Full Disclosure: Telling Patients When Not Being a Research Subject is a Good Choice

Abstract

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.