南非精神分裂症基因组学研究中细胞系创建及永生化同意的预测因素
Predictors of consent to cell line creation and immortalisation in a South African schizophrenia genomics study.
作者信息
Campbell Megan M, de Vries Jantina, Mqulwana Sibonile G, Mndini Michael M, Ntola Odwa A, Jonker Deborah, Malan Megan, Pretorius Adele, Zingela Zukiswa, Van Wyk Stephanus, Stein Dan J, Susser Ezra
机构信息
Department of Psychiatry and Mental Health, University of Cape Town, J-Block, Groote Schuur Hospital, Observatory, Cape Town, South Africa.
Department of Medicine, University of Cape Town, Groote Schuur Hospital, Observatory, Cape Town, 8000, South Africa.
出版信息
BMC Med Ethics. 2018 Jul 11;19(1):72. doi: 10.1186/s12910-018-0313-2.
BACKGROUND
Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during this consent process?
METHODS
760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent.
RESULTS
Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant's consent. Participants recruited from the South African Eastern Cape (as opposed to the Western Cape), and older participants (aged between 40 and 59 years), were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness (schizophrenia vs control) nor education (primary vs secondary school) were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit.
CONCLUSIONS
These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies.
背景
细胞系永生化在非洲基因组学研究和生物样本库中所占比重日益增加。然而，对于非洲研究环境中影响细胞系创建和永生化同意书签署的因素，我们却知之甚少。我们通过对为一项南非精神疾病基因组学研究招募的科萨族参与者样本进行三个问题的探究，来填补这一空白：第一，同意储存细胞系的参与者比例是多少？第二，同意书签署的预测因素有哪些？第三，参与者在同意过程中提出了哪些问题？
方法
760名患有精神分裂症的科萨族人和760名对照者在性别、年龄、教育程度和招募地区方面进行了匹配。我们使用描述性统计来确定同意创建和永生化细胞系的参与者比例。采用逻辑回归方法来检验同意书签署的预测因素。研究招募人员的反馈意见被收集并讨论，以确定参与者提出的关于同意书签署的关键问题。
结果
约40%的参与者同意储存细胞系。寻求同意书签署的招募人员是参与者同意与否的一个重要预测因素。从南非东开普省招募的参与者（与西开普省相对）以及年龄较大的参与者（40至59岁）更有可能同意；这两组人更有可能持有传统的科萨族价值观。疾病（精神分裂症患者与对照者）和教育程度（小学与中学）均不是同意书签署的显著预测因素。参与者提出的关键问题包括两个广泛的主题：对细胞永生化含义的澄清，以及个人和社区利益相关问题。
结论
这些发现为非洲基因组学研究中可能同意细胞系永生化的参与者比例提供了指导，并强化了研究招募人员在寻求同意书签署过程中所起的重要且有影响力的作用。我们的结果强化了支撑同意选择的文化和背景因素，特别是围绕共享和互惠方面。最后，这些结果为越来越多的文献提供了支持，这些文献对将严重精神疾病患者视为健康研究，特别是基因组学研究的过度脆弱目标群体的污名化观念提出了挑战。
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