Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.
Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.
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DOI：
10.1177/17470161221131497
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发表时间：
2023-01
期刊：
影响因子：
1.7
通讯作者：
Fox, Robert J.
中科院分区：
文献类型：
--
作者：
Sankary, Lauren R.;Zelinsky, Megan E.;Ford, Paul J.;Blackstone, Eric C.;Fox, Robert J.
临床研究中神经系统疾病参与者的伦理招募需要获得最初和持续的知情同意。本研究的目的是描述研究人员在获得神经系统疾病研究参与者的知情同意时所面临的障碍，并确定研究人员用于克服这些障碍的策略。本研究设计为一项基于网络的美国研究人员调查，并附有可选的后续访谈。通过分层有目的的抽样策略，我们选择了一部分完成调查的参与者，并邀请他们通过电话或视频会议进行深入的定性访谈。数据分析采用混合方法，包括调查回复的内容分析和访谈回复的主题分析。在1年多的时间里，我们收到了113份来自美国研究人员的调查回复，这些研究人员直接参与了获得神经学研究参与者的知情同意。常见的知情同意障碍包括：认知和沟通障碍（如失语症）、对研究参与者不切实际的期望、对医学研究的不信任、时间限制、识字障碍、缺乏可用的社会支持以及与实际或资源有关的限制。加强知情同意的策略包括：让关系密切的人参与进来，以帮助参与者理解与研究相关的信息；与更有经验的研究人员合作，促进获得知情同意的培训；鼓励参与者在讨论同意之前阅读同意书；以及使用印刷材料和视觉参考资料。除了传达与研究相关的信息外，本研究中的研究人员还支持在对研究的误解、不切实际的期望、有限的理解、不信任和/或来自亲密他人的压力的背景下，支持知情同意所必需的审议的伦理责任。研究结果强调了在神经学研究中对参与获得知情同意的研究人员进行培训的重要性，以应对特定疾病的挑战，并支持潜在研究参与者及其亲密他人的决策过程。
The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.
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影响因子：
8.3
作者：
Boden-Albala B;Carman H;Southwick L;Parikh NS;Roberts E;Waddy S;Edwards D
通讯作者：
Edwards D
影响因子：
7.4
作者：
Geller, Stacie E.;Koch, Abigail R.;Carnes, Molly
通讯作者：
Carnes, Molly
影响因子：
5.5
作者：
Davis, Terry C.;Arnold, Connie L.;Miele, Lucio
通讯作者：
Miele, Lucio
影响因子：
4.2
作者：
Clark, Luther T;Watkins, Laurence;Regnante, Jeanne M
通讯作者：
Regnante, Jeanne M
DOI：
10.1016/j.jstrokecerebrovasdis.2019.104447
发表时间：
2019-12-01
影响因子：
2.5
作者：
Janssen, Paula M.;Chalos, Vicky;Dippel, Diederik W. J.
通讯作者：
Dippel, Diederik W. J.