title: Written informed consent for living kidney donors: practices and compliance with CMS and OPTN requirements.
abstract: We sought to assess how written informed consent practices for candidate living kidney donors have changed over the last 5 years and to assess compliance with Centers for Medicare and Medicaid (CMS) and Organ Procurement and Transplantation Network (OPTN) regulations that took effect in 2007. We requested evaluation consent forms from US centers that performed >5 living kidney transplants during the prior year (n = 184). We received 148 consent forms; each was reviewed for information provided and inclusion of CMS- and OPTN-required elements. We found that nearly all transplant centers now obtain written consent for living kidney donor evaluation. However, most centers' evaluation consent forms do not include all CMS and OPTN requirements. Multiple items balancing donor and recipient interests and confidentiality were omitted. In addition, information about payment for routine follow-up care, complications related to surgery and other health problems following surgery were highly variable and frequently ambiguous. As centers revise their consent forms to address the 2013 OPTN policies, our findings may help them identify areas of potential deficiency. We propose that UNOS develop a uniform donor evaluation consent form to improve the clarity, consistency and efficiency of living donor consent.
authors.affiliation: Section of Organ Transplantation and Immunology, Department of Surgery, Yale University School of Medicine, New Haven, CT.
authors.forename: C
authors.initials: C
authors.lastname: Thiessen
authors.forename: Y A
authors.initials: YA
authors.lastname: Kim
authors.forename: R
authors.initials: R
authors.lastname: Formica
authors.forename: M
authors.initials: M
authors.lastname: Bia
authors.forename: S
authors.initials: S
authors.lastname: Kulkarni
mesh_terms: D032962:Consent Forms; D046148:Donor Selection; D005500:Follow-Up Studies; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D006291:Health Policy; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence*; D016030:Kidney Transplantation / Q000941:ethics* / Q000523:psychology; D019520:Living Donors / Q000941:ethics* / Q000523:psychology; D006278:Medicare; D017410:Practice Guidelines as Topic; D011379:Prognosis; D009927:Tissue and Organ Procurement / Q000458:organization & administration*; D014481:United States
keywords: Ethics; health policy; informed consent; living donors; renal transplantation