Major changes to NIH and AHRQ grant submissions with human subjects research

Training sessions for research administrators

December 1, 2017

NIH is implementing significant changes to the application process for all research with human subjects and broadening the definition of what is considered a clinical trial. These changes will apply to all NIH and AHRQ submissions (both grants and contracts) with due dates on or after January 25, 2018 (the official release date for Forms E support in Grants.Duke and SPS Proposals will be Monday, December 11, 2017). To meet these new requirements, faculty will need to allow ample time for planning and preparing their applications to ensure successful submission.

The required changes are part of NIH’s efforts to avoid duplication, exercise proper stewardship of public funding, and promote broad, transparent, timely and responsible dissemination of information from NIH-funded studies. Changes to the application process will ease identification of proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria. To assist faculty investigators and the research administrator community, tools and training are being provided to help:

  • develop and collect information that will be required for applications for research with human biospecimens or with human subjects, including for clinical trials,
  • understand that all funding opportunity announcements are being re-issued and what that means for applications,
  • determine whether the work proposed is considered a clinical trial under NIH’s expanded definition,
  • guide faculty and staff through the new data and attachments required for the application, and the entry and attachment of these new items in SPS Web and Grants.Duke.

We offered information sessions for faculty this fall to make them aware of these changes.  Beginning in December, we will offer training sessions for research administrators and clinical research staff working with faculty on grant preparation.  Please plan to attend one of the following sessions:

Date

Time

 Location

Dec 6    

1:00-3:00    

 Trent Semans Great Hall

Dec 8

1:00-3:00

 Trent Semans Great Hall

Dec 11

9:30-11:30

   Perkins Library 217 (geared to Campus Administrators)

Dec 12    

9:30-11:30    

   Trent Semans Great Hall

 

More information is available on the NIH website (in NOT-OD-17-062), and in this recent communication to NIH applicants. Applicants are being reminded (via NOT-OD-17-105) that proposals must be complete and compliant with NIH policies and instructions at the time of submission, so every effort is being made to prepare our research community for these major changes.

If you have questions, please email researchinitiatives@duke.edu