Institutional Review Board
Whether additional IRB requirements apply to multisite /collaborative research often depends on whether an external site or personnel are engaged in human subjects research. Marist College relies on the federal guidance on engagement in research to determine whether IRB oversight for external sites or personnel is required and, if so, what IRB reliance mechanism to use to ensure oversight is in place. Researchers are encouraged to review the resources below to help determine what additional requirements may apply to their study and to contact the IRB Chairperson with any questions.
Federally-funded cooperative (i.e, "multi-site") human research studies are required per the Common Rule (45 CFR 46.114)(link is external) to utilize a single IRB-of-Record (sIRB) to streamline the review process for human participant protections and to avoid duplicate review by an institutional review board at each site.
Under the sIRB model, an IRB at one of the collaborating institutions agrees to provide IRB oversight for all participating institutions via an authorization agreement (a.k.a. "reliance" or "collaborative" agreement) or a commercial IRB is contracted to provide the oversight functions for the project. These agreements/contracts document the respective authority, roles, responsibilities, and communication plans among the IRB-of-Record (i.e., the "reviewing IRB") and the institutions relying on that IRB (i.e., "relying site" and "relying IRB") for project oversight.
Authorization agreements must be approved by the IRB Chair.
Marist IRB of Record
In some cases, Marist College may agree to serve as the IRB of record for an external site or individual engaged in human subjects research as part of a study reviewed by a Marist College IRB. Please review the guidance below for information on when the IRB may agree to serve as the IRB of record.
Relying on an Outside IRB
In some cases, the Marist College may cede IRB oversight to a non-Marist College IRB, particularly when the involvement of Marist College personnel is limited (e.g., data analysis). Studies eligible for review through an existing IRB reliance partnership also may qualify for review by a non- Marist College IRB. Please see the guidelines and FAQ below for additional information on when the IRBs will consider ceding IRB review as well as how to request review by a non-Marist College IRB.
What is a multisite study?
From an IRB perspective, multisite research includes projects or studies that involve collaboration with sites or individuals with not a Marist employee or student. Some examples of multisite and collaborative research include:
An investigator with a Marist appointment is conducting a study involving other institutions.
Marist investigator conducting a study at a community-based site with a community partners.
Marist investigator sharing identifiable or coded data/images/specimens collected for a study with researchers at another university or institution