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非洲基因组学中个体结果的反馈是否应纳入知情同意过程?来自博茨瓦纳一个艾滋病毒-结核病基因组学研究项目的参与者观点。

Should Feedback of Individual Results be Integrated into the Consent Process in African Genomics? Participants' Views from an HIV-TB Genomics Research Project in Botswana.

作者信息

Ralefala Dimpho, Kasule Mary, Wonkam Ambroise, Matshaba Mogomotsi, de Vries Jantina

机构信息

Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.

Office of Research and Development, University of Botswana, Gaborone, Botswana.

出版信息

AJOB Empir Bioeth. 2022 Jan-Mar;13(1):48-56. doi: 10.1080/23294515.2021.1941414. Epub 2021 Jul 1.

DOI:10.1080/23294515.2021.1941414
PMID:34197280
Abstract

Whilst informed consent is a key component of considering whether individual genomic research results could or should be fed back to research participants, little is known about the views of African research participants on its role.We carried out a qualitative study to explore views of adolescents and parents or caregivers regarding informed consent for feedback of individual results from a genomics research project in Botswana. We conducted 24 deliberative focus group discussions with 93 participants (44 adolescents and 49 parents or caregivers) and 12 in-depth interviews (6 adolescents and 6 parents).Our findings revealed that most participants would like to be informed about the possibility of discovering individual genetic results during the consent process and that consent be obtained for feedback during the enrollment process. They further expressed that in cases where prior consent to feedback was not obtained, then participants should be re-contacted where life-saving genetic information is discovered. Participants emphasized the need for researchers to ensure that participants' decisions regarding feedback of results are well-informed. Autonomy, transparency, and communication were identified as key values to uphold during the consent process.In conclusion, obtaining participants' consent for feedback of results is important to ensure that their rights and wellbeing are protected in research. This is critical in building trust relationships between participants and researchers.

摘要

虽然知情同意是考虑是否能够或应该向研究参与者反馈个人基因组研究结果的关键组成部分,但对于非洲研究参与者对其作用的看法却知之甚少。我们开展了一项定性研究,以探讨青少年及其父母或照顾者对于博茨瓦纳一个基因组研究项目中个人结果反馈的知情同意的看法。我们与93名参与者(44名青少年以及49名父母或照顾者)进行了24次审议性焦点小组讨论,并进行了12次深度访谈(6名青少年和6名父母)。我们的研究结果显示,大多数参与者希望在同意过程中被告知发现个人基因结果的可能性,并在登记过程中就反馈获得同意。他们还表示,在未事先征得反馈同意的情况下,如果发现了救命的基因信息,应该再次联系参与者。参与者强调研究人员需要确保参与者关于结果反馈的决定是在充分知情的情况下做出的。自主性、透明度和沟通被确定为在同意过程中要秉持的关键价值观。总之,获得参与者对结果反馈的同意对于确保他们在研究中的权利和福祉得到保护很重要。这对于建立参与者与研究人员之间的信任关系至关重要。

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