Ethics review (IRB, research ethics committee)

Ethics review is the gate every trial passes through before it opens and stays under while it runs. A committee independent of the investigators and sponsor, with lay members as well as scientists and clinicians, examines the protocol, the investigator's brochure, the consent form and the recruitment materials and asks a fixed set of questions: is the scientific question worth the risks, are the risks minimised and the benefits fairly distributed, is the selection of participants fair, is consent informed and voluntary, is privacy protected, and are vulnerable participants (children, prisoners, people who cannot consent for themselves, people in economic hardship) given extra protection? The committee can approve, require changes, or refuse. Once the trial opens it receives amendments, safety reports and periodic progress reports, and it can suspend a trial that departs from its protocol. The principles come from the Nuremberg Code, the Declaration of Helsinki and, in the United States, the Belmont Report, and are codified in the Common Rule and in the ICH E6 Good Clinical Practice guideline that regulators worldwide require trials to follow.

Multi-centre trials have historically needed separate review at each site, which added months. The United States now mandates a single IRB for most multi-site federally funded research, the United Kingdom runs a national system through the Health Research Authority, and the European Union's Clinical Trials Regulation coordinates one assessment across member states through a single portal. The Indian trials in the corpus, from the cluster-randomised screening trials to the Tata Memorial low-dose immunotherapy and olanzapine trials, went through India's ethics committee system and its Clinical Trials Registry, a reminder that the same principles apply through different national machinery.

Ethics review is often confused with two other things. It is not regulatory approval: a regulator such as the FDA or the MHRA authorises the investigational drug and reviews the trial's design for a possible licence, while the ethics committee protects the people in it, and both are needed. And it is not the data monitoring committee, which watches the unblinded results as the trial runs. Ethics review is also where equipoise is tested: a committee should refuse a trial whose control arm is known to be inferior, and a trial answering a question already settled.