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. 利益相关者对向艾滋病毒感染者反馈个人药物基因组学研究结果的伦理考量的看法。

'. Stakeholders' perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV.

作者信息

Nabukenya Sylvia, Kyaddondo David, Twimukye Adelline, Munabi Ian Guyton, Waitt Catriona, Mwaka Erisa S

机构信息

Makerere University College of Health Sciences, Uganda.

Infectious Diseases Institute, Uganda.

出版信息

Res Ethics. 2024 Apr;20(2):363-387. doi: 10.1177/17470161231207739. Epub 2023 Oct 31.

Abstract

This study aimed to explore stakeholders' perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored five prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified.

摘要

本研究旨在探讨利益相关者对于向艾滋病毒感染者反馈个人药物基因组学研究结果的伦理考量的看法。一种定性调查方法包括与30名社区代表进行五次焦点小组讨论、与研究人员进行12次关键信息访谈以及与研究伦理委员会成员进行12次深入访谈。2021年9月至2022年2月期间,共有54名参与药物基因组学研究以及艾滋病毒治疗与护理的利益相关者参与了数据收集。该研究探讨了五个突出主题:(i)界定要反馈给参与者的研究结果的性质;(ii)让研究参与者为接收结果做好准备;(iii)就反馈结果获得知情同意;(iv)关于卫生人员向参与者反馈结果的意见;以及(v)关于应如何向参与者传达研究结果的意见。受访者确定了各种反馈个人结果且将伦理风险降至最低的策略,包括设立一个多元化且独立的委员会,根据当地情况进行风险效益评估;在整个研究过程中持续讨论可能出现的结果类型及其影响;以及聘请遗传咨询师向参与者传达结果。本研究确定的策略应进一步研究并独立验证。

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