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IRB Approval Requirements for Collaborative or Multi-Site Research Studies
Research projects often involve collaboration between researchers at ISU and those at other universities. In general, human subjects research activities conducted by employees of an external site fall under the jurisdiction of that site’s Institutional Review Board (IRB). When researchers collaborate, that can mean that IRB approval by multiple IRBs is required.
In some cases, there is a way to avoid duplicate review. The IRBs at each site can enter into formal agreements called Reliance Agreements or IRB Authorization Agreements (IAA), allowing one IRB to serve as IRB of Record—that is, to be the IRB that assumes responsibilities for review of research activities conducted by researchers at multiple institutions.
Typical options for reliance/IAA’s involve:
- ISU agrees to serve as IRB of Record for the research activities conducted by ISU personnel and collaborating researchers at external sites
- The entire project, including activities of collaborating/external investigators, is reviewed by the ISU IRB
- The ISU PI assumes responsibility for coordinating IRB review (including all future review activities) for the human subjects research activities of ISU and collaborating researchers
- ISU agrees to defer or cede IRB review requirements to the collaborating institution; the IRB at the collaborating institution serves as IRB of Record
- The research activities of ISU employees fall under the oversight of an IRB at the collaborating institution.
- The ISU PI is responsible for following the policies, procedures, submission requirements, etc. of the IRB at the collaborating institution.
Which option is best?
Research collaboration arrangements vary, and thus the “best” option for IRB oversight depends on the specific situation for each project. The best option also depends on funding agency requirements, and whether a study qualifies for exemption. Establishing these agreements can also take some time. Principal Investigators are encouraged to contact IRB staff for guidance early in the process.
Special circumstances for NIH-funded research: Effective January 25, 2018, the National Institutes of Health (NIH) will require use of a single IRB (sIRB) for ethical review of nearly all NIH-funded non-exempt multi-site research (some exceptions are possible). The policy covers situations where the same protocol is conducted by two or more domestic sites. For these studies, a research team must select one IRB to serve as IRB of Record—that is, to be the single IRB—for all sites, and must include a plan describing the use of the single IRB with funding submissions. Principal Investigators planning to seek NIH funding should consult with the ISU IRB very early in the proposal stage for guidance on single IRB arrangements.
Do all research activities involving external personnel require formal agreements?
Whether IRB oversight is required for the activities of researchers at an external site depends on whether or not they are formally “engaged” in human subjects research as defined by federal guidance. In general, they are “engaged” if they will be involved in direct recruitment of participants, obtaining participants’ informed consent, collecting data, or analysis of private and identifiable information about participants. Some activities, such as agreeing to post an IRB-approved recruitment flyer or allowing a researcher access to facilities, would not normally render a site “engaged”. Determining whether an external site or external personnel are engaged in research can be difficult and Principal Investigators are encouraged to consult with IRB staff (IRB@iastate.edu). Additionally, external sites have their own policies that researchers must follow.
Basic Information for IRB Authorization Agreements
Reliance agreements/IAA’s require basic information about the project(s) and institution. Project information will vary; relevant information about ISU is as follows:
ISU Federalwide Assurance Number: FWA00002678
ISU IRB Registration Numbers:
IRB #1: IRB00000473
IRB #2: IRB00005531 (Reviews research involving prisoners as subjects)
ISU Signatory Official: Sarah Kaatz, Director, Office for Responsible Research (IAA signatory designee for IO)