Tindana Paulina, de Vries Jantina
Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana; email:
Department of Medicine, Faculty of Health Sciences, University of Cape Town, 7925 Cape Town, South Africa; email:
Annu Rev Genomics Hum Genet. 2016 Aug 31;17:375-93. doi: 10.1146/annurev-genom-083115-022456. Epub 2016 Feb 22.
Genomic research and biobanking are increasingly being conducted in the context of collaborations between researchers in high-income countries and those in low- and middle-income countries. Although these scientific advancements have presented unique opportunities for researchers to contribute to cutting-edge scientific projects and address important health problems, they have also challenged existing ethical and regulatory frameworks, particularly in sub-Saharan Africa. Broad consent is a model that allows the use of human biological samples and associated data in future research that may be unrelated to the original study. Drawing on emerging perspectives in low- and middle-income countries, we argue that broad consent is equivalent to consent to governance and that a robust governance framework for genomics and biobanking should seek to promote global health and research equity and take into account five key elements: respect, authentic community engagement and trust building, the preservation of privacy and confidentiality, feedback of results, and capacity strengthening.
基因组研究和生物样本库越来越多地在高收入国家的研究人员与低收入和中等收入国家的研究人员合作的背景下进行。尽管这些科学进展为研究人员参与前沿科学项目和解决重要健康问题提供了独特机会，但它们也对现有的伦理和监管框架提出了挑战，特别是在撒哈拉以南非洲地区。广泛同意是一种允许在未来可能与原始研究无关的研究中使用人类生物样本及相关数据的模式。借鉴低收入和中等收入国家的新观点，我们认为广泛同意等同于对治理的同意，并且一个强大的基因组学和生物样本库治理框架应致力于促进全球健康和研究公平，并考虑五个关键要素：尊重、真实的社区参与和信任建立、隐私和保密的保护、结果反馈以及能力加强。
