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责任、治理与生物库:伦理与治理委员会是守护者还是纸老虎?

Accountability, governance and biobanks: the ethics and governance committee as guardian or as toothless tiger?

机构信息

Birmingham Law School, University of Birmingham, UK.

出版信息

Health Care Anal. 2011 Sep;19(3):231-46. doi: 10.1007/s10728-011-0195-7.

Abstract

The huge potential of biobanks/genetic databases for the research community has been recognised across jurisdictions in both publicly funded and commercial sectors. But although there is tremendous potential there are likewise potential difficulties. The long-term storage of personal health information and samples poses major challenges. This is an area is fraught with ethical and legal uncertainties. Biobanks raise many questions of the control of rights, of consent, of privacy and confidentiality and of property in human material. It is thus unsurprising then that there has been a lively debate as to how biobanks should operate, the boundaries of participation and what governance structure, if any they should adopt, a debate which has been engaged in across the academic community and by funders and researchers alike. This paper asks despite the good intentions can ad hoc ethics and ethics and governance committees long term provide an effective solution to the legal and regulatory challenges arising from biobanks.

摘要

生物库/基因数据库在研究界的巨大潜力在公共资助和商业领域的各个司法管辖区都得到了认可。但是,尽管有巨大的潜力,也同样存在潜在的困难。个人健康信息和样本的长期存储带来了重大挑战。这是一个充满伦理和法律不确定性的领域。生物库引发了许多关于权利控制、同意、隐私和保密性以及人类材料所有权的问题。因此,毫不奇怪,人们就生物库应该如何运作、参与的界限以及如果应该采用任何治理结构展开了激烈的辩论,学术界、资助者和研究人员都参与了这场辩论。本文提出一个问题,即尽管有良好的意愿,但临时伦理和伦理治理委员会能否长期为生物库带来的法律和监管挑战提供有效解决方案。

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