Ethical problems in clinical research in non-small cell lung cancer. The expert surrogate studies

Abstract

Ethical aspects of clinical research The dilemma of the clinician-investigator. Progress in medicine requires clinical research and clinical trials have therefore become an accepted part of the practice of oncology. Clinical researchers, however, face ethical problems which have not yet been fully resolved [ 11. Doctors who are involved in clinical research retain their traditional role as caregivers in the service of today’s patients but they have also become scientists in the service of future generations. This dual role brings with it a potential conflict of interest because, when doctors become scientists, patients become potential research subjects and may be considered as a means to an end, as well as an end in themselves [l+ The profession has recognized this problem and has developed guidelines to protect the interests of both the patient and the doctor in this complex new relationship. Codes of practice for clinical researchers comprise two kinds of rules: (a) those which affirm the patient’s basic rights in the context of an experiment; and (b) those which define what constitutes an ethical experiment [5,6]. The patient’s rights. All ethical codes demand that patients must give their informed consent before they are involved in a clinical experiment [5,6]. This rule is based on the principle of respect for autonomy which has come to occupy a central position in modem medical ethics [7]. However, people who have recently learned that they are seriously ill may not be psychologically capable of considering the implications of participating in a clinical trial [S], and detailed medical information may, in any case, be of little value to those who have not been trained to interpret it [9]. Many empirical studies have shown that patients who have given their informed consent for treatment or investigation may have little understanding of that to which they have c.onsented [lO-131. In our own clinic, we found that, while cancer patients usually know their diagnosis, they frequently misunderstand the purpose of their treatment and overestimate its potential benefits [14]. Thus, it is unreasonable to assume that every patient is able to carry out the kind of cost/benefit analysis required to reach a rational decision about participation in a