1. The Center for Symptom Management The NIH review process Kathryn Lee, RN, PhD April 3, 2009 MDP

2. The Center for Symptom Management

3. Grant Mechanisms R series (research projects) R01 -individual research R03- small, short-term R21- exploratory/developmental R15 – certain institutes with little NIH funding

4. The Center for Symptom Management 1946 One Review Platform for 62 years The First NIH Study Section The Last NIH Study Section 2008

5. The Center for Symptom Management The Letter of Intent (LOI) Used by federal agencies/foundations Filter applications to their interest area Appoint appropriate reviewers Specific to the agency, typically ask for Abstract NIH Biosketch Nomination letter (some, but not all)

6. The Center for Symptom Management Writing an LOI- Start Early  Limited to 1-2 pages Title of proposal lBackground of applicant (or Biosketch) lObjectives lDesign and Methods lStatistical analysis plan

7. The Center for Symptom Management LOI: Can really help your process  finalize key aims/questions  get prepared to submit a well designed application in short time frame  Start a relationship with your future program officer

8. The Center for Symptom Management Letters of Intent They’re Not Easy ! “If I had more time, I would have written you a shorter letter.” Mark Twain

9. The Center for Symptom Management National Institutes of Health NIH Mission: Promote biomedical and behavioral research to help improve the health of all Americans Carried out through 27 Institutes and Centers

10. The Center for Symptom Management FY 2007 NIH Budget is $28.6 Billion Spending Outside NIH $24.1 B Spending at NIH $4.5 B

11. The Center for Symptom Management Goal of Peer Review Independent, fair, thorough, and competent review of each application Identify and rank appropriately those applications that show the greatest promise of advancing biomedical science and/or improving disease prevention, diagnosis and treatment

12. The Center for Symptom Management Role of Reviewer  Provide judgment of the scientific merit of each application; NOT TO DETERMINE FUNDING  Criteria for selecting reviewers Record of scientific excellence Able to see “big picture” Fair and balanced Willing to follow guidelines and stay w/in required time frame Articulate opinions in a clear, concise manner Open minded to the views of other reviewers

13. The Center for Symptom Management Conflict of Interest  Worked with key personnel in past 3 years or currently  Financial gain  Close relative of key personnel  PI is from your institution  Recognized scientific disagreement  PI was your student/major dissertation advisor  You are applying for job at PI’s institution  PI is applying for job at your institution

14. The Center for Symptom Management Review Details  Each application 3-4 assigned reviewers Primary, Secondary – full written critique Discussant(s)- summary paragraph

15. The Center for Symptom Management Tips for Reviewers  Focus on science, not “grantsmanship”  Keep in mind “big picture”  Distinguish between major problems and minor concerns or differences in approach  “lack of detail” – what is missing and why it matters  “Trust me” proposal

16. The Center for Symptom Management Written Critiques  Address each of 5 review criteria  Address human subjects/inclusion  Overall evaluation/summary paragraph  Be specific, constructive, and concise Not a time for mentoring  Do not identify yourself

17. The Center for Symptom Management Review Criteria Significance 1= exceptional 9 = poor Approach (1 - 9) Innovation (1 - 9) Investigators (1 - 9) Environment (1 - 9)  Overall IMPACT

18. The Center for Symptom Management New Scoring Strengths Weaknesses Poor 9 Marginal8 Fair7 Low Impact Satisfactory6 Good5 Very Good4 Moderate Impact Excellent3 Outstanding2 Exceptional1 High Impact Guidance on weighing strengths and weaknesses Overall Impact Score

19. The Center for Symptom Management Chair’s Role  Ensure that all appropriate viewpoints are expressed  Ensure that discussion is fair, balanced, and appropriate  Promote consistent scoring  Summarize panel’s views  Time management

20. The Center for Symptom Management Percentiles  Scores are translated into percentiles which are used to make funding decisions  Currently most institutes funding at 8-15 th percentile  Score clustering results makes it easier to fund out of order

21. The Center for Symptom Management Dual Review System for Applications 2 nd Level of Review NIH Institute/Center Council 1st Level of Review Scientific Review Group (SRG)

22. The Center for Symptom Management Streamlining  Purpose: make more efficient use of time at meetings  Goal: streamline 50-60%, so proposals that are not competitive are not discussed  Streamlining does NOT equal BAD

23. The Center for Symptom Management CSR Peer Review: 2008  77,000 applications received  56,000 applications reviewed  16,000 reviewers  240 Scientific Review Officers  1,600 review meetings

24. The Center for Symptom Management Major Complaints About NIH Peer Review  Process is too slow  Not enough senior/experienced reviewers  Process favors predictable research instead of significant, innovative, or transformative research  Time and effort required to write and review are a heavy burden on applicants and reviewers

25. The Center for Symptom Management Assign Applications Accurately & Efficiently Retooled for electronic submission Applications are now submitted electronically Assign applications using text fingerprinting, and text mining programs Full Implementation by early 2009

26. The Center for Symptom Management Fund best research earlier & reduce burden on applicants, reviewers, & NIH  More flexible deadlines  Abolish A2 applications

27. The Center for Symptom Management Improve Quality & Transparency of Peer Review May-July meetings 2009  Shorten summary statements, follow template for each criteria  Change the rating system Use 1-9 integers Score each criteria Provide score for all applications (even those not discussed) Spring 2010  Shorten applications, aligning with review criteria Impact, investigator, innovation (if applicable), research strategy, facilities

28. The Center for Symptom Management Number of Applications Submitted Historical Growth

29. The Center for Symptom Management Reviewer’s Load Applications Per Reviewer October Council Rounds

30. The Center for Symptom Management RO1 Resubmission Within 4 Months of Original Application

31. The Center for Symptom Management Confidentiality  “What happens in study section stays in study section” Materials are proprietary Don’t discuss outside of the meeting Don’t show application to anyone else Avoid web sites associated with grant

32. The Center for Symptom Management NIH resources  Proposal writing guides  Avoiding common mistakes in an application SON website link to NIH website at: http://nurseweb.ucsf.edu/www/ix-rs.shtmlhttp://nurseweb.ucsf.edu/www/ix-rs.shtml.