Every clinical trial in India must be reviewed by a registered ethics committee. Here is what that committee checks and how it protects participants.
An ethics committee is an independent group that reviews a clinical study before it starts and keeps watching it while it runs. Its job is to protect the rights, safety and well-being of the people who take part.
Who sits on an ethics committee?
Members typically include medical and non-medical experts, such as clinicians, a pharmacologist, a legal expert, a social scientist or representative of a non-governmental organisation, and a lay person from the community. This mix ensures that a study is judged from more than a purely scientific point of view.
What does the committee review?
- Whether the study is scientifically sound and worth doing.
- Whether the expected benefits justify the possible risks.
- Whether the informed consent form is clear, complete and in a language participants understand.
- How participants will be recruited, and whether anyone could feel pressured to join.
- Arrangements for medical care and compensation if a participant is harmed.
Oversight does not stop at approval
During the study, the committee reviews serious adverse events, protocol changes and progress reports. It can ask for changes, or suspend a study, if participant safety is at risk.
Registration in India
Under the New Drugs and Clinical Trials Rules, 2019, ethics committees that review clinical trials must be registered with the Central Licensing Authority. Sponsors and sites should confirm this registration before a study begins.
This article is a general overview and not legal or regulatory advice.