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This section has been reviewed and approved by the PLWC Editorial Board, 7/05
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 individuals who enroll.
Regulation of clinical trials
Clinical trials are governed by a rigorous, multi-layered review and oversight process. The process is designed specifically to protect the rights and safety of individuals who enroll in clinical trials. Institutional Review Boards (IRBs) are responsible for overseeing individual clinical trials. As such, they review and approve all aspects of clinical trials. 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).
Federal agencies. The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have responsibility for drug approval and research oversight. Both agencies set regulations to ensure the safety of clinical trial participants.
Institutional Review Boards (IRBs). 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.
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 develop severe side effects or drop out of the study, the DSMB may recommend stopping the study. Alternatively, sometimes the new treatment works so well that it is ethically wrong to continue to give one set of patients the older 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 trials that are taking place in many cities because they review all of the data from each 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
Beyond these checks and balances, research institutions are required to obtain informed consent from every cancer 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 trial if there are adverse effects from the therapy.
These safeguards are in place specifically to protect a person enrolled in a cancer clinical trial. The informed consent process begins with this document, but does not end there. Informed consent is an ongoing interactive process between the patient and the health-care team, which allows the patient the opportunity to ask questions and have their concerns addressed, as well as remain up-to-date on any relevant new information that is related to that particular trial or therapy. The National Cancer Institute (NCI) offers further information about the informed consent process on their website at www.nci.nih.gov/clinicaltrials/conducting/informed-consent-guide/page2.
The informed consent process should include these facts. - Why the research is being done
- What will be done during the trial and for how long
- What risks and benefits are involved in the 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.
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.
See Questions to Ask the Research Team for helpful tips on talking with your research team.
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.
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