The National Institutes of Health (NIH) has issued a policy on the use of single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH. Effective date of this policy is January 25, 2018.

The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections.

 

Definition of "multi-site" research: 

Multi-site” means that the same research procedures (i.e., protocol) are being conducted at one or more domestic sites and that each site is under the control of a local participating investigator. This typically involves a lead site that receives the grant or contract directly from NIH and that then establishes a subaward or subcontract to each participating site. The research could be a clinical trial, an observational study, or a basic clinical research study.

“Same research protocol”: Protocols that address the same research questions, involve the same methodologies, and evaluate the same outcomes are considered to be the “same research protocol.” Additionally, sites that are accruing research participants for studies that are identical except for variations due to local context consideration would be considered to be conducting the “same research protocol.” If a study involves a separate site for study coordination or coordination of data and statistical analyses and the site is conducting the same protocol as the other participating sites, then all sites would be expected to rely on the designated single IRB.

Definition of “Collaborative Research”: Research that engages more than one institution and for which there is a division of labor among the institutions (i.e., the institutions are not all conducting the same procedures). 

Definition of “IRB of record”: The IRB of record is the IRB that assumes responsibilities for another institution or independent investigator for a specific study, group of studies, or for all research conducted by the institution/investigator.  This relationship must be documented in advance by a reliance agreement. 

Definition of “Prime recipient”: This refers to an institution that is directly receiving funding for a study from a federal research sponsor, whether or not the institution is conducting any of the research procedures. The institution is almost always considered the lead institution among the institutions participating in the research.