Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 12, Dec., 2022

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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.

Back Issue December 2022

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Excerpt from pg. 3 … Major Changes to IRB Regs And Protecting Subjects (#2)

As we described in our lead article last month, the FDA has proposed many changes to its current human subject protection regulations that definitely will affect many IRBs.

We summarized several changes in that article and we will continue to do so in this and future articles. This should help to prepare IRBs for the numerous federal regulatory modifications that are coming in the future.

For example, one area for which FDA is now analyzing public input involves information that an IRB may, or may not, review in a human subjects’ research protocol, as follows:

FDA’s longstanding policy on preparatory activities to a clinical investigation is that some specific activities are not considered to fall within the definition of a clinical investigation, and therefore do not require IRB review or informed consent under FDA’s regulations.

For example, we generally have not considered performing a survey of patient records at a site to determine whether the site has a sufficient number of patients with the condition of interest for the clinical investigation to be feasible to require informed consent and IRB review (87 Fed.
Reg. 58739, September 28). …