Sánchez-Ibañez Jacinto, Humphreys Christine, Lomero Mar, Escoto Manuel, Weiss Matthew J, Wilson Murray, López-Fraga Marta
A Coruña Tissue Bank, Cryobiology Unit, A Coruña University Hospital, Spain.
Eye Bank of Canada (Ontario Division), Toronto, ON, Canada.
Transplant Direct. 2023 Apr 28;9(5):e1466. doi: 10.1097/TXD.0000000000001466. eCollection 2023 May.
Organ, tissue, and cell donation and transplantation legislation and policies vary substantially worldwide, as do performance outcomes in various jurisdictions. Our objective was to create expert, consensus guidance that links evidence and ethical concepts to legislative and policy reform for tissue and cell donation and transplantation systems.
We identified topic areas and recommendations through consensus, using nominal group technique. The proposed framework was informed by narrative literature reviews and vetted by the project's scientific committee. The framework was presented publicly at a hybrid virtual and in-person meeting in October 2021 in Montréal, Canada, where feedback provided by the broader Forum participants was incorporated into the final manuscript.
This report has 13 recommendations regarding critical aspects affecting the donation and use of human tissues and cells that need to be addressed internationally to protect donors and recipients. They address measures to foster self-sufficiency, ensure the respect of robust ethical principles, guarantee the quality and safety of tissues and cells for human use, and encourage the development of safe and effective innovative therapeutic options in not-for-profit settings.
The implementation of these recommendations, in total or in part, by legislators and governments would benefit tissue transplantation programs by ensuring access to safe, effective, and ethical tissue- and cell-based therapies for all patients in need.
器官、组织和细胞捐赠与移植的立法及政策在全球范围内差异很大，不同司法管辖区的实施成果也是如此。我们的目标是制定专业的共识性指南，将证据和伦理概念与组织和细胞捐赠及移植系统的立法和政策改革联系起来。
我们采用名义群体技术，通过共识确定主题领域和建议。拟议的框架以叙述性文献综述为依据，并经项目科学委员会审核。该框架于2021年10月在加拿大蒙特利尔举行的一次线上线下混合会议上公开介绍，更广泛的论坛参与者提供的反馈被纳入了最终文稿。
本报告就影响人体组织和细胞捐赠与使用的关键方面提出了13项建议，这些方面需要在国际上加以解决，以保护捐赠者和接受者。它们涉及促进自给自足的措施、确保遵循严格的伦理原则、保证用于人类的组织和细胞的质量与安全，以及鼓励在非营利环境中开发安全有效的创新治疗方案。
立法者和政府全部或部分实施这些建议，将使组织移植项目受益，确保所有有需要的患者都能获得安全、有效且符合伦理的基于组织和细胞的治疗方法。
