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.
Employing the nominal group technique, the group, consisting of legal scholars, a transplant coordinator/clinician, and a patient advocate, recognized key areas of foundational legal concern and formulated recommendations. Based on their areas of expertise, group members conducted narrative literature reviews, which, in turn, generated a range of academic articles, policy documents, and legal sources, ultimately informing the recommendations. Identifying best practices from relevant sources across each subtopic resulted in the recommendations found within this document.
Our collective agreement coalesced around twelve recommendations, compartmentalized into five subject categories: (i) legal parameters and legislative purview, (ii) consent guidelines for donation, (iii) organ and tissue allocation protocols, (iv) operational procedures for OTDT systems, and (v) implications for patient travel in transplantation and the prevention of illicit organ trafficking. Differentiating between foundational legal principles, we have separated those with strong support from those needing additional attention and resolution. Ten contentious areas are explored, and relevant recommendations are presented and discussed.
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). Torin 1 solubility dmso While common ground exists regarding some doctrines, their practical application remains a subject of debate. The continuous progression of OTDT necessitates a re-evaluation of legal recommendations to remain consistent with the advancement of knowledge, technology, and best practices in the field.
Our recommendations consist of principles strongly established within the OTDT structure (for example, the dead donor rule), but also include aspects arising from recent advancements in the field's practical implementations (such as mandatory referral). While many principles enjoy broad acceptance, a unified approach to their application remains elusive. As the OTDT domain transforms, a re-evaluation of existing legal recommendations is essential to maintain alignment with evolving knowledge, technological innovations, and best practices.
The statutes and guidelines for organ, tissue, and cell donation and transplantation exhibit substantial global disparity, a pattern replicated in the performance outcomes of diverse legal systems. Expert consensus guidance, linking evidence and ethical principles for legislative and policy reform, was the aim for tissue and cell donation and transplantation systems.
By employing the nominal group technique, we achieved consensus regarding topic areas and recommendations. The proposed framework was developed through narrative literature reviews and subsequently validated by the project's scientific committee. Torin 1 solubility dmso 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.
International action is necessary, as detailed in this report's 13 recommendations, to address crucial aspects impacting the donation and use of human tissues and cells, thereby protecting donors and recipients. Addressing self-sufficiency, adherence to strong ethical principles, the safety and quality of human tissues and cells, and encouraging the development of safe and effective innovative therapeutic solutions in not-for-profit settings are key objectives.
Implementing these recommendations, completely or partially, by legislators and governments would greatly enhance tissue transplantation programs, guaranteeing equitable access to safe, effective, and morally sound tissue and cell-based therapies for all needing them.
Tissue transplantation programs will benefit significantly from the full or partial implementation of these recommendations by legislators and governments, guaranteeing safe, effective, and ethical tissue- and cell-based therapies for all patients.
International discrepancies in organ and tissue donation and transplantation (OTDT) frameworks and legislation contribute to a varied performance across transplantation systems. 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. Legislative and regulatory guidance is intended for those aiming to establish or amend OTDT legislation and associated policies, encompassing all system stakeholders.
This Forum, a joint initiative of Transplant Quebec, the Canadian Donation and Transplantation Program, and a multitude of national and international donation and transplantation organizations, commenced. Seven domains were determined by the scientific committee, with designated domain working groups subsequently identifying specific 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 Forum's meticulous planning and execution included the full integration of patient, family, and donor partners at each step. Thirteen countries were represented by a collective of 61 participants who worked together to produce the recommendations. From March to September 2021, virtual meetings served as the platform for reaching a consensus regarding topic identification and recommendations. Informed by participant-conducted literature reviews, the nominal group technique produced a consensus. In Montreal, Canada, recommendations were presented at a hybrid in-person and virtual forum during October 2021.
The Forum's output included ninety-four recommendations, detailed with 9 to 33 per subject area, and an ethical framework established for appraising new policy approaches. Each accompanying article details the recommendations, along with their grounding in established literature and relevant ethical or legal principles.
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.
Despite the limitations in accounting for the extensive global range of population diversity, healthcare infrastructure, and available resources within OTDT systems, the recommendations aimed for the broadest possible scope of applicability.
To maintain the public's faith and honesty in organ and tissue donation and transplantation (OTDT), governmental bodies, policymakers, clinical authorities, and decision-makers must guarantee that policies seeking to stimulate donation and transplantation follow internationally-agreed-upon ethical guidelines. This international forum's Baseline Ethical Domain group, as described in this article, provides guidance to stakeholders on evaluating ethical aspects of their systems.
Transplant Quebec initiated this Forum, which was co-hosted by the Canadian Donation and Transplantation Program, along with collaborations from various national and international donation and transplantation organizations. Administrative, clinical, and academic experts in deceased and living donation ethics, along with two Patient, Family, and Donor partners, comprised the domain working group. A framework for evaluating existing and new policies was established following a series of virtual meetings, from March to September 2021, involving literature reviews by working group members, resulting in the establishment of internationally accepted baseline ethical principles. Torin 1 solubility dmso A consensus on the framework was ultimately determined through the implementation 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. We did not attempt to determine what constitutes ethical behavior, but rather presented an approach to evaluating policy decisions.
New and existing OTDT policy decisions can utilize the proposed framework for effectively transforming widely accepted ethical principles into tangible evaluation criteria. Internationally, the framework's application is enabled by its capacity to adapt to local circumstances.
The proposed framework allows for the conversion of widely accepted ethical principles into practical assessments for both new and existing OTDT policy decisions. Adaptable to local contexts, the framework's broad international applicability is noteworthy.
Outlined in this report are recommendations by one of seven domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum). Expert counsel on the structure and role of Organ and Tissue Donation and Transplantation (OTDT) systems is the intention. Individuals within the OTDT network who are dedicated to designing or optimizing existing systems are the intended audience.
Under the leadership of Transplant Quebec, the Forum was co-organized by the Canadian Donation and Transplantation Program, and supported by numerous 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. Topic areas and corresponding recommendations were identified through consensus, employing the nominal group technique as our method. The selected topics were shaped by narrative literature reviews and scrutinized by the Forum's scientific panel.