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Ethics committees

Before a clinical trial can take place it must first be reviewed by an independent ethics committee (IEC) (also known as an "institutional review board"). The trial cannot start unless the IEC takes a favourable view of the protocol.

Ethics committees are made up of doctors, nurses, scientists and lay people. Depending on the trial being reviewed the committee may be based in a particular institute, such as a hospital, or may be regional or national.

Their role is to protect the rights, safety, and well-being of participants in clinical trials and ensure that trials are necessary and comply with relevant national and/or international standards. The committee must review and approve the trial protocol and in some countries, the investigators undertaking research and the facilities involved. They also review and approve the information to be provided in the process of obtaining informed consent, and any advertising materials that will be used to recruit people to the trial.

The trial can only go ahead when the IEC has approved the study and the documentation for potential participants. The committee can ask for changes to the trial protocol or documentation before allowing it to proceed.

Once a trial has been approved, the IEC must be consulted about changes that could affect the study design and/or participants' safety, and must be informed if any unexpected or serious events occur.

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