Public Attitudes toward Consent When Research Is Integrated into Care-Any "Ought" from All the "Is"?

Public Attitudes toward Consent When Research Is Integrated into Care-Any "Ought" from All the "Is"?
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当研究被整合到护理中时,公众对同意的态度--从所有的“是“到”应该”?

DOI:
10.1002/hast.1242
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发表时间:
2021-03
期刊:
The Hastings Center report
影响因子:
--
通讯作者:
Largent EA
Largent EA
中科院分区:
其他
文献类型:
--
作者:
Morain SR;Largent EA

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将学习融入正在进行的临床活动的研究方法提供了加速知识生成的潜力,以改善个人和人群的健康。然而,将研究纳入临床护理提出了困难的伦理和监管问题。多项实证研究探讨了患者和公众对同意方法的态度,以务实的研究。然而,关于由此产生的经验数据在解决规范性辩论中的适当作用,仍然存在悬而未决的问题。我们建议,数据的可接受性或知情的偏好应优先考虑;建议谨慎考虑给予多数人的观点的权重;并确定经验数据可以被推翻的情况。我们认为,实证数据支持规范的论点,同意的更改应在务实的研究默认;放弃是适当的,只有当务实的研究,否则是不切实际的,也有足够高的社会价值。最后,我们建议开展更多工作,以指导政策决定。
Research approaches that integrate learning into ongoing clinical activities offer the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet, integrating research into clinical care raises difficult ethical and regulatory questions. Multiple empirical studies have explored patients’ and public attitudes toward approaches to consent for pragmatic research. Open questions remain, however, regarding the appropriate role of the resulting empirical data in resolving normative debates. We propose that data on acceptability or informed preferences should be prioritized; suggest caution regarding the weight given to majority viewpoints; and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and also has sufficiently high social value. We conclude with suggestions for additional work to guide policy decisions.
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