Riva Luciana, Resta Giorgio, Gambino Alberto, Petrini Carlo
Bioethics Unit, Italian National Institute of Health, Rome, Italy.
Dipartimento di Giurisprudenza, Università di Roma 3, Rome, Italy.
New Bioeth. 2019 Dec;25(4):349-358. doi: 10.1080/20502877.2019.1679965.
The use of human biological materials (HBMs) involves a number of issues from both an ethical and a legal point of view. In recent decades, the purposes for which this material has been used have increased. The development of therapeutic products has led to the configuration of a market in which products have acquired an economic value. As soon as the private sector crosses the threshold of access to the use of human cells and tissues, a conflict may arise between the altruistic principles motivating the act of donation and the profit-making objectives . When donated material emerges from the public management setting and becomes a source of profit, the instrument of informed consent may not adequately protect the dignity of the donors. In the era of medical biotechnology revolution, any use of the donated material must be justified and consistent with the values motivating the act of donation.
从伦理和法律角度来看，人类生物材料（HBMs）的使用涉及诸多问题。近几十年来，这种材料的使用目的不断增加。治疗产品的发展催生了一个产品具有经济价值的市场格局。一旦私营部门跨越获取人类细胞和组织使用权的门槛，捐赠行为背后的利他主义原则与盈利目标之间可能就会产生冲突。当捐赠材料脱离公共管理范畴并成为利润来源时，知情同意这一手段可能无法充分保护捐赠者的尊严。在医学生物技术革命的时代，对捐赠材料的任何使用都必须合理且符合促使捐赠行为发生的价值观。
