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Clinical trial participants should know that their rights are protected. Laws enacted after World War II require that all study subjects give their “informed consent” before they participate in a clinical trial. This means that subjects must be given information about everything that will take place in a clinical trial, and they must agree (in writing) to participate. The informed consent process is designed to ensure that people are aware of the potential benefits and risks associated with their participation in a trial. More importantly, it helps assure that nobody is ever “coerced” or forced to participate in a trial.
In addition to the protections afforded by informed consent, clinical trials are required to have oversight by an independent ethics committee or Institutional Review Board (IRB). According to the United States Food and Drug Administration (FDA), an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving people. The IRB review process includes, but is not limited to, the examination of study protocols, study-related advertising, and patient compensation; and plays a critical role in ensuring that the safety, rights, and welfare of study volunteers are protected. The IRB has the authority to approve, require modifications to, or disapprove research. Protocols that are determined to be inappropriate are not approved.
Volunteers have the option to discontinue their involvement in a clinical trial at any time, for any reason. Investigators also have the right to terminate a volunteer’s participation in a study if they believe it poses an inappropriate risk to the patient. Discontinuation or termination is never to be associated with any imposed penalty.
If you are considering participation in a clinical trial, you should be aware that the informed consent process offers you an opportunity to ask questions about the study. Questions such as: "What are your credentials?" or "What is the purpose of the study?" or "What are the risks of participation?" are appropriate to ask if this information is unclear. Every investigator who conducts clinical trials research is required to provide full informed consent, which includes providing complete and satisfactory answers to any questions that you may have. You also may wish to speak with your primary care doctor.
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