While legal systems differ significantly from one region to another, the aim was to establish comprehensive, consensual guidelines for legal authorities and policymakers addressing the core concepts underlying organ and tissue donation and transplantation (OTDT) systems globally.
A group of legal academics, a transplant coordinator/clinician, and a patient partner, applied the nominal group technique to pinpoint key legal issues and suggest suitable recommendations. Group members' expertise-driven narrative literature reviews, which encompassed academic articles, policy documents, and legal sources, informed the recommendations. Recommendations included herein are derived from best practices identified from pertinent sources relating to each subtopic.
We reached a unified position on twelve recommendations, structured under five subcategories: (i) legal definitions and legislative scope, (ii) consent stipulations for donation, (iii) organ and tissue distribution policies, (iv) operational procedures for OTDT systems, and (v) logistical considerations for transplantation and combating organ trafficking. We categorized those foundational legal principles, separating those with strong evidentiary support from those needing additional analysis and resolution. Ten areas of controversy are scrutinized, and recommendations relevant to them are addressed.
In our recommendations, some principles firmly reside within the OTDT framework (such as the dead donor rule), whereas others integrate newer trends in the field (e.g., mandatory referral). RXC004 concentration Although many standards are widely recognized, the manner of their practical implementation is not consistently agreed upon. 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.
Recommendations that we offer incorporate principles deeply embedded in the OTDT framework (specifically, the dead donor rule), but others demonstrate the influence of recent advancements in the field (for instance, mandated referral). Acknowledged principles notwithstanding, diverse perspectives persist regarding appropriate implementation strategies. Given the dynamic nature of the OTDT environment, legal guidance must be adapted and revisited to reflect the ever-changing landscape of knowledge, technology, and operational approaches.

Across the globe, the laws and regulations concerning organ, tissue, and cell donation and transplantation demonstrate considerable variation, much like the subsequent outcomes in different legal jurisdictions. The creation of expert, unified guidance, connecting evidence and ethical concepts to legislative and policy improvements for tissue and cell donation and transplantation systems was our primary objective.
Through consensus and the nominal group technique, we determined key subject areas and suggested improvements. Using narrative literature reviews as a foundation, the proposed framework underwent review and validation by the project's scientific committee. RXC004 concentration 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.
Concerning the donation and use of human tissues and cells, this report offers 13 recommendations on critical elements that need international attention to protect 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.
Tissue transplantation programs would benefit from legislators and governments adopting these recommendations, partially or entirely, ensuring that all patients needing them have access to secure, efficient, and morally sound tissue- and cell-based therapies.
Legislators and governments' full or partial adoption of these recommendations would bolster tissue transplantation programs, guaranteeing all deserving patients access to safe, effective, and ethically sound tissue- and cell-based therapies.

The international variability in organ and tissue donation and transplantation (OTDT) laws and regulations impacts the effectiveness of the entire system. This article elucidates the objectives and methods employed in an international forum, convened to develop consensus-based recommendations regarding the critical legal and policy characteristics of an optimal OTDT system. This document intends to offer guidance to legislators, regulators, and other system stakeholders involved in creating or reforming OTDT legislation and policy.
The Canadian Donation and Transplantation Program, in partnership with Transplant Quebec and various national and international donation and transplantation organizations, launched this forum. The scientific committee, and associated domain-specific working groups, categorized recommendations for seven key areas: 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 Forum's design and implementation were enriched by the constant involvement of patient, family, and donor partners at every stage of the process. Recommendations were collaboratively developed by 61 participants originating from 13 diverse countries. From March to September 2021, virtual meetings served as the platform for reaching a consensus regarding topic identification and recommendations. Following the literature reviews carried out by participants, a consensus was obtained utilizing the nominal group technique. During October 2021, a hybrid in-person and virtual forum in Montreal, Canada, featured the presentation of recommendations.
The Forum's proceedings yielded ninety-four recommendations, encompassing nine to thirty-three suggestions per domain, along with an ethical framework for the evaluation of new policies. Recommendations from each discipline, along with the justifications linking them to pertinent academic literature and ethical or legal principles, are presented in the accompanying articles.
Despite the limitations imposed by the immense global disparity in populations, healthcare infrastructure, and available resources for OTDT systems, the recommendations were formulated to be as universally applicable as possible.
Although the recommendations lacked the scope to account for the significant global variations in populations, healthcare infrastructure, and resources available to OTDT systems, they were nevertheless written with a view toward maximum applicability.

For upholding the public's confidence and moral standards in organ and tissue donation and transplantation (OTDT), the relevant policymakers, governments, clinical leaders, and decision-makers must ensure that policies meant to increase donation and transplantation activities uphold internationally agreed-upon ethical principles. This article elucidates the output from the international forum's Baseline Ethical Domain group, which aims to help stakeholders consider ethical implications of their systems.
This Forum was jointly organized by Transplant Quebec and the Canadian Donation and Transplantation Program, collaborating with several national and international donation and transplantation organizations. Experts in deceased and living donation ethics, encompassing administrative, clinical, and academic fields, and two Patient, Family, and Donor partners, constituted the domain working group. Virtual meetings, held between March and September 2021, enabled working group members to complete literature reviews, resulting in a policy framework for evaluating existing and emerging ideas, ultimately used to identify internationally recognized baseline ethical principles. RXC004 concentration The framework's consensus was secured through the methodical application of the nominal group technique.
Grounded in the 30 fundamental ethical precepts articulated in the World Health Organization's Guiding Principles, the Declaration of Istanbul, and the Barcelona Principles, we developed an ethical framework, presented visually as a spiral of considerations. This framework aids decision-makers in enacting these precepts into policies and daily procedures. The goal was not ethical determination, but the presentation of a method for evaluating policy decisions.
The proposed framework provides a mechanism for incorporating widely accepted ethical principles into the evaluation process for both new and existing OTDT policy decisions. This framework, capable of adapting to local contexts, possesses broad international applicability.
The proposed framework allows for the practical evaluation of widely accepted ethical principles within new or existing OTDT policy decisions. The framework's adaptability to local contexts allows for broad international application.

One of the seven domains within the International Donation and Transplantation Legislative and Policy Forum (the Forum) has contributed recommendations to this report. Expert guidance on the design and performance of Organ and Tissue Donation and Transplantation (OTDT) systems is the objective. OTDT stakeholders are the intended recipients; their aim is to establish or improve existing systems.
With the pioneering efforts of Transplant Quebec, the Forum was co-hosted by the Canadian Donation and Transplantation Program, collaborating with various national and international donation and transplantation organizations. This domain group comprised administrative, clinical, and academic experts in OTDT systems, plus three patient, family, and donor representatives. We employed the nominal group technique to achieve consensus on the identification of topic areas and corresponding recommendations. Guided by narrative literature reviews, the Forum's scientific committee selected and validated the topics.