Scientific Institute for Quality of Healthcare, Section Ethics, Philosophy, and History of Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Tissue Eng Part B Rev. 2010 Aug;16(4):397-403. doi: 10.1089/ten.TEB.2009.0666.
This article is part of the EuroSTEC project, which aims at developing tissue engineering-based treatments for structural disorders present at birth. EuroSTEC is positioned at the intersection of three areas with their own ethical issues: (1) regenerative medicine, (2) research with pregnant women and fetuses, and (3) research with neonates. Because of the overlap of these three areas in this project, we can expect to be confronted with new ethical challenges. To be able to respond adequately and timely to current and possible future ethical issues, a prospective and anticipatory ethical analysis is essential. To obtain a first survey of ethical issues that might arise during the different phases of the project, the Delphi method was used. The professionals directly involved in the EuroSTEC project were questioned about their views on possible ethical issues. The first round yielded 27 ethical issues, which the respondents were asked to prioritize in the second round. For the fundamental research phase, issues deemed most important were privacy and informed consent of the tissue donor. For the animal experimentation phase, three issues were mentioned (in order of decreasing priority): the suffering of animals, the use of animals as means to an end, and the limited adequacy of the animal models. Issues that were deemed most important during the clinical (trial) phase pertained to the problem of weighing risks and benefits for the fetus/child and the pregnant woman.
本文是 EuroSTEC 项目的一部分，该项目旨在开发基于组织工程的治疗方法，以治疗出生时存在的结构紊乱。EuroSTEC 位于三个具有自身伦理问题的领域的交叉点：（1）再生医学，（2）对孕妇和胎儿的研究，以及（3）对新生儿的研究。由于该项目中这三个领域的重叠，我们预计会面临新的伦理挑战。为了能够及时、充分地应对当前和可能出现的未来伦理问题，前瞻性和预期性的伦理分析是必不可少的。为了初步了解项目不同阶段可能出现的伦理问题，采用了德尔菲法。直接参与 EuroSTEC 项目的专业人员被问及他们对可能出现的伦理问题的看法。第一轮产生了 27 个伦理问题，要求受访者在第二轮中对这些问题进行优先排序。在基础研究阶段，被认为最重要的问题是组织捐献者的隐私和知情同意。在动物实验阶段，提到了三个问题（按优先顺序递减）：动物的痛苦、将动物作为达到目的的手段以及动物模型的充分性有限。在临床试验阶段，被认为最重要的问题涉及到权衡胎儿/儿童和孕妇的风险和利益的问题。
