Medical Research with Children: Ethics, Law and Practice

Medical Research with Children: Ethics, Law and Practice
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儿童医学研究:伦理、法律和实践

DOI:
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发表时间:
1987
期刊:
The Yale Journal of Biology and Medicine
影响因子:
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通讯作者:
S. Gollamudi
S. Gollamudi
中科院分区:
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文献类型:
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作者:
S. Gollamudi

文献摘要

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对儿童的研究给人类提出了特殊的问题:如何在不损害任何个别儿童利益的情况下,追求直接或间接造福于所有儿童的医学知识?对可能无法给予充分知情同意的儿童进行测试或程序是否道德?其中涉及许多伦理和法律原则,其中的不一致足以让任何即将开始临床研究的儿科研究人员感到困惑。自纳粹暴行以来,国家和国际协会以及各个政府立法机构多年来制定了大量指导方针。然而,这些指导方针经常试图定义儿童研究的合法性,而不是道德性(不幸的是,两者并不总是一致)。尽管对后一个主题进行了广泛的争论,尤其是伦理学家保罗·拉姆齐和理查德·麦考密克,但医学研究从业者在这方面几乎没有明确的答案。儿童医学研究:伦理、法律和实践在弥补这一缺陷方面做出了值得称赞的工作。该文本基于一个工作组的讨论,该工作组的召集目的是“重新研究该问题并发布一份报告,旨在鼓励反思,或许还可以帮助研究伦理委员会成员履行其职责”。三年内他们在英国会面了二十五次。小组成员包括医生、哲学家、律师和其他相关专业人士,使该书具有明显平衡的前景。引言中明确阐述了这些目标,并且肯定已经实现。工作组决定只考虑对从出生那一刻到16岁的活产儿童的研究,从而避免了对胎儿或受精卵的研究主题。虽然这可能被认为是一个缺点,因为大多数活跃的辩论都是关于这些主题的,但深入研究这些问题只会引起混乱,并且会掩盖其余讨论的亮点。共有十章,所有章节的组织都是为了让医学学术界的成员能够从最简单的道德理想出发,并得出一些可行的指导方针。第 1 章到第 5 章将论点摆在读者面前。定义了各种道德和技术术语,并提出了可能的含义。哲学和法律探究保持简短和简洁,使医学界能够轻松理解和……
Research on children poses special problems to humanity: how does one go about pursuing medical knowledge, directly or indirectly beneficial to all children, in a way that does not jeopardize the interests of any individual child? Is it ethical to perform tests or procedures on a child who may not be able to give fully informed consent? There are many ethical and legal principles involved, with enough inconsistencies to bewilder any pediatric researcher about to begin a clinical study. A multitude of guidelines have been developed over the years since the Nazi atrocities, both by national and international associations and by various governmental legislatures. Yet these guidelines often tried to define what is legal in research on children, not what is ethical (unfortunately, the two do not always coincide). While there has been extensive debate on the latter subject, most notably by ethicists Paul Ramsey and Richard McCormick, very few definitive answers are available to practitioners of medical research in this regard. Medical Research with Children: Ethics, Law, and Practice does a commendable job in remedying this lack. The text is based on the discussions of a working group convened to study "the question afresh and publish a Report designed to encourage reflection and, perhaps, to help members of Research Ethics Committees in the discharge of their duties." They met in England twenty-five times over three years. Group members included physicians, philosophers, lawyers, and other related professionals , giving the volume a noticeably balanced outlook. The goals were clearly stated in the Introduction and are certainly achieved. The working group decided to consider only research on live-born children from the moment of birth to the age of 16 years, thus avoiding the topic of research on the fetus or on fertilized eggs. While this may be considered a drawback in that most of the active debates are on these topics, delving into these issues would have caused only confusion and would have masked the highlights of the rest of the discussions. There are ten chapters, all organized so that a member of the medical academic community can progress from the simplest of ethical ideals and conclude with some workable guidelines. Chapters 1 through 5 set the arguments in before the reader. Various ethical and technical terms are defined, and possible implications are presented. Philosophical and legal inquiry is kept brief and concise, allowing the medical community easily to understand and …