Ethical considerations of study participants in dental caries clinical trials

During the past 30 years there has been increasing concern for ethical considerations that pertain to the conduct of human biomedical research. Consequently, many national and international medical and dental organizations and agencies have developed regulations, policies or ethical guidelines for the protection of human subjects who take part in clinical investigations. In the United States, more than 500 research institutions have established permanent committees to review research in humans conducted by their institutions. Members of these committees must represent a broad range of backgrounds, interests, and concerns. Prospective study subjects must be able to make an informed decision on whether to participate in any study, without any element of force, deceit, duress, or other form of constraint or coercion. Obtaining informed consent for studies of children, the mentally infirm, and persons with restricted civil freedom presents special problems. Ethical considerations also raise questions on appropriate designs for clinical studies, e.g. use of untreated controls. Dental studies, particularly those testing caries-preventive agents, raise special questions of design, informed consent, ethical procedures and the use of diagnostic radiographs. The director of a clinical study is responsible for the conduct of all personnel connected with the investigation.