Reminder: New human subjects requirements for applications to NIH & AHRQ

Wednesday, September 26, 2018
By Joanna Downer, PhD, Associate Dean of Research Development, Duke 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.

If you have an NIH or AHRQ application that includes work with human subjects, keep in mind that these changes are so extensive that considerable advance preparation may be required to enable on-time submission.

Resources to help ensure compliance with these new requirements include templates and videos of past presentations available on the Duke Office of Research Administration website. The videos of past presentations on the ORA website 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. The ORA website also links to key NIH resources.


If you still have questions, there are also human resources available. General questions can go to the Duke Office of Research Initiatives; questions about human subjects in complex research grants can go to Martha Payne or Joanna Downer in the School of Medicine Office of Research Development. These “Forms E” resources are available to all of Duke.


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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