If your proposed research involves federal funding, human subjects, and multiple research locations, please fill out our Pre-Consultation Intake Form prior to submitting your grant. You may contact firstname.lastname@example.org for any additional questions.
Single IRB Policies and Background
The single IRB (sIRB) mandate is a set of complementary federal policies that require certain types of federally-funded research that involve multiple institutions to use one IRB to accomplish IRB review and approval for all of the institutions conducting the study/trial. The Single IRB Model allows multiple institutions that conduct the same protocol to cede to a single IRB for review.
Effective 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.
- 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.
Effective January 20, 2020: Projects sponsored by signatories of the revised Common Rule, involving multiple research locations conducting human subjects research, with IRB approval dates on or after January 20, 2020, must use a sIRB. This is mandated by the Cooperative Research provision which expands upon and supersedes the NIH’s Single IRB policy.
- 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.
For more information please see our Single IRB Guidance Document for more information.
The Pre-Consultation Process
Northwestern investigators who plan to submit proposals for federal funding opportunities that involve human research performed at more than one site, or who plan to be a sub-contracted site on a proposal submitted by an investigator outside of Northwestern, must undergo Single IRB Pre-Consultation.
The pre-consultation process was developed to engage with the research community during proposal time to ensure relevant information in alignment with Single IRB requirements are included in the final submission. Single IRB Pre-Consultation is required when either requesting the Northwestern University IRB serve as the IRB of Record, or cede IRB review to an external IRB.
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 or collaborative study where Northwestern will either be the lead or a participating site. To initiate the process please complete the pre-consultation intake form. Upon receipt of the completed form, the review process for all pre-consultation requests will begin within 2-3 days. The Northwestern IRB will evaluate on a case-by-case basis whether we are suited to serve as the Single IRB for the proposed multi-site or collaborative project. The main evaluation 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 review
- Other considerations such as (involvement of an IND or IDE, vulnerable populations, biosafety, COI…etc.)
During the review of the information provided, the Northwestern IRB Office will provide one of the following:
- Documentation that Single IRB requirement does not apply
- Letter of Support indicating our willingness to cede IRB review
- If the Northwestern University IRB Office determines it is not a good candidate to serve as the IRB of Record for a proposal we will assist the investigator with identifying a willing IRB in the following order: External IRB at one of the proposed participating sites, Trial Innovation Network IRBs, or a preferred commercial IRB partner
- Letter of Support indicating our willingness to serve as the IRB of Record
- The PI will also be provided with an invoice for the fees associated with the review of the external site(s)
Failure to go through Single IRB Pre-Consultation before federal grant submission time may result in:
- Delay in OSR proposal review and submission to the federal funding agency,
- Delay in IRB review if subsequently funded, and
- In situations where the proposal states Northwestern will serve as the IRB of Record, the investigator is responsible for locating funds for IRB review and the Northwestern IRB may not be able to serve as the IRB for the proposed research.
Single IRB Fees
Effective September 1, 2019, sIRB studies where Northwestern is the IRB of Record for external site(s) are subject to review fees.
If you submit a pre-consultation request for the Northwestern IRB to serve as the Single IRB, and your project is a fit with the institutional evaluation criteria, the IRB will issue you an invoice with the fees associated with your study. The IRB fees take into account the number of sites, number of IRB submissions, the complexity of the research (minimal risk vs. greater than minimal risk), and the number of years the study will require IRB review.
Grant applications subject to the revised Common Rule should include a sIRB Plan with the following elements:
- Name of the sIRB of Record
- sIRB capabilities
- Relying IRB capabilities
- Communication plan
- 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; and (3) designate who will maintain records of the reliance agreements
NIH Grant Resources
The NIH Single IRB Policy requires sIRB plan information in grant applications for multi-site research submitted on and after January 25, 2018. For general information see Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and for specific details see Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
For budgeting of sIRB fees, see Section F “Other Direct Costs” of the PHS G.300 – R&R Budget Form. For information on charging direct and indirect costs for single IRB activities, see the Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-Site Research. Per NIH guidance, if you intend to request an exception to the sIRB policy based on compelling justification, do not account for this exception in your proposed budget. The proposed budget must reflect all necessary sIRB costs without an exception (i.e. applicants should not assume that an exception will be granted when considering what sIRB costs to include in the budget). See the NIH FAQs on Costs of the NIH Policy on the Use of a Single IRB for Multi-Site Research for more information.