EDITORIAL

Ethical Significance of Ethics-Related Empirical Research

Franklin G. Miller

Correspondence to: Franklin G. Miller, Ph.D., Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bldg. 10, Rm. 1C118, Bethesda, MD 20892–1156 (e-mail: fmiller{at}nih.gov).

Empirical research designed to address ethical issues in medicine and biomedical research has grown enormously over the past 15 years. However, the value of ethics-related empirical research, which depends on the ethical significance of research questions and study results, has not received the careful, critical attention it deserves. The article by Joffe and Weeks (1) in this issue of the Journal highlights some of the challenges in the state-of-the-art of empirical research on ethical issues in clinical research.

The authors orient their research and interpret their findings in terms of two ethically important and related ideas: the differences between medical research and medical care and the therapeutic misconception. The ethically significant differences between clinical trials and medical care encompass the contrasting purposes of these activities, which are the topic of the authors’ study; the characteristic methods of clinical trials (e.g., randomization, double-blind conditions, use of placebos, drug washouts, treatment by protocol); and the justification of risks (2,3). Accordingly, it is valuable to understand the extent to which physician–investigators understand the important differences in purpose between clinical trials, which are devoted to generating scientific knowledge with the aim of improving treatment of future patients, and medical care, which is devoted to the diagnosis and treatment of particular patients. The key finding that a substantial proportion of oncologists responding to a questionnaire reported that the main societal purpose of clinical trials is to benefit participants raises significant ethical issues.

The "therapeutic misconception" is a term coined by Appelbaum and his colleagues (4) to describe the tendency of interviewed psychiatric patients to confuse their participation in clinical trials with the personalized clinical attention characteristic of medical care. Although the therapeutic misconception is believed by many ethical commentators to be widespread, no systematic data are available on its prevalence (5).

Moreover, the ethical significance of therapeutic misconceptions about clinical research among patient volunteers is unclear. Joffe and Weeks (1) assert that "The therapeutic misconception arguably constitutes the most important threat to the validity of informed consent to research." Does it follow that any manifestation of the therapeutic misconception among research participants invalidates their consent to participate in research, thus making their enrollment unethical? In other words, is an accurate understanding and appreciation of the differences between participating in clinical trials and receiving medical care necessary for informed consent? Because the extent of the therapeutic misconception is likely to be a matter of degree, what level of this misconception undermines informed consent? How should investigators in the informed-consent process, or consent monitors, assess the presence of therapeutic misconceptions among prospective subjects and intervene to dispel them? There is no consensus on how to answer these ethical questions. In addition to the need for more careful thought about the implications of the therapeutic misconception for informed consent, further empirical research is needed to address these questions. This research will require the development of a standard operational definition of the therapeutic misconception among research participants and validated tools for measuring it.

How are the views of physician–investigators about the purpose of clinical trials relevant to the presence of therapeutic misconceptions among patient volunteers? Presumably these views are linked by the hypothesis that is suggested but not explicitly asserted by Joffe and Weeks (1), that those investigators who see the purpose of clinical trials in a therapeutic light are more likely to foster therapeutic misconceptions among the patients whom they recruit for research participation and inform about the trial. This hypothesis may be worthy of attention in future research. Nevertheless, if we are unclear about the ethical significance of the therapeutic misconception among patient volunteers, then it is difficult to interpret the ethical significance of the findings of this study concerning oncologists’ views about the purpose of clinical trials.

What difference does it make ethically that between 13% and 38% of various oncologic subspecialists stated that the main societal purpose of clinical trials is to provide patients with state-of-the-art therapy (1)? On the one hand, it is encouraging that most sampled oncologists correctly identified the purpose of clinical trials as generating knowledge aimed at improving treatment for future patients. On the other hand, the fact that most oncologists can identify the "correct" answer does not mean that they are doing a satisfactory job of helping patients appreciate the differences between clinical trials and medical care.

In any case, Joffe and Weeks are right to find it ethically worrisome that substantial proportions of oncologists, especially pediatric oncologists, appear to misconceive the purpose of clinical trials. Although the implications of these findings for informed consent are interesting and worthy of further investigation, their bearing on the professional integrity of physician-investigators may have greater significance (6). As Joffe and Weeks point out, to the extent that investigators see their role through a therapeutic lens, investigators may fail to appreciate the inherent ethical tensions between scientific investigation and protection of research participants. Clarity about the differences and potential conflicts between patient care and clinical investigation is ethically important at all stages of clinical research, from study design, to subject recruitment and selection, to informed consent, to monitoring the condition of research participants, to deciding when to stop research participation because of adverse events or clinical deterioration. Correctly understanding the purpose of clinical trials is only one dimension of recognizing how treatment in the context of a clinical trial differs from personalized medical care in fundamentally important ways.

The practices of medicine and biomedical research, and the discipline of bioethics, have much to gain from well-focused empirical research on ethical issues. The value of ethics-related empirical research, as in the case of all research, flows from the importance of the questions it seeks to answer. Lack of clarity about the ethical significance of research questions leaves the ethical significance of study findings open to question. Much of ethics-related empirical research can be criticized with respect to the ethical significance of research questions and results. Acuity of ethical thinking is a necessary condition for excellence in empirical research devoted to understanding ethical issues in medicine and biomedical research.

REFERENCES

1 Joffe S, Weeks JC. Views of American oncologists about the purposes of clinical trials. J Natl Cancer Inst 2002;94:1847–53.[Abstract/Free Full Text]

2 Levine RJ. Ethics and regulation of clinical research. 2nd ed. New Haven (CT): Yale University Press, 1986.

3 Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701–11.[Abstract/Free Full Text]

4 Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 17:20–4.

5 Lidz CW, Appelbaum PS. The therapeutic misconception: problems and solutions. Med Care 2002;40(9 Suppl):V55–63.[Medline]

6 Miller FG, Rosenstein DL, DeRenzo EG. Professional integrity in clinical research. JAMA 1998;280:1449–54.[Abstract/Free Full Text]


This article has been cited by other articles in HighWire Press-hosted journals:


             
Copyright © 2002 Oxford University Press (unless otherwise stated)
Oxford University Press Privacy Policy and Legal Statement