Anyone considering whether to take part in a clinical trial probably realizes the opportunity not only offers a chance to receive state-of the-art healthcare and preview a new therapy, but also to contribute to science and society. Despite these benefits, it’s only natural to want to weigh the pros and cons, to consider what potential risks trial participants may face.
So how much does someone considering whether to join a clinical trial know about the risks and rewards of the trial, and how are they protected as they make their decision — and beyond that, if they choose to take part in the trial?
The first way would-be clinical trial participants are protected is through the informed consent process. Under regulations written and overseen by the Food and Drug Administration, every clinical trial participant must have given his or her informed consent, given after receiving detailed information on the trial.
Informed consent disclosures come from the doctors and nurses on the research team; they explain in detail the purpose, procedures, treatments and potential risks and benefits of the trial under consideration. They must also make clear the rights of participants in the trial, including their right to decide and, if they opt to participate, to later change their mind and withdraw from the trial at any time.
The prospective trial participant must have an opportunity to discuss the trial with the principal investigator and others on the research team. The information provided about the trial must come in language the prospective participant can understand. Finally, if willing to join the trial, the participant signs an informed consent form with the detailed information on the trial.
Beyond the informed consent process, under federal rules, every health institution conducting clinical trials must have an Institutional Review Board, or IRB. This body, composed of at least five members, has the duty to review clinical trial design and management to ensure that participants’ rights are being protected. Every trial must be reviewed at least annually, and the IRB has the power to change or even halt a clinical trial that has departed from its approved protocol or appears to be harming participants.
IRB members must include at least one scientist and at least one non-scientist. At least one member must not be affiliated with the healthcare institution and not closely related to anyone with ties to the institution. Many IRB members are physicians, other healthcare professionals, patient advocates, social workers or community leaders.
Further, before a government-funded clinical trial can start signing up participants, a scientific review panel must review and approve its clinical protocol; many privately-funded trials have opted for a similar preliminary review by scientific experts.
As further safeguards, some clinical trials also use safety monitoring committees or a Data and Safety Monitoring Board (DMSB), an independent panel of medical experts, statisticians and others that review early trial results and advise the IRB. Phase III clinical trials must have a DSMB, which can end a clinical trial over safety issues, or if it determines trial results have been achieved.