Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 37, No. 6, June, 2022
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.
IRBs and Including Older Adults as Subjects (#2)
As we noted last month, there is a growing awareness among IRBs of the need to see more older adults listed as subjects in research protocols, especially for cancer studies (see the April HRR, p. 4).
Titled “Including Older Adults in Cancer Clinical Trials,” a relevant and newly final guidance from FDA contains major changes from the previous draft which was issued on March 6, 2020 (85 Fed. Reg. 13167), such as the need for:
“… capture of comorbidity information, clarification that this guidance applies to both small and large studies, added guidance on decentralization and recruitment efforts for community oncologists, an improved definition of adequate representation in a study trial, clarification of trial design stratification, and added references to other guidances” (87 Fed. Reg. 11718, March 2).