NIH has issued initial guidance on the implementation of the Revised Common Rule NOT-OD-19-050.
The effective date for the amended regulation is January 21, 2019. It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule, including those that implemented the three burden-reducing provisions during the delay period (July 19, 2018 through January 20, 2019).
Key changes that may impact NIH studies include the following:
- NIH will no longer require Institutional Review Boards (IRBs) to review entire grant applications and contract proposals related to research. The IRB must continue to review and approve the research protocol for all NIH-supported non-exempt human subjects research studies.
- NIH will require clinical trial informed consent documents to be posted on a public federal government website;
- NIH will no longer require for annual IRB reviews for certain categories of research, and
- NIH is implementing changes to exemption codes. Applicants should take note of changes to categories of research qualifying for exemption and take care to select the appropriate category (see Exempt Human Subjects Research infographic).