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Current Issues Reminders Compliance Electronic Research Administration Outreach

NIH Update Spring 2005 University of North Carolina-Chapel Hill Research Administration Support Group April 21, 2005. Current Issues Reminders Compliance Electronic Research Administration Outreach. Current Issues. Imperatives for NIH. Accelerate pace of discoveries in life sciences

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Current Issues Reminders Compliance Electronic Research Administration Outreach

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  1. NIH UpdateSpring 2005University of North Carolina-Chapel Hill Research Administration Support Group April 21, 2005

  2. Current IssuesRemindersCompliance Electronic Research AdministrationOutreach

  3. Current Issues

  4. Imperatives for NIH • Accelerate pace of discoveries in life sciences • Enable deeper understanding of pathobiology of disease prior to irreversible damage • Translate research more rapidly from laboratories to patients and back • Explore novel biomedical strategies orders of magnitude more effective than current ones • NIH Roadmap

  5. What is the NIH Roadmap? • A framework of priorities the NIH as a whole must address in order to optimize its entire research portfolio. • A set of initiatives that are central to extending the quality of healthy life for people in this country and around the world. • A vision for a more efficient and productive system of biomedical and behavioral research.

  6. New Pathways to Discovery Re-engineering the Clinical Research Enterprise Research Teams of the Future Three Themes of the Roadmap

  7. Molecular Libraries and Imaging Re-engineering the Clinical Research Enterprise Building Blocks, Biological Pathways and Networks Structural Biology Public-Private Partnerships Implementation Groups Bioinformatics and Computational Biology High-risk Research Interdisciplinary Research Nanomedicine NIH Roadmap: Trans-NIH teams manage… Re-engineering the Clinical Enterprise New Pathways to Discovery Research Teams of the Future

  8. New Pathways to DiscoveryGenomic era offers unprecedented opportunities • Building Blocks for Biological Pathways, Networks • Molecular Libraries and Imaging • Structural Biology • Bioinformatics and Computational Biology • Nanomedicine

  9. Research Teams of the FuturePromoting innovation • Interdisciplinary Research Teams • Centers • Training • “Out-of-the-Box” Thinkers • Director’s Pioneer Award • Public-Private Partnerships • Central point of contact at NIH

  10. Re-engineering the Clinical Research Enterprise • Translational Research through: • Regional Centers • Core Services • Harmonize and Simplify Clinical Research Regulatory Processes • Integrate Clinical Research Networks • Strengthen Clinical Research Workforce • Regional Centers of Excellence for Training • National Clinical Research Corps

  11. NIH Roadmap Goals • Accelerate basic research discoveries and speed translation of those discoveries into clinical practice • Explicitly address roadblocks that slow the pace of medical research in improving the health of the American people

  12. Additional Information on the NIH Roadmap • Roadmap website: http://nihroadmap.nih.gov/ • RFA’s and PA’s posted in the NIH Guide for Grants and Contracts http://grants1.nih.gov/grants/guide/index.html

  13. The NIH Budget

  14. FY 2005 Budget$28.59 Billion Research Project Grants 53% $15.3 billion Training 3% $761 million

  15. FY ‘06 President’s Budget Request • $28.740 billion • ~ .5% increase over FY 2005 • Approximately 9,463 competing RPG awards • ~ 247 over FY 2005 • Major initiatives • NIH Roadmap • Biodefense • Neuroscience Blueprint • AIDS

  16. NIH Rate NIEHS Rate RPG Success Rates 16% 27% 29% 25% 18% 20% 29% 29% 25% 19% 21% 31% 30% 27% 28% 31% 32% 31% 32% 25% 25% 25%

  17. Salary Cap • Restricts the amount of direct salary under a grant or contract to Executive Level I of the Federal Executive Pay Scale • Executive Level I increase effective January 1, 2005 $180,100 $175,700 January 7, 2005 NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-024.html

  18. Public Access to NIH Research Information

  19. New Public Access Policyto Publications Resulting from NIH-funded Research NIH-funded investigators are requested to submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported, in whole or in part, with direct costs from NIH. Effective May 2, 2005 NIH Guide, February 3, 2005 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html

  20. Why Public Access? ACCESSProvide electronic access to NIH-funded research publications for patients, families, health professionals, teachers, and students. ARCHIVEKeep a central archive of NIH-funded research publications—for now and in the future, preserving vital medical research results and information for years to come. ADVANCE SCIENCECreate an information resource that will make it easier for scientists to mine medical research publications, and for NIH to better manage its entire research investment.

  21. Updated Criteria for Evaluating Research Grant Applications

  22. Updated Review CriteriaEffective Jan 2005 • Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? • Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

  23. Updated Review Criteria (cont) 3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

  24. Updated Review Criteria (cont) 5.Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? NIH Guide Notice, October 12, 2004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-002.html

  25. NIH Policy on Late Submission of Grant Applications

  26. NIH Policy on Late Submission of Grant Applications • NIH expects grant applications to be submitted on time • Late applications • Generally are not accepted, except in rare instances • Unaccepted late applications will be returned without review • Are only considered for standing receipt dates • Permission is not granted in advance • Must be accompanied by a cover letter with compelling reasons for the delay • Window of consideration for late applications is two weeks • NIH will not consider accepting late applications for the Special Receipt Dates for RFAs and PARs NIH Guide, January 27, 2005 http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-030.html

  27. Model Organisms

  28. New NIH Policy on Sharing of Model Organisms for Biomedical Research NIH Guide Notice, May 7, 2004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html FAQs and sample sharing plans available at: http://grants.nih.gov/grants/policy/model_organism/index.htm Investigators submitting an NIH application/proposal beginning with the October 1, 2004 receipt date are expected to include a specific plan for sharing and distributing unique model organism research resources generated using NIH funding in the application/proposal OR state appropriate reasons for why such sharing is restricted or not possible.

  29. Sharing Model Organisms (cont.) • Applicants should specify • A reasonable time frame for periodic deposition of material and associated data • If, or how, they will exercise their intellectual property rights • Investigators may request funds in their application/proposal to defray reasonable costs • Reviewers will review the plan and may comment in an administrative note • Reviewers will generally not include their assessment in the overall priority score. • Failure to comply with NIH research resource sharing policies, guidelines, and the accepted plan may be considered by NIH staff in future funding decisions.

  30. National Science Advisory Board for Biosecurity (NSABB)

  31. National Science Advisory Board for Biosecurity (NSABB) New Board to provide advice and guidance regarding biological research that has the potential for misuse and could pose a biologic threat to public health or national security • Will advise heads of Federal entities that conduct/support life sciences research • Managed by NIH • Further information and updates available at: http://www.biosecurityboard.gov

  32. FY 2005 Kirschstein-NRSA News

  33. FY 2005 Kirschstein-NRSA News • $1,000 increase in Institutional Allowance for Individual Postdoctoral Fellowships only • No stipend increase this year • Revising the Individual Fellowship Application and Progress Report Form Pages and Instructions. Expect new version to be available by Fall 2005. NIH Guide, February 4, 2005 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-032.html

  34. Revised PHS 398 and 2590 Forms

  35. PHS 398 (rev. 9/04) • Revised PHS 398 forms are accepted for submission/receipt dates on or after 12/1/04. • All applications received on or after May 10, 2005 must use the new instructions and forms. • Applications using the old forms received after May 9 will be returned. NIH Guide, November 2, 2004 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-006.html Revised instructions and forms http://grants.nih.gov/grants/forms.htm

  36. PHS 398 (rev. 9/04) Reorganized into 3 Parts • Part I: Instructions (now are truly just application instructions) • Part II: Supplement Instructions for Preparing the Human Subjects Section of the Research Plan • Part III: Policies, Assurances, Definitions & Other Information

  37. Changes of Note to the PHS 398 (rev. 9/04) Instructions • Font Size Requirement: NIH now requires the use of Arial-11 or Helvetica-11 point font. • Face Page: Added “Clinical Trials Indicator”. • Form Page 2 • Description now includes separate instruction for PI to clearly describe public health relevance. • Created designated area for Stem Cell information. • Added new section for “Other Significant Contributors”.

  38. Changes of Note to the PHS 398 (rev. 9/04) Instructions • Significant Revisions, particularly in Part II, Human Subjects Research Supplement, to address NIH implementation of OHRP Guidance on research involving coded private information or biological specimens. • Instructions for Modular and Non-Modular Budgets and have been revised to implement the new policy on Direct Cost Limitations. • The modular budget format no longer applies to SBIR/STTR grant applications.

  39. Change in Calculation of Direct Costs for Applications with Consortium F&A Costs All applications that involve consortium/contractual facilities and administrative (F&A) costs are to exclude the facilities and administrative (F&A) costs requested by consortium participants from the total direct cost request. Effective for all applications that have submission/receipt dates on or after Dec 1, 2004 NIH Guide notice, November 2, 2004: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html

  40. New PHS 398 Modular Budget Format Page • Added 2 new rows (DC less Consortium F&A and Consortium F&A) and 1 new column (Sum Total)

  41. New PHS 398 Budget Page - Form Page 4 • Separated Consortium DC & F&A Costs • Instructions revised to use Subtotal for Face Page Item 7a

  42. PHS 2590(rev. 9/04) • Revised PHS 2590 forms may be used now • All progress reports received on or after May 1, 2005 must use the new version. NIH Guide, November 2, 2004 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-007.html Revised instructions and forms http://grants.nih.gov/grants/forms.htm

  43. Changes of Note to the PHS 2590 Instructions • Grantees need only submit a signed original and one copy. • Uses new definition of “Key Personnel” implemented in the NIH Grants Policy Statement (rev. 12/03) • “Other Significant Contributors” introduced in the PHS398 (rev. 9/04) has been incorporated • The SNAP progress report instructions for the first 2 SNAP questions have been modified as follows: • SNAP Question #1 - requires submission of complete Other Support information with any change • SNAP Question #2, Reworded so level of effort question only applies to the PI and other personnel named on the Notice of Grant Award.

  44. Centralized Receipt of Non-Competing Progress Reports • Effective with non-competing progress reports due on/after October 1, 2004 • Does NOT change the mailing address used for all new and competing grants nor that process • Only for NIH progress reports • Goal of improving efficiency NIH Guide Notices, July 23 and September 2, 2004 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-054.html http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html

  45. Applications and Forms:Questions? Dedicated e-mail address for questions on format: format@mail.nih.gov Frequently asked questions on format: http://www.format.nih.gov

  46. New Grant Mechanism

  47. New High Priority, Short-term Project Award (R56) • Funding high-priority new or competing renewal R01 applications that fall just outside the funding limits of the participating NIH Institutes and Centers • One or two years of funding • INVESTIGATORS MAY NOT APPLY FOR AN R56 GRANT - Recipients of R56 awards will be selected by IC staff • Awarded beginning in Fiscal Year 2005 • Additional information is available at http://grants.nih.gov/grants/funding/r56.htm NIH Guide, June 15, 2004 http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-04-047.html

  48. Career Development Awards

  49. Mentored career awardees (K awardees) may now hold concurrent support from an NIH career award and as a PI an NIH research grant or project leader on a multi-project grant. Policy on Concurrent Support for Mentored Career Awardees NIH Guide, November 14, 2003 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html Information About Career Development Awards http://grants.nih.gov/training/careerdevelopmentawards.htm

  50. New Policy on Concurrent Support for Mentored Career Awardees • May reduce level of effort on career awards in last two years of support and replace with an NIH research grant or subproject -- awardee must remain in mentored situation • Awardee must serve as a PI or subproject Director • Effort required on career award may be reduced to no less than 50% and be replaced by effort from the research award so total level of research commitment remains at >75% for the duration of the mentored career award • Applies to K01, K07, K08, K22, K23, and K25, and individuals mentored through institutional K12 awards • Policy effective for competing research applications submitted on or after February 1, 2004

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