Note: Pearl IRB updated this blog on August 9, 2021, and we will continue to update this in the future as necessary.
Formal review procedures for human subject studies were established in reaction to unethical research practices in the 20th century. The Code of Federal Regulations, 21 CFR 56 and 45 CFR 46 (the “Common Rule”), contains general standards for the composition, operation, and responsibilities of an Institutional Review Board (IRB). The IRB is a committee that is officially designated to approve, monitor, and review biomedical and behavioral research involving humans. An institutional review board might also be called an ethical review board (ERB), independent ethics committee (IEC, e.g., in the European Union), or a research ethics board (REB). Additional terms may include independent review board, central IRB (cIRB), single IRB (sIRB), local IRB, IRB of record, and commercial IRB.
So, what’s the difference in these terms? Are they the same? What group do I need to engage for my research study? Does it matter?
IRB of Record
Federal guidelines use the term “IRB of record” most often. The IRB of record assumes primary responsibility for the review and approval of a clinical study. Any IRB overseeing human subject protections for a clinical study is considered the IRB of record. Examples include commercial IRBs, a university IRB, or a commercial IRB serving as a single/central IRB.
Institutional Review Board vs. Independent Review Board
An independent IRB is one that is not associated with an institution. The Central Institutional Review Board for the National Cancer Institute (NCI cIRB) is an example of an independent federal IRB while Pearl IRB is an example of an independent commercial IRB. Unlike a university that performs research, a contract research organization (CRO) or pharmaceutical company are establishments that may not have an internal IRB. These institutions would need to depend on an external independent IRB for review of their human subject studies.
Single IRB vs. Central IRB
The term single IRB was introduced in 2016 with the release of the NIH policy on IRB review for multisite research. In the NIH policy, a designated sIRB may be either independent or associated with an institution. Essentially, an sIRB and cIRB are equivalent: one IRB of record overseeing all clinical trial sites taking part in a multisite study. The Common Rule was revised in 2018. At that time the collaborative (multi-site) research provision was updated to require that U.S. institutions engaged in cooperative research conducted or supported by a Common Rule agency must rely on a sIRB to review and approve that research conducted at domestic sites [45 CFR 46.114(b)]. The compliance date for this collaborative research provision was January 20, 2020.
Main Points
The meaning of these terms will likely vary with the user. A university researcher will rely on their IRB. If this university IRB has a backlog of studies to review, the researcher may want to rely on an external, independent commercial IRB. A CRO performing a multisite study for a pharma company may refer to an external commercial IRB as a central IRB.
However, at the end of the day, an IRB’s organizational affiliation, label, or physical location are significantly less important than its primary purpose of overseeing clinical research to assure the protection of human subjects.