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