title: Equipoise: ethical, scientific, and clinical trial design considerations for compatible pair participation in kidney exchange programs.
abstract: Compatible living donor/recipient pair participation (CPP) in kidney exchange (KE) transplantation may substantially increase transplant volumes and significantly mitigate the O blood group donor shortage in KE. Initial ethical analysis did not support CPP for two primary reasons: (1) KE would be "unbalanced," and (2) the possibility of undue influence experienced by the compatible pair living donor. Recent developments with CPP (modeling studies and small clinical experiences), have demonstrated substantial potential for increasing KE volumes. This encouraged us to reconsider initial ethical concerns, with a focus on the potential for a design of a prospective CPP clinical trial. This ethical reconsideration led us to conclude that the concept of unbalanced kidney exchanges (manifested primarily by differential benefit between compatible and incompatible pairs) is no longer as clear cut as originally conceived. In addition, application of two concepts substantially diminishes ethical concerns including: (1) "quasi-compatible" pairs, and (2) a priori definition of mitigating factors. We conclude that genuine uncertainty exists regarding whether kidney exchange is best performed with or without compatible pair participation and that a clinical trial is therefore warranted.
authors.affiliation: Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.
authors.forename: M C
authors.initials: MC
authors.lastname: Cuffy
authors.affiliation: Department of Surgery, Columbia University Medical Center, New York, NY.
authors.forename: L E
authors.initials: LE
authors.lastname: Ratner
authors.affiliation: MacLean Center for Clinical Medical Ethics, University of Chicago, Chicago, IL.
authors.forename: M
authors.initials: M
authors.lastname: Siegler
authors.affiliation: Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.
authors.forename: E S
authors.initials: ES
authors.lastname: Woodle
mesh_terms: D000367:Age Factors; D001787:Blood Group Incompatibility; D002986:Clinical Trials as Topic / Q000941:ethics*; D004992:Ethics, Medical; D006648:Histocompatibility; D006801:Humans; D016030:Kidney Transplantation / Q000941:ethics*; D019520:Living Donors; D010353:Patient Education as Topic; D010358:Patient Participation; D012107:Research Design; D057212:Therapeutic Equipoise; D009927:Tissue and Organ Procurement / Q000941:ethics
keywords: clinical trial design; donors and donation: paired exchange; ethics and public policy; kidney transplantation/nephrology