Types of Ethics Committees in Research

An Institutional Review Board (IRB) is the U.S. term for the research ethics committee as defined in 45 CFR 46. A Research Ethics Committee (REC) is the equivalent in the UK, European Union, Australia, and other Commonwealth nations. The fundamental function is identical—independent ethical review of human subjects research—but regulatory frameworks, membership requirements, and operational procedures differ by country. An IRB operates under U.S. federal law; an REC operates under UK legislation (Health Research Authority) or EU Clinical Trials Regulation. When conducting research in a given country, researchers must obtain approval from that country's ethics body (IRB if U.S., REC if UK, etc.).

Not entirely. In multi-site trials, the coordinating site's IRB/REC may review the protocol centrally to ensure consistency, but each participating site must have ethics approval from its own institutional IRB/REC. In the UK, a single Research Ethics Committee may conduct centralized review for NHS-related research across multiple NHS trusts; a single decision applies to all sites. In the U.S., the FDA allows cooperative agreements where one IRB serves as the reviewing board for all sites (central IRB review), but this requires written agreements between all participating institutions and is increasingly common in large trials. International trials require separate approvals in each country.

Some low-risk research may be exempt from full ethics review under regulatory definitions. In the U.S., 45 CFR 46.104 lists six categories of exempt research: (1) research in an educational setting involving educational practices/curricula, (2) research involving collection of educational tests/survey data, (3) research on existing de-identified data or specimens, (4) research on publicly available data, (5) taste/quality evaluations of food/beverages, and (6) certain types of public benefit and service programs research. In the UK, some health services research may not require REC review if it qualifies as audit or evaluation of established practice, but this distinction is increasingly narrow. Many institutions require expedited review even for exempt studies to document the exemption. Researchers must check their institution's policy—the existence of an exemption category does not automatically exempt a study; the IRB/REC must make the determination.

Conducting human subjects research without ethics approval is a serious breach with legal and professional consequences. The research cannot be published in ICMJE-member journals (98% of major medical journals), which require ethics approval as a publication condition. Institutions can impose sanctions on investigators: suspension of research privileges, loss of institutional affiliation, or termination of employment. Funding agencies (NIH, NSF, Wellcome Trust, EU) require ethics approval as a grant condition and may impose funding restrictions if violations are discovered. Professional bodies (medical boards, psychological associations) may discipline members who conduct unapproved research. In some cases, particularly if research causes harm, civil liability or criminal charges may result. Additionally, any data collected is typically unusable and cannot be ethically analyzed or published.