Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 6, June, 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 June 2023

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Excerpt from pg. 4 … IRBs and Research With Children (#7)

We continue this month with more highlights from the FDA’s draft guidance titled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.”

Note that this is the same set of FDA recommendations discussed in the lead article of this HRR, wherein the SACHRP responds to said explanations with its own recommended changes and updates for IRBs.

We resume with:
Given that investigational drugs generally are considered to have the potential to cause harm, the use of an investigational drug in a clinical investigation that includes children is unlikely to be considered minimal risk under 21 CFR part 50, subpart D.

Investigational devices, however, can vary significantly in design and intended uses (e.g., monitoring, diagnostic, or therapeutic devices). …