Amidst the diversity of legal systems found across different jurisdictions, our strategy was to develop a well-researched, expert-confirmed set of recommendations for legal and policy professionals pertaining to the fundamental elements within organ and tissue donation and transplantation (OTDT) systems throughout the world.
Within the nominal group technique framework, the collaboration of legal academics, a transplant coordinator/clinician, and a patient representative yielded topic areas and suggestions for foundational legal concerns. The recommendations were the result of narrative literature reviews conducted by group members, leveraging their diverse areas of expertise, leading to a broad array of academic articles, policy documents, and legal sources. Recommendations included herein are derived from best practices identified from pertinent sources relating to each subtopic.
Twelve recommendations were approved by consensus, divided into five areas: (i) legal terms and legislative boundaries, (ii) requirements for consent to donation, (iii) mechanisms for allocating organs and tissue, (iv) guidelines for the operation of OTDT systems, and (v) the regulations surrounding patient travel for transplants and the prevention of illegal organ trade. Foundational legal principles have been divided into two subsets: those with solid support and those demanding further investigation and resolution. Ten contentious issues, alongside their suggested remedies, are analyzed and deliberated upon.
Our recommendations incorporate tenets firmly established within the OTDT framework (such as the dead donor rule), while others incorporate more contemporary advancements in practice (like mandatory referral). see more Despite the broad acceptance of certain fundamental principles, divergence of opinion exists concerning their operational implementation. The ongoing transformation of the OTDT landscape mandates a re-evaluation of legal recommendations, ensuring they reflect the advancements in knowledge, technological development, 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). Commonly agreed-upon principles notwithstanding, a consensus on their execution often proves elusive. Evolving OTDT norms necessitate a critical review of existing legal prescriptions, allowing them to remain consistent with burgeoning knowledge, technological innovations, and real-world applications.
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. We endeavored to produce expert, cohesive guidance, aligning evidence with ethical principles and legislative/policy reforms impacting tissue and cell donation and transplantation systems.
Topic areas and recommendations emerged from our consensus-based approach, facilitated by the nominal group technique. Informed by narrative literature reviews, the proposed framework received the endorsement of the project's scientific committee. see more In October 2021, the framework was unveiled to the public at a hybrid virtual and in-person meeting in Montreal, Canada; participant feedback from the broader Forum was then incorporated into the final manuscript.
This report underscores 13 recommendations for addressing critical aspects of the donation and use of human tissues and cells internationally, safeguarding both donors and recipients. Measures to promote self-reliance, uphold strong ethical standards, guarantee the quality and safety of human tissues and cells, and encourage the creation of safe and effective innovative therapies in non-profit settings are addressed.
Implementing these recommendations, either completely or partially, by legislators and governments would positively influence tissue transplantation programs by ensuring the availability of safe, effective, and ethical tissue- and cell-based therapies to all patients requiring them.
To guarantee access to safe, effective, and ethical tissue- and cell-based treatments for all patients requiring them, legislators and governments should, in full or in part, implement these recommendations within their respective jurisdictions.
The international variability in organ and tissue donation and transplantation (OTDT) laws and regulations impacts the effectiveness of the entire system. This document elaborates on the aims and procedures of an international forum, whose goal was to formulate consensus recommendations about the essential legal and policy factors of an ideal OTDT system. For those policymakers and system stakeholders seeking to create or improve OTDT legislation and policy, this document provides guidance.
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. Every phase of the Forum's design and implementation involved the active participation of patient, family, and donor partners. The generation of recommendations was supported by a collective of 61 participants representing 13 distinct countries. The virtual meetings held between March and September 2021 brought about a consensus decision on topic identification and recommendations. Participants, after conducting literature reviews, employed the nominal group technique to arrive at a consensus. Recommendations were disseminated at a combined in-person and virtual forum in Montreal, Canada, in the month of October 2021.
A set of ninety-four recommendations, ranging from nine to thirty-three per subject area, and an ethical framework for assessing new policies, were the fruits of the Forum's deliberations. The articles accompanying this document feature recommendations from each specialized field, supported by their connection to current literature and relevant ethical or legal precepts.
Given the profound global variations in population demographics, healthcare infrastructure, and resources available to OTDT systems, the recommendations aimed to be as widely applicable as circumstances permitted.
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.
In order to maintain the public's trust and integrity in organ and tissue donation and transplantation (OTDT), policymakers, governments, and clinical and decision-making bodies must verify that any policies promoting donation and transplantation adhere to the fundamental ethical precepts established by international accords, declarations, and resolutions. An international forum's Baseline Ethical Domain group's output, described in this article, is meant to direct stakeholders in examining the ethical dimensions of their systems.
The Canadian Donation and Transplantation Program, in partnership with numerous national and international organizations, co-hosted this Forum, which was initiated by Transplant Quebec. In the domain working group, administrative, clinical, and academic experts in the ethics of deceased and living donation were present, as were two Patient, Family, and Donor partners. Based on literature reviews performed by members of the working group, a framework for the assessment of existing and newly proposed policies was designed through a series of virtual meetings, between March and September 2021, leading to the identification of internationally recognized baseline ethical principles. see more The nominal group technique was instrumental in achieving a consensus on the framework's design.
Employing the 30 baseline ethical precepts outlined in the WHO Guiding Principles, the Istanbul Declaration, and the Barcelona Principles, we constructed an ethical framework, visually represented as a spiraling sequence of considerations, intended to facilitate decision-makers' integration of these ethical tenets into their policies and practical applications. The goal was not ethical determination, but the presentation of a method for evaluating policy decisions.
New or existing OTDT policy decisions can leverage the proposed framework, enabling the translation of widely accepted ethical principles into actionable evaluations. Adapting the framework to local circumstances enables its broad use internationally.
The proposed framework, applicable to new or existing OTDT policy decisions, can transform widely accepted ethical principles into practical evaluations. Internationally, the framework's ability to adapt to local contexts is significant.
Within the International Donation and Transplantation Legislative and Policy Forum (the Forum), this report incorporates recommendations specific to one of its seven domains. Providing expert knowledge concerning the architecture and functioning of Organ and Tissue Donation and Transplantation (OTDT) systems is the purpose. The focus group for this initiative consists of OTDT stakeholders engaged in developing or refining current systems.
The Forum, a collaborative endeavor launched by Transplant Quebec, was co-hosted by the Canadian Donation and Transplantation Program, with the significant involvement of multiple national and international donation and transplantation organizations. Experts in OTDT systems, spanning administrative, clinical, and academic fields, and three patient, family, and donor partners, were part of this domain group. By employing the nominal group technique, we achieved consensus to establish topic areas and pertinent recommendations. After being initially informed by narrative literature reviews, the selected topics were subsequently validated by the Forum's scientific committee.