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Overview

The purpose of the Forum is to create expert, consensus guidance for stakeholders who aspire to link evidence and ethical concepts to legislative and policy reform of organ and tissue donation and transplantation (OTDT) systems. The main focus will be deceased solid organ donation, but aspects of living and tissue donation will be considered.

While Canadian initiated, the goal is to create recommendations that will be of value to OTDT systems across the world.

The Forum will consist of a series of virtual meetings between chapter working groups culminating in a hybrid (in-person and virtual) conference in the city of Montréal, Québec October 14-15, 2021. The Forum will be co-hosted by Transplant Québec and the Canadian Donation and Transplantation Research Program (CDTRP), with the support of Canadian Blood Services (CBS), the Canadian Society of Transplantation and The Transplantation Society.

The hybrid conference will be preceded by virtual meetings over the first half of 2021. These facilitated virtual meetings will allow chapter working groups to promote discussion, identify challenges, and create lists of topics that merit recommendations in their respective chapters of the final manuscript. Each working group will have to present one recorded virtual meeting (webinar) during which members of other working groups will be asked to provide feedback either during or after the webinar. Based on gathered evidence and consensus reached during discussions, chapter authorship groups will then draft their respective chapter that will populate the final manuscript.

The two day in-person conference will include summaries of the virtual sessions and round table discussions designed to finalize consensus recommendations to be included in the Forum consensus manuscript.

The principal output will be a manuscript of consensus recommendations based on international consensus. This manuscript will be submitted for publication in a peer reviewed, scientific journal.

Subsequent dissemination and knowledge translation will include presentation at scientific meetings, workshops, distribution in the lay press, and follow-up scientific publications.

Planning committee: This committee consists of representatives from Transplant Québec, CDTRP, CBS, and CST. This committee is responsible for recruiting members of the scientific committee, organizing logistics of the Forum, defining terms of reference for participants, identifying and managing potential conflicts of interest, and ensuring deliverables such as the consensus manuscript and the other knowledge translation.

Scientific Committee: This committee is responsible for defining the content and scope of each chapter, suggesting members of each chapter authorship committee, and finalizing the subjects of presentations and the speaker selection for virtual and hybrid sessions.

Chapter working groups (5-10 members) will be responsible for generating the topics that merit recommendations, gathering and summarizing relevant evidence related to these topics, and creating draft recommendations. Three to five individuals will be identified for each chapter’s working group who will be responsible to report the proceedings of all sessions relevant to their chapter during the chapter’s webinar and draft the chapter in a manuscript format that would be eligible for peer-reviewed, scientific publication.

Patient, family, and donor (PFD) partners will be included both in the scientific committee and incorporated into chapter working groups to ensure patient experiences across the spectrum of the OTDT continuum are reflected in recommendations.

The planning committee has engaged facilitation experts with experience in the process of consensus building forums. Chapter leads will have the opportunity to meet with facilitators prior to their webinar to ensure that consensus is consistently created across chapter working groups.

The event will involve stakeholders from a broad spectrum of populations impacted by the OTDT system. As such we plan to invite OTDT focused physicians and health professionals, organ and tissue donation organization administrators and employees, elected officials, government officials, researchers, legal and bioethics experts, patient family and donor partners, OTDT patient interest groups (e.g. the Kidney Foundation), and health journalists.

As several Canadian provinces and many other countries are currently considering revising their OTDT legislation, the forum will provide opportunities to virtually host specific sessions to discuss those issues further. These sessions will allow participants to identify gaps, needs, challenges, and opportunities for improvement to their particular system. Sessions could be organized on request from participating members, subject to approval by the Planning Committee and the organizational capacities of the Forum.

In Scope:

  • Fundamental ethical principles related to OTDT
  • Consideration of legal systems required for OTDT, including consent models for donation, organ and tissue gift acts, and mandatory referral laws
  • Comparison and evaluation of models of organ donation organizations most associated with successful OTDT systems
  • Interactions between deceased organ and tissue donation systems
  • Legal and system considerations of living donation programs
  • Issues related to research and innovation in OTDT systems

Out of Scope:

  • Specific concerns related to a single jurisdiction
  • Clinical practices guidelines related to care of an individual patient (e.g. donor management or post-transplant immunosuppression)
February 2021
  • Introductions and Launch
March 2021
  • Chapter Leads meet with Facilitators for Training
    Chapter Leads and Authorship Committees Meet
April 2021
  • Chapter Leads and Authorship Committees Meet
  • Deliberations over scope of content to develop
May 2021
  • Virtual Meetings take place
June 2021 to August 2021
  • Drafting and deliberations of publications among Chapters
September 2021
  • Review of drafts from each Chapter among Scientific Committee
October to November 2021
  • Prepare and send for publication

Chapters

Chapter 1 – Baseline Ethical Principles

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. 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
  • Ms. Carmen Carrière, CDTRP Patient, Family and Donor Researcher Partnership Platform
  • Mr. Austin Kinsella, CDTRP Patient, Family and Donor Researcher Partnership Platform

Scope and Core Themes:

  • Self-sufficiency: Jurisdictions should strive for self-sufficiency by providing sufficient organs for their residents.
  • Efficacy: Jurisdictions should implement legislation/policy/laws etc., that work.
  • Universality: Speaks to the concept of margins of appreciation (MoA). Speaks to setting limits, and MoA should accommodate where disagreements occur as long as it does not contradict a universal principle (i.e. murder for donation).
  • Protection: Jurisdictions should think about and implement policies that protect the vulnerable, including donors, recipients, and others impacted by donation and transplantation.

Chapter 2 – Legal Foundations

Lead: Prof. Maeghan Toews, University of Adelaide, Adelaide, Australia

Authorship Committee:

  • Prof. Jennifer Chandler, University of Ottawa, Ottawa, Canada
  • Ms. Meredith Maloof, Indigenous Law Centre – University of Saskatchewan, Winnipeg, 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
  • Ms. Kim Soutar, CDTRP Patient, Family and Donor Researcher Partnership Platform

Scope and Core Themes:

  • Public Trust
  • Equity & Fairness & Justice
  • Individual Autonomy
  • Respect for Human Rights
  • Improve population health/wellbeing through donation and transplantation

Chapter 3 – Donation System Architecture

Leads: Dr. Howard Nathan, Gift of Life Donor Program, Philadelphia, United States and 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
  • 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


Scope and Core Themes:

  • Data collection and reporting: At all stages of the donation and transplantation care pathways; Needs to be timely, accurate and easily accessible for those who need it; Needs to drive decision making, action, and improvements; Needs to be safely and legally stored.
  • Roles; accountability; legal authority: It needs to be clear who does what, why and when and where accountability lies at local, regional and national levels and under which This includes accountability for safety; quality assurance; quality improvement; regulators etc
  • Frameworks and best practice guidance: clinical; legal guidance to help interpret the law; ethical guidance to inform clinical decision making; used to inform action at local, regional and national levels; maintains public and clinical confidence in the system
  • Education (clinical and public): Training and education to support the clinical service; public awareness to improve awareness and support, dispel myths, support community leaders in raising awareness at a local level
  • Collaboration: At all stages of the care pathway; between all stakeholders (critical care teams; ODOs; regulators; transplant teams etc.); provide seamless care for donors and their families; support organ viability assessment; local, regional, national and international to share learning and best practice

Chapter 4 – Consent Model and Emerging Legal Issues

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

Scope and Core Themes:

  • Consent Models: to include opt-in, opt-out, reciprocity, incentives, and mandated choice.
  • Operational Delivery: how to convert policy into practice.
  • Engagement: when introducing a change, you need support (public, health professionals, faith groups, charities, etc.)
  • Donor Registry: explore the merits of a registry.

Chapter 5 – Living Donation

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?

Chapter 6 – Tissue Donation

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
  • Mr. Étienne Fissette, Héma-Québec, Montreal, 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

Scope and Core Themes:

  • Self-sufficiency (and where relevant, cells) for human application: based on voluntary, non-remunerated donation, and security of supply.
  • Quality and safety of tissues and cells for human application
  • Robust ethical principles:
  • Fostering the development of safe and effective innovative options for the not-for-profit setting

Chapter 7 – Research and Innovation in OTDT and Emerging Issues

Lead: Dr. Mélanie Dieudé, Executive Director, The Canadian Donation and Transplantation Research Program (CDTRP); Université de Montréal; Montreal, 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

Proposed content:

  • Research Consent
  • Data Management: including data collection, storage, and sharing
  • Research ethical standards
  • Patient partnerships in research