carry out the project? Is there any evidence of the investigator’s potential to do creative and innovative research? Is there any evidence of investigator’s inclination to challenge paradigms and take intellectual risks? Overall Impact: assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the three core review criteria. CONFIDENTIAL 21

22. B IOMEDICAL E NGINEERING Outline What’s up with the NIH? What happens to my grant after it is submitted? What happens at a study section?

23. B IOMEDICAL E NGINEERING Review Process for a Grant

24. B IOMEDICAL E NGINEERING NIH Dual Level Review System Output: Awards or Resubmission 3-7 months 1-3 months 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 Output: Funding Recommendations NIH IC Director

25. B IOMEDICAL E NGINEERING Two Level Review Process  Center for Scientific Review (CSR) Receipt, Referral, & Review –Receives all grant applications –Assigns (“Refers”) to o study sections for review o 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

26. B IOMEDICAL E NGINEERING 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

27. B IOMEDICAL E NGINEERING NIH Grant Application Process – Summary  Grant application in the CSR; is logged in and given a 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 )http://www.csr.nih.gov/Video/Video.asp

28. B IOMEDICAL E NGINEERING NIH Grant Application Process – Summary  2 days after review meeting, PI can see priority score or that application was not discussed in the Commons  Roughly 4 weeks after review, summary statement will be posted on the NIH Commons, or 1-2 weeks for new PI  Applications undergo second-level review by 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 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

29. B IOMEDICAL E NGINEERING Relevant Scientific Review Groups 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:MOSS 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] One of the five divisions – the Division of Translational and Clinical Sciences includes: 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:SBIB Bioengineering, Technology, and Surgical Sciences [BTSS] Medical Imaging Study Section [MEDI]

30. B IOMEDICAL E NGINEERING Center for Scientific Review The CSR study section rosters are public You can request that your proposal be reviewed by a particular study section Program officers from several institutes attend each study section A few grants are not reviewed by CSR, but are reviewed by institute-run committees  training grants, K-awards, some R03s, and special initiatives

31. B IOMEDICAL E NGINEERING Final thoughts 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 pretty fair

32. B IOMEDICAL E NGINEERING

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

34. B IOMEDICAL E NGINEERING 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

35. B IOMEDICAL E NGINEERING NIH study section meeting

36. B IOMEDICAL E NGINEERING 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

37. B IOMEDICAL E NGINEERING 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

38. B IOMEDICAL E NGINEERING NIH Scoring System ImpactFull DescriptionScore – Descriptor High Exceptionally strong with essentially no weaknesses 1 – Exceptional Extremely strong with negligible weaknesses 2 – Outstanding Very strong with only some minor weaknesses 3 – Excellent Medium Strong but with numerous minor weaknesses 4 – Very Good Strong but with at least one moderate weakness 5 – Good Some strengths but also some moderate weaknesses 6 – Satisfactory Low Some strength but with at least one major weaknesses 7 – Fair A few strengths and a few major weaknesses8 – Marginal Very few strengths and numerous major weaknesses9 – Poor 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

39. B IOMEDICAL E NGINEERING 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

40. B IOMEDICAL E NGINEERING 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

41. B IOMEDICAL E NGINEERING 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)

42. B IOMEDICAL E NGINEERING 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

43. B IOMEDICAL E NGINEERING 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!