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为改善同意理解并确定这如何影响参与 HIV 治愈研究的意愿而制定同意书:一项实验性调查研究。

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study.

机构信息

8785University of California San Francisco, USA.

2331University of North Carolina Chapel Hill, USA.

出版信息

J Empir Res Hum Res Ethics. 2021 Feb-Apr;16(1-2):78-87. doi: 10.1177/1556264620981205. Epub 2020 Dec 14.

Abstract

HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory-a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

摘要

HIV 治愈研究存在严重风险和微小收益。我们调查了参与者如何理解这些风险,以及什么因素影响他们参与的意愿。通过基于互联网的和面对面的便利抽样,86 名 HIV+参与者完成了一项实验性调查。参与者被随机分配阅读一份标准的知情同意书,描述一项假设的 HIV 治愈研究,或一份使用模糊痕迹理论改编的知情同意书,这是一种决策模型,旨在促进复杂信息处理。我们测量了对 HIV 治愈研究的同意理解和认知(例如,安全/有害)和情感(例如,关注,满意)评估。阅读改编后的知情同意书的参与者对知情同意的理解有所提高,但只有积极的情感评估与参与意愿相关。知情同意过程可以使用决策理论来促进对研究信息的理解。

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