Clinical trials are federally regulated, and strict safeguards are in place to protect participants’ safety and ensure confidentiality. Informed consent is an important part of understanding and deciding to participate in a specific study. This process enables potential volunteers to learn the facts about the study before making the decision to participate. Informed consent also ensures that volunteers understand what is happening as the trial progresses.
To help you decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. The informed consent document also explains the trial’s benefits (such as the possibility of receiving the treatment after the trial is over, if it proves successful) and risks (such as potential side effects). If you decide to participate, then you sign the document. It is important to remember that informed consent is not a contract – you may withdraw from a clinical trial at any time.
Once you’re enrolled in a study, you’ll work with a team that includes doctors, nurses, and other health professionals. Team members will give you medical exams and take a detailed medical history at the beginning of the study. They will also monitor you throughout the trial and stay in touch after it is completed.
Keep in mind that participating in a clinical trial does not take the place of ongoing medical care by your primary physician and health care team. If you’re thinking of volunteering for a clinical trial, be sure to speak with your doctor before you enroll. In addition, while you are enrolled in the trial, your doctor should be informed of the study’s progress.