University of North Carolina at Chapel Hill.
J Law Med Ethics. 2012 Fall;40(3):612-29. doi: 10.1111/j.1748-720X.2012.00694.x.
Genomic biobanks present ethical challenges that are qualitatively unique and quantitatively unprecedented. Many critics have questioned whether the current system of informed consent can be meaningfully applied to genomic biobanking. Proposals for reform have come from many directions, but have tended to involve incremental change in current informed consent practice. This paper reports on our efforts to seek new ideas and approaches from those whom informed consent is designed to protect: research subjects. Our model emerged from semi-structured interviews with healthy volunteers who had been recruited to join either of two biobanks (some joined, some did not), and whom we encouraged to explain their concerns and how they understood the relationship between specimen contributors and biobanks. These subjects spoke about their DNA and the information it contains in ways that were strikingly evocative of the legal concept of the trade secret. They then described the terms and conditions under which they might let others study their DNA, and there was a compelling analogy to the commonplace practice of trade secret licensing. We propose a novel biobanking model based on this trade secret concept, and argue that it would be a practical, legal, and ethical improvement on the status quo.
基因组生物库带来了独特且前所未有的伦理挑战。许多批评者质疑当前的知情同意制度是否能够真正适用于基因组生物库。改革的建议来自各个方面，但往往涉及对当前知情同意实践的渐进式改变。本文报告了我们从知情同意旨在保护的对象（即研究对象）那里寻求新理念和方法的努力。我们的模型源自对健康志愿者的半结构化访谈，这些志愿者被招募加入两个生物库（有些加入了，有些没有），我们鼓励他们解释自己的担忧，以及他们如何理解标本提供者和生物库之间的关系。这些受试者以令人惊讶的方式描述了他们的 DNA 及其所含信息，这与法律上的商业秘密概念惊人地相似。然后，他们描述了他们可能允许他人研究其 DNA 的条件和条款，这与常见的商业秘密许可做法有很强的类比性。我们基于这一商业秘密概念提出了一种新颖的生物库模型，并认为这将是对现状的一种实用、合法和合乎道德的改进。
