Brief overview
The University of Missouri engages in agreements in which an IRB relies on the review of one IRB known as a Single IRB (sIRB) in multisite research studies. These agreements may be altered and vary in scope and terms. They are designed to reduce duplication of IRB review efforts and increase efficiency by designating a sIRB.
Multiple sites relying on a single IRB (sIRB)
Effective January 20, 2020, the sIRB review requirement for all multisite research projects sponsored by one of the federal common rule agencies went into effect. The requirement hopes to streamline the IRB review process and avoid duplicate review by an IRB at each site. National Institutes of Health (NIH) also requires the review of a sIRB. This common rule requirement applies to expedited and full board research, as well as exempt studies that require limited IRB review. The NIH policy is the same except it does not apply to exempt research.
There are three exceptions to this requirement. Those include: (1) International site(s) participation; (2) Individual IRB review is required by law (e.g., American Indian or Alaskan Native tribal law]; and (3) A federal agency determines and documents the sIRB model is not appropriate.
It is important to engage the MU IRB early in these cases so the study doesn’t encounter any unnecessary delays.
- If MU IRB is not selected as the sIRB, you are still required to submit an abbreviated reliance application through eCompliance and local reviews must occur. See Scenario 2 below for additional information.
- If MU is selected as the sIRB, ongoing conversations with the MU IRB must occur. See Scenario 1 below for additional information. This will require the submission of the Initial Request for MU to be the IRB of Record form in eCompliance.
SMART IRB agreement
MU is a participating institution in the SMART IRB online platform where investigators and institutions can request, track, and document reliance/authorization agreements. The SMART IRB reliance agreement clearly defines roles and responsibilities and eliminates the need for the Institutional Official to sign reliance agreements for each study. SMART IRB is often used with MU multisite research and is documented in eCompliance for each project utilizing this agreement. Click here for more information on the SMART IRB online reliance system.
Site engagement in human research
Not every multisite study requires a reliance / authorization agreement, and these determinations are made by the IRB. The institutions entering into an agreement must be engaged in research. In general, an institution is engaged when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. Contact the IRB for assistance with this determination. Click here to see the U.S. Department of Health & Human Services, Office of Human Research Protections - Guidance on Engagement.
MU IRB policy on reliance
MU IRB Policy on Multisite Research & IRB Reliance Process
MU IRB review fees
IRB Fees Associated with Single IRB Review
How the appropriate IRB of Record is selected
- Must have an approved FWA.
- Accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
- Take into consideration the site of the overall Principal Investigator and the role of each investigator(s).
- IRB expertise - select an IRB with sufficient knowledge of the community from which the subjects are drawn.
- Funding agency requirements, prime grantee site.
- Consult with the Institutional Official and IRB from each organization to determine the appropriate IRB of record.
Instructions and responsibilities
- Scenario 1: MU IRB is the Single IRB – Submission Process
- Scenario 2: MU IRB Relying on Another IRB – Submission Process
- Scenario 3: Adding an Individual with No IRB Affiliation