1. The Review Process

2. Mail room 1  Approximately 50,000+ grant applications are submitted to NIH each year,  25-30% are funded  Competing grant applications are received for three review cycles per year

3. REVIEW PROCESS FOR NIH RESEARCH GRANTS School or Other Research Center (Applicant) Principal Investigator Initiates Research Idea Conducts Research Submits application Allocates Funds $$ Center for Scientific Review Scientific Review Group Institute Advisory Council or Board Institute Director Assign toIC and IRG Review forScientific Merit Evaluate for Relevance Recommends Action Takes final action for NIH Director Research Grant Application (PI) National Institutes of Health

4. Dual Review System for Grant Applications Second Level of Review Advisory Council Assesses Quality of SRG Review of Grant Applications Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy First Level of Review Scientific Review Group (SRG) Provides Initial Scientific Merit Review of Grant Applications Rates Applications and Recommends for Level of Support and Duration of Award

5. STUDY SECTIONS DO NOT FUND ! INSTITUTES FUND!

6. Where can you help yourself in the review process?

7. YOU DO! The words that are in your application Your title Your abstract Your specific aims Your methods Self referral—cover letter WHO/WHAT DETERMINES WHICH STUDY SECTION REVIEWS THE APPLICATION?

8. Use the NIH Web site to Find the right study section To review your grant

9. Talk to your Program Officer before writing the grant –He will probably suggest a study section –He will probably tell you if a dual institute assignment would be logical Remember: Institutes fund/study sections do not fund! –Look over the list of reviewers for that study section Make sure there are specialists who can cover your research topics –Write your cover letter and suggest your institute assignment and study section If it makes sense, usually will comply Establish a strong connection with your Program officer

10. WHO ASSIGNS REVIEWERS TO MY APPLICATION? Scientific Review Administrator Assignment to Specific Reviewers Based on application content Based upon expertise of reviewers Based upon knowledge of the field May consult with Institute staff May consult with chairperson Suggestions from PI on type of expertise needed to evaluate (NEVER names) Considers review history

11. Tips to getting a good review

12. Struggle for survival Reviewers look for flaws in grants to reduce the pack. There is limited funding so only the strong survive! Be sure the grant is as air tight as possible.

13. Timing is everything Have preliminary data to show the experiments are feasible Could be data from former preceptor’s lab, but it is a plus to have your own lab functional.

14. Fishing expedition “In addition to proposing a research design that is a fishing expedition, the applicant also proposes to use every type of bait and piece of tackle ever known to mankind.” -NIH Generally grants should be hypothesis driven. Some exceptions, for instance Bioengineering Grants proposed to develop technology.

15. Too much/Too fast Lesson: Ambition good/ Insane ambition bad Less space to argue aims More to criticize “Stream of consciousness” writing implies undisciplined approach Remember these are 3-5 year grants not the next decade of work

16. A carefully prepared manuscript is most important Logical Formatting, formatting, formatting Remember 10-15 grants per reviewer Reviewer has a day job--your grant may be read on the plane! Write for easy referencing to key points Have colleagues critique--in field and out of field If an out of field person doesn’t get it-- your reviewer may not get it Write for the generalist, not the specialist Often the best applications are from first time applicants. As important a document as a journal article Spend considerable time and effort.

17. What happens during review?

18. The Big Box Arrives about 5 weeks Before the meeting. Copies of all the Grants and originals Of the grants to be Reviewed with supporting Material. All applications reviewed prior to the meeting. Comments are written BEFORE the meeting

19. Reviewers: Primary, secondary, tertiary reviewers. Primary and secondary write complete review, tertiary a summary.

20. Study section work load Typically 70-100 grants Twenty reviewers Approximately 10-15 grants per reviewer Consequence—rare other than the assigned 3 reviewers will examine a grant in detail. Others will mostly just ask questions.

21. 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. ____________________ ____________________ Certification of No Conflict of Interest SIGNATURES  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. Confidentiality

22. So what are reviewers looking for? Significance: Does the study address an important problem? How will scientific knowledge be advanced? Covered in proposal Approach: Are design and methods well-developed and appropriate? Are problem areas addressed? Covered in proposal Innovation: Are there novel concepts or approaches? Are the aims original and innovative? Covered in proposal  Investigator: Is the investigator appropriately trained? Biosketch and Letters of reference for young investigators  Environment: Does the scientific environment contribute to the probability of success? Are there unique features of the scientific environment? Your institution and resources list

23. NRSAs and K Awards Looking for a training plan as well as research Strong letters are critical! These are about you--not just the research For K awards: Institute letters are needed Make sure of institute/division/mentor commitment to your development

24. Triage 30% of low scoring grants Reviewers are asked for scores of remaining grants –If there is a discrepancy=debate Everyone votes a score and the final score is tallied Total time on your grant if debate 15-20 minutes Toss the grant in pile and move onto the next one What goes on behind closed doors.

27. What happens next? The SRA logs the score and summary statement in the computer –Usually within three days of the study section meeting You get a hard copy a few weeks later –If you are new and anxious, many times the SRAs will let you call them But be nice! They respond best to requests! Over the next couple of years things will change –You will be able to access the “Commons” NIH database and find out as soon as the SRA puts in the information

28. The comments in the summary statements are never about you as a person. The comments are about the material that you provided in your application and the way in which you provided the information. Don’t take it personally Take it professionally

29. So you have your score early… –Are you going to get funding? Study sections do not fund/Institutes fund! –You need to talk to the Program Officer not the SRA-his job is done –Program Officer can’t guarantee funding But she can tell you if it is probable or not Also can give you additional feedback regarding review Am I funded?

30. You must satisfy the needs of reviewers and the needs of the funding agency

31. Council Actions  Assesses Quality of SRG Review  Concurs with study section action or  Modifies SRG (study section) action Can not change priority score Most important for grants in the gray zone.  Makes Recommendation to Institute Staff on Funding, Evaluates Program Priorities and Relevance and Advises on Policy  Funding based on scientific merit, program priorities, and available funds

32. Should I revise the grant? Were you close to the funding line with good comments in the summary statement? –Then resubmit:you have three shots –May have more preliminary data now and have resolved problems –Talk with the program officer about your revision! Didn’t even get scored? –May consider a new approach or question –New grant application

33. The comments in the summary statements only list some of the weaknesses not all of the weaknesses. Subsequent reviewers may identify new weaknesses. When you revise your application use the time as an opportunity to improve the entire application.

34. Revised grants May go to same reviewers Reviewers like to see their comments taken seriously Some argue with the review— Be very sure that the arguments are solid Often drop most offending aims. If the previous grant had a reasonable score and the criticisms are seriously addressed, should have a good chance of funding. This means substantial changes or clarifications, not just cosmetic ones! May also consider another study section for resubmission Usually if you didn’t get a good assignment in first place

35. Questions?