MSU HRPP Manual Section 2-2-G
Revised Common Rule Single IRB Requirement
Revised Common Rule (2018 Requirements)
(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.” 45 CFR 46.114 (2018 Requirements)
Requirement
Unless an exception applies, for non-exempt cooperative research projects subject to the Revised Common Rule (2018 Requirements) and that are conducted or supported by a Federal department or agency, Institutional Review Board (IRB) review and approval by a single IRB review is required.
U.S. Health and Human Services (HHS) Exception
With respect to U.S. Health and Human Services (HHS)- conducted or supported research, the U.S. Office for Human Research Protections (OHRP) has determined that the following research is excepted from the single IRB mandate:
- Cooperative research conducted or supported by HHS agencies other than the National Institutes of Health (NIH), if an IRB approved the research before January 20, 2020, or
- Cooperative research conducted or supported by NIH if either:
- the NIH single IRB policy does not apply, and the research was initially approved by an IRB before January 20, 2020, or
- NIH excepted the research from its single IRB policy before January 20, 2020.
Revised Common Rule Exceptions
The following research is also excepted from the requirement for single IRB review:
- 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
- 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.
If a study appears to require a single IRB, documentation from a representative of the Federal department or agency supporting or conducting the research would typically need to be provided to the Michigan State University (MSU) Human Research Protection Program (HRPP) to confirm the exception from the single IRB requirement.
U.S. National Institutes of Health Single IRB Requirement
The Revised Common Rule Single IRB requirement is in addition to the U.S. NIH grant policy requirement for single IRB review. Please see HRPP Manual Section 2-2-F-iii, Use of a Single IRB (U.S. Department of Health and Human Services, National Institutes of Health) for NIH requirements.
If a study is conducted or supported by NIH, both the NIH Single IRB Policy for Multi-site Research and the Revised Common Rule Single IRB requirement for cooperative research would apply. A single IRB must be used if it was required under either the NIH Single IRB Policy for Multi-site Research or the Revised Common Rule Single IRB requirement.
Selection of the Single IRB
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.
When a cooperative research study may require a single IRB, the MSU Principal Investigator contacts the MSU HRPP to identify the single IRB. When an MSU IRB will be identified as the single IRB, the MSU HRPP must agree upon the selection of MSU as the single IRB. When MSU will be involved as a participating site, the MSU HRPP must still agree to reliance upon another institution as the single IRB. If the federal department or agency supporting or conducting the research has identified the single IRB, the MSU HRPP must still agree to the single IRB selection.
When MSU is the lead institution (e.g., primary awardee), selection of the single IRB will be dependent upon factors such as:
- Complexity of the proposed study
- Expertise
- Number and types of sites (academic, hospital, other)
- Location of research
- Risk level
- Resources
In some instances, use of an independent (commercial) IRB as the Single IRB may be required. See HRPP Manual 1-4, Reliance on External Independent (Commercial) Institutional Review Boards.
MSU does not typically enter into Institutional Authorization Agreements to serve as the Reviewing IRB when MSU is a subcontractee for a Small Business Innovation Research (SBIR) / Small Business Technology Transfer (STTR) award. See HRPP Manual 1-3, Use of Institutional Authorization Agreements.
Costs
When MSU serves as the single IRB, researchers cannot include direct costs to support the administrative tasks of supporting a single IRB in the budget.
When an independent (commercial) IRB or when another institution’s IRB serves as the single IRB, the Federal department or agency supporting the research’s requirements related to costs apply.
This policy and procedure supersedes those previously drafted.
Approved By: Senior Vice President for Research and Innovation on 1-28-2020. Revision 1 approved by Assistant VP Regulatory Affairs on 11-27-2021.