IRBs

IRBs, or Institutional Review Boards, are committees designated to review research involving human participants to protect their rights and welfare and to ensure compliance with ethical and regulatory standards. They assess potential risks and benefits, the adequacy of informed consent, the handling of private information, and the fair selection of subjects. In the United States, IRBs operate under regulations such as the Common Rule (45 CFR 46) and, for certain products, FDA rules; in other countries similar bodies are known as research ethics committees or ethics commissions with national or local guidelines. An IRB is typically affiliated with an institution and has authority to approve, require modifications, or disapprove a research protocol, and to conduct continuing review of approved studies.

Composition and operation: IRBs are intended to be diverse, including scientists, non-scientists, and unaffiliated community members to provide varied perspectives. Members review study protocols, consent documents, recruitment materials, and data protection plans. They monitor ongoing studies for compliance and can suspend or terminate approval if continuing risks to participants are identified.

Procedures and criteria: Submissions undergo processes that may include a convened vote (full board) or expedited review for minimal-risk research, with some categories eligible for exempt status. Criteria for approval include risk minimization, informed consent that is appropriate and well documented, adequate privacy protections, equitable subject selection, and protections for vulnerable populations. Continuing review is typically required to ensure ongoing compliance.

Impact and trends: IRBs play a central role in safeguarding human subjects and ensuring regulatory compliance, while navigating challenges such as multi-site studies, reliance agreements, training requirements for researchers, and evolving data privacy considerations.