The importance of public engagement in clinical xenotransplantation

Daniel J. Hurst, David K. C. Cooper
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Abstract

Over the past several decades, significant scientific progress in xenotransplantation has brought the field to the threshold of clinical trials. In the past 3 years in the United States, experimental pig kidney and heart xenotransplantation have been performed on human subjects recently declared dead by neurological criteria (decedents). In addition, two pig heart transplants have been carried out in living patients under the United States Food and Drug Administration's expanded access guidelines. However, though there has been a flurry of activity there remain unanswered questions regarding how the public views xenotransplantation, what concerns may exist, and how to address these concerns in a meaningful way. This paper aims to underscore the importance of public engagement in xenotransplantation, emphasizing the ongoing need for studies to assess public opinions. The current evidence on public engagement studies is reviewed and gaps in our understanding are identified. We propose practical steps to advance this field. Additional studies to determine the extent of racial/ethnic differences in attitudes to xenotransplantation should be conducted. Empirical and descriptive analysis of certain religious viewpoints—especially minority faiths—would be valuable. As public engagement is an important aspect of public acceptance of novel research that is accompanied by risk, we suggest that xenotransplantation biotechnology companies might consider leading the way in funding this research.

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公众参与临床异种移植的重要性
在过去的几十年里,异种移植在科学上取得了重大进展,使这一领域迈入了临床试验的门槛。在过去 3 年中,美国对最近根据神经学标准宣布死亡的人类受试者(死者)进行了实验性猪肾和猪心异种移植。此外,根据美国食品和药物管理局的 "扩大准入准则",已在活着的病人身上进行了两例猪心脏移植手术。然而,尽管出现了一系列活动,但关于公众如何看待异种器官移植、可能存在哪些担忧以及如何有意义地解决这些担忧等问题仍未得到解答。本文旨在强调公众参与异种器官移植的重要性,并强调目前需要对公众意见进行评估研究。本文回顾了目前有关公众参与研究的证据,并指出了我们认识上的差距。我们提出了推动这一领域发展的实际步骤。应开展更多研究,以确定种族/民族对异种器官移植态度的差异程度。对某些宗教观点--尤其是少数民族信仰--进行经验性和描述性分析也很有价值。由于公众参与是公众接受伴随风险的新型研究的一个重要方面,我们建议异种移植生物技术公司可以考虑带头资助这项研究。
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