In spite of variations in legal frameworks among jurisdictions, our aspiration was to generate a unified, expert-agreed set of recommendations for policymakers and legal practitioners on the foundational issues within organ and tissue donation and transplantation (OTDT) systems throughout the world.
A group of legal academics, a transplant coordinator/clinician, and a patient partner used the nominal group technique to pinpoint critical areas and suggest actionable recommendations in foundational legal matters. The recommendations, shaped by narrative literature reviews conducted by group members specializing in their respective fields, yielded a collection of academic articles, policy documents, and legal sources. By examining relevant sources for each subtopic, best practices were determined, and these practices form the basis of the accompanying recommendations.
Twelve recommendations, categorized under five subject headings, were endorsed in a unified manner: (i) legal definitions and legislative limitations, (ii) consent conditions for donation, (iii) the allocation of organs and tissue, (iv) operation of OTDT systems, and (v) travel constraints for transplant operations and the prohibition of organ trafficking. We have classified legal principles, distinguishing those with established foundations from those needing more investigation and resolution. Ten topics of disagreement, along with practical recommendations, are addressed and thoroughly examined.
Our recommendations align with fundamental OTDT principles (the dead donor rule, to cite one example), and also reflect modern developments in practice (such as the requirement of mandatory referral). check details Despite widespread acceptance of some core principles, a unified approach to their application is often elusive. Recognizing the ongoing advancement of OTDT, a review of current legal recommendations is paramount to maintaining their applicability in the context of evolving knowledge, technological innovation, and practical implementation.
Our recommendations integrate principles firmly established within the OTDT framework (such as the dead donor rule), while others incorporate more current advancements in practice (for instance, mandatory referral). While some fundamental principles are broadly acknowledged, their precise implementation often sparks debate. To maintain the law's relevance in the face of changing OTDT norms, recommendations must be revisited to reflect current knowledge, technological shifts, and evolving professional standards.
International variations in the laws and policies pertaining to organ, tissue, and cell donation and transplantation manifest themselves in disparate performance outcomes across various legal jurisdictions. To achieve legislative and policy reform in tissue and cell donation and transplantation, we aimed for expert, unanimous guidance, integrating evidence and ethical considerations.
By employing the nominal group technique, we achieved consensus regarding topic areas and recommendations. The scientific committee of the project rigorously examined the proposed framework, whose genesis was in narrative literature reviews. check details The framework, presented publicly at a hybrid virtual and in-person meeting in Montreal, Canada, during October 2021, benefited from the valuable feedback provided by Forum participants and was subsequently finalized in the manuscript.
This report stipulates 13 recommendations pertaining to critical aspects influencing the donation and utilization of human tissues and cells, which demand international attention for the safeguarding of donors and recipients. Strategies are outlined for self-sufficiency, ethical integrity, the quality and safety of human tissues and cells, and innovation in safe and effective therapeutic options for not-for-profit use.
Tissue transplantation programs will gain from the adoption, in full or in part, of these recommendations by legislators and governments, which will ensure access to safe, efficacious, and morally sound tissue and cellular therapies for all patients requiring them.
By adopting these recommendations, either fully or partially, legislators and governments can help tissue transplantation programs ensure all patients gain access to safe, effective, and ethically sound tissue- and cell-based treatments.
The international variability in organ and tissue donation and transplantation (OTDT) laws and regulations impacts the effectiveness of the entire system. The international forum's rationale and methods for creating consensus recommendations on essential legal and policy attributes of an ideal OTDT system are comprehensively described in this article. This document provides guidance for legislators, regulators, and other system stakeholders, concerning the development or modification of OTDT legislation and policy.
The Canadian Donation and Transplantation Program, in partnership with Transplant Quebec and numerous national and international organizations, jointly launched this forum. Seven distinct areas were highlighted by the scientific committee, with their associated working groups designating particular topics for recommendations including 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. The planning and execution of the Forum were thoroughly informed by the collaboration of patient, family, and donor partners at all stages. Recommendations were created through the collaborative efforts of 61 participants, distributed among 13 countries. A consensus regarding topic identification and recommendations was reached via a series of virtual meetings held between March and September of 2021. Using the nominal group technique, participants arrived at a consensus based on the literature reviews they had performed. Montreal, Canada, hosted a hybrid in-person and virtual forum in October 2021, where recommendations were presented.
Ninety-four recommendations, spanning 9 to 33 per domain, and an ethical framework to evaluate new policy ideas, were the core outputs of the Forum's proceedings. The accompanying articles present recommendations from each area of study, supported by justifications that connect these recommendations to existing research and ethical/legal frameworks.
Though the recommendations couldn't encapsulate the vast global diversity of populations, healthcare infrastructures, and accessible resources for OTDT systems, they were written with the goal of broad applicability.
Though the recommendations fell short of capturing the immense global variability in populations, healthcare infrastructure, and resources available to OTDT systems, they were intended to be broadly applicable across different contexts.
The integrity and public trust in organ and tissue donation and transplantation (OTDT) rests on policymakers, governments, clinical leaders, and decision-makers ensuring that any policies intending to augment donation and transplantation activities satisfy the ethical baselines stipulated by international agreements, pronouncements, and resolutions. This article details the results produced by the Baseline Ethical Domain group of an international forum, offering stakeholders tools for assessing these ethical concerns within their systems.
Multiple national and international donation and transplantation organizations, alongside the Canadian Donation and Transplantation Program, co-hosted this Forum, a project launched by Transplant Quebec. The working group addressing domain issues was made up of administrative, clinical, and academic experts in deceased and living donation ethics and two Patient, Family, and Donor partners. Working group members' literature reviews, supplemented by a series of virtual meetings from March to September 2021, led to the creation of a policy consideration framework, which then informed the identification of internationally accepted baseline ethical principles. check details Consensus on the framework resulted from the use of the nominal group technique.
From the 30 fundamental ethical principles within the World Health Organization Guiding Principles, the Declaration of Istanbul, and the Barcelona Principles, an ethical framework was developed. This framework, presented as a graphic spiral of considerations, supports decision-makers in applying these principles to both policies and daily practice. We eschewed a discussion of ethics, opting instead for a description of a policy evaluation method.
The proposed framework allows for the application of widely accepted ethical principles to both new and pre-existing OTDT policy decisions, thereby facilitating practical evaluation. This framework, capable of adapting to local contexts, possesses broad international applicability.
The framework's application to existing or new OTDT policy decisions can facilitate translating widely accepted ethical principles into actionable evaluations. The framework accommodates local contexts and can be implemented internationally.
Recommendations from one of the seven domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum) are included in this report. Expert counsel on the structure and role of Organ and Tissue Donation and Transplantation (OTDT) systems is the intention. OTDT stakeholders are the intended recipients; their aim is to establish or improve existing systems.
The Forum, a joint initiative between Transplant Quebec and the Canadian Donation and Transplantation Program, involved numerous national and international donation and transplantation organizations in its co-hosting role. Experts in OTDT systems, spanning administrative, clinical, and academic fields, and three patient, family, and donor partners, were part of this domain group. With the nominal group technique supporting our efforts, we reached consensus on topic areas and developed recommendations. The Forum's scientific committee scrutinized the selected topics, which were initially informed by narrative literature reviews.
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