Written informed consent for living liver donor evaluation: Compliance with centers for medicare and medicaid services and organ procurement and transplantation network guidelines and alibi offers

Authors

  • Carrie Thiessen,

    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
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  • Yunsoo A. Kim,

    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
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  • Peter S. Yoo,

    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
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  • Manuel Rodriguez-Davalos,

    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
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  • David Mulligan,

    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
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  • Sanjay Kulkarni

    Corresponding author
    1. Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT
    • Address reprint requests to Sanjay Kulkarni, M.D., Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, 333 Cedar Street, FMB 121, New Haven, CT 06410. Telephone: 203-785-2556; FAX: 203-785-7162; E-mail: sanjay.kulkarni@yale.edu

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  • There were no grants or financial support, and the authors have no conflicts of interest to disclose.

Abstract

We examined written informed consent forms for living liver donor evaluations to determine whether they incorporated elements required by the Centers for Medicare and Medicaid Services (CMS) and suggested by the Organ Procurement and Transplantation Network (OPTN). We contacted each of the 41 US centers that performed at least 1 living donor liver transplant in 2011; 37 centers reported active living donor evaluation programs. Twenty-six centers shared their consent form for living donor evaluation (response rate = 70%). Each document was double-coded for consent element content. We found that 57% of the centers included the 9 mandated CMS elements. Although the OPTN guidelines are non-binding, 78% of the centers used consent forms that addressed at least two-thirds of the elements recommended by OPTN. Only 17% of the centers provided written offers of an alibi to donors who withdrew from the evaluation. On the basis of our findings, we offer suggestions that may be relevant to ongoing revisions to the OPTN living liver donor consent policy and may help centers to improve the clarity of their written consent forms. Liver Transpl 20:416–424, 2014. © 2014 AASLD.

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