Single IRB Policies
In 2018 NIH policy and in 2020 HHS federal regulations require certain types of federally-funded research projects involving multisite research using the same research protocol to use a sIRB model to accomplish IRB review for all participating institutions. See below for more detail on the policies and note the effective dates
The NIH Policy, effective January 25, 2018
- Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program. It does not apply to Foreign Sites, career development (K), research training (T) or fellowship awards (F) and noncompeting continuation awards.
- Exceptions: VA sites; international sites; sites involving tribal nations.
Please see the NIH FAQ's on the Single IRB Policy for Multi-Site Research
- Applies to: All sites in the United States participating in a federally funded multi-site research study following the Common Rule requirements.
- Exceptions: 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 of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.
NIH Grant Proposal Submissions
See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide. The information presented below is from this resource, but also includes University of Michigan specific information and links to useful resources.
U-M is a participating site (not the lead site)
If U-M will be a participating site for a study meeting the requirements of the sIRB Policy, requests for a letter of support to cede IRBMED oversight to an external IRB should be submitted to email@example.com at least 3 weeks prior to the external site’s grant submission due date. The IRBMED cannot guarantee its willingness to rely on an external IRB without sufficient prior notice to evaluate the request.
U-M is the lead site and IRBMED will serve as sIRB
Required by NIH
The NIH sIRB Policy requires the following new information in grant applications for multi-site research submitted after January 25, 2018:
Human Subjects section
A sIRB Plan including the following elements (this sIRB Plan is provided by IRBMED when IRBMED has agreed to be the sIRB):
- IRBMED named as the sIRB of record
- Indication that: (1) All sites, including any added after award, agree to rely on the sIRB; (2) Sites will sign a reliance agreement that will include a communication plan; (3) IRBMED will maintain records of the reliance agreements
Budget and Budget Justification
Any IRB fees that will be charged as direct costs, and any personnel costs directly related to managing the IRB arrangements. See the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information.
- IRBMED is developing fees that will be announced for inclusion in future grant submissions (anticipated release later in 2019)