Ethics of clinical oncology research

Abstract

Ever since the earliest days of cancer research, ethical issues have been integral. In 1891, a French physician, Victor Cornil, reported that to determine whether cancer was contagious, a small section of breast tumor removed from the breast of one woman was implanted in her contralateral noncancerous breast. The surgical resection and implant were conducted when the patient was anesthetized and without the patient's consent. When this research study was initially reported it was condemned as criminal. In 1892, another cancer surgeon, William Coley, was conducting studies to determine whether artificial erysipelas (induced inflammation) would have antineoplastic effects. In describing one patient with a sarcoma, he noted that initially the patient was most reluctant to undergo the treatment. But after some deliberation he consented, and on the 21st of April 1892 I began inoculations. Since that time, there has been substantial thought about the ethical issues involved in clinical oncology research, producing both more systematic analyses and important empirical data relevant to these issues. We delineate a general framework for analyzing the ethics of clinical research studies and then examine ethical issues involved in individual topics: (1) randomization and clinical equipoise; (2) informed consent; (3) Phase I oncology research; (4) stored biologic samples; (5) genetic testing; and (6) conflict of interest. © 2006 Springer Science+Business Media, Inc.