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Overview

Transplant Québec and the Canadian Donation and Transplantation Research Program co-hosted The International Donation and Transplantation Legislative and Policy Forum (the Forum). The Forum assembled 61 international experts in donation and transplantation, including patient, family, and donor partners, to provide guidance on the structure of an ideal organ and tissue donation and transplantation (OTDT) system. The Forum developed 94 evidence informed expert consensus recommendations with the objective of improving organ and tissue donation and transplantation laws and policy.

Seven working groups – called “Domain” – were responsible for generating the topics that merit recommendations, gathering and summarizing relevant evidence related to these topics, and creating recommendations. The recommendations link evidence and ethical concepts to legislative and policy reform and are applicable to jurisdictions developing or reforming their OTDT system. See the details of each Domain below.

Lead: Dr. Dale Gardiner, NHS Blood and Transplant, London, United Kingdom
Authorship Committee:
  • Dr. Curie Ahn, National Medical Center, Seoul, South Korea
  • Dr. Aviva Goldberg, University of Manitoba, Winnipeg, Canada
  • Dr. Matthew Weiss, Transplant Québec, Québec, Canada
  • Dr. Andrew McGee, Australian Centre for Health Law Research, Faculty of Business and Law, QUT, Brisbane, Australia
  • Dr. Sanjay Nagral, Jaslok Hospital & Research Centre, Mumbai, India
  • Prof. Christy Simpson, Department of Bioethics, Dalhousie University (Primary appt); Australian Centre for Health Law Research (Adjunct appt); Canadian Blood Services (Bioethics Consultant), Halifax, Canada
  • Mr. Austin Kinsella, CDTRP Patient, Family and Donor Researcher Partnership Platform

SUMMARY

The Baseline Ethical Principles domain proposes an ethical framework to assist stakeholders and decision-makers in incorporating ethical principles into OTDT practice and policy to maintain public trust and integrity. 

The domain acknowledged the importance of international standards of baseline ethical principles within OTDT regulations, policies, and legislation, as outlined in the World Health Organization (WHO) Guiding Principles, the Declaration of Istanbul, and the Barcelona Principles. What is less well-established is how to evaluate newly proposed practices or programs according to these principles.  

The proposed framework will assist those responsible for making and approving ethical policy decisions consistent with the established international agreements, declarations, and resolutions on the ethical underpinnings of an OTDT system. 

Access the publication | Download Domain Summary

Lead: Prof. Maeghan Toews, University of Adelaide, Adelaide, Australia
Authorship Committee:
  • Prof. Jennifer Chandler, University of Ottawa, Ottawa, Canada
  • Dr. Matthew Weiss, Transplant Québec, Québec, Canada
  • Prof. Thadeus Masson Pope, Mitchell Hamline School of Law, Ottawa, Canada
  • Mr. Alberto Sandiumenge, University Hospital Vall d’Hebron, Barcelona, Spain
  • Mr. Roger Pape, CDTRP Patient, Family and Donor Researcher Partnership Platform

SUMMARY

The Legislation and Policy domain provides expert guidance for legislative and policy reform. The 12 recommendations outlined in the chapter focus on (1) legal definitions and legislative scope; (2) consent requirements for donation; (3) allocation of organs and tissue; (4) operation of OTDT systems; and (5) travel for transplant and organ trafficking.  

Given that OTDT systems vary in how they are regulated, and local cultural, social, and economic factors impact law and policy, the 12 recommendations address fundamental issues in OTDT. Thus, the recommendations could apply wholly or in part to any jurisdiction developing or reforming its system.  

Access the publication | Download Domain Summary

Leads: Dr. Howard Nathan, Gift of Life Donor Program, Philadelphia, United States, Ms. Susan Gunderson, LifeSource, Minneapolis, United States, and Ms. Claire Willement, NHS Blood and Transplant, London, United Kingdom
Authorship Committee:
  • Mr. Louis Beaulieu, Chief Executive Officer, Transplant Québec, Montreal, Canada
  • Dr. Matthew Weiss, Transplant Québec, Québec, Canada
  • Mr. Manuel Escoto, Canadian Donation and Transplantation Research Program, Edmonton, Canada
  • Mr. Anthony Clarkson, NHS Blood and Transplant, London, United Kingdom
  • Mr. David Hartell, Canadian Blood Services, Ottawa, Canada
  • Dr. Günther Kirste, Albert Ludwigs University Freiburg, Medical Center, Freiburg, Germany
  • Ms. Helen Opdam, Australian Organ and Tissue Authority, Victoria, Australia
  • Dr. Haibo Wang, China Organ Transplant Response System, Hong Kong, China
  • Ms. Linda Powell, CDTRP Patient, Family and Donor Researcher Partnership Platform
  • Mr. Richard Ippersiel, CDTRP Patient, Family and Donor Researcher Partnership Platform

SUMMARY

The Organ Donation Organization Architecture domain provides expert guidance on the components of an effective organ donation organization (ODO), its relationship with OTDT stakeholders, and markers of best practices supporting an effective donation and transplantation care pathway and continuous improvement. 

The 33 recommendations represent the foundational markers of a safe, fair, and transparent system that maximizes the number of organs available for transplantation and maintains public trust across all stages of the care pathway. 

Access the publication | Download Domain Summary

Lead: Mr. Phil Walton, NHS Blood and Transplant, London, United Kingdom
Authorship Committee:
  • Dr. Stephen Beed, Dalhousie University, Halifax, Canada
  • Dr. Alicia Perez Blanco, Organizacion nacional de trasplantes (ONT), Madrid, Spain
  • Ms. Alexandra Glazier, New England Organ Bank (CEO), Boston, United States
  • Dr. Daniela Salomão, Health Department of the Distrito Federal Government, Sao Paulo, Brazil
  • Dr. Matthew Weiss, Medical Director – Organ Donation, Transplant Québec, Quebec, Canada
  • Ms. Kim Jordison, CDTRP Patient, Family and Donor Researcher Partnership Platform
  • Ms. Jennifer Kingdon, CDTRP Patient, Family and Donor Researcher Partnership Platform

SUMMARY

The Organ and Tissue Donation Consent Model and Intent to Donate Registries domain provides expert guidance for jurisdictions implementing or reforming their consent model. The consent model working group does not recommend one type of consent model over another.  

Instead, the 11 recommendations outlined in this domain discuss the main factors influencing the success of a consent model. These factors include the type of consent model (opt-in vs opt-out), donor registry, marketing campaigns/public education, and the education of healthcare professionals. 

Access the publication | Download Domain Summary

Lead: Dr. Elmi Muller, University of Cape Town, Cape Town, South Africa
Authorship Committee:
  • Dr. Prosanto Chaudhury, McGill University Health Centre; Medical Director – Organ Transplantation, Transplant Québec; Montreal, Canada
  • Dr. Jongwon Ha, Department of Surgery, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea
  • Mr. Kirit Mistry, South Asian Health Action Patient, Family, Donor Partner
  • Dr. Michel Paquet, Centre hospitalier de l’Université de Montréal (CHUM), Montreal, Canada
  • Dr. Sunita Singh, University of Toronto, Toronto General Hospital / University Health Network, Toronto, Canada
  • Ms. Shilpa Raju, CDTRP Patient, Family and Donor Researcher Partnership Platform
  • Mr. Larry Workfolk, CDTRP Patient, Family and Donor Researcher Partnership Platform
Scope and Core Themes:
  • Donor safety: clinical safety for the donor, long-term follow-up, access to treatment if needed, and donors who travel to donate
  • Non-directed anonymous donors: kidney exchange program, open chains, advanced donation (voucher system)
  • Financial neutrality & other barriers to living donation: financial barriers, education awareness, cultural & gender issues, disparate access, prioritization, insurability, and long-term follow-up
  • Public solicitation: Use of various platforms, including social media, to solicit a donor
  • Minor donors: Not a core theme, but should it be included?
Lead: Dr. Jacinto Sanchez Ibañez, Galician Health Services, A Coruna University Hospital, Coruna, Spain
Authorship Committee:
  • Ms. Maria del Mar Lomero Martinez, Council of Europe, Strasbourg, France
  • Dr. Matthew Weiss, Transplant Québec, Québec, Canada
  • Mr. Manuel Escoto, Canadian Donation and Transplantation Research Program, Edmonton, Canada
  • Ms. Marta Fraga, Council of Europe, Strasbourg, France
  • Ms. Christine Humphreys, Eye Bank of Canada – Ontario Division, Toronto, Canada
  • Mr. Murray Wilson, CDTRP Patient, Family and Donor Researcher Partnership Platform

SUMMARY

The Tissue and Cell Donation domain provides expert legislative and policy reform guidance. The 13 recommendations outlined in the chapter focus on (1) self-sufficiency of supply, (2) ethics, (3) quality and safety, and (4) innovation for non-profit organizations.  

Given that legislation and policies impacting tissue and cell donation and transplantation vary significantly across jurisdictions, this field’s issues warrant separate considerations from other challenges affecting OTDT systems. The recommendations are not intended to provide a prescriptive pathway for implementation. Instead, the recommendations provide a general framework for developing a fair, ethical, safe, and accessible system supporting patient outcomes and self-sufficiency.   

Access the publication | Download Domain Summary

Lead: Dr. Mélanie Dieudé, Héma-Québec; CDTRP; Université de Montréal; Montréal, Canada
Authorship Committee:
  • Dr. Florence Cayouette, Children’s Hospital of Eastern Ontario, Ottawa, Canada
  • Dr. Prosanto Chaudhury, McGill University Health Centre; Medical Director – Organ Transplantation, Transplant Québec; Montreal, Canada
  • Dr. Henrietta Consolo, University of Glasgow, Glasgow, United Kingdom
  • Dr. Sonny Dhanani, Children’s Hospital of Eastern Ontario, Ottawa, Canada
  • Mr. Manuel Escoto, Canadian Donation and Transplantation Research Program, Edmonton, Canada
  • Prof. Fadi Issa, University of Oxford, Oxford, United Kingdom
  • Dr. Gabriel Oniscu, Edinburgh Transplant Centre & University of Edinburgh, Edinburgh, United Kingdom
  • Ms. Karen Rockell, UK Organ Donation & Transplantation Research Network Patient, Family, Donor Partner
  • Dr. Wenshi Jiang, Shenzhen, People’s Republic of China
  • Dr. Nicholas Murphy, CDTRP Trainee

SUMMARY

The Research and Innovation in Organ Donation domain provides expert guidance on developing a high-performing and ethically robust deceased donation research framework. The 16 recommendations cover the areas of (1) patient, family, donor, and public involvement in research; (2) donor, surrogate, and recipient consent within a research ethics framework; and (3) data management.  

The recommendations are intended to strengthen a jurisdiction’s OTDT system while building and maintaining public trust. The domain followed the US National Academics of Science, Engineering, and Medicine report’s goals of developing a robust and ethical deceased donation research framework. 

Access the publication | Download Domain Summary

Download Domain Summaries

Timeline of activities

Knowledge Translation Strategy

With the recommendations finalized, the next step is to support their movement into action, at regional, national, and international levels. The primary output will be a series of open access publications outlining the recommendation and supporting evidence. The recommendations will also be distributed through scientific conferences, webinars, fast facts information sheets and summary reports.

The objectives of the Forum’s KT strategy are to:
  • Raise awareness and promote action on the Forum’s recommendations of organ and tissue donation and transplantation policy and legislative changes;

  • Inform patients, families, and donors (PFD) health professionals, transplant and donation centers (ODOs), Federal, Provincial, and Territorial Governments;

  • Influence behaviour and support evidence-based action from policy makers within governments and health care settings;

  • Support PFD partners and patient groups who are engaged in driving change.

The CDTRP team along with Transplant Québec completed so far three information Fact Sheets:

  • Mandatory Referral
  • Data Collecting and Public Reporting
  • Consent Models

The Mandatory Referral fact sheet helped Alberta government policy makers better understand this topic as they review, debate, and process Bill 205. Portions of this fact sheet were stated as part the Bill’s debate by Members of the Alberta Legislative Assembly on May 2, 2022.

You can download the Fact Sheets below.
Mandatory Referral Fact Sheet
Data Collection and Public Reporting Fact Sheet
Consent Models Fact Sheet

Presentations

CDTRP Research Connect Series | May 16, 2023

International Forum Outputs regarding Donation System Architecture, Consent Models and Emerging Legal Issues with Dr. Matthew Weiss & Claire Williment

Alberta Transplant Institute Seminar Series | April 27, 2022

Organ Donation and Transplantation: Legal and Ethical Foundations of an effective system with Dr. Matthew Weiss

The Forum’s Scientific & Planning Committees

(in alphabetical order)

  • Louis Beaulieu
  • Marcelo Cantarovich
  • Jennifer Chandler
  • Prosanto Chaudhury
  • Rosanne Dawson
  • Mélanie Dieudé
  • Ed Ferre
  • Aviva Goldberg
  • Susan Gunderson
  • David Hartell
  • Sam Shemie
  • Marie Josée Simard
  • Matthew Weiss
  • Jennifer Woolfsmith

(in alphabetical order)

  • Louis Beaulieu
  • Prosanto Chaudhury
  • Mélanie Dieudé
  • Manuel Escoto
  • Patricia Gongal
  • David Hartell
  • Lee James
  • Catherine Lachance
  • Stéphanie Larivière
  • Annie-Carole Martel
  • Marie Josée Simard
  • Kristian Stephens
  • Matthew Weiss

Partnerships

Transplant Quebec, The Canadian Donation and Transplantation Research Program, The Transplantation Society, the Canadian Society of Transplantation, Canadian Blood Services, and the International Society for Organ Donation and Procurement are all official partners who have contributed to the scientific content and will partner with the distribution of the recommendations.