The role of community consultation in the ethical conduct of research without consent.
The role of community consultation in the ethical conduct of research without consent.
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社区协商在未经同意的研究道德行为中的作用。
DOI：
10.1080/15265160600685853
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发表时间：
2006
期刊：
影响因子：
--
通讯作者：
Wilets,Ilene
中科院分区：
文献类型：
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作者：
Richardson,LynneD;Rhodes,Rosamond;Ragin,DeborahFish;Wilets,Ilene
@ R，”集中在这些法规的一个有问题的方面，即社区咨询和公开披露的要求（霍洛威2006）。她对社区咨询的不利评价似乎是对目前制度化医学和医学研究所使用的“社区”概念进行更普遍起诉的工具。虽然这种批评可能是合理的，霍洛威的论点是没有说服力的，她选择的例子似乎考虑不周。Satcher（2001）对真实的社区的多样性和复杂性的描述并不矛盾，任何熟悉她的著作的人指责Lillie-Blanton等人都是虚伪的。（2001）文化偏见。然而，具体来说，我们希望对霍洛威的断言提出异议，即在紧急情况研究的学科中，社区被用作“个人自治的令人不安的替代”（霍洛威，2006，7）。正如施密特等人在其对21 CFR 50.24的制定和规定的出色总结中指出的那样，社区咨询要求是每当为紧急研究授予知情同意例外时提供的特殊保护之一（施密特等人2006）。社区咨询既不是个人知情同意的道德替代品，也不是法律的替代品，但如果进行得当，它可以促进重要的道德目标。由于生命受到威胁的健康状况，他们被剥夺了自主权，尊重人的原则要求这些人得到保护。在紧急治疗的情况下，假定病人希望得到救生措施，保健提供者通常根据假定同意的原则行事。无法同意紧急研究的个人的假定偏好就不那么清楚了。通过限制知情者的例外，
@ R,” focuses on a problematic aspect of these regulations, namely the requirements for community consultation and public disclosure (Holloway 2006). Her unfavorable appraisal of community consultation appears to be a vehicle for a more general indictment of the notion of “community” as currently used by institutionalized medicine and medical research. Although this criticism may be justified, Holloway’s arguments are not persuasive and her chosen exemplars seem ill-considered. There is nothing paradoxical about Satcher’s (2001) description of the diverse and complex nature of real communities, and it is disingenuous for anyone familiar with her writings to accuse Lillie-Blanton et al.(2001) of biased cultural notions. Specifically, however, we wish to take issue with Holloway’s assertion that, within the discipline of emergency research, community is being used as a “troubling displacement for individual autonomy”(Holloway 2006, 7). As Schmidt et al. point out in their excellent summary of the development and provisions of 21 CFR 50.24, the requirement for community consultation is one of the special protections provided whenever an exception from informed consent is granted for emergency research (Schmidt et al. 2006). Community consultation is neither an ethical nor legal substitute for individual informed consent but, when properly conducted, it can advance important ethical goals.Individuals who succumb to a medical emergency are often unable to give their informed consent for emergency treatment. Having been deprived of their autonomy by the life-threatening medical condition from which they are suffering, the principle of respect for persons demands that these individuals be protected. In the case of emergency treatment, patients are presumed to want life-saving measures and health care providers routinely act under the doctrine of presumed consent. The presumed preference of an individual who is unable to consent to emergency research is much less clear. By limiting the exception from informed