Single IRB Review
sIRB for Federally-Funded Research
Effective January 20, 2020, reliance on a single IRB (sIRB) is required for non-exempt cooperative research projects that:
- involve more than one institution conducted in the United States; and are
- funded or supported by a federal agency that has adopted the Common Rule regulations.
Reliance on a single IRB (sIRB) is not required when:
- more than single IRB review is required by law (including tribal law); or
- the Federal agency supporting the research determines and documents that use of a single IRB is not appropriate for the particular context.
Currently, minimal federal guidance is available regarding specific implementation expectations and procedures. Funding agencies may adopt sIRB-related processes currently in use by NIH. As guidance becomes available, ETSU will publish updated resources to inform the campus community. To facilitate compliance beginning on the January 20, 2020 effective date, please refer to the following steps:
Prior to Funding Proposal Submission (approx. 60 days before submission deadline):
Step 1: Work with collaborators across all sites to identify the IRB that will serve as the sIRB. Contact the chosen IRB office to verify they are willing to assume responsibility as sIRB.
IMPORTANT: East Tennessee State University IRB will not serve as sIRB for multi-site, clinical trials subject to the sIRB mandate. When ETSU is the lead site on a funding proposal or award, the principal investigator may: A. Identify a qualified IRB at a collaborating site that is willing to serve as sIRB; or B. sIRB responsibilities may be handled by an independent IRB. Costs associated with independent IRB review are the responsibility of the PI and may be included in the funding proposal budget.
Step 2: Work with the selected sIRB to obtain information about any review fees for inclusion in the grant budget.
Step 3: Ascertain the willingness of all participating sites to rely on the sIRB. To obtain a letter of support from the ETSU IRB, email the following information to IRB@etsu.edu:
- ETSU PI Name
- Whether ETSU is the lead/prime or a participating site
- Name of the lead PI and lead site
- Name of the proposed sIRB
- Title of the grant proposal/application
- Grant submission deadline (or deadline for providing information to the lead site)
- Name(s) of the participating sites and Site PIs, if known
- Any additional relevant information (such as any prior contact with the sIRB, sIRB contact person information, etc.)
- A brief description of your project.
Step 4: Develop a communication plan outlining the following:
- roles and responsibilities associated with IRB review
- processes for communication and notifications between researchers at collaborating sites and the sIRB
- reporting policies among participating sites and sIRB
- which institution is responsible for any associated clinical trial posting requirements
- which institution is responsible for NIH Genomic Data Sharing Policy, if applicable
Note: Some funding agencies may require submission of a communication plan with the proposal.
Upon Notification of an Award
If ETSU has agreed to serve as the sIRB, submit a New Protocol Submission xform in IRBManager as usual. The xform is conditioned to ask about other sites and allows you to upload pertinent supporting documents. Be prepared to submit local context information and a site-specific informed consent document for each participating site.
NOTE: The IRBs at each collaborating site will need to establish a reliance agreement (also called an IRB Authorization Agreement (IAA) with the sIRB. Reliance agreements are reviewed and signed by institutional officials at each participating site and at the site of the sIRB. Investigators DO NOT have the authority to sign reliance agreements on behalf of ETSU.
If requesting to rely on an external sIRB:
Step 1: Send a formal request for ETSU to rely on an external IRB by completing a Request to Rely xForm in IRBManager. The xForm is conditioned to ask questions only pertinent to the reliance arrangements when you indicate that researchers at other institutions will be involved and you wish for the ETSU IRB to rely on another institution’s IRB for oversight.
Step 2: Obtain sIRB approval following their established processes.
NOTE: Local Context Information: The sIRB may require local context information specific to ETSU, such as contact information for the ETSU IRB, ETSU required informed consent language, ETSU-specific policies such as child-abuse reporting, etc. To obtain this information, please email IRB@etsu.edu.
Step 3: Communicate the outcome of initial and subsequent sIRB review with the ETSU IRB office via electronic submission forms in IRBManager, as appropriate. ETSU maintains a shadow file of all external IRB submissions, so all materials reviewed by the sIRB should be provided to ETSU for our records.
Step 4: Conduct the study in a manner that ensures compliance with the sIRB approved protocol and all policies and procedures of the sIRB as well as applicable ETSU policy.
NOTE: sIRB review addresses only one aspect of responsible research. The ETSU PI is also responsible for ensuring compliance with all applicable federal, state, and local regulations and laws as well as with ETSU institutional requirements and policies related to research. See the Office of the Vice President for Research website for guidance regarding a variety of aspects of responsible research.
- sIRB Guidance
- Reliance Request Guidance
- ETSU Reliance Examples
- ETSU IRB Policy 21 External Reliance
- Relying Site Survey
- Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- Single IRB Policy for Multi-Site Research (NIH)
- Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
- AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114(b)