Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients' and the public's attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people's informed, rather than initial, preferences on this subject. In addition, we advise 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 has sufficiently high social value.

中文翻译：

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将研究纳入护理时公众对同意的态度——所有“是”中的任何“应该”？

整合到正在进行的临床活动中的研究具有加速知识生成以改善个人和人群健康的潜力。然而，将研究纳入临床护理提出了困难的伦理和监管挑战，包括如何或是否获得知情同意。多项实证研究探讨了患者和公众对务实研究同意方法的态度。然而，关于如何使用所得经验数据来解决规范和政策辩论以及哪种数据最值得考虑的问题仍然存在。我们建议优先考虑人们认为可接受的数据，以同意进行务实的研究，以及人们对这一主题的知情偏好数据，而不是最初的偏好数据。此外，我们建议谨慎对待多数观点的权重，并确定可以覆盖经验数据的情况。我们认为，经验数据支持规范性论点，即同意的改变应该是实用研究的默认设置；仅当实用性研究不可行且具有足够高的社会价值时，才适用豁免.