Revised Common Rule (Final Rule)

The Revised Common Rule was initially issued on January 19, 2017 with an intended implementation date of January 19, 2018. As you may know, the implementation was delayed twice in the last year. The final implementation and compliance date is now January 21, 2019.

The revisions are not applicable to FDA and Department of Justice regulated research. The FDA plans to post a notice of draft revised FDA regulations intended to harmonize with the revised rule. If you are involved in the conduct of FDA-regulated research, you should be aware that these changes may be directly applicable to your research in the future. We will let you know if and when those changes occur.

LIMITED IRB REVIEW FOR EXEMPTION CATEGORIES

Limited IRB Review [PDF]

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