Xenograft recipients and the right to withdraw from a clinical trial.

Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from...

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Publicado en:Bioethics Vol. 38; no. 4; pp. 308 - 316
Autores principales: Bobier, Christopher, Hurst, Daniel J., Rodger, Daniel, Omelianchuk, Adam
Formato: Artículo
Publicado: Wiley-Blackwell May2024
Materias:
Acceso en línea:Ver este registro en EBSCOhost
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      dt: May2024
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      pub: Wiley-Blackwell
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        10.1111/bioe.13262
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        atl: Xenograft recipients and the right to withdraw from a clinical trial.
      aug:
        au:
          Bobier, Christopher
          Hurst, Daniel J.
          Rodger, Daniel
          Omelianchuk, Adam
        affil:
          Department of Theology and Philosophy, Associate Director, Hendrickson Institute for Ethical Leadership, St. Mary's University of Minnesota, Winona Minnesota,, USA
          Department of Family Medicine Rowan University School of Osteopathic Medicine Stratford, New Jersey,, USA
          Institute of Health and Social Care, School of Allied and Community Health, London South Bank University, London, UK
          Department of Psychological Sciences, Birkbeck, University of London, London, UK
          Center for Medical Ethics and Health Policy at Baylor College of Medicine, Houston Texas,, USA
      su:
        Patients
        Patients' rights
        Human research subjects
        Termination of treatment
        Clinical trials
        Infectious disease transmission
        Public health
        Law
        Legislation
        Disease risk factors
        Transplantation of organs, tissues, etc.
        Xenografts
        Zoonoses
        Biosurveillance
      sug:
        subj:
          Patients
          Patients' rights
          Human research subjects
          Termination of treatment
          Clinical trials
          Infectious disease transmission
          Public health
          Law
          Legislation
          Disease risk factors
          Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
          Health and Welfare Funds
          Transplantation of organs, tissues, etc.
          Xenografts
          Zoonoses
          Biosurveillance
      keyword:
        patient rights
        public health
        xenotransplantation
        zoonosis
        patient rights
        public health
        xenotransplantation
        zoonosis
      ab: Preclinical xenotransplantation research using genetically engineered pigs has begun to show some promising results and could one day offer a scalable means of addressing organ shortage. While it is a fundamental tenet of ethical human subject research that participants have a right to withdraw from research once enrolled, several scholars have argued that the right to withdraw from xenotransplant research should be suspended because of the public health risks posed by xenozoonotic transmission. Here, we present a comprehensive critical evaluation of the claim that xenotransplant recipients should be required to waive their right to withdraw from lifelong biosurveillance. We conclude that if xenotransplantation requires participants to waive their right to withdraw, then clinical trials may not be justifiable, given the ethical and legal obstacles involved with doing so. Consequently, if clinical trials are permitted with a right to withdraw, then they may pose a significant public health risk.
      pubtype: Academic Journal
      doctype: Article
      src: R
    language: English
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