Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 5, May, 2023

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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.

HRR May 2023

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Excerpt from pg. 3 … IRBs and Research With Children (#6)

We continue this month with more highlights from the FDA’s draft guidance titled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

We resume by presenting the brief caveat and remaining IRB tips contained in the guidance’s section titled “A. Principle of Scientific Necessity.”

The principle of scientific necessity is encompassed in two regulatory requirements: the equitable selection of subjects (21 CFR 56.111(a)(3)) and minimization of risk (21 CFR 56.111(a)(1)). …

Regarding the equitable selection of subjects, IRBs should consider the purposes of the research and the setting where the research will be conducted and should be aware of the unique challenges of research involving children. ...”