Written informed consent for living liver donor evaluation: Compliance with CMS

[Clark]

http://onlinelibrary.wiley.com/doi/10.1002/lt.23822/abstract

Written informed consent for living liver donor evaluation: Compliance with CMS & OPTN guidelines and alibi offers
Carrie Thiessen MD, PhD, Yunsoo A. Kim BA, Peter S. Yoo MD, Manuel Rodriguez-Davalos MD, David Mulligan MD, Sanjay Kulkarni MD
DOI: 10.1002/lt.23822

Abstract
We examined the written informed consent forms for living liver donor evaluation to determine if they incorporated the 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 one living donor liver transplant in 2011. 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 utilized consent forms that addressed at least two-thirds of the elements recommended by OPTN. Only 17% of centers provided written offers of an alibi to donors who withdrew from evaluation. Based on our findings, we offer suggestions that may be relevant to ongoing revisions to OPTN living liver donor consent policy and may help centers improve the clarity of their written consent forms.