Are Clinical Trials Safe? What to Know About Safety, Ethics, and Your Rights

If you’re thinking of participating in a clinical trial for cancer treatment, you may wonder if it’s safe or not. There are many safeguards in place to reduce risk as much as possible.

Safeguard #1: The Institutional Review Board, or IRB

The IRB is a committee of independent researchers, clinicians, statisticians, and more. 

“They’re all getting together on a frequent basis to monitor the clinical trials to make sure that the clinical trial plan is safe, that it’s ethical, that the informed consent is as complete as possible, and to make sure that there’s safety protocols in place,” says June Y. Hou, MD, Gynecologic Oncologist at Columbia University’s Irving Medical Center.

Safeguard #2: Informed Consent

Before agreeing to participate, you would sit with the research team to hear about the logistics, possible risks and benefits, and goals of the trial. Then, you may agree to participate and sign the consent form, if you choose.

Safeguard #3: The Four Stages

The stages of a clinical trial are structured to reduce risk to participants. 

For example, in stage 1, researchers work with a small group of 15 people or so to check for signs of safety. Doctors can monitor these participants very closely to detect and treat issues early. 

After confirming safety, they can move on to later stages with more participants.

Safeguard #4: Data Safety Monitoring Board, or DSMB

Similar to the IRB, the Data Safety Monitoring Board is a committee of independent researchers, statisticians, clinicians, and more. The DSMB usually participates in stage 3 of clinical trials to monitor and review data from the trial. 

The DSMB may end the trial early for safety concerns, or if the trial team has already gotten the answer to their research question.

Safeguard #5: You can leave the trial early

You might choose to leave the trial if the treatment is not working for your cancer, or if you are having “serious or unanticipated side effects,” says Hou. In fact, you can leave the trial for any reason at all.

“There are no financial or legal punitive actions … if they choose to leave a clinical trial early,” says Hou.

Hou adds that if you have any other questions about your rights and safety when participating in a clinical trial, you should reach out to the research team.