Department of Family Medicine, Rowan-Virtua School of Osteopathic Medicine, Stratford, New Jersey, USA.
Department of Epidemiology and Surgery, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
Xenotransplantation. 2024 Mar-Apr;31(2):e12847. doi: 10.1111/xen.12847.
With decades of pre-clinical studies culminating in the recent clinical application of xenotransplantation, it would appear timely to provide recommendations for operationalizing oversight of xenotransplantation clinical trials. Ethical issues with clinical xenotransplantation have been described for decades, largely centering on animal welfare, the risks posed to the recipient, and public health risks posed by potential spread of xenozoonosis. Much less attention has been given to considerations relating to potentially elevated risks faced by those who may care for or otherwise have close contact with xenograft recipients. This paper examines the ethical and logistical issues raised by the potential exposure to xenozoonotic disease faced by close contacts of xenotransplant recipients-defined herein as including but not limited to caregivers, household contacts, and sexual partners-which warrants special attention given their increased risk of exposure to infection compared to the general public. We discuss implications of assent or consent by these close contacts to potentially undergo, along with the recipient, procedures for infection screening and possible quarantine. We then propose several options and recommendations for operationalizing oversight of xenotransplantation clinical trials that could account for and address close contacts' education on and agency regarding the risk of xenozoonosis.
经过几十年的临床前研究，最近异种移植的临床应用达到了高潮，现在似乎是时候为异种移植临床试验的操作提供建议了。几十年来，临床异种移植的伦理问题一直存在，主要集中在动物福利、对受者的风险以及潜在的异种传染病传播对公共卫生的风险上。人们对那些可能照顾或与异种移植受者有密切接触的人可能面临的潜在风险考虑得较少。本文探讨了异种移植受者密切接触者（包括但不限于护理人员、家庭接触者和性伴侣）面临的潜在接触异种传染病的风险所带来的伦理和后勤问题，鉴于他们与公众相比，接触感染的风险增加，因此需要特别关注。我们讨论了这些密切接触者同意或同意与受者一起接受感染筛查和可能的检疫程序的潜在影响。然后，我们提出了几种操作建议和建议，以对异种移植临床试验进行监督，这些建议可以考虑并解决密切接触者对异种传染病风险的教育和代理问题。
