ABSTRACT

Background: Despite calls for a controlled organ donation after circulatory death (cDCD) consent process that is more rigorous, consistent, and transparent, little is known about the cDCD consent processes utilized by U.S. hospitals. The objective of this research was to describe the cDCD consent policies of U.S. transplant hospitals, including consent for antemortem interventions (AMI), in order to inform the development of a more rigorous and sound consent process. Methods: Cross-sectional study data of cDCD policies of U.S. transplant hospitals were collected between July 2013 and October 2014. Respondents submitted their policies for investigator review and/or completed a 25-item Web-based survey describing their hospital's cDCD and AMI policies. There were 209 U.S. adult transplant hospitals identified through the Organ Procurement and Transplantation Network (OPTN). Results: One hundred responses were received, representing 48% of all 209 U.S. transplant hospitals and 60% of the 168 transplant centers with an identified knowledgeable informant. In 79 policies (79%), organ procurement organization representatives (OPOs) are given sole responsibility for obtaining signed cDCD consent. Thirty-four policies (34%) give OPOs the responsibility for obtaining written AMI consent, 13 policies give it to treating physicians, and 6 policies state that AMI consent must be obtained collaboratively. Treating physicians have no delineated responsibilities in the cDCD and AMI consent process in 70 (70%) and 58 (58%) policies, respectively. We observed wide variability in the acceptability of first-person authorization (FPA) for cDCD and AMI; FPA was rejected as evidence of consent for cDCD and AMI in 7 and 11 policies, respectively. Conclusions: The cDCD consent policies of U.S. transplant hospitals are highly variable and inconsistent in addressing key aspects of the consent process. The major policy differences observed raise questions about what constitutes a sound and comprehensive cDCD consent policy.