Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 7, July, 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 July 2023 issue

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Excerpt from pg. 4 … IRBs and Major Changes to Federal Regulations (#8)

This is the final installment of our coverage of one of FDA’s announcements that it is planning numerous changes to its regulations on the protection of human research subjects.

For details on the other FDA proposals that will affect many IRBs, please refer to our HRRs for the months of September, 2022, through the present issue.

The focus of this final article is on FDA’s timeframe for modifying multiple IRB regulations.

Note that the “proposal” cited below consists of nineteen pages of small print text published in three columns in the FEDERAL REGISTER.