Joining a clinical trial is not required. If you’re uncomfortable joining a trial, tell your doctor. Your doctor and health care team will take good care of you whether or not you join a trial. Even after you’ve joined a clinical trial, you may quit at any time. You do not have to do anything that makes you uncomfortable or unhappy.
Throughout the trial, researchers report to the OHRP, FDA and IRB. The trial can be shut down at any time to protect the people in it. They will stop the trial if there are any unexpected risks, such as dangerous side effects. The FDA and the OHRP also make sure patients give informed consent before joining a clinical trial.
Informed consent helps you learn about a clinical trial. During this process, the study coordinator will tell you about:
- The purpose of the clinical trial
- The possible risks and benefits
- Other treatment options you may have
- Your rights as a participant in the clinical trial
During the informed consent process, be sure to ask questions about anything that you don't understand. You can also:
- Ask questions at any time during the study
- Talk about the clinical trial with your doctor, your family and friends before joining
It's also important for you to know that:
- Being in any clinical trial is voluntary.
- You may or may not directly benefit from being in a clinical trial.
- If you join a clinical trial, you can quit at any time.
- If you decide to quit the clinical trial, it won't affect the quality of your care at your hospital or clinic.