What is a research ethics committee?

Under the 2024 Declaration of Helsinki (paragraph 23), the protocol must be submitted to the concerned committee for consideration, comment, guidance and approval before the research begins. The committee must be transparent, independent of the researcher, the sponsor and other undue influence, adequately resourced and qualified, and include at least one member of the general public. It can monitor ongoing research, recommend changes, withdraw approval or suspend the study, and no protocol amendment may be made without its approval.

CIOMS (2016) asks that all proposals for health-related research involving humans go to a committee, which decides whether the study qualifies for ethical review and assesses its ethical acceptability; an exemption depends on the nature of the research and applicable law. Review looks at, among other things, the design, risk minimization, the balance of risks and benefits, and feasibility. CIOMS says payment must never be offered or accepted to obtain a committee’s approval.

The legal status, composition and operation of committees differ between countries (ICH E6(R3)), so this page describes international norms rather than local rules. The ICMJE expects authors to have sought approval from an independent local, regional or national review body and to document it when editors ask.