在非洲获取基因组学研究的知情同意：对H3Africa同意文件的分析
Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.
作者信息
Munung Nchangwi Syntia, Marshall Patricia, Campbell Megan, Littler Katherine, Masiye Francis, Ouwe-Missi-Oukem-Boyer Odile, Seeley Janet, Stein D J, Tindana Paulina, de Vries Jantina
机构信息
Department of Medicine, University of Cape Town, Cape Town, South Africa.
Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio, USA.
出版信息
J Med Ethics. 2016 Feb;42(2):132-7. doi: 10.1136/medethics-2015-102796. Epub 2015 Dec 7.
BACKGROUND
The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.
METHODS
A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results.
RESULTS
Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results.
CONCLUSION
H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.
背景
全球基因组学和生物样本库研究的兴起促使了适用于此类研究的不同知情同意模式的发展。本研究分析了非洲人类遗传与健康（H3Africa）联盟的研究人员所使用的同意书文件。
方法
采用定性文本分析方法，对H3Africa项目中样本和数据收集所使用的同意书文件进行分析。主题领域包括同意模式类型、遗传学/基因组学解释、数据共享以及检测结果反馈。
结果
对19个H3Africa项目中的13个项目的知情同意书文件进行了分析。7个项目采用宽泛同意，5个项目采用分层同意，1个项目采用特定同意。遗传学大多从遗传特征、遗传与健康、基因与疾病因果关系或疾病易感性方面进行解释。只有1个项目对个体基因检测结果的反馈做出了规定。
结论
H3Africa研究采用了三种同意模式——特定同意、分层同意和宽泛同意。我们概述了H3Africa研究人员向潜在研究参与者解释基因组学概念所采用的不同策略。为了进一步确保参与基因组研究的决定是明智且有意义的，我们建议开发创新的知情同意流程方法，最好与非洲的研究参与者、研究伦理委员会和研究人员协商进行。
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