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Purpose of Review <p>The 2023 Securing the U.S. Organ Procurement and Transplantation Network Act mandated the most significant governance changes to organ transplantation in decades. This review analyzes the implementation of these reforms, arguing that while the legislation successfully addressed corporate conflicts of interest, it failed to resolve the foundational dynamics that prioritize professional autonomy over public accountability.</p> Recent Findings <p>The separation of the OPTN Board from its legacy contractor created a new entity (INVEST) yet retained a governance structure dominated by industry insiders. This failure to empower non-clinical voices precipitated the mass resignation of patient representatives in 2025. Concurrently, federal oversight has shifted toward aggressive sub-regulatory directives from HRSA. This top-down approach risks exchanging industry capture for bureaucratic overreach and faces legal vulnerability following the Supreme Court’s overturn of Chevron.</p> Summary <p>To restore legitimacy, the OPTN must transition from a self-regulatory model to a public trust framework. Drawing on the governance architecture of the Financial Industry Regulatory Authority (FINRA), this paper proposes a structural requirement where independent public members outnumber industry representatives on the Board. This shift is essential to eliminate capture, ensure fiduciary rigor, and permanently align the system with the public interest.</p>

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Beyond Self-Regulation: Moving Toward a Public-Trust Model in Organ Transplant Governance

  • 期刊论文

  • 发表日期：

    2026年5月22日

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  • James Alcorn,
  • Samantha Klitenic,
  • Macey Levan

摘要

Purpose of Review

The 2023 Securing the U.S. Organ Procurement and Transplantation Network Act mandated the most significant governance changes to organ transplantation in decades. This review analyzes the implementation of these reforms, arguing that while the legislation successfully addressed corporate conflicts of interest, it failed to resolve the foundational dynamics that prioritize professional autonomy over public accountability.

Recent Findings

The separation of the OPTN Board from its legacy contractor created a new entity (INVEST) yet retained a governance structure dominated by industry insiders. This failure to empower non-clinical voices precipitated the mass resignation of patient representatives in 2025. Concurrently, federal oversight has shifted toward aggressive sub-regulatory directives from HRSA. This top-down approach risks exchanging industry capture for bureaucratic overreach and faces legal vulnerability following the Supreme Court’s overturn of Chevron.

Summary

To restore legitimacy, the OPTN must transition from a self-regulatory model to a public trust framework. Drawing on the governance architecture of the Financial Industry Regulatory Authority (FINRA), this paper proposes a structural requirement where independent public members outnumber industry representatives on the Board. This shift is essential to eliminate capture, ensure fiduciary rigor, and permanently align the system with the public interest.