The Revised Common Rule's Cooperative Research Provision (45 CFR 46.114)
Background
The revised Common Rule (i.e., the 2018 Requirements) requires at 45 CFR 46.114(b) that all institutions located in the United States that are engaged in cooperative research conducted or supported by a Common Rule department or agency rely upon approval by a single IRB for the portion of the research that is conducted in the United States.
45 CFR 46.114 states:
(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
(b)(1) Any institution located in the United States that is engaged in cooperative research 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.
(2) The following research is not subject to this provision:
(i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or
(ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context.
(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
The compliance date of 45 CFR 46.114(b) of the 2018 Requirements is January 20, 2020. For studies subject to the 2018 Requirements:
- Reliance on a single IRB of record in cooperative research is optional before January 20, 2020, even for research subject to the 2018 Requirements.
- Reliance on a single IRB of record in cooperative research is required beginning January 20, 2020, unless the study meets the criteria for an exception described in §46.114(b)(2) of the 2018 Requirements.
The requirement for the use of a single IRB in cooperative research only applies to US institutions and the portion of the collaborative research conducted within the US.
For research activities subject to the 2018 Requirements: While §46.114(b) of the 2018 Requirements has a delayed compliance date, other 2018 Requirements that are integrated with the cooperative research provision are not delayed. If an institution is conducting cooperative research subject to the 2018 Requirements and voluntarily relies on a single IRB from January 21, 2019 through January 19, 2020, that institution must document its reliance on that IRB for oversight of research. It must also document the responsibilities that each entity will undertake to ensure compliance with the requirements of the Common Rule (see §§46.103(e), 46.115(a)(9) of the 2018 Requirements).
Ongoing studies subject to the pre-2018 Requirements (i.e., where the study has not been transitioned to comply with the 2018 Requirements) are not required to use a single IRB in cooperative research on and after January 20, 2020.
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Exception Determinations
In November 2019, OHRP issued an exception determination (as permitted by 45 CFR 46.114(b)(2)(ii)) stating that certain categories of cooperative research supported or conducted by HHS and subject to the 2018 Requirements are not required to comply with the revised Common Rule's single IRB mandate.
Read the full text of the November 2019 HHS Exception determination
The transition provision of the 2018 Requirements (i.e., 45 CFR 46.101(l)) states that all research subject to the 2018 Requirements must comply with the requirement that federally supported or conducted cooperative research rely on the approval of a single IRB for the portion of the research conducted in the United States, unless excepted from this requirement (per 45 CFR 46.114(b)). The compliance date of this requirement is January 20, 2020 (45 CFR 46.101(l)(2)).
Based on feedback from the regulated community, OHRP determined that for HHS cooperative research subject to the 2018 Requirements, and for purposes of 45 CFR 46.114(b)(2)(ii), the following cooperative research studies may continue to be reviewed by multiple IRBs, in lieu of a single IRB:
(1) Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB initially approved the research before January 20, 2020.
(2) Cooperative research conducted or supported by NIH if either:
(a) the NIH Single IRB Policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
(b) NIH excepted the research from its Single IRB Policy before January 20, 2020.
Note that this determination is only made for purposes of section 46.114(b)(2)(ii) – namely, for determining whether certain cooperative research may be excepted from the single IRB mandate. This determination does not prevent, nor should it be viewed as discouraging, the voluntary use of a single IRB in cooperative research subject to the 2018 Requirements that would fall within the above two categories. Further, note that category (2)(b), above, applies for the duration of NIH’s exception from its policy for the particular research study; categories (1) and (2)(a) apply for theduration of the research.
This exception determination only applies to HHS supported or conducted research protocols. Also note that the exception applies to any portion of a cooperative research protocol. In other words, this determination is protocol specific not site specific.
Access the November 22, 2019 Determination of Exception Federal Register Notice (PDF)
This exception determination only applies to HHS supported or conducted research protocols. Also note that the exception applies to any portion of a cooperative research protocol. In other words, this determination is protocol specific not site specific.
Additional Resources
- Read the official regulatory text for the 2018 Requirements
- Read about the history of the revised Common Rule rulemaking process
- Watch videos summarizing the changes in the revised Common Rule
- Read Q&As about the revised Common Rule
- See the list of guidance (draft and final) that have been issued on the revised Common Rule
- Review revised Common Rule terms
Content last reviewed on August 1, 2019
