National Institutes of Health (NIH) Single IRB (sIRB) Requirement Guidance
The purpose of this guidance is to assist investigators and departmental administrators with the implementation of federal single Institutional Review Board (IRB) requirements.
As of January 25, 2018, the NIH will require multi-site, non-exempt human subjects research to use a single Institutional Review Board (sIRB) to oversee the research project, with some exceptions. This policy aims to streamline the IRB review process.
The NIH policy applies to:
- The domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.
- All competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after the policy effective date of January 25, 2018.
- All solicitations for contracts issued on or after the policy effective date of January 25, 2018.
This policy does not apply to career development, research training or fellowship awards. Further, ongoing, non-competing awards will not be expected to follow the policy until the grantee submits a competing renewal application after the policy is in effect.
Until recently, the costs of IRB review were viewed by federal funding agencies to be part of the indirect costs (aka F&A, Facilities & Administrative, costs) institutions receive in support of extramural activities. The NIH Single IRB Policy now permits institutions to charge for some components of IRB review when the institution either acts as the Reviewing IRB for the study or contracts with an independent IRB (aka commercial IRB) to serve as the Reviewing IRB.
Researchers are expected to include the following as part of the funding application for studies that fall under the NIH single IRB review policy:
- a plan describing the use of a single IRB that will be selected to serve as the IRB of record for all study sites
- a statement confirming that participating sites will adhere to the sIRB Policy
- identification of the single IRB that will oversee the study
- a description of how communications between sites and the Reviewing IRB will be handled
- when appropriate, costs for single IRB review
According to NIH, the Agency’s acceptance of the submitted single IRB plan will be incorporated as a term and condition in the Notice of Award or in the Contract Award.
Process for sIRB at UW-Madison:
- As part of grant or contract preparation, investigators should contact the relevant UW IRB Office to help identify an appropriate IRB to oversee the study.
- An appropriate Reviewing IRB could be a UW IRB, another institution’s IRB, or an independent IRB.
- The UW IRB office will need to provide the study team with documentation supporting the proposed IRB before the grant or contract proposal can be forwarded to NIH and often can provide a letter of support for the researcher’s application.
- Investigators should also discuss with the UW IRB Office whether they need to budget for IRB review costs in their funding proposal regardless of whether a UW IRB is being proposed to serve as the Single IRB for the study.
- If an independent IRB will be used, the study team will need to work with that IRB to determine what fee schedule will apply and how to estimate the budget for that IRB’s review.
Frequently Asked Questions:
- What is a single IRB (sIRB)?
Single IRB review means that a single IRB of record (aka Reviewing IRB) conducts the ethical review for sites participating in a multi-site study. To use a single IRB, institutions must enter into formal arrangements called reliance agreements to document which institution will serve as the Reviewing IRB and which will cede IRB review to that institution.
- What about the revisions to the Common Rule and other federally funded studies?
Revisions to the Common Rule, which is the primary regulation governing most federally supported research, are pending and include a requirement for single IRB review for non-exempt “cooperative research projects” that involve human subjects. The Common Rule defines cooperative research projects as those “that involve more than one institution”. The reviewing IRB could 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.
Note that the Common Rule expectation is broader than that of the NIH policy in that the former does not distinguish between studies wherein all sites are conducting the same study and the latter suggests single IRB review is required even if the activities at each site vary. Like the NIH policy, the Common Rule requirement applies only to domestic sites and for research conducted within the United States.
The Common Rule includes exceptions to the single IRB requirement, which are:
- 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.
- What does this mean for study teams?
Requirements to use a single IRB to oversee a research study usually require research teams to assume additional responsibilities, especially in the case of an Overall Principal Investigators (PIs) or when serving as Lead Study Team for a project. Overall PIs or Lead Study Teams, for example, generally assume a central role in providing information to the Reviewing IRB from investigators at institutions relying on the Reviewing IRB (i.e., relying site study teams) as well as ensuring the relying site study teams with the most current versions of IRB-approved documents and IRB determinations (e.g., approval notices for initial reviews, continuing reviews, and amendments). These additional responsibilities may require additional personnel and systems (e.g., online platforms) to manage communication between sites. When investigators are putting together budgets for a research study, they should consider whether to propose funding for a coordinating center (to help manage communication), regulatory support (e.g., to prepare the multi-site IRB application), and document management (e.g., to distribute IRB determinations and IRB-approved documents).
- What does the same protocol mean?
A Frequently Asked Questions (FAQs) document issued by NIH defines the phrase “same research protocol” as “protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes”. Additionally, the FAQs clarify that sites accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.”