Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 1, Jan., 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.

January 2023 Issue Cover

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Excerpt from pg. 3 … IRBs and Major Changes to Federal Regulations (#3)

We continue this month with more of the many changes that FDA has proposed for its regulations on protecting human research subjects.

A large number of those proposed changes are to achieve “harmonization” with the requirements of the Common Rule on informed consent, IRB reviews, data confidentiality, etc.

However, FDA is also proposing not to make some changes, as can be seen in the following excerpt.

We note that the revised Common Rule also retains an exception to the requirement for documentation of informed consent at 45 CFR 46.117(c)(1)(i) for situations in which the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality