IMPORTANT: This article was updated on April 30, 2018, to reflect an update on Common Rule implementation.
On April 19, 2018, HHS released an NPRM proposing to delay the general compliance date for the revised Common Rule until January 21, 2019. A 30-day comment period will be open until May 21, 2018.
In addition to delaying the general compliance date, the NPRM proposes to allow institutions to implement three "burden-reducing provisions" of the revised rule during the delay period:
(1) use of the revised definition of "research," which deems four categories of activities not to be research;
(2) the allowance for no annual continuing review of certain categories of research; and
(3) the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research.
Read the April 2018 NPRM in the Federal Register.
Note: The revised Common Rule does NOT apply to FDA-regulated or human subjects research supported by the Department of Justice.
- What does this mean for GT researchers?
- What are new exempt categories?
- What are changes to consent forms?
- What are changes to continuing review?
For answers to these questions, read more.