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涉及人类受试者的生物医学和行为研究中的基本伦理原则。

Basic ethical principles in the conduct of biomedical and behavioral research involving human subjects.

作者信息

Engelhardt H T

出版信息

Tex Rep Biol Med. 1979;38:139-68.

PMID:531757
Abstract

Moral postures concerning research involving human subjects are diverse in part because of the diversity of issues at stake in, for example, disputes over conflicts of rights and duties, concerning values, and with regard to duties to persons with interests in goods and values. I have presented three ethical principles around which to gather these questions: I) respect for human subjects as free agents; II) concern to foster the best interests of human subjects; and III) concern to maximize the benefits accruable to society. I have indicated that these three abstract considerations arise around four procedural foci for research involving humans: A) the requirement of free and informed consent of competent human subjects; B) the requirement of proxy consent from incompetent human subjects; C) the avoidance of coercion in the consent context; and D) an interest in having research involving humans redound to the general good of society. These are at best guidelines, or outlines, of the central ethical issues at stake. They must in each case of research be applied with care and followed with prudence. One can never have a means of simply deducing answers. Basic ethical principles represent, rather, our best attempt to map out the terrain of rights and values.

摘要

关于涉及人类受试者的研究的道德立场多种多样,部分原因在于所涉问题的多样性,例如在权利与义务冲突、价值观以及对涉及物品和价值观的人的义务等争议中。我提出了三条伦理原则来归纳这些问题:一、将人类受试者视为自由主体予以尊重;二、关注促进人类受试者的最大利益;三、关注使社会可获得的利益最大化。我已表明,这三条抽象考量围绕涉及人类的研究的四个程序重点产生:A)有行为能力的人类受试者需自由且知情同意;B)无行为能力的人类受试者需代理同意;C)在同意过程中避免胁迫;D)关注使涉及人类的研究有益于社会的总体利益。这些充其量只是所涉核心伦理问题的指导方针或概述。在每项研究中都必须谨慎应用并审慎遵循。人们永远不可能有简单推导答案的方法。基本伦理原则更确切地说代表了我们描绘权利和价值观领域的最佳尝试。

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