理解基因组研究中知情同意的关键要素：以乌干达一项儿科艾滋病毒/结核病研究项目为例。
Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda.
机构信息
College of Health Sciences, Makerere University, Uganda.
College of Humanities and Social Sciences, Makerere University, Uganda.
出版信息
J Empir Res Hum Res Ethics. 2022 Oct;17(4):483-493. doi: 10.1177/15562646221100430. Epub 2022 May 12.
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.
一些研究报告指出，人们对基因组研究的知情同意书的理解不够充分。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内容的理解程度。本研究采用横断面调查，纳入了 123 名参与儿科基因组结核病/艾滋病研究的儿童的父母/看护者。仅有 47.2%的参与者对同意书信息有充分的理解。客观（实际）和主观（感知）理解评分的平均值分别为 78.7%和 91.7%。参与者对同意书的大多数内容有充分的理解，但对一些内容的理解程度较差，包括可预见的风险、保护保密性以及因研究相关损伤的赔偿。总体而言，对知情同意书关键内容的理解不够充分，实际理解和感知理解之间存在差异。
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