Clinical trials follow strict rules to keep patients safe. In the U.S., clinical trials may be checked by these organizations:
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. The trial will be stopped if there is any unexpected harm, such as dangerous side effects.
The Belmont Report
is a document that includes guidelines for researchers to make sure people in clinical trials are protected. This report was created because of the Tuskegee Syphilis study, where African Americans in the clinical trial were lied to and denied treatment.
The guidelines in this report are:
1. To respect people. This means:
- You should be treated with respect.
- You should make your own medical decisions.
- You should get truthful, accurate information.
- Your agreement to join a trial must be freely and voluntarily given.
2. Do not harm. This means:
- Researchers will prioritize avoiding harm to you, even if the information they’re collecting from you could help others in the future.
- Researchers will increase benefits to you whenever possible.
3. Be fair. This means:
- The benefits (good) and harms (bad) of research should impact all groups of people equally, rather than just one group.
- Everyone should get the same opportunity to join a trial.
- The safety and well-being of someone should not be risked for the benefit of others.
The right to information. Before joining a clinical trial, you have the right to learn about it in a way that you can understand. This is called the informed consent process. During this process, you and your study coordinator will discuss:
- The purpose of the clinical trial
- The possible benefits and harms associated with participating in the trial
- Other treatment options you may have
- Your rights as a participant in the clinical trial
The right to not join and the right to leave. Joining a clinical trial is your choice. If you’re uncomfortable joining a trial, tell your doctor. You can also speak with a patient advocate or get a second opinion from a different doctor. Your health care team must 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 don’t have to do anything that you’re uncomfortable with.
The right to privacy and confidentiality. Your privacy and confidentiality are protected when you join a clinical trial. Privacy means you have the right to decide when and how to share your body, thoughts and experiences with others. Confidentiality is how your doctors will protect your information. During the informed consent process, you and your doctors will talk about what information will be collected if you participate in a trial and how it may be shared. For example, you may talk about what samples you may give and who will have access to your test results.