Notice Number: NOT-HS-18-014

Key Dates
Release Date: August 2, 2018

Issued by
Agency for Healthcare Research and Quality (AHRQ)

Purpose

The purpose of this notice is to provide guidance to the Agency for Healthcare Research and Quality (AHRQ) 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 U.S. Department of Health and Human Services Office of Human Research Protections (OHRP) issued a Final Rule delaying implementation of the Common Rule until January 21, 2019. The Rule provides recipients with the option to implement three burden-reducing provisions during the delay period (July 19, 2018, through January 20, 2019).

The three provisions include the definition of research , which deems certain activities not to be research; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) to review grant applications or other funding proposals related to the research.

Studies taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Common Rule requirements during the delay period. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Common Rule requirements for the balance of the study's duration.

For AHRQ 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 AHRQ-supported non-exempt human subjects research studies, and recipients must still provide certification to AHRQ that the research protocol has been reviewed and approved by the IRB.

Additional details, including requirements and processes for adopting the new provisions, can be found in the Final Rule (83 FR 28497 at https://www.federalregister.gov/documents/2018/06/19/2018-13187/federal-policy-for-the-protection-of-human-subjects-six-month-delay-of-the-general-compliance-date).

Inquiries

Please direct all inquiries to:

Hope Hongzhu He, JD, MPA, MA
Human Protections Administrator (HPA)
Agency for Healthcare Research and Quality (AHRQ)/ HHS
Office of Extramural Research, Education, and Priority Populations (OEREP)
Email: [email protected]