April 25 update on addressing the new Human Subjects Requirements for NIH and AHRQ applications

Tuesday, April 10, 2018
By Joanna Downer, Associate Dean for Research Development, School of Medicine


As many of you already know, major changes to requirements for NIH and AHRQ applications proposing research with human subjects went into effect for deadlines January 25, 2018, and later. These reflect a change in the application "forms" set from Forms D to Forms E, and hence are referred to as "Forms E" for short.

The new requirements apply to all NIH and AHRQ mechanisms, and they are extensive -- whether you propose a clinical trial or other research with human subjects. Moreover, aligned with the new NIH and AHRQ requirements, there are now four "Clinical Trial Questions" that everyone must answer in the SPS record -- regardless of sponsor.

Building on a Duke-wide information and support blitz in November, December, and January for deadlines in early 2018, the "Forms E team" is now launching a second round of communications to be sure applicants for the May, June, and July deadlines are fully prepared. These changes are so extensive that considerable advance preparation may be required to enable on-time submission.

The presentation on Wednesday, April 25, 10-11 am in Perkins 217 is titled “Human Subjects Requirements for NIH and AHRQ Applications: Overview of Changes” and will be presented by Martha Payne, PhD, MPH, of the School of Medicine’s Office of Research Development. The talk will be livecast through WebEx (login at Join the WebEx meeting with call-in 1-650-479-3207 and meeting code 859 883 616). The recording also will be added to the ORA’s “Forms E” webpage for future reference.

Appropriate for faculty, grant administrators and research staff, the talk will include a summary of the new NIH and AHRQ requirements, how to manage this new human subjects information in the Duke systems, what information is required for routing, and additional resources and tools to help you be successful. Martha will also cover some frequently asked questions, and will leave time for audience questions.

If you or a colleague has an upcoming NIH or AHRQ application for work with human subjects, specimens, or data, the new requirements apply. Be prepared!

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