When to Request Use of a Single IRB for Research Collaboration Between SEMC and BUMC
For studies involving collaboration between investigators at St. Elizabeth’s Medical Center (SEMC) and BU Medical Campus (BUMC), it may be beneficial to explore an arrangement where one institution acts as the ‘Single IRB.’ These arrangements require a reliance agreement between the two institutions, which is coordinated by the staff at the SEMC IRB and the Boston Medical Center/BUMC IRB. In these scenarios, one institution agrees to allow the other institution to act as their IRB of record. For certain types of studies, this may streamline the IRB review process and increase efficiency. However, this type of agreement is not always possible, or, it may instead lead to additional unnecessary complexity. Below are some examples of research studies that may or may not be eligible for use of a Single IRB.
Eligible for Use of a Single IRB:
Studies involving only one site (SEMC or BUMC) that is actively recruiting and enrolling their own subjects. The other site is ‘engaged in human subjects research’ because they are conducting analyses of identifiable data, or, because they meet other engagement criteria that do not involve recruiting and consenting subjects at their site.
Potentially Eligible for Use of a Single IRB:
- Studies in which both SEMC and BUMC are recruiting and consenting their own subjects. In this instance, the efficiency of the use of a Single IRB will be evaluated by the SEMC IRB and BUMC IRB on a case by case basis. Factors include the study topic, study complexity, and risk level.
- Studies in which both SEMC and BUMC are engaged in research, but the study involves no subject interaction. An example of this is a study that involves no subject interaction at either site, but does involve the use and analysis of identifiable data (such as a retrospective chart review).
Not Eligible for Use of a Single IRB:
- Research that qualifies for an exemption determination under 45 CFR 46.104.
- Industry-sponsored clinical trials that are ceded to the sponsor-selected Single IRB.
- Studies for which BUMC or SEMC (or both) are already ceded to a different Single IRB.
If you have any questions about use of a Single IRB for your study, please reach out to the following contacts:
Contact
Boston University Medical Campus
Matthew Ogrodnik
Director of the Office of Human Research Affairs
(617) 358-6559 | maogrodn@bu.edu
Roz Schomer
IRB Reliance Specialist
(617) 358-5329 | roz@bu.edu
St. Elizabeth’s Medical Center
Meghan Cashman
IRB Manager
(617) 789-2804 | meghan.cashman@steward.org
IRB Office
irb@steward.org
Location
Boston University Chobanian & Avedisian School of Medicine
72 East Concord Street
Boston MA 02118
St. Elizabeth’s Medical Center
736 Cambridge Street
Brighton, MA 02135
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