扩大有关人类人造胎盘试验的伦理辩论

Alice Cavolo, D. Pizzolato
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摘要

人造胎盘(AP)是一种模拟人类胎盘的技术,用于治疗极早产儿。作为一项具有侵入性和风险性的技术,它将为人体试验带来重要的伦理问题。因此,我们在本专题片段中提供了进一步研究问题的蓝图。首先,咨询将具有双重作用,即提供试验信息和(非)治疗咨询。这就需要进行额外的培训,并开发专门的决策辅助工具,为咨询和家长决策提供支持。其次,需要更多利益相关者的参与。直接利益相关者,如家长、临床医生和研究人员,可以帮助开发决策辅助工具,并就可能被忽视的问题提供见解。社会也应参与其中,以确定是否应为 AP 试验和实施提供补贴,以及不提供补贴的伦理影响。第三,应进行适当的成本效益分析,以确定该技术的确切成本。
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Expanding the ethical debate on human artificial placenta trials
Artificial placentas (APs) are technologies that mimic the human placenta to treat extremely preterm infants. Being an invasive and risky technology, it will raise important ethical questions for human trials. Hence, in this Topic Piece we provide a blueprint of further issues to investigate. First, counselling will have the double role of providing trial information as well as (non) treatment counselling. This requires extra training and the development of ad hoc decision aids to support counselling and parents’ decision-making. Second, more stakeholder involvement is needed. Direct stakeholders, such as parents, clinicians, and researchers, can help develop the decision aids and provide insight on potentially overlooked issues. Society should also be involved to determine whether AP trials and implementation should be subsidized, and the ethical implications of not subsidizing. Third, a proper cost-benefit analysis should be conducted to determine the exact cost of the technology.
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