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Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study.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。
J Empir Res Hum Res Ethics. 2021 Feb-Apr;16(1-2):78-87. doi: 10.1177/1556264620981205. Epub 2020 Dec 14.
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Ethics of HIV cure research: an unfinished agenda.HIV 治愈研究的伦理问题:一个未竟的议程。
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本文引用的文献

1
Participant Perspectives in an HIV Cure-Related Trial Conducted Exclusively in Women in the United States: Results from AIDS Clinical Trials Group 5366.仅在美国女性中开展的 HIV 治愈相关试验中的参与者观点:美国艾滋病临床试验组 5366 的结果。
AIDS Res Hum Retroviruses. 2020 Apr;36(4):268-282. doi: 10.1089/AID.2019.0284.
2
The significance and expectations of HIV cure research among people living with HIV in Australia.澳大利亚 HIV 感染者对 HIV 治愈研究的意义和期望。
PLoS One. 2020 Mar 4;15(3):e0229733. doi: 10.1371/journal.pone.0229733. eCollection 2020.
3
"Cure" Versus "Clinical Remission": The Impact of a Medication Description on the Willingness of People Living with HIV to Take a Medication.“治愈”与“临床缓解”:药物描述对艾滋病毒感染者服药意愿的影响。
AIDS Behav. 2020 Jul;24(7):2054-2061. doi: 10.1007/s10461-019-02769-1.
4
HIV Cure Research: Risks Patients Expressed Willingness to Accept.艾滋病治愈研究:患者表示愿意接受的风险。
Ethics Hum Res. 2019 Nov;41(6):23-34. doi: 10.1002/eahr.500035.
5
Unintended HIV-1 Infection During Analytical Therapy Interruption.分析治疗中断期间意外的HIV-1感染。
J Infect Dis. 2020 Apr 27;221(10):1740-1742. doi: 10.1093/infdis/jiz611.
6
What is the effect of self-identified HIV activism in willingness to participate in HIV cure-related clinical trials? Results from the ANRS-APSEC study.自我认定的艾滋病病毒维权行动对参与艾滋病病毒治愈相关临床试验的意愿有何影响?法国国家艾滋病研究机构-艾滋病预防与研究协会(ANRS-APSEC)研究的结果。
J Virus Erad. 2019 Sep 18;5(3):152-162. doi: 10.1016/S2055-6640(20)30045-5.
7
Applying the Behavioural and Social Sciences Research (BSSR) Functional Framework to HIV Cure Research.将行为和社会科学研究(BSSR)功能框架应用于 HIV 治愈研究。
J Int AIDS Soc. 2019 Oct;22(10):e25404. doi: 10.1002/jia2.25404.
8
Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting.抗逆转录病毒治疗中断分析在 HIV 研究试验中的建议——共识会议报告。
Lancet HIV. 2019 Apr;6(4):e259-e268. doi: 10.1016/S2352-3018(19)30052-9. Epub 2019 Mar 15.
9
Unintended HIV-1 Transmission to a Sex Partner in a Study of a Therapeutic Vaccine Candidate.在一项治疗性疫苗候选物研究中,一名性伴侣意外感染 HIV-1。
J Infect Dis. 2019 Jul 2;220(220 Suppl 1):S5-S6. doi: 10.1093/infdis/jiz012.
10
Putting participants at the centre of HIV cure research.将参与者置于HIV治愈研究的中心。
Lancet HIV. 2019 Mar;6(3):e147-e149. doi: 10.1016/S2352-3018(19)30031-1. Epub 2019 Feb 13.

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.

DOI:10.1177/1556264620981205
PMID:33307932
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8035136/
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。