Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 39, No. 9, September, 2024
Back Issues
Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt below. Click the image below for the first two pages of this issue.
Excerpt from pg. 3 … IRBs and Improving Subject Enrollment (#2)
As we presented in last month’s HRR, appropriate enrollment of human subjects requires careful IRB analysis during IRB reviews.
A new FDA guidance addressing ethical subject enrollment topics is titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.”
Before we continue with our usual highlights summary of this guidance, note that FDA is accepting public comments on its contents until September 26.
More information about this comment process, and on the guidance itself, is available from: Lola Fashoyin-Aje of FDA’s Oncology Center of Excellence at 240-402-0205; or Tamy Kim of CDER at 301-796-1125; or James Myers of CBER at 240-402-7911; or Josh Chetta of CDRH at 240-402-4910.
In general, this guidance applies to many types of clinical studies involving drugs, biologics, and medical devices.
However, also in general, FDA does not require such a plan for “small studies conducted during the exploratory clinical stage”…