Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda.

IF 1.7 4区哲学 Q2 ETHICS Journal of Empirical Research on Human Research Ethics Pub Date : 2022-10-01 Epub Date: 2022-05-12 DOI:10.1177/15562646221100430

Francis Anyaka Amayoa, Frederick Nelson Nakwagala, John Barugahare, Ian Guyton Munabi, Erisa Sabakaki Mwaka

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Abstract

Several studies have reported inadequate comprehension of informed consent for genomic research. This study aimed to assess research participants' understanding of critical elements of informed consent for genomic research. A cross-sectional survey involving 123 parents/caregivers of children participating in a paediatric genomic TB/HIV study was conducted. Only 47.2% of the participants had adequate understanding of consent information. The mean objective (actual) and subjective (perceived) understanding scores were 78.7% and 91.7% respectively. Participants adequately understood most elements of consent however, some elements were poorly understood including foreseeable risks, protection of confidentiality and compensation for research related injury. Overall there was inadequate comprehension of critical elements of informed consent and there was dissonance between actual and perceived comprehension of informed consent.

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了解基因组研究中知情同意的关键要素：乌干达儿科艾滋病-结核病研究项目案例。

有几项研究报告称，人们对基因组研究知情同意书的理解不足。本研究旨在评估研究参与者对基因组研究知情同意书关键要素的理解。123名参与儿科结核病/艾滋病毒基因组研究的儿童的父母/监护人接受了横断面调查。只有 47.2% 的参与者充分理解了同意信息。客观（实际）和主观（感知）理解的平均得分分别为 78.7% 和 91.7%。参与者充分理解了同意书的大部分内容，但对一些内容理解不深，包括可预见的风险、保密保护和与研究相关的伤害赔偿。总体而言，参与者对知情同意书的关键要素理解不足，对知情同意书的实际理解与感知理解不一致。

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来源期刊

Journal of Empirical Research on Human Research Ethics 医学-医学：伦理

CiteScore

3.50

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.