NIH Implementation of the Burden-Reducing Provisions of the 2018 Common Rule

Notice Number: NOT-OD-18-211

Key Dates
Release Date: July 18, 2018

Related Announcements
None

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this notice is to provide guidance to the extramural research community regarding the implementation of the three burden-reducing provisions in the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule).  The HHS Office of Human Research Protections (OHRP) issued a Final Rule delaying implementation of the Common Rule until January 21, 2019. While general compliance is delayed, the Rule provides recipients with the option to implement three burden-reducing provisions during the delay period (July 19, 2018 through January 21, 2019).

These burden-reducing provisions include (1) the 2018 Requirements’ definition of ‘‘research,’’ which deems certain activities not to be research, (2) removal of the requirement for annual reviews for certain categories of research, and (3) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications related to the research.

Studies that choose to implement the burden-reducing provisions during the delay period must, beginning January 21, 2019, comply with all of the 2018 Common Rule requirements for the remainder of the study. An institution’s decision about whether to transition a study to the 2018 Requirements to take advantage of the three burden-reducing provisions might vary depending on the nature and progress of the study, including any elements of the study to be conducted on or after January 21, 2019. ¬†Additional details, including requirements and processes for adopting the new provisions, can be found in the Final Rule (83 FR 28497).

For recipients that implement the burden reduction provisions, IRB review of grant applications or other funding proposals and annual reviews for certain categories of research will no longer be required.  However, certification of IRB review will still be required for all NIH-supported non-exempt human subjects research studies, and recipients must still provide certification to NIH that the research protocol has been reviewed and approved by the IRB.

Inquiries

Please direct all inquiries to:

Office of Policy for Extramural Research Administration
Telephone: 301-435-0949
Email: grantspolicy@mail.nih.gov