Human Research Report Digital Newsletter
Protecting Research Subjects and Researchers
Vol. 38, No. 1, Jan., 2023
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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”…