Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, and Alberta Health Services, Edmonton, AB, Canada.
Intensive Care Patient and Family Partnership Committee, Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.
Can J Anaesth. 2024 Jul;71(7):1015-1022. doi: 10.1007/s12630-024-02723-3. Epub 2024 Mar 8.
The acceptability of waiver of consent for participation in clinical research in intensive care unit (ICU) settings is uncertain. We sought to survey the Canadian public to assess levels of support, comfort, and acceptability for waived consent for low-risk clinical trials.
We performed a prospective cross-sectional survey of the Canadian public aged 18 yr or older. The survey was conducted by Ipsos between 19 and 23 November 2020. The survey content was derived from a literature review and in consultation with a patient and family partnership committee. The survey focused on attitudes and beliefs on waived consent for participation in low-risk clinical trials in ICU settings. The survey contained 35 items focused on sociodemographics, general health status, participation in medical research, and levels of support and comfort with research and with waived consent. The survey used a case study of a low-risk clinical trial intervention in ICU patients. Analysis was descriptive.
We included 2,000 participants, 38% of whom reported experience with ICU and 16% with medical research. Participation in medical research was more common among those with postsecondary education, those with chronic disease, and those who were employed in health care. Most (80%) would support a model of waived consent for low-risk clinical trials, citing medical benefits (36%) and low perceived risk (34%). Most (77%) were comfortable with personally participating in a low-risk clinical trial. Most (80%) believed waived consent approaches were acceptable. Half (52%) believed the waived consent process should provide information about the research and include the option of opting out. When asked whether participants should always give full informed consent, regardless of the practicality or level of risk, 74% and 72% agreed, respectively.
There is public support for models of waived consent for participation in low-risk pragmatic clinical trials in ICU settings in Canada; however, this is not universal. This information can inform and guide education, ethics, policy, and legal discussion on consent models.
在重症监护病房（ICU）环境下，参与临床研究时放弃同意的可接受性尚不确定。我们旨在调查加拿大公众，评估对低风险临床试验豁免同意的支持、舒适度和可接受程度。
我们对年龄在 18 岁或以上的加拿大公众进行了一项前瞻性的横断面调查。这项调查是由益普索公司于 2020 年 11 月 19 日至 23 日进行的。调查内容源自文献综述，并与患者和家庭合作委员会进行了磋商。调查重点是对 ICU 环境下参与低风险临床试验的豁免同意的态度和信念。调查包含 35 个项目，重点关注社会人口统计学、一般健康状况、参与医学研究以及对研究和豁免同意的支持和舒适度。调查采用了 ICU 患者低风险临床试验干预的案例研究。分析采用描述性方法。
我们纳入了 2000 名参与者，其中 38%的人报告有 ICU 经历，16%的人有医学研究经历。接受过高等教育、患有慢性病和从事医疗保健工作的人更有可能参与医学研究。大多数（80%）人支持低风险临床试验的豁免同意模式，理由是医疗获益（36%）和低感知风险（34%）。大多数（77%）人对个人参与低风险临床试验感到舒适。大多数（80%）人认为豁免同意方法是可以接受的。有一半（52%）人认为豁免同意程序应提供有关研究的信息，并包括选择退出的选项。当被问及无论实际情况或风险水平如何，参与者是否应始终给予完全知情同意时，分别有 74%和 72%的人表示同意。
在加拿大，公众支持 ICU 环境下参与低风险实用临床试验的豁免同意模式；然而，这并非普遍情况。这些信息可以为关于同意模式的教育、伦理、政策和法律讨论提供信息和指导。
