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Important Federal Updates
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  1. Yale University Important Federal Updates Sara Rockwell Associate Dean for Scientific Affairs Professor of Therapeutic Radiology and Pharmacology Yale School of Medicine Penny Cook Director, Strategic Research Initiatives Office of Research Compliance and Education/Research Administration Alison Bonds Grant and Contract Manager Office of Grant and Contract Administration

  2. Today’s Agenda • Learn about important changes in sponsored projects administration • Changes in the NIH Peer Review System • Changes in the NIH Application process • Reminders of additional modifications to policies • New requirements for NSF awards

  3. January 25, 2010 Submissions May/June 2009 Reviews Enhancing Peer Review: Overview & Timeline • A2 applications phased out • Identification of Early Stage Investigator (ESI) R01 applications • Enhanced review criteria • New scoring system • Criterion scoring • Structure critiques • Clustering of new investigator applications • Restructuring Applications • Shorter Page Limits • New Instructions From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  4. Goals of Restructured Applications • To focus the applicants and reviewers on the same elements • To help ensure a more efficient and transparent review process • Reduce burden • Focus on the essentials of science • Avoid information overload From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  5. Overview of the Application Changes • Application forms will be revised in three sections • Research Plan • Biographical Sketches • Resources and Facilities • Revisions will apply to all competing applications: new, renewal, and resubmissions • HANDOUT: NOT-OD-09-149: Restructured Application Forms and Instructions for Submission for FY 2011 Funding From Dr. Alan Willard’s Video presentation (NIH – November 2009

  6. Major Changes to the Research Plan • Specific aims will request new language relative to the impact of the proposed research • Research Strategy will be created as a new section and will include 3 of the current sections • Background and Significance • Preliminary Studies/Progress Report • Research Design and Methods From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  7. New Research Plan Components • Introduction – 1 pg (except R25, K12, Ts and Ds) • Specific Aims – 1 pg • Research Strategy – 6pp to 12 pp (check FOA) • A. Significance • B. Innovation • C. Approach • Human Subjects Sections • Protections, women/minorities, enrollment, children • Other research plan sections • Animals, select agents, multi PI/PD, consortiums • Resource sharing plan • Appendix From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  8. Changes to Biographical Sketch • The Biosketch of each investigator must be specific to a given application – Handout: Form and Sample • Personal Statement has been added • “Briefly describe why your experience and qualification make you particularly well-suited for your role in the project • Publication requirements have been revised • Limit list of publications/manuscripts to no more than 15 • Applicant is encouraged to make selections based on recency, importance to the field, and or relevance to the application From Dr. Alan Willard’s Video presentation (NIH – November 2009

  9. Changes to Resources and Facilities • Instructions added to resources: • “Provide a description of how the scientific environment will contribute to the probability of success of the project” • “For Early Stage Investigators (ESIs), describe the institutional investment in the success of the investigator” • NOT-OD-09-149: Restructured Application Forms and Instructions for Submissions for FY 1011 funding From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  10. Application Alignment with Review Criteria: Major Examples Significance Investigator(s) Innovation Approach Environment Research Strategy a. Significance Biosketch Research Strategy b. Innovation Research Strategy c. Approach Resources Criteria Application From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  11. Shorter Page Limits • Introduction will normally be 1 page • Exceptions include introduction to resubmission for training grants (Ts), K12s and R25s (3pp) • Specific Aims will normally be 1 page • Research Strategy will be limited to 6 or 12 pages for most NIH grant types • Candidate Info & Strategy will normally be 12 pages for K awards (except K12s) • Research Training Program Plan will normally be 25 pages including Training grants, K12s, and R25s • Check instructions related to specific FOA • Handout – Table of Page Limits From Dr. Alan Willard’s Video presentation (NIH – November 2009

  12. Steps to Success • Know what is changing • Begin thinking about your Research Strategy now • Create a new Biosketch using the new format • Make sure that you download the correct application package and instructions now that they have become available (Dec 09) • Applications submitted using incorrect forms will be delayed and may not be reviewed From Dr. Alan Willard’s Video presentation (NIH – November 2009

  13. Steps to Success • Use new forms for applications due on or after January 25, 2010 • Applicants MUST return to the reissued parent Announcements or updated Funding Opportunity Announcements (FOAs) & download new forms and instructions • Choose the correct Electronic or Paper Forms • SF424 (R&R) ADOBE_FORMS_B • PHS 398 Revision date “June 2009”) • Read the instructions carefully From Dr. Alan Willard’s Video presentation (NIH – November 2009

  14. For additional information on changes to the NIH Peer Review System • Read more about upcoming changes • Policy announcements • NOT-OD-09-149: Restructured Forms and Instructions for Submissions for FY 2011 Funding • NOT-OD-10-002: Clarification on Timing and Page Limits for Restructured Application Forms and Instructions that are required for due dates on or after January 25, 2010 • Details of Application Changes • Training & Communications Resources • http://enhancing-peer-review.nih.gov From Dr. Alan Willard’s Video presentation (NIH – November 2009)

  15. Reminders about Additional NIH Changes • Changes to NRSA and K Awards • Institutional Training and Institution Career development Programs will transition to electronic submission through Grants.gov using the SFA424 (R&R) forms for due dates on or after 1/25/2010 • Supplemental instructions for K12 applications will be included in the individual FOAs

  16. Reminders About Additional NIH Changes • Individual Fellowship Progress Reports for continuation of support must now identify any changes in the use of human embryonic stem cells • Form Page 2 has been revised is now required (as of 1/1/10)

  17. Reminders About Additional NIH Changes • Clinical Trials.Gov • Trials initiated after 9/27/07 must be registered no later than 21 days after the first patient is enrolled or by 12/26/07 whichever is later

  18. Additional NIH Changes • New Salary Cap– NOT-OD-10-041 • Every year since 1990 Congress has legislatively mandated a provision limiting the direct salary that an individual may receive under an NIH grant.  For FY 2010, Public Law 111-117: Consolidated Appropriations Act, 2010 restricts the amount of direct salary to Executive Level I of the Federal Executive Pay scale. The Executive Level I annual salary rate was $196,700 for the period 1/1/09 to 12/31/09. Effective January 1, 2010, the Executive Level I salary level increased to $199,700. • Five Day Error Correction Window – NOT-OD-10-042 – January 25, 2010 – May 7, 2010 • Grants with a 5:00pm grants.gov timestamp on the deadline date will receive a five-day window for error correction. Proof of on-time submission and description of all changes made within the window must be documented in the Cover Letter.

  19. For Faculty Providing Peer Review Service • Revises the continuous process for submission and review of applications – See NOT-OD-09-155 • To individuals who have participated in peer review as regular or temporary members 6 times in 18 months • For the inaugural eligibility period ending 4/30/09 individuals so identified will be able to participate in this opportunity from 10/1/09 – 9/30/10 • The eligibility list will be revised annually, for an eligibility period from October 1 of one year through September 30 of the following year

  20. NSF Training Certification • Effective January 4, 2010, all institutions submitting proposals to the NSF must certify that they have a training plan in place in the responsible conduct of research for undergraduate and graduate students and postdoctoral scholars who will be supported by NSF. • This certification must be in place at the time of proposal submission. Training plans need not be submitted with the proposal, however, they must be provided for review upon request. • The Provost’s Office is working with departmental faculty to assure that Yale can meet the certification requirements. • Further announcements regarding availability of specific training opportunities will be announced in early January.

  21. NSF Grants.gov Application Guide • Effective December 1, 2009 • Significant changes include: • Next Steps – Post Submission to Grants.gov • Reflects availability of Research.gov to track status of grant applications to NSF • NSF Cover Page • Includes the Grants for Rapid Response Research RAPID) and EArly-concept Grants for Exploratory Research (EAGER) mechanisms • Application Checklist • No longer required to be submitted with each application • Converted to a checklist for used for administrative review, prior to submission