Prainsack Barbara, Buyx Alena
King's College, London, UK.
Med Law Rev. 2013 Winter;21(1):71-91. doi: 10.1093/medlaw/fws040. Epub 2013 Jan 16.
New opportunities for large-scale data linkage and data-mining have rendered biobanks one of the core resources of medical research in the twenty-first century. At the same time, research biobanking has been seen to pose particular ethical and legal challenges pertaining to, for example, data protection, and the minimisation of other risks for participants. These measures have in turn led to heavy administrative, logistical, and financial costs and attracted criticism for unduly impeding disease research. Based on a newly formulated approach to solidarity, we propose an approach to governance that recognises people's willingness to participate in a public research biobank, and poses stronger emphasis on harm mitigation. We argue that such a model avoids some of the pitfalls of previous approaches. It also allows moving beyond overly restrictive and burdensome, exclusively autonomy-based governance towards governance that is reflective of people's willingness to accept costs to assist others.
大规模数据关联和数据挖掘的新机遇使生物样本库成为21世纪医学研究的核心资源之一。与此同时，人们发现研究性生物样本库在数据保护等方面带来了特殊的伦理和法律挑战，以及将参与者的其他风险降至最低。这些措施反过来导致了沉重的行政、后勤和财务成本，并因过度阻碍疾病研究而受到批评。基于新制定的团结方法，我们提出一种治理方法，该方法认可人们参与公共研究生物样本库的意愿，并更加强调减轻危害。我们认为，这种模式避免了先前方法的一些缺陷。它还能超越过于严格和繁重的、完全基于自主性的治理，转向反映人们愿意接受成本以帮助他人的治理方式。
