Weiss Matthew J, Cantarovich Marcelo, Chaudhury Prosanto, Dieudé Mélanie, Hartell David P, Martel Annie-Carole, Patriquin Chelsea, Shemie Sam D, Simard Marie-Josée, Woolfsmith Jennifer, Delmonico Francis, Domínguez-Gil Beatriz
Transplant Québec, Montréal, QC, Canada.
Division of Critical Care, Department of Pediatrics, Centre Mère-Enfant Soleil du CHU de Québec, Québec, QC, Canada.
Transplant Direct. 2023 Apr 28;9(5):e1351. doi: 10.1097/TXD.0000000000001351. eCollection 2023 May.
Organ and tissue donation and transplantation (OTDT) legislation and policies vary around the world, and this variability contributes to discrepancies in system performance. This article describes the purpose and methodology of an international forum that was organized to create consensus recommendations related to key legal and policy attributes of an ideal OTDT system. The intent is to create guidance for legislators, regulators, and other system stakeholders who aim to create or reform OTDT legislation and policy.
This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. Seven domains were identified by the scientific committee' and domain working groups identified specific topics for recommendations: Baseline Ethical Principles, Legal Foundations, Consent Model and Emerging Legal Issues, Donation System Architecture, Living Donation, Tissue Donation, and Research and Innovation Systems and Emerging Issues. Patient, family, and donor partners were integrated into every stage of the planning and execution of the Forum. Sixty-one participants from 13 countries contributed to recommendation generation. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by participants. Recommendations were presented at a hybrid in-person and virtual forum in Montreal, Canada, in October 2021.
Ninety-four recommendations (9-33 per domain) and an ethical framework for evaluating new policies were developed during the Forum proceedings. The accompanying articles include the recommendations from each domain and justifications that link the consensus to existing literature and ethical or legal concepts.
Although the recommendations could not account for the vast global diversity of populations, healthcare infrastructure, and resources available to OTDT systems, they were written to be as widely applicable as possible.
器官和组织捐赠与移植（OTDT）的立法和政策在世界各地各不相同，这种差异导致了系统绩效的差异。本文描述了一个国际论坛的目的和方法，该论坛旨在就理想的OTDT系统的关键法律和政策属性达成共识性建议。目的是为旨在制定或改革OTDT立法和政策的立法者、监管者及其他系统利益相关者提供指导。
该论坛由魁北克移植协会发起，由加拿大捐赠与移植项目共同主办，并与多个国家和国际捐赠与移植组织合作。科学委员会确定了七个领域，领域工作组确定了具体的建议主题：基本伦理原则、法律基础、同意模式及新出现的法律问题、捐赠系统架构、活体捐赠、组织捐赠以及研究与创新系统及新出现的问题。患者、家属和捐赠者伙伴参与了论坛规划和执行的每个阶段。来自13个国家的61名参与者为生成建议做出了贡献。主题确定和建议共识在2021年3月至9月的一系列虚拟会议上完成。通过应用由参与者进行的文献综述提供信息的名义群体技术达成了共识。建议于2021年10月在加拿大蒙特利尔举行的线下与线上相结合的论坛上提出。
在论坛过程中制定了94条建议（每个领域9 - 33条）以及一个评估新政策的伦理框架。随附的文章包括每个领域的建议以及将共识与现有文献以及伦理或法律概念联系起来的理由。
尽管这些建议无法考虑到OTDT系统所面临的全球人口、医疗基础设施和可用资源的巨大差异，但它们的撰写尽可能具有广泛的适用性。
