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 (Virtual Meetings)

Chapter 1 – Baseline Ethical Principles

Lead: Dr. Dale Gardiner
Authorship Committee: Dr. Sanjay Nagral, Dr. Aviva Goldberg, Dr. Curie Ahn, Prof. Christy Simpson, Dr. Andrew McGee

Proposed Content:

  • Declaration of Istanbul
  • Medical Tourism
  • Equity and access in allocation
  • The Dead Donor Rule
  • Valid consent/authorization
  • Reciprocity/Incentives
  • Imminent Death Donation

Chapter 2 – Legal Foundations

Lead: Prof. Maeghan Toews
Authorship Committee: Prof. Jennifer Chandler, Prof. Thadeus Masson Pope, Ms. Meredith Maloof, Mr. Alberto Sandiumenge, Mr. Roger Pape

Proposed Content:

  • Legal support for definition of death – brain and/or circulatory
  • Confidentiality between donor and recipient
  • Mandatory referral
  • Quality assurance
  • Data sharing between entities
  • Consent/ incentives / consideration
  • Equity and access
  • Directed deceased donation

Chapter 3 – Donation System Architecture

Leads: Dr. Howard Nathan and Ms. Susan Gunderson
Authorship Committee: Dr. Haibo Wang, Dr. Günther Kirste, Mr. David Hartell, Ms. Helen Opdam, Mr. Anthony Clarkson, Ms. Claire Williment


Proposed Content:

  • Hospital-based vs independent organ donation organization
  • Funding model
  • Quality assurance
  • Data collection and reporting
  • Guideline and best practice development

Chapter 4 – Consent Model and Emerging Legal Issues

Lead: Mr. Phil Walton
Authorship Committee: Dr. Matthew Weiss, Dr. Stephen Beed, Dr. Daniela Salomão, Mrs. Alexandra Glazier, Dr. Alicia Perez Blanco

Proposed content:

  • Deemed vs. opt-in consent
  • Reciprocity
  • Forced choice systems

Chapter 5 – Living Donation

Lead: Dr. Elmi Muller
Authorship Committee: Dr. Michel Paquet, Dr. Jongwon Ha, Dr. Prosanto Chaudhury, Dr. Sunita Singh, Mr. Kirit Mistry

Proposed content:

  • Remuneration for donors
  • Altruistic, anonymous living donation
  • Public solicitation

Chapter 6 – Tissue Donation

Lead: Dr. Jacinto Sanchez Ibañez
Authorship Committee: Ms. Christine Humphreys, Ms. Heather Machin, Mr. Étienne Fissette, Ms. Marta Fraga, Ms. Maria del Mar Lomero Martinez

Proposed content:

  • Impact of legislation on tissue systems
  • Capacity to recover from more potential donors
  • Tissue exchange and tissue bank models

Chapter 7 – Research and Innovation in OTDT and Emerging Issues

Lead: Dr. Mélanie Dieudé
Authorship Committee: Dr. Gabriel Oniscu, Dr. Prosanto Chaudhury, Dr. Sonny Dhanani, Prof. Fadi Issa, Dr. Florence Cayouette, Ms. Karen Rockell, Dr. Henrietta Consolo, Mr. Wenshi Jiang, Mr. Manuel Escoto

Proposed content:

  • Issues of consent
  • Lack of obstruction to perform research
  • Medical Assistance in Dying
  • Xenotransplantation
  • Ex-vivo, NRP