Ethical Considerations

Federal regulations insure that the rights of subjects in a clinical trial are protected. Each clinical trial must be approved and monitored by a committee known as an Institutional Review Board, which has medical, scientific, and non-scientific members. Institutional Review Boards review and approve trial documents such as the protocol and informed consent form as well as the advertising materials needed to attract subjects. The purpose of the Institutional Review Board is to protect the rights, safety, and well-being of the study subjects.

The Food and Drug Administration requires that all participants in a clinical trial be informed of the details of the study. This process is called informed consent. Informed consent usually involves a lengthy document (informed consent form) that describes key facts about the study including: the purpose of the research, what the goals are, what procedures will be done, what the possible risks are, what the possible benefits are, and what other treatments are available for the target disease. In addition, the informed consent form stresses that the subject can leave the study at any time. An important component of the informed consent process is that the subject has the opportunity to ask questions regarding the study and/or the consent form.

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