Miller F G, Rosenstein D L, DeRenzo E G
Department of Medical Education, University of Virginia School of Medicine, Charlottesville, USA.
JAMA. 1998 Oct 28;280(16):1449-54. doi: 10.1001/jama.280.16.1449.
In response to public concern over abuses in human medical experimentation, 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 consent forms. However, the effectiveness of regulatory mechanisms in ensuring the ethical conduct of clinical research is limited. Little attention has been devoted to the nature and role of professional integrity of physician investigators, a conscientious framework for guiding investigators in the socially important but morally complex activity of clinical research. Professional integrity is vital in forging an ethically sound relationship between investigators and patient volunteers, a relationship that differs in important ways from the patient-physician relationship in standard clinical practice. We examine critically 2 models of the moral identity of physician investigators, the investigator as clinician and the investigator as scientist; in neither of these 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 clinician and scientist must be integrated to manage conscientiously the ethical complexity, ambiguity, and tensions between the potentially competing loyalties of science and care of volunteer patients.
为回应公众对人体医学实验中不当行为的关注，在过去30年里，临床研究伦理的主导方法一直是监管，尤其是通过机构审查委员会对科学方案和书面同意书进行审查与批准。然而，监管机制在确保临床研究道德行为方面的有效性是有限的。很少有人关注医师研究者职业操守的本质和作用，职业操守是指导研究者开展临床研究这一具有社会重要性但道德复杂的活动的一个尽责框架。职业操守对于在研究者与患者志愿者之间建立道德健全的关系至关重要，这种关系在重要方面不同于标准临床实践中的医患关系。我们批判性地审视了医师研究者道德身份的两种模式，即作为临床医生的研究者和作为科学家的研究者；在这两种模式中，医师研究者都无法完全消除临床研究带来的道德冲突。医师研究者的职业操守取决于与临床研究事业相适应的连贯道德身份。临床医生和科学家的角色必须整合起来，以切实管理科学与关爱志愿者患者这两种潜在相互竞争的忠诚之间的伦理复杂性、模糊性和紧张关系。
