Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?
Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?
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DOI：
10.1038/ejhg.2012.282
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发表时间：
2013-09-01
影响因子：
5.2
通讯作者：
Solberg, Berge
中科院分区：
文献类型：
--
作者：
Steinsbekk, Kristin Solum;Myskja, Bjorn Kare;Solberg, Berge
在生物库研究的努力中，关于何种类型的同意以及何种形式的捐赠者-生物库关系符合高道德标准存在争议。到目前为止，“广泛同意”模式已被用于许多当今的生物库项目。然而，它一直被一些学者认为是一个务实的，而不是一个可接受的道德解决方案。有人呼吁进行改革，其依据是避免家长式作风，打算履行自主原则，希望增加用户参与，质疑专家的作用，以及主张减少自上而下的治理。最近，一种被称为“动态同意”的方法被提出来应对这些挑战。动态同意使用现代沟通策略来通知，参与，提供选择，最后但并非最不重要的是获得同意的每一个研究项目的基础上生物库资源。乍一看，动态同意似乎很有吸引力，我们已经确定了这种模式优越性的六个主张;与自主性，信息，增加参与，控制，社会鲁棒性和互惠性有关的主张。然而，经过更仔细的检查，似乎有几个弱点与动态同意的方法，其中包括邀请人们进入治疗的误解，以及个性化的研究项目的伦理审查的风险。当比较这两种模式时，广泛的同意仍然有效，可以被认为是纵向生物库研究的一个很好的伦理解决方案。尽管如此，在广泛的模式有改进的潜力，并可以通过适应一些现代通信策略中提出的动态同意的方法来满足批评。
In the endeavour of biobank research there is dispute concerning what type of consent and which form of donor-biobank relationship meet high ethical standards. Up until now, a 'broad consent' model has been used in many present-day biobank projects. However it has been, by some scholars, deemed as a pragmatic, and not an acceptable ethical solution. Calls for change have been made on the basis of avoidance of paternalism, intentions to fulfil the principle of autonomy, wish for increased user participation, a questioning of the role of experts and ideas advocating reduction of top-down governance. Recently, an approach termed 'dynamic consent' has been proposed to meet such challenges. Dynamic consent uses modern communication strategies to inform, involve, offer choices and last but not the least obtain consent for every research projects based on biobank resources. At first glance dynamic consent seems appealing, and we have identified six claims of superiority of this model; claims pertaining to autonomy, information, increased engagement, control, social robustness and reciprocity. However, after closer examination, there seems to be several weaknesses with a dynamic consent approach; among others the risk of inviting people into the therapeutic misconception as well as individualizing the ethical review of research projects. When comparing the two models, broad consent still holds and can be deemed a good ethical solution for longitudinal biobank research. Nevertheless, there is potential for improvement in the broad model, and criticism can be met by adapting some of the modern communication strategies proposed in the dynamic consent approach.