1. NIH Challenge Grants in Health and Science Research RFA OD-09-003

2. Background New funds to NIH for 2009 and 2010 as part of the ARRA Challenge areas should have a high impact Novel research that addresses knowledge gaps, opportunities, new technologies, data generation, or research methods

3. Nuts and Bolts Deadline is April 27, to DEH by April 13 th ! Non-modular budget up to $500,000 / year total cost for two years Earliest start date 9/30/09 Research plan is limited to 12 pages NO resubmissions

4. Useful websites http://grants.nih.gov/grants/guide/rfa- files/RFA-OD-09-003.htmlhttp://grants.nih.gov/grants/guide/rfa- files/RFA-OD-09-003.html http://grants.nih.gov/recovery/faqs_challen ge.htmlhttp://grants.nih.gov/recovery/faqs_challen ge.html

5. Useful (?) websites http://grants.nih.gov/grants/funding/challen ge_award/Omnibus.pdf --a 181 page documenthttp://grants.nih.gov/grants/funding/challen ge_award/Omnibus.pdf http://www.niehs.nih.gov/recovery/challeng egrants.cfm --NIEHS Challenge topicshttp://www.niehs.nih.gov/recovery/challeng egrants.cfm http://grants.nih.gov/grants/funding/challen ge_award/IC_ChallengeWebPage.htmhttp://grants.nih.gov/grants/funding/challen ge_award/IC_ChallengeWebPage.htm --all institutes

6. Review Criteria The new (2010) criteria will be used for Recovery Act FOAs. http://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-025.htmlhttp://grants.nih.gov/grants/guide/notice- files/NOT-OD-09-025.html For comparison of current and new criteria http://grants.nih.gov/grants/peer/side_by_s ide_comparison.dochttp://grants.nih.gov/grants/peer/side_by_s ide_comparison.doc

7. Grant preparation Project summary / abstract Bibliography and references – 1 page Biosketch – 2 pages. Limit publications to TEN (10) Specific Aims – 1 page Research plan—12 pages

8. Additional sections Inclusion Enrollment Report Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Inclusion of Children Vertebrate Animals Select Agent Research MPI Leadership Plan Consortium/ Contractual Arrangements Letters of Support Resource Sharing Plans – Data Sharing Plan, Sharing Model Organisms, and Genome-Wide Association Studies

9. Research Plan Research area and project title The challenge and potential impact Approach Timeline and milestones

10. The Challenge / Potential Impact What is the research opportunity, scientific knowledge gap or technology that will be addressed? How broad is the potential impact in science and/or health?

11. The Challenge / Potential Impact Which community will be affected? What is the size of the community? Will the potential impact be major?

12. The Challenge / Potential Impact What is the disease or condition that will be studied ? What is the hypothesis to be tested concerning mechanisms underlying this disease/condition?

13. The Challenge / Potential Impact How will the work disrupt the standard paradigm or create a paradigm where none exists? How will the results transform our understanding of this disease/condition?

14. The Approach Provide enough information that reviewers can determine what, in general, you are proposing to do, but do not include a detailed experimental plan.

15. The Approach If your methodology is novel, what is unconventional and exceptionally innovative about your approach? How does your approach differ from what other investigators have attempted to do?

16. Timeline and Milestones Why is the proposed research uniquely suited to the stated goals of the challenge initiative? What is the likelihood of success? Provide a timeline for the proposed research. To facilitate evaluation of progress reports, describe when you anticipate that essential components of the project will be completed.

17. New Scoring System 9-point scale (1 = exceptional; 9 = poor) Before review meeting, reviewers and discussant will give a 1 – 9 for each area: Significance Investigator(s) Innovation Approach Environment You will receive the scores for these criteria, even if your grant is “triaged”

18. New Scoring System (cont) Priority Scores: Before the review meeting, each reviewer and discussant will give a preliminary impact score for that application. This score is evaluation of the overall impact, rather than a weighted average to previous review criteria.

19. Other ARRA Concepts Comparative Effectiveness Research (CER) »Role of trials versus observational studies »Establishing priorities »Optimally using existing resources »Coordinating federal agencies and other research collaborators »Improving research methods »What’s the importance of cost? Public-Private Partnerships http://ppp.od.nih.gov/ http://ppp.od.nih.gov/

20. Caveats! No plan survives contact with the enemy “High achievement always takes place in the framework of high expectation.” –Charles Kettering