Austin Melissa A, Harding Sarah E, McElroy Courtney E
Institute for Public Health Genetics, University of Washington, Seattle 98195-7236, USA.
Genet Med. 2003 Nov-Dec;5(6):451-7. doi: 10.1097/01.gim.0000093976.08649.1b.
To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally.
Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research.
We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable.
The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.
描述群体遗传数据库研究特有的伦理、法律和社会问题，并确定国际建议和准则在全球“基因库”项目开发中解决这些问题的相关性。
基于我们之前对八个国际基因库的描述，我们对相关出版物进行了全面的电子检索和文献综述，并查阅了适用于基因库研究的国家和国际文件。
我们识别并描述了基因库开发特有的五类伦理、法律和社会问题：赞助与利益分享、伦理委员会的中立性和监管权力、公众参与、知情同意和数据保护。我们用特定基因库的例子来说明这些问题。当前的国际准则并未涵盖所有这些问题，其中许多准则不具体且无法执行。
基因库发展的趋势有望为医学领域带来新发现，并极大地改善公众健康。然而，对于与基因库开发和实施相关的更明确、可执行且协调一致的国际准则的需求日益增长。通过比较基因库中出现的伦理、法律和社会问题，研究人员可以更好地评估如何最好地利用这些项目来改善公众健康，同时保护参与人群。
