Ethics Center, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Account Res. 2012;19(1):1-12. doi: 10.1080/08989621.2011.622173.
Clinical research to improve care across the broad spectrum of health care has led to better quantity and quality of life for many patients. However, imposing arbitrary restrictions that might result in the exclusion from clinical research of patients who are at the end of life, or patients with a high risk of dying, is undesirable. Such exclusions may violate the principle of justice, by denying these patients a valid opportunity to make an important socio-medical contribution, and could make it difficult or impossible to advance clinical knowledge about the care of these patients. This article reviews issues relevant to the conduct of research on dying patients and those who are at high risk of dying, and outlines special considerations for ensuring that such research is ethical. In particular, precautions should be taken to ensure that informed consent is obtained from patients who are capable (or their substitute decision maker if the patient is not capable), free from coercion, and not harboring false expectations about the likelihood of benefiting from the study intervention. The unique circumstances surrounding the timing of this research (at the end of life or potentially there) may warrant that some patients be considered vulnerable, requiring special protective measures. Adhering to these principles will help ensure that dying patients or patients at high risk of dying can still participate in research that has the potential to advance knowledge and improve future care.
临床研究改善了广泛的医疗保健服务，为数以百万计的患者带来了更高的生活质量和更好的生活体验。然而，任意施加限制，可能会导致处于生命末期或死亡风险较高的患者被排除在临床研究之外，这是不可取的。这种排除可能违反公正原则，剥夺了这些患者做出重要社会医疗贡献的机会，并且可能使我们难以或无法推进有关这些患者护理的临床知识。本文回顾了与临终患者和高死亡风险患者的研究相关的问题，并概述了确保此类研究符合伦理规范的特殊考虑因素。特别应注意确保有能力的患者（或如果患者没有能力，则由其替代决策者）获得知情同意，不受胁迫，并且对从研究干预中获益的可能性没有错误的期望。这项研究（在生命末期或可能存在）的时间安排所带来的特殊情况可能使一些患者被认为是脆弱的，需要特殊的保护措施。坚持这些原则将有助于确保临终患者或高死亡风险患者仍能参与有潜力推进知识并改善未来护理的研究。
