Chemoprevention trials in cancer research--ethical considerations.
The idea of preventing cancer with a pill sounds attractive to most people. But several ethical issues need to be addressed before a chemoprevention trial is started. Undue fear of cancer--not only among the participants--may be triggered if the information to the public is not formulated with great care. Since prolonged treatment is typically required, the participants' quality of life may become impaired: they may even perceive themselves as already sick. The ethical implications of placebo treatment for many years need careful consideration. The investigators must also have a plan for how to take care of the participants after the study. The benefits of the intervention are small and not noticeable for the individual, who will never know whether he/she would otherwise have developed cancer. But participants who get cancer despite their efforts to comply with the study protocol will likely feel double disappointment. It is of paramount importance that people are given a realistic, honest, and understandable account of both benefits and risks/disadvantages before they decide to participate.
Department of Medical Epidemiology, Karolinska Institutet, Stockholm, Sweden.
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D002986:Clinical Trials as Topic; D035061:Control Groups; D003362:Cost-Benefit Analysis; D004992:Ethics, Medical; D006801:Humans; D009369:Neoplasms / Q000517:prevention & control*; D010919:Placebos; D035842:Research Subjects; D012306:Risk; D018570:Risk Assessment
D010919:Placebos