The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded studies that involve multiple institutions to use a single IRB to accomplish IRB review and approval for all of the institutions. The basis for the Single IRB Model is to allow multiple institutions that are conducting the same protocol to use a single IRB for review.
There are two policies that require the use of a Single IRB (NIH Single IRB Policy and Common Rule Update).
Single IRB Policies
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 current 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
The revised Common Rule, effective January 19, 2020
- Applies to: All sites in the United States participating in a federally funded cooperative research study (involves more than one site).
- 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.
What Changes on January 25, 2018
All competing NIH grant applications (new, renewal, revision or re-submission) for multi-site studies with NIH receipt dates on or after January 25, 2018 must include a plan describing the use of a sIRB for the study.
It is recommended that you contact the Northwestern IRB at least 5 weeks prior to the grant application due date to discuss options for IRB review of a multi-site study where Northwestern will either be the lead or participating site. Please complete the pre-consultation intake form. All pre-consultation requests will be scheduled within 2-3 days following receipt of the completed form. You may contact firstname.lastname@example.org for any additional questions. During the review of the information provided, the Northwestern IRB will determine if it is appropriate for us to serve as the IRB of Record or if the study should be ceded to an External IRB. If it is determined that an External IRB will serve as the IRB of Record for all sites, the Reliance Agreement Team will provide the Investigator/Research Team with the appropriate letter of support to include with the grant proposal.
Will NU act as the IRB of Record for External Sites (single IRB)
During pre-consultation, the NU IRB will evaluate on a case-by-case basis whether we are suited to serve as the sIRB for the proposed multi-site project.
The main evalation criteria are:
- The risk level of the proposed research
- The number of participating sites
- The location of the participating sites
- The number of years the study will require IRB approval
- Other considerations such as (involvement of an IND or IDE, vulnerable populations, Biosafety, COI...etc)
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 Northwestern University specific information and links to useful resources.
NU is a participating site (not the lead site)
If Northwestern will be a participating site for a study meeting the requirements of the Single IRB Policy, a request for a letter of support can be submitted to email@example.com. Request for a letter of support should be submitted at least 2 weeks prior to the external sites grant submission. The NU IRB cannot guarantee its willingness to rely on an external IRB that has been selected without prior notice.
NU is the lead site
Required by NIH
The NIH Single IRB Policy requires the following new information in grant applications for multi-site research submitted on and after January 25, 2018:
Human Subjects section
A Single IRB Plan should include the following elements:
- Name of the sIRB of record
- Indicate 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) Indicate who will maintain records of the reliance agreements
See details in Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
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.
Multi-Site Study: A multi-site study uses the same protocol to conduct non-exempt human research at more than one site.
Participating Site: In a multi-site study a participating site is a domestic entity that will rely on the sIRB to carry out the site's IRB review of human research for the study. In eIRB+ this is called a "pSite", in which a separate submission will be required for each external site relying upon the NU IRB.
sIRB: An sIRB (Single Institutional Review Board) is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study.
Relying IRB: An IRB designating an agreement to cede review to an external IRB for a particular study.