Review Boards & Informed Consent
How are people in clinical trials protected?
Institutional Review Boards (IRBs) approve and monitor all clinical trials. The IRB is made up of doctors, community advocates, and others. These people make sure that the trial is ethical, safe, and well planned. They also help protect the rights of people in the study. The IRB makes sure the risks are as low as possible. In addition, the IRB ensures that names of people in the trial are kept secret.
What is informed consent?
Informed consent is an agreement between the clinical trial sponsors, investigators, and the participants. This form explains all of the important facts about the treatment being studied, the purpose of the study, and procedures involved. It also states risks and hoped-for benefits. The doctor or nurse in the clinical trial will explain all of these details to each person in the study. He or she will also give the informed consent form to each person to carefully read and sign.
Are people free to drop out of a clinical trial?
Yes. Anyone can leave a study at any time. However, it is helpful for future patients if the participant informs the team about why he or she is leaving the trial.