A scoping review of the legal and ethical challenges with the use of normothermic regional perfusion in controlled donation after circulatory determination of death from 2005 to 2023

Am J Transplant. 2024 Aug 30:S1600-6135(24)00532-X. doi: 10.1016/j.ajt.2024.08.023. Online ahead of print.

Abstract

Use of normothermic regional perfusion (NRP) to enable organ reconditioning and assessment in donation after circulatory determination of death is controversial. We conducted a scoping review of peer-reviewed articles, news media, legal literature, and professional society position statements addressing ethical and/or legal issues in use of NRP in controlled donation after circulatory determination of death from January 1, 2005, to January 5, 2024. Thematic analysis, assessing the 4 principles of bioethics (autonomy, beneficence, nonmaleficence, and justice) and subthemes identified within each, was conducted for the 112 publications meeting inclusion criteria. More than 30 publications addressed the topic in each of 2022 and 2023, vs ≤6 per year previously. Nonmaleficence was the most frequently addressed bioethical principle (111/112 publications), and the most varied, with 14 subthemes. Attitudes toward NRP differed by type of NRP: of 72 publications discussing thoracoabdominal NRP, 22 (30.6%) were "In Favor," 39 (54.2%) were "Neutral," and 11 (15.3%) were "Against"; of 44 discussing abdominal NRP, 23 (52.3%) were "In Favor," 20 (45.5%) were "Neutral," and 1 (2.3%) was "Against." Attitudes differed by authors' country, degree, and affiliation, and by the clinical focus of the publishing journal. Overall, our review shows that the ethical and legal issues raised by NRP remain unresolved, and the debate centered on nonmaleficence.

Keywords: donation after circulatory determination of death; ethics; laws; normothermic regional perfusion.