Written informed consent for living kidney donors: Practices and compliance with CMS and OPTN requirements

摘要

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. Although nearly all US transplant centers now obtain written consent for evaluation of living kidney donors, most centers utilize consent documents that do not include all informational elements required by the Centers for Medicare & Medicaid Services or the Organ Procurement and Transplantation Network.