Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 36, No. 5, May, 2021

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.

Click to Subscribe

Excerpt from pg. 3 … IRBs and Diversity In Clinical Trials (#2)

“We continue this month with a topic we introduced in the March HRR; namely, how IRBs and researchers can increase the diversity of human subjects in their studies. Inadequate representation of various ages, gender, cultural background, ethnicity, and other population characteristics have long limited the applicability of many experimental study results.

A recent FDA guidance addressing this issue contains specific recommendations for IRBs and others on how to meet this challenge. The focus of this guidance is on drug studies. We now resume excerpting key segments of that guidance with the advice that researchers should:

• Consider whether exclusion criteria from phase 2 studies — which may be very restrictive and are often transferred to phase 3 protocols — can be eliminated or modified for phase 3 trials, which have a different objective than phase 2 studies, to avoid unnecessary limits on the study population (“Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs,” November, 2020, p. 5 of 19; on the Web at”