A Normative Justification for Distinguishing the Ethics of Clinical Research from the Ethics of Medical Care
In the research ethics literature, there is strong disagreement about the ethical acceptability of placebo-controlled trials, particularly when a tested therapy aims to alleviate a condition for which standard treatment exists. Recently, this disagreement has given rise to debate over the moral appropriateness of the principle of clinical equipoise for medical research. Underlying these debates are two fundamentally different visions of the moral obligations that investigators owe their subjects. Some commentators and ethics documents claim that physicians, whether acting as care givers or researchers, have the same duty of beneficence towards their patients and subjects: namely, that they must provide optimal medical care. In discussing placebo surgery in research on refractory Parkinson's disease, Peter Clark succinctly states this view: “The researcher has an ethical responsibility to act in the best interest of subjects.” The Declaration of Helsinki, a leading code of ethics for clinical research, also appears to accept this ethical view when it embraces the physician's oath, “The health of my patient will be my first consideration.” We, however, argue that researchers owe significant moral obligations to patient-subjects, but do not have the same duty of therapeutic beneficence that binds physicians treating patients. Thus far, while both sides have provided reasons for their respective views and critiques of contrary perspectives, neither side has shown how its view is rooted in and justified by a more general account of what we morally owe to each other. This paper provides that needed, theoretical moral justification for distinguishing the ethical guidelines governing medical care and research, respectively. We examine whether there are legitimate reasons for patient-subjects to demand the ethical orientation of therapeutic beneficence in the research setting, and whether there are otherwise good reasons from the physician-researchers' perspective to conclude that they owe their subjects the same duties owed to patients under medical care. Our inquiry is limited to normal competent adults as the set of potential research subjects, recognizing that the ethics of conducting research on children and mentally incompetent persons requires separate treatment.
Paul Litton & Franklin G. Miller, A Normative Justification for Distinguishing the Ethics of Clinical Research from the Ethics of Medical Care, 33 J.L. Med. & Ethics 566 (2005)