Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia
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DOI：
10.1111/jgs.16620
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发表时间：
2020-07-01
影响因子：
6.3
通讯作者：
Karlawish, Jason
中科院分区：
文献类型：
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作者：
Largent, Emily A.;Hey, Spencer Phillips;Karlawish, Jason
嵌入式实用临床试验（epct）为改善对痴呆症患者（PLWD）及其护理伙伴的护理提供了机会，但它们也带来了一系列复杂的伦理和监管挑战。这些挑战始于参与者的身份认同。干预措施的提供方式可能难以确定谁是人类受试者，因此谁需要伦理和监管保护。知情同意这一核心的人类受试者保护需要被考虑，但可能与实用主义研究设计的目标相冲突。因此，必须考虑放弃或更改知情同意是否合理。如果需要知情同意，那么如何获得知情同意的问题就出现了，因为研究人员必须承认PLWD的脆弱性，部分原因是能力下降，同时对他人的依赖也增加了。此外，研究人员应该认识到，许多进行epct的地点将不熟悉人类受试者的研究法规和伦理。在本报告中，国家老龄化研究所嵌入实用性阿尔茨海默病（AD）和AD相关痴呆（AD/ADRD）临床试验（IMPACT）合作实验室的监管和伦理核心讨论了epct在PLWD中的关键伦理和监管挑战。一个中心论点是，研究人员应该努力在设计epct的早期预测和解决这些挑战，作为确保依从性和推进科学的一种手段。中国生物医学工程学报，2016,31(2):444 - 444。
Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identifywhois a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science.J Am Geriatr Soc 68:S37-S42, 2020.