PROFESSIONAL INTEGRITY IN CLINICAL RESEARCH

In response to public concern over abuses in human medical experimenta tion, the dominant approach to the ethics of clinical research during the past 30 years has been regulation, particularly via institutional review board review and approval of scientific protocols and written c onsent forms. However, the effectiveness of regulatory mechanisms in e nsuring the ethical conduct of clinical research is limited. Little at tention has been devoted to the nature and role of professional integr ity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity o f clinical research. Professional integrity is vital in forging an eth ically sound relationship between investigators and patient volunteers , a relationship that differs in important ways from the patient-physi cian relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the invest igator as clinician and the investigator as scientist; in neither of t hese 2 models can the physician investigator eliminate completely the moral conflicts posed by clinical research. The professional integrity of physician investigators depends on a coherent moral identity that is proper to the enterprise of clinical research. The roles of clinici an and scientist must be integrated to manage conscientiously the ethi cal complexity, ambiguity, and tensions between the potentially compet ing loyalties of science and care of volunteer patients.