Department of Orthopedic Surgery, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
US Department of Justice, Trial Attorney, Washington, District of Columbia, USA.
J Orthop Res. 2021 Aug;39(8):1603-1610. doi: 10.1002/jor.24885. Epub 2020 Oct 30.
This discussion presents many of the ethical, legal, and financial issues that underlie the contemporary regulatory framework for research with human biospecimens. Some considerations, such as claims of donor control over their biospecimens, could potentially constrain researchers' freedom of action. We first consider concepts underlying consent to donate biospecimens for research. A requirement to obtain consent for donation of a biospecimen could conceptually be based upon the autonomy of the donor, or on property rights of the donor, or a combination of both concepts. If these concepts affect how consent is implemented, it could have significant downstream consequences for research and researchers. We present elements of the revision of the common rule that affect the use of human biospecimens including the current consent regulations based on transparency and autonomy, and the distinction between consent for, and ownership of, biospecimens. One of the major judicial opinions that denied property rights for biospecimens is described together with some implications for the research community of attributing ownership of biospecimens to their donors. We then consider transactional aspects of biospecimen donation. Considering biospecimens as a negotiable commodity presents both constraints and opportunities for donors and researchers. Compensation for biospecimens can be negotiated under contract law. Allowing donor control of the secondary research use of deidentified biospecimens could have an inhibiting effect on research. If donors possessed such control, even deidentification would not necessarily eliminate their ability to influence future research. Accordingly, new models of biospecimen donation are appearing in which the research community will have a substantial interest.
本讨论介绍了许多伦理、法律和财务问题，这些问题构成了人类生物样本研究的当代监管框架的基础。一些考虑因素，如捐赠者对其生物样本的控制权主张，可能会限制研究人员的行动自由。我们首先考虑捐赠生物样本用于研究的同意背后的概念。要求获得捐赠生物样本的同意，从概念上讲，可以基于捐赠者的自主性，也可以基于捐赠者的财产权，或者这两个概念的结合。如果这些概念影响同意的实施方式，那么这可能会对研究和研究人员产生重大的下游影响。我们介绍了影响人类生物样本使用的共同规则修订的要素，包括基于透明度和自主性的当前同意法规，以及对生物样本的同意和所有权的区分。描述了否定生物样本财产权的一项主要司法意见，以及将生物样本的所有权归属于其捐赠者对研究界的一些影响。然后，我们考虑生物样本捐赠的交易方面。将生物样本视为可协商的商品，既为捐赠者和研究人员带来了限制，也带来了机会。根据合同法，可以协商生物样本的补偿问题。允许捐赠者控制去识别生物样本的二次研究用途可能会对研究产生抑制作用。如果捐赠者拥有这种控制权，即使进行了去识别处理，也不一定能消除他们对未来研究的影响能力。因此，新的生物样本捐赠模式正在出现，研究界对此将有浓厚的兴趣。
