Hastings Cent Rep. 2021 Mar;51(2):22-32. doi: 10.1002/hast.1242.
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.
将研究融入到日常临床活动中具有加速知识产生的潜力，从而改善个人和人群的健康。然而，将研究融入临床护理提出了具有挑战性的伦理和监管问题，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实用研究同意方法的态度。然而，关于如何在解决规范和政策辩论中使用这些实证数据以及哪种数据最值得考虑，仍然存在疑问。我们建议优先考虑有关人们对实用研究同意可接受性的看法的数据，以及关于人们在这个问题上知情而非最初偏好的数据。此外，我们建议在考虑多数观点的权重时要谨慎，并确定何时可以推翻实证数据。我们认为，实证数据支持了这样的规范论点，即同意的变更应该成为实用研究中的默认做法；只有当实用研究否则不切实际且具有足够高的社会价值时，放弃同意才是合适的。
