Ethical Issues of Chemoprevention Clinical Trials.

BACKGROUND: Chemoprevention of malignancy is a new concept in clinical medicine, and little is written about the ethics of identifying and enrolling eligible subjects in chemoprevention clinical trials. METHODS: The authors identify the ethical issues raised in the conduct of clinical chemoprevention trials and review the ethical considerations that should guide clinical researchers in the design and conduct of this new type of clinical trial. RESULTS: The ethics of chemoprevention clinical trials are complicated because (1) chemoprevention lies at the intersection of disease management and health promotion, (2) there are conflicting interests competing in these trials, and (3) multiple values play a role in determining the nature and magnitude of the risks and benefits of chemoprevention of cancer. Ethical questions related to these trials concern the enrollment of healthy individuals rather than cancer patients, confidentiality in recruitment, the enrollment of "high-risk" subjects, randomization, informed consent, trial monitoring, and competing outcomes and toxicities. CONCLUSIONS: These issues will be resolved with the accumulating clinical experience and ethical deliberations that accompany ongoing clinical chemoprevention research studies.