Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
J Med Ethics. 2019 Feb;45(2):131-139. doi: 10.1136/medethics-2018-104846. Epub 2018 Oct 26.
Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of 'mini-organs' in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a 'consent for governance' model that contributes to responsible innovation and clinical translation in this exciting field.
生物技术的最新发展使得人们能够从人体组织中制造出越来越复杂的产品，例如人类干细胞系、合成胚胎样结构和类器官。这些发展伴随着商业利益的增长。尽管商业化可以激发科学和临床的潜力，但从人体组织中获利在伦理上存在争议，并引起了公众的关注。传统的生物伦理框架——礼物与市场——不适合捕捉由此产生的实际和伦理复杂性。因此，我们提出了一种替代方法，以识别、评估和处理日益商业化的复杂人体组织产品交换所带来的伦理挑战。我们以类器官技术为例，这是一种先进的干细胞技术，能够在培养皿中培养“迷你器官”。首先，我们考察了类器官的道德价值，并认识到它们是一种混合体，与人和他们的身体以及技术和市场都以模糊的方式相关。其次，我们表明，类器官的商业化是通过将类器官的工具价值和商业价值与其与人及其身体的联系分离来合法化的。这种分离是通过一系列的解缠结步骤来实现的，其中包括同意和商品化。第三，我们认为，深度解缠结在伦理上具有挑战性：（1）社会利益可能会受到压力，因为商业化类器官技术的理由，即刺激有益于社会的生物医学创新，可能无法实现；（2）捐赠者的利益被置于第三方利益之下，类器官的关系道德价值可能没有得到充分认识。第四，我们提出了一种“同意治理”模式，有助于在这个令人兴奋的领域实现负责任的创新和临床转化。
