So you’re thinking about volunteering for one of our clinical trials, yet something might still be holding you back? Perhaps one of the foremost questions in your mind is ‘How will I be protected?’ or ‘What are my rights and what about them?’ There are actually several provisions to protect the welfare and rights of clinical trial volunteers.
The Food and Drug Administration (FDA) requires that every potential clinical trial volunteer be given complete information about the study before they agree to take part. This is called ‘informed consent’. It is written information letting volunteers know the following: that the study involves an unproven drug or device; the purpose of the research; the duration of the study; what will happen in the study and which parts are experimental; possible risks or discomforts; possible benefits; other procedures or treatments that they may want to consider; that FDA may look at study records, but records will be kept secret; whether medical treatments are available if volunteers are hurt, what those treatments are, where they can be found, and who will pay for it; the contact person for questions about the study, their rights, or if they get hurt; that they can quit any time. The informed consent must be signed before a volunteer can participate in a study, and it is not a contract, therefore, you may leave the study at any time and for any reason.
The Institutional Review Board is another means of protecting volunteers. Institutional Review Boards are usually composed of scientists, doctors, and other people from the research center’s local community who review the research process. They make sure that there is the least possible risk to volunteers, and that risks are reasonable in relation to the expected benefits. They also see to it that the volunteer selection is fair and that informed consent is done correctly. The FDA is involved as well, by inspecting records and scientists, clinics, and other research sites involved in a study. This is to ensure that volunteers are protected and that the studies are properly conducted. Sometimes, there are also specially-appointed committees especially in tests of treatments for serious or life-threatening diseases.
While it is crucial to gather the right number of volunteers for a clinical trial to prosper, we here at HCRC firmly believe protection of the rights and well-being of the volunteers are ultimately more important.
