AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)

Notice Number: NOT-HS-20-005

Key Dates
Release Date: January 10, 2020

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Issued by
Agency for Healthcare Research and Quality (AHRQ))

Purpose

The purpose of this Notice is to provide guidance to the extramural research community for the implementation of the Use of a Single Institutional Review Board for Cooperative Research under the Revised Common Rule at 45 CFR 46.114(b).

The HHS Office of Human Research Protections (OHRP) published the Final Rule in the Federal Register on January 19, 2017 and amended the Final Rule to delay the general compliance date until January 21, 2019 (45 CFR part 46 Protection of Human Subjects).

The Final Rule, at 45 CFR 46.114 (b) (cooperative research), requires that any institution located in the United States that is engaged in cooperative research as defined under 45 CFR 46.114 (a) must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. On November 22, 2019, the OHRP has announced its determination of exception for two categories of research from the required use of a single institutional review board (IRB) (https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/114b-exception1/index.html )

The compliance date for 45 CFR 46.114 (b) (cooperative research) of the Final Rule is January 20, 2020.

For cooperative research applications and contract proposals submitted on or after January 20, 2020, the Single IRB plan should be identified and included by the applicant within the grant application or the contract proposal. The adequacy of the Single IRB plan will not factor into the peer review score or overall rating of the Protection of Human Subjects section. However, for grant applications, a note may be included in the summary statement if the Single IRB plan appears to be missing or is incomplete, and this must be addressed before an award can be made. For contracts, the Request for Proposals will include requirements about what must be provided to AHRQ regarding the Single IRB prior to the time of award and beyond.

If the applicant/offeror or awardee believes that one or more research sites should be exempt from the use of the single IRB of record, they must request an exception and provide justification in the Single IRB plan.

The proposed budget in the grant application/contract proposal should reflect all necessary Single IRB costs without an approved other exception. Applicants should not assume that an exception will be granted when considering what Single IRB costs to include in the budget.

For any post-award changes that necessitate an exception request, awardees must contact their assigned Program Official and must provide justification.

In all cases, reliance on an external IRB must be documented by a written agreement that is available for review by the HHS Office for Human Research Protections (OHRP) upon request.

For more information, please refer to the Revised Common Rule at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML, and the OHRP's guide on the single IRB requirement at https://www.hhs.gov/ohrp/regulations-and-policy/single-irb-requirement/index.html.

Inquiries

Please direct all inquiries to:

Hope Hongzhu He, JD, MPA, MA
Human Protections Administrator
Agency for Healthcare Research and Quality
Telephone: (301) 427-1905
E-mail: HopeHongzhu.He@ahrq.hhs.gov