Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 39, No. 3, March, 2024

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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.

Vol. 39, No. 3, March, 2024
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Excerpt from pg. 3 … IRBs and Limited IRB Reviews (#5)

We continue here with more IRB tips based on the SACHRP response to the OHRP guidance titled Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions” (see the FEDERAL REGISTER notice in Fed. Reg. 88, p. 39438).

We resume our coverage of the SACHRP’s recommendations regarding OHRP’s proposals regarding “broad consent” and what those items mean for IRBs. More specifically, SACHRP addresses aspects of situations where IRB members may disagree with each other.

The limited IRB reviewer description should address both the role of the reviewer in limited IRB review and the scope of the limited IRB review when/if either:
the reviewer does not agree with the previous broad consent determination or
believes that the approved broad consent form does not meet the relevant requirements“…