Full disclosure: telling patients when not being a research subject is a good choice.
Informed consent to participation in research generally requires giving a person information about the alternatives to being in the research study. It is quite common, however, for research subjects not to be given one particularly significant piece of information: the possibility of obtaining the "new" treatment being studied directly from a doctor without participating in the study. Since many people enroll in studies precisely to get such a new treatment, they frequently would prefer that option--which guarantees them that new treatment--to enrolling in a study where there is only a 50% chance of getting the new treatment. This issue becomes more complicated in the context of pediatric oncology research, since physician-researchers in this field have entered into a unique informal agreement not to offer such new treatments outside of research studies. That agreement, which in effect forces physicians to behave in a manner that subordinates the well-being of some of their current patients to that of future patients, is ethically and legally questionable.
Menikoff
Jerry
J
Institute for Bioethics, Law, and Public Policy, University of Kansas, Kansas City, USA. Jmenikof@kumc.edu
D002755:Choice Behavior; D030881:Disclosure; D005006:Ethnicity / Q000523:psychology; D006801:Humans; D007938:Leukemia / Q000628:therapy; D033282:Parental Consent; D010290:Parents / Q000523:psychology; D010372:Pediatrics; D010817:Physician-Patient Relations; D016032:Randomized Controlled Trials as Topic; D035842:Research Subjects