Patient safety is the highest priority in clinical trials. Clinical trials are governed by a rigorous review and oversight process designed to protect the rights and safety of people who enroll.

Regulation of clinical trials

Institutional Review Board (IRB). An IRB is an independent committee of doctors, statisticians, community advocates, and others who ensure that a clinical trial is ethical and that the rights of study participants are protected. Every clinical trial in the United States must be approved and monitored by an IRB to make sure the risks are as low as possible and are outweighed by the potential benefits. All institutions that conduct or support medical research involving people must, by federal regulation, have an IRB that approves the clinical trial before it begins and reviews the research periodically until it is completed.

Federal agencies. A number of federal agencies also share responsibility for approval and oversight including the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). The FDA and the NIH have responsibility for drug approval and research oversight. Both agencies set regulations to ensure the safety of clinical trial participants.

Data Safety Monitoring Board (DSMB). The DSMB is a group of doctors, medical ethicists, statisticians, and other health professionals that monitors the clinical trial for safety and scientific relevance during the trial. For example, if the new treatment is causing many patients to drop out of the study because of severe side effects, the DSMB may recommend stopping the study. Alternatively, sometimes the new treatment works so well that it is unethical to continue to give one group of patients the standard treatment. In this case, the DSMB may recommend closing that arm of the treatment and offering those people the new treatment. A DSMB is especially useful for large clinical trials that are taking place in many cities because they review all of the data from each clinical trial location.

A DSMB is separate from an IRB. The IRB usually looks at the clinical trial before it starts. The DSMB reviews the study after it starts and makes recommendations to the IRB about stopping or continuing the study.

Informed consent

Research institutions are required to obtain informed consent from every clinical trial participant. It is important to understand that there is an informed consent document and an ongoing informed consent process. The informed consent document provides the patient with written information on all aspects of the clinical trial, including the potential risks and benefits. A person has a right to know and understand the type of therapy he or she will receive, the side effects he or she may experience as a result of the therapy, his or her role as a participant, the fact that he or she may leave the trial at any time, and that he or she will be removed from the clinical trial if there are adverse effects from the therapy.

These safeguards are in place specifically to protect a person enrolled in a clinical trial. The informed consent process begins with this document, but does not end there. Informed consent is an ongoing process between the patient and the health care team. It allows the patient to ask questions, hear responses to his or her concerns, and keep current on any new information that is related to that specific clinical trial or therapy.

The informed consent process should include these facts:

• Why the research is being done
  
  
• What will be done during the clinical trial and for how long
  
  
• What risks and benefits are involved in the clinical trial
  
  
• What other treatments are available
  
  
• The right to leave the trial at any time

If English is not your native language, you can ask for the consent documents in languages other than English. Because joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study before you make a decision. Get a list of questions to ask the research team.

It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time. Read more about informed consent.

Freedom to withdraw from a clinical trial

You can change your mind and leave a clinical trial at any time—before the study starts, during the study, or during the follow-up period. Participating in research is always voluntary. Even if you decide to participate, you can always withdraw from the study without affecting your relationship with your doctor.

More Information

Clinical Trials

Additional Resources

National Cancer Institute: A Guide to Understanding Informed Consent