...analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.

In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs. The conflation between the ethics of clinical research and the ethics of clinical medicine is traced to an error in ethical judgment and reasoning derived from misguided moral intuition. In what follows I illustrate and diagnose this therapeutic misconception about the ethics of clinical research, offer some hypotheses to suggest why it has taken hold in ethical thinking, and reply to objections to this critique.

IN COHERENCE IN THE ETHICS OF CLINICAL RESEARCH: THE DECLARATION OF HELSINKI

The conflation between the ethics of clinical research and the ethics of clinical medicine is notably manifested in The Declaration of Helsinki, which stipulates "ethical principles for medical research involving human subjects." (2) Principle number 3 states, "The Declaration of Geneva of the World Medical Association binds the physician with the words, 'The health of my patient will be my first consideration.'" This is certainly a sound principle for the ethics of therapeutic medicine; however, its appearance in the leading international code of ethics for clinical research is puzzling. It implies that clinical research should be governed by the patient-centered therapeutic beneficence characteristic of medical care.

The Declaration also contains principle number 5 stating that "In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society." This provides sound guidance for clinical research insofar as it directs investigators to avoid exploiting research subjects and seriously compromising their well-being for the sake of science. However, if considerations relating to the well-being of research subjects should always take precedence over the interests of science and society, how can any research risks be justified that are not compensated by potential medical benefits to the subjects? It is generally considered ethical for physician-investigators to perform nontherapeutic research interventions, such as blood draws, lumbar punctures, and imaging procedures, in studies of pathophysiology of disease and to measure outcomes of clinical trials. Although these research risks are often no more than minimal, they potentially threaten subjects' well-being. An ethical code for guiding a practice is incoherent if it stipulates principles the application of which would make the practice impossible.

DIFFERENCES BETWEEN CLINICAL RESEARCH AND CLINICAL MEDICINE

Physicians in clinical practice aim at providing optimal medical care for individual patients who seek their help. The prospect of medical benefits for individual patients justifies the risks of medical interventions. Clinical medicine, accordingly, is governed ethically by the principles of therapeutic beneficence and therapeutic nonmaleficence.

Clinical research is not a therapeutic activity devoted to the personal care of particular patients. It is designed to answer scientific questions by producing generalizable knowledge. Physician-investigators design and conduct scientific experiments to learn about disease and its treatment in groups of patients, with the ultimate aim of improving medical care. Basic features of randomized clinical trials, often erroneously described as "therapeutic research," (3) exhibit the ethically...

NOTE: All illustrations and photos have been removed from this article.



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