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  1. 1. 1 NIH Clinical Center,CTSAs NIH Molecular Libraries Initiative Disease Target ID Assay Dev. HTS Probe to Lead Pre- Clinical FDA IND Ph. I Ph. II Ph. III FDA Review NIHRAID NIHTRND New NIH FDA Partnerships CAN Provides a Framework for Integration And for Process Engineering Cures Acceleration Network
  2. 2. 2 Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) Small Grant (R03) Research Project Grant (R01) Independent Scientist Award (K02) Senior Scientist Award (K05) Approx. Stage of Research Training and Development Mechanism of Support GRADUATE/ MEDICAL STUDENT POST DOCTORAL EARLY MIDDLE SENIOR CAREER Predoctoral Institutional Training Grant (T32) NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Midcareer Investigator Award in Patient-Oriented Research (K24)Exploratory/Develop ment Grant (R21) NIH Offers Funding Programs to Support Scientists at Every Stage of Their Career *Graph represents a small sample of NIH funding mechanisms available.
  3. 3. 3 • NIH Director’s ARRA Funded Pathfinder Award to Promote Diversity – Supports investigators who intend to pursue new research directions related to workforce diversity – Total funding ~ Up to $2M total costs over 3 year period • New Innovator Award – Supports small number of exceptionally creative new investigators – Provides up to $300,000 in direct costs • Transformative R01 – Common Fund initiative for exceptionally innovative, high risk, original and/or unconventional research projects – Supports both individuals and collaborative investigative teams – Total funding ~ Up to $25 million total costs for 5 year period • NIH Director’s Pioneer Award – Supports exceptionally creative individual scientists – Total funding ~ $5 million for 5 year period Opportunities for Tomorrow: Investing in Innovative Researchers
  4. 4. 4 EARLY STAGE & NEW INVESTIGATORS NIH fosters research independence of early career investigators.
  6. 6. 6 Enhancing Peer Review A Self-Study by the NIH in Partnership with the Scientific Community to Strengthen Peer Review in Changing Times Keeping the Goal in Mind: “Fund the Best Science, by the Best Scientists, with the Least Administrative Burden.” Former NIH Director, Dr. Elias A. Zerhouni
  7. 7. 7 Summary of Recommendations More at: http://enhancing-peer-review.nih.gov
  8. 8. 8 Enhancing Peer Review at NIH: Timeline January 2009 May/June 2009 January 2010 Submissions Changes SO FAR •Phase out of A2 applications •Identification of Early Stage Inv. applications •Enhanced review criteria •New scoring system •Criterion scoring •Structured critiques •Clustering of New Inv. Applications •Score order review Changes NOW •Alignment of applications & review criteria •Shorter Research Plans
  9. 9. 9 Executive Order 13505 Removing Barriers to Responsible Research Involving Human Stem Cells - March 9, 2009 Human Embryonic Stem Cells
  10. 10. 10 NIH Guidelines for Human Stem Cell Research Effective July 7, 2009 • Establish criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be included in new Registry as eligible for use in NIH funding • All hESCs must be: • Derived from embryos created by IVF for reproductive purposes and no longer needed for that purpose • Donated by individuals who sought reproductive treatment and who gave voluntary written consent for human embryos to be used for research purposes • Centralize processes and procedures for NIH reviews of hESCs • 64 lines now approved on the Registry including H7 & H9 • Applicants will cite hESCs from the Registry in grant applications • NOT-OD-10-056 - Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research • NOT-OD-10-063 - Status of Certain Human Embryonic Stem Cell Lines http://hescregapp.od.nih.gov/comments/FR_Notice_2-23-2010.pdf More at: http://stemcells.nih.gov
  11. 11. 11 Financial Conflict of Interest (FCOI)
  12. 12. 12 Federal Regulation on Financial Conflict of Interest (FCOI) 42 CFR Part 50, Subpart F Purpose: The regulation promotes objectivity by NIH- funded research by ensuring that the research is not biased by an Investigator’s conflicting financial interests. Who is Responsible?  Investigator Responsible for complying with his/her Institution’s policies and procedures and for disclosing the necessary financial information.  Institution Responsible for compliance including developing, maintaining, and communicating a written and enforced FCOI plan.  NIH As the grantor agency, NIH has primary is responsible for oversight and compliance by reviewing all Institutional reports of FCOI.
  13. 13. 13 Major Areas Addressed in the NPRM • Significant Financial Interest (SFI) • Investigator Disclosure • Reporting to PHS Awarding Component (NIH) • Public Notice • Scope • Investigator Training
  14. 14. 14 Future Challenges for NIH • Translation of Basic Science • Scientific Workforce • Emerging Technologies and Data Needs • Ethical and Social Implications of Research • Economic Impact of Research • Academic/Biomedical Industry Relationships • Post-ARRA Funding Issues • Accountability and Transparency – making the case
  15. 15. 1515 NIH encourages applicants to describe their research in terms that are easily understood by:  Congress  Public  Scientists  Administrators  Peer Reviewers ____________________________________ Titles, abstracts and statements of public health relevance should: • Convey the value of the research in plain language – clear, succinct, and professional • Be comprehensible to both scientists and the public • Relay the potential impact of the research on health This information on funded grant applications is publicly available on NIH’s RePORTER Web Site at http://ProjectRePORTER.NIH.gov. Communicating Research Intent