Informed consent is an essential requirement prior to clinical trial participation, however some 'vulnerable' groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity. Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population. This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.

译文

:知情同意是参加临床试验之前的一项基本要求,但是,某些“弱势”群体,例如具有认知障碍的人和处于医疗紧急情况下的人,可能缺乏决定性的同意能力。在设计和进行涉及这些人群的临床试验时,这在道德和实践方面提出了挑战,因此常常被排除在外。尽管最近在改善知情同意程序方面取得了进展,但对招募缺乏能力的成年人的关注却很少。排除标准是临床试验结果外部有效性的重要决定因素。将这些人群排除在外,以及由于识别和替代代理决策者的挑战而引起的基于同意的招聘偏见,导致无法代表临床人群的试验。本文讨论了缺乏决定性同意能力的成年人参与临床试验的情况,并介绍了过去十年的进展以及将这一代表性不足的人群纳入研究的其余伦理挑战。

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