Professional integrity in clinical research.

Professional integrity in clinical research.
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临床研究的专业诚信。

DOI:
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发表时间:
1998
期刊:
Journal of the American Medical Association (JAMA)
影响因子:
--
通讯作者:
Evan G. DeRenzo
Evan G. DeRenzo
中科院分区:
--
文献类型:
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作者:
F. Miller;D. Rosenstein;Evan G. DeRenzo

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为了回应公众对滥用人体医学实验的关切,过去30年来,对临床研究伦理的主要做法是监管,特别是通过机构审查委员会审查和批准科学方案和书面同意书。然而,监管机制在确保临床研究的道德行为方面的效力有限。很少有人关注的性质和作用的专业诚信的医生的研究人员,一个认真的框架,指导研究人员在社会上重要的,但道德上复杂的临床研究活动。职业诚信对于在研究者和患者志愿者之间建立道德上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。我们严格审查2模型的道德身份的医生研究者,研究者作为临床医生和研究者作为科学家,在这两种模式都不能完全消除的道德冲突所造成的临床研究。医生研究者的职业诚信取决于一个连贯的道德身份,这是适当的临床研究企业。临床医生和科学家的角色必须整合,以认真管理伦理的复杂性,模糊性,以及科学和志愿者患者护理之间潜在的竞争忠诚之间的紧张关系。
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.
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发表时间: 1997
影响因子: --
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发表时间: 1995-05-01
影响因子: 45.3
作者:
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