Close contacts of xenograft recipients: Ethical considerations due to risk of xenozoonosis

Abstract

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.

The importance of public engagement in clinical xenotransplantation

“…Unlike many novel therapies, xenotransplantation presents the small but potentially consequential risk of xenozoonosis—the transmission of a pathogenic microorganism from the porcine graft to the xenograft recipient and possibly from the recipient to the public. This could potentially put at risk those who have no special or close relationship with the patient, a group termed “bystanders” [ 5 ]. These potential risks must therefore be made known during the informed consent process to individuals who potentially may participate in xenotransplantation clinical trials and also to the communities in which clinical trials are being planned so that dialogue can take place.…”