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在护理与研究的交叉点上管理生物材料:利用干血斑进行生物样本库建设。

Governing biological material at the intersection of care and research: the use of dried blood spots for biobanking.

作者信息

Douglas Conor M W, van El Carla G, Faulkner Alex, Cornel Martina C

机构信息

VU University Medical Center Amsterdam, EMGO Institute for Health and Care Research, Section Community Genetics, Amsterdam, the Netherlands.

出版信息

Croat Med J. 2012 Aug;53(4):390-7. doi: 10.3325/cmj.2012.53.390.

Abstract

A series of governance issues currently surrounds the multiple uses and multiple users of dried blood spots (DBS) for research purposes. Internationally there is a discussion on storing DBS resulting from newborn screening for public health and using them as the basis for large biobank-like collections to facilitate biomedical research. If such a transformation were to be formalized, then DBS would sit at the intersection of care (ie, public health) and research, with the mechanisms through which such a collection could be managed not totally self-evident. What is more, a DBS collection raises questions about the fuzzy boundaries between privacy and anonymity; how to control or define quality control uses of DBS; medical vs nonmedical uses; as well as benefit sharing and stakeholder involvement. Our goal here is to explore some of the key questions relating to DBS governance by way of the bio-objects and bio-objectification concepts. By embracing - rather than resisting to - the blurring of boundaries and problems in categorization that have come to characterize bio-objects and bio-objectification processes recently described in this journal, we attempt to highlight some issues that might not be currently considered, and to point to some possible directions to go (or avoid). Building from our knowledge of the current DBS situation in the Netherlands, we outline questions concerning the uses, management, collection, and storage of DBS.

摘要

目前,围绕干血斑(DBS)用于研究目的的多种用途和多个用户存在一系列管理问题。在国际上,正在讨论储存新生儿筛查产生的干血斑用于公共卫生,并将其作为大型生物样本库类收集的基础,以促进生物医学研究。如果这种转变得以正式确定,那么干血斑将处于医疗保健(即公共卫生)和研究的交叉点,而管理此类收集的机制并非完全显而易见。此外,干血斑收集引发了关于隐私和匿名之间模糊界限的问题;如何控制或定义干血斑的质量控制用途;医疗用途与非医疗用途;以及利益分享和利益相关者参与。我们在此的目标是通过生物对象和生物对象化概念来探讨一些与干血斑管理相关的关键问题。通过接受——而非抵制——最近在本期刊中描述的生物对象和生物对象化过程所特有的界限模糊和分类问题,我们试图突出一些当前可能未被考虑的问题,并指出一些可能的发展方向(或避免的方向)。基于我们对荷兰当前干血斑情况的了解,我们概述了有关干血斑的用途、管理、收集和储存的问题。

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