No patient can be enrolled in a clinical trial before an institutional review committee has accepted the protocol and the informed consent form.

During this process, the scientific aspects of a trial are evaluated by experienced clinical researchers in each institution where the study is performed. Modifications to the protocol suggested by the IRC should be carefully considered by the investigators.

The committee should comprise at least five sufficiently qualified members: both sexes must be represented and members should be sensitive to local racial and cultural issues. There should be at least one nonscientific member and one member who is not affiliated with the institution. There should be no conflicting interests for any of the committee members.

The elements of the informed consent to be considered by the members of the committee are numerous. These are specifically outlined in the Declaration of Helsinki.

Confirmation of acceptance of a study by the IRC must be transmitted with the signed agreement form to the government authorities.