GENERAL GUIDANCE ON THE USE OF ANOTHER INSTITUTION'S IRB
Each approved Single Project Assurance designates an Institutional Review Board (IRB) which is authorized to review and approve cooperative protocols. However, though it may be permissible under 45 CFR 46.114 for an institution to rely on an IRB of another OPRR-approved institution for protocol review, institutions planning such an arrangement should seek prior guidance from OPRR to avoid unnecessary delays. It is in the best interests of institutions to appreciate that review by another's qualified IRB (i.e., OPRR-approved) raises questions about membership qualifications that would likely be inherently satisfied when reviews are confined to protocols conducted in the IRB's own institution. Local laws, institutional policies and constraints, professional and community standards, and population differences are examples of pertinent local factors that can influence the setting of research (see 46.103(d), 107(a), and 111(a)(3)). For example, the considered opinion of an IRB of one institution may be blind to information that would alter its decision for another where:
- institutions draw from culturally dissimilar patient populations;
- institutions are located in different states or other geographical subdivisions with varied legal or regulatory constraints;
- institutions are not accustomed to each other's operational policies, constraints, procedures, or commitments; or
- there is uncertain satisfaction of drug control responsibilities, or other FDA requirements.
Apparent efficiencies of such review to avoid perceived duplication of effort may be shortsighted if detached from concomitant review of the setting in which such protocols are to be conducted. Accordingly, reliance on another IRB should not be considered lightly. In spite of a joint willingness between institutions, OPRR may not approve a proposed arrangement if there are circumstances that are not appropriate. Therefore, such plans should include consultation with OPRR to avoid delays.
Several options for IRB arrangements are available which OPRR has found to comply with the letter and intent of both 45 CFR 46.114 and the regulations as a whole.
Institutional sites that are geographically close enough to comfortably contribute membership to a common IRB can share in bearing the costs of operation while simultaneously providing reviews for protocols that may be used by physicians at some or all of the sites. This approach results in one IRB that can be equally cited as their own IRB of record by all sites that contribute to its membership.
A second approach is for one IRB with unique expertise, a legal or administrative preference for involvement, or otherwise to host reviews for other nearby institutional sites with consultant representation from each site present for all initial and continuing reviews of protocols jointly used by these sites. In this approach only the hosting institution has its own IRB. The other sites rely on another's IRB but in such a way as not to defeat the intent of 45 CFR 46.
The most obvious way to fully comply with the regulations is for each site to host its own IRB. An institution that has a standing IRB which is qualified to perform reviews for a specified research activity would be expected to do or justify not doing so before approval would be considered for other options. If a local hospital exists with an applicable OPRR-approved Assurance for the research in question, a second institution may seek permission to rely upon such an IRB when justified. OPRR understands the propriety of considering and approving reliance on another's IRB when a plausible case is made apparent. For example, an IRB with a suitably diversified membership might exist at one site to host IRB reviews for another site due to: (1) the cosmopolitan nature of the host site; (2) a wide catchment area from which patients and subjects are referred to it, (3) or reasons as may otherwise be of a compelling and pertinent nature. However, institutional constraints are less easily accounted for between institutions when there is little or no intimate understanding of each other's staff, equipment, policy, practices, and legal issues. Each case deserves individual consideration.