Shabani Mahsa, Dove Edward S, Murtagh Madeleine, Knoppers Bartha Maria, Borry Pascal
1 Department of Public Health and Primary Care, Center for Biomedical Ethics and Law, University of Leuven , Leuven, Belgium .
2 J. Kenyon Mason Institute for Medicine, Life Sciences and the Law, School of Law, University of Edinburgh , Edinburgh, United Kingdom .
Biopreserv Biobank. 2017 Oct;15(5):469-474. doi: 10.1089/bio.2017.0045. Epub 2017 Aug 24.
Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is warranted. In this article, we review these oversight practices and argue that they reveal a compelling need to clarify the scope of ethical considerations by oversight bodies and to delineate core elements such as "objectionable" data uses. Ethical oversight of genomic data sharing would be considerably improved if the relevant ethical considerations by research ethics and DACs were coordinated. We therefore suggest several mechanisms to achieve greater clarification of ethical considerations by these committees, as well as greater communication and coordination between both to ensure robust and sustained ethical oversight of genomic data sharing.
关于负责任的基因组数据共享的讨论通常围绕伦理和法律问题展开，如个人、家庭和社区的同意、隐私和保密。为确保基因组数据共享的伦理基础，在整个研究生命周期中，研究伦理和数据访问委员会（DAC）的监督是必要的。在本文中，我们回顾了这些监督实践，并认为它们揭示了一个迫切需求，即需要明确监督机构的伦理考量范围，并界定诸如“令人反感的”数据使用等核心要素。如果研究伦理和DAC的相关伦理考量能够协调一致，基因组数据共享的伦理监督将得到显著改善。因此，我们提出了几种机制，以实现这些委员会对伦理考量的更清晰阐释，以及两者之间更好的沟通与协调，从而确保对基因组数据共享进行有力且持续的伦理监督。
