Institutional Review Board & Good Clinical Practice

The independent ethics committee — called an Institutional Review Board (IRB) in the U.S. and a Research Ethics Committee elsewhere — that must review and approve human research before it begins and monitor it thereafter, to protect participants' rights, safety, and welfare. For a significant-risk BCI study, ethics-board approval is required in addition to the regulator's IDE. The board scrutinizes the consent process, the risk–benefit balance, the equity of participant selection, data protection, and the handling of adverse events, and it can require modifications, suspend, or terminate a study.

This review operates within Good Clinical Practice (GCP), the international quality standard for designing, conducting, and reporting trials, and rests on foundational research-ethics principles of respect for persons, beneficence, and justice. Ethics oversight is a continuing relationship, not a one-time gate: protocol changes, newly recognized risks, and serious adverse events must all be reported back for ongoing review.