1. 1 Inside the NIH 2009 NIH Overview of Program Funding and Grants Administration Sally Rockey, PhD Deputy Director, NIH Office of Extramural Research (OER) Office of the Director October 28, 2008

2. 2 The National Institutes of Health (NIH) –Welcome –Change in Leadership –NIH Budget –Inside the NIH –Building Partnerships

3. 3 NIH Mission “NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.”

4. 4 Balanced National Biomedical Research Portfolio NIH – $29 B Clinical Research Basic Research Translational Research Private Sector – $59 B Clinical Research Basic Research Translational Research Basic Discovery Today Provides the Foundation for Tomorrow’s Medicine

5. 5 NIH Congressional Appropriations FY1997- FY2008 (dollars in billions)

6. 6 FY2007: Top 5 States Receiving NIH Awards #1CALIFORNIA$3.2 B #2MASSACHUSETTS$2.2 B #3NEW YORK$1.9 B #4PENNSYLVANIA$1.4 B #5TEXAS$1.1 B Award Trend Information available at: http://grants.nih.gov/grants/award/awardtr.htm http://grants.nih.gov/grants/award/awardtr.htm

7. 7 Inside NIH Focus on New Investigators Help Wanted: The Roadmap & Translational Research New Directions in Peer Review Important Changes to the Public Access Policy Assuring Objectivity in Research

8. 8 FY2009: NIH Continues to Focus on Investigators –Encourage established investigators by: Continuing to use the NIH Directors Bridge Award Program. Addresses the need for a highly productive pool of researchers by providing support for new investigators and sustaining established investigators, who have little or no additional research support. –Preserve the ability of new scientists with fresh ideas to enter the competitive world of NIH funding by: Maintaining an average yearly number of approximately 1,500 new investigators receiving their first NIH R01-equivalent grants. Supporting new investigators with programs such as the Pathway to Independence and the NIH Director's Innovator Awards. More information available: http://officeofbudget.od.nih.gov/PDF/Press%20info-2008.pdf http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-036.html

9. 9 FIRST Check box http://grants.nih.gov/grants/new_investigators/Workforce_Info09072007.ppt#355,14,New%20Ext ramural%20Principal%20Investigators NIH Exceeds Goal FY ’07 & ‘08: Funded approx. 1600 new R01 investigators

10. 10 Roadmap for Medical Research Roadmap is “a framework of priorities” and “a set of initiatives central to extending benefits to patients." NIH continues to focus on 3 Roadmap “Themes”: –Research Teams of the Future –Re-engineering the Clinical Research Enterprise –New Pathways to Discovery It is a trans-NIH initiative which funds new research ideas using pooled monies from all of the Institutes/Centers. The Common Fund was established by NIH in 2004 and enacted into law by Congress to provide funding to support cross-cutting, trans-NIH programs, such as these. More at: http://nihroadmap.nih.govhttp://nihroadmap.nih.gov

11. 11 Roadmap for Medical Research NIH Focusing on Three Broad Roadmap “Themes”: –Research Teams of the Future –Re-engineering the Clinical Research Enterprise –New Pathways to Discovery Transformative R01 Program supports highly creative, “out-of-the-box” projects that test novel concepts and truly transformative ideas. Applications can be submitted from all areas of biomedical science with highlighted areas below: –Understanding and Incenting Behavior Change –3-D Tissue Models –Functional Variation in Mitochondria –Transition from Acute to Chronic Pain –Formulation of Novel Protein Capture Reagents –Evidence for Pharmacogenomics Clinical Studies –http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-029.htmlhttp://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-029.html More at: http://nihroadmap.nih.gov

12. 12 New Directions in Peer Review The Charge: The increasing breadth, complexity, and interdisciplinary nature of biomedical science are creating new challenges for the system used by NIH to support biomedical and behavioral research Peer review is a key component of this system “Fund the best science, by the best scientists, with the least administrative burden…”

13. 13 A Self-Study by the NIH in Partnership with the Scientific Community to Strengthen Peer Review in Changing Times Goal: “To fund the Best Science, by the Best Scientists, with the Least Administrative Burden.” NIH Director, Dr. Elias A. Zerhouni What NIH is Doing to Meet this Challenge

14. 14 Enhancing Peer Review: Summary of Recommendations More at: http://enhancing-peer-review.nih.gov

15. 15 Enhancing Peer Review: Current Implementation Activities Examples of current implementation activities: All applications will receive a score. R01 applications will be shorter and will be restructured to align with review criteria. A2 applications have been eliminated. Support of early stage investigators (those within 10 years of terminal degree and/or end of residency). Cluster new investigator applications together in review.

16. 16 Public Access Policy Implementation Beginning April 7, 2008, –All articles arising from NIH funds must be submitted to PubMed Central upon acceptance for publication. –Manuscripts are to be made publicly available on PubMed Central no later than 12 months after publication. –Institutions and investigators must ensure copyright transfer or other publication agreements allow compliance with the Policy. Beginning May 25, 2008 –Applications, proposals or progress reports submitted to NIH must include the PMC or NIH Manuscript Submission reference number when citing articles covered by the policy.

17. 17 NIH Public Access Policy is Now Mandatory The Policy implements Division G, Title II, Section 218 of PL 110-161 (Consolidated Appropriations Act, 2008) which states: SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law. See NOT-OD-08-033 for implementation: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html

18. 18 http://publicaccess.nih.gov/index.htm

19. 19 NIH Oversight of Extramural Financial Conflicts of Interest Health Service (PHS) Regulation 42 CFR Part 50, Subpart F42 CFR Part 50, Subpart F Responsibility for the identification and management of investigators’ FCOI is placed with the institution, which oversees the investigator’s activities. As the grantor agency, NIH has primary responsibility for overseeing institutional compliance with these requirements. NIH Takes Steps with Resources and Contacts: Web Based Tutorial For Investigators: http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm New Pilot Program Announced for Reporting FCOI: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-001.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-001.html Division of Grants Compliance and Oversight Home page: http://grants.nih.gov/grants/compliance/compliance.htm http://grants.nih.gov/grants/compliance/compliance.htm Dedicated e-mail: FCOIcompliance@mail.nih.govFCOIcompliance@mail.nih.gov

20. 20 Financial Conflict of Interest (FCOI) Regulation Compliance (including accurate & timely reporting) Institutional Policy ImplementationManagementOversight Institution DisclosureCompliance Investigator Oversight NIH PHS regulation 42 CFR Part 50, Subpart F 1995

21. 21 We have answers We’re here to help http://grants1.nih.gov/grants/oer.htm

22. 22 NIH and YOU! Building Partnerships in Biomedical Research! The NIH values its partnerships with academia and private industry, which all play crucial roles in uncovering knowledge that will lead to better health for everyone. The NIH supports research endeavors worldwide, while providing opportunities for today and tomorrow’s researchers to share their vision and innovation. The future rests on your ideas and those who support them!

23. 23 NIH Transforming medicine through discovery