title: 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.
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.
authors.affiliation: Section of Transplantation and Immunology, Department of Surgery, Yale School of Medicine, New Haven, CT.
authors.forename: Carrie
authors.initials: C
authors.lastname: Thiessen
authors.forename: Yunsoo A
authors.initials: YA
authors.lastname: Kim
authors.forename: Peter S
authors.initials: PS
authors.lastname: Yoo
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodriguez-Davalos
authors.forename: David
authors.initials: D
authors.lastname: Mulligan
authors.forename: Sanjay
authors.initials: S
authors.lastname: Kulkarni
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D020407:Internet; D016031:Liver Transplantation / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000592:standards; D019520:Living Donors; D008484:Medicaid; D006278:Medicare; D009927:Tissue and Organ Procurement / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States