Ethical guidance for randomized controlled trials of donor interventions in deceased organ donation: a scoping review of international guidelines, consensus statements, and expert recommendations

Abstract

Deceased donor interventions are nontherapeutic interventions to improve the likelihood of successful donation and transplant outcomes. Randomized controlled trials (RCTs) could strengthen the evidence base for donor interventions, but such trials face difficult ethical challenges. We sought to systematically map authoritative guidance pertaining to ethical challenges in donor intervention RCTs. Following Arksey and O’Malley’s scoping review methodology, we searched Ovid MEDLINE and hand-searched reference lists. Records were included if they provided guidance on at least one ethical challenge in donor intervention RCTs, provided the guidance emerged from regulatory bodies, professional organizations, consensus statements or guidelines, or expert authorship groups that employed deliberative methods in deriving recommendations. Two reviewers independently screened articles and extracted data. Among 712 unique records, 14 met inclusion criteria. Guidance converged on several points: deceased donors should not be classified as research participants; consent to donation does not equate to consent to research; and two-stage consent models and centralized oversight are recommended. However, discordance persisted on issues such as how consent should be obtained, whether organ recipients should be afforded research participant status, and oversight requirements. No guidance directly addressed donor intervention research in donation after circulatory death. While existing guidance provides partial direction, ethical uncertainties remain. Dedicated, internationally applicable guidelines are needed to enable transformative donor intervention RCTs and preserve trust in donation and transplantation research.