Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA.
Genome Res. 2011 Jul;21(7):1001-7. doi: 10.1101/gr.120329.111. Epub 2011 Jun 1.
In 2007, the National Human Genome Research Institute (NHGRI) established the Electronic MEdical Records and GEnomics (eMERGE) Consortium (www.gwas.net) to develop, disseminate, and apply approaches to research that combine DNA biorepositories with electronic medical record (EMR) systems for large-scale, high-throughput genetic research. One of the major ethical and administrative challenges for the eMERGE Consortium has been complying with existing data-sharing policies. This paper discusses the challenges of sharing genomic data linked to health information in the electronic medical record (EMR) and explores the issues as they relate to sharing both within a large consortium and in compliance with the National Institutes of Health (NIH) data-sharing policy. We use the eMERGE Consortium experience to explore data-sharing challenges from the perspective of multiple stakeholders (i.e., research participants, investigators, and research institutions), provide recommendations for researchers and institutions, and call for clearer guidance from the NIH regarding ethical implementation of its data-sharing policy.
2007 年，美国国立人类基因组研究所（NHGRI）成立了电子医疗记录和基因组学（eMERGE）联盟（www.gwas.net），旨在开发、传播和应用将 DNA 生物库与电子病历（EMR）系统相结合的方法，以进行大规模、高通量的遗传研究。eMERGE 联盟面临的主要伦理和管理挑战之一是遵守现有的数据共享政策。本文讨论了在电子病历（EMR）中共享与健康信息相关的基因组数据所面临的挑战，并探讨了在大型联盟内部以及遵守美国国立卫生研究院（NIH）数据共享政策的情况下共享这些数据所涉及的问题。我们利用 eMERGE 联盟的经验，从多个利益相关者（即研究参与者、研究人员和研究机构）的角度探讨数据共享挑战，为研究人员和机构提供建议，并呼吁 NIH 就其数据共享政策的伦理实施提供更明确的指导。
