Human experimentation and human rights.

Abstract

ion of the research question tends to objectify the person-patient.27 It does so to a significantly greater extent than in therapeutic interactions, even though similar problems of objectification arise in therapeutic settings when doctors attend too much to the disease of the body in the bed and not to the person before them. The readiness with which clinical research continues to be viewed as an extension of clinical practice, both similarly grounded in the millennia-long Hippocratic commitment to the welfare of the individual patient, overlooks the transformation of medical practice since the age of medical science. Throughout most of medical history, research was limited to careful bedside observation of the effects of innovative treatments, with the interests of the individual patient as a polestar. In today's world, on the other hand, the interests of patient-subjects may yield to varying extents to the interests of science. This revolutionary development has not been accompanied by a thoroughgoing re-examination of physicians' ethical obligations in a postHippocratic age. Examples in point are the many cooperative clinical trials, generally randomized clinical trials (RCTs),30 in which institutions throughout the 27. See infra note 66 and accompanying text. 28. In a conversation between a senior physician and a medical intern, the former asked how much the intern knew about "patients as human beings." The question led to a rather nonproductive exchange which the intern ended abruptly with the exasperated comment: "I cannot answer your questions. You're interested in patients. I'm interested in the disease in the body in the bed." RAYMOND S. DUFF & AUGUST B. HOLLINGSHEAD, SICKNESS AND SOCIETY 128 (1968). 29. Medical practice has become transformed in other ways as well which should have led to greater involvement of patients in the medical decision-making process: Medicine's recent ascent from empiricism to science has brought forth spectacular technologic advances in the diagnosis and treatment of disease. Today the numerous options available for the treatment of many diseases allow patients greater choice. Moreover, the introduction into medicine of scientific reasoning, aided by the results of carefully conducted research, permits doctors to be more discriminating between knowledge, ignorance and conjecture in their recommendations for or against a treatment. For the first time in medical history, it is possible, even medically and morally imperative, to give patients a voice in medical decision making; possible, because knowledge and ignorance can be better specified; medically imperative, because a variety of treatments are available, each of which can bestow benefits or inflict harm; morally imperative, because patients, depending on the lifestyle they wish [to lead) after treatment, must be given a choice. Duty and Caring, supra note 20, at 189. 30. The randomized clinical trial (ReT) is generally regarded as the gold standard for the evaluation of therapeutic agents. The ReT has four main elements. 1) It is "controlled," i.e., one part of the subject population receives a therapy that is being tested while another part, as similar as possible ... , receives either another therapy or no therapy.... 2) The significance of its results is established through statistical analysis. . .. 3) When it is feasible, a double-blind