Research that addresses the world's health challenges is at the core of our mission to discover and share knowledge to advance health. If you are seeking to enroll in a clinical trial, you are not alone. The Duke Health System enrolls patients in ~1800 trials at any one time. The participants in these studies help answer important questions about the best ways to diagnose and treat various medical conditions.
Clinical research is impossible without the selfless participation of patients, however we think it is important that you know your rights and what to expect if you decide to enroll in a study.
Before you agree to participate in a study, you should:
- Clearly understand the study. The research staff must explain the goals, possible benefits, and possible risks of the study to your satisfaction.
- Check with your personal doctor, who knows your medical history and can help you decide whether you should participate in a clinical trial. Your doctor also can be a source of information about the risks and benefits of the proposed treatment(s).
- Have a good understanding about your current state of health. You will be told about the known side effects and other health risks of the treatment(s), but not all of the risks can be known when you decide to participate in a trial. Once you decide to participate in a clinical trial, you will need to sign an Informed Consent form. This form provides a detailed explanation of the purpose of the trial and the types of treatment to be studied. It also discusses the probability of your receiving a given treatment, the known risks and benefits of each treatment, and any costs related to the study that you would be expected to pay.
- The consent form also lets you know whom to contact more information, and fully explains your rights in a clinical trial, including:
- the right to confidentiality
- the right to medical treatment for any trial-related injury
- the right to withdraw from the study without penalty or loss of other medical care