International Donation and Transplantation Legislative and Policy Forum: Methods and Purpose.

Organ and tissue donation and transplantation (OTDT) legislation and policies vary around the world, and this variability contributes to discrepancies in system performance. This article describes the purpose and methodology of an international forum that was organized to create consensus recommendations related to key legal and policy attributes of an ideal OTDT system. The intent is to create guidance for legislators, regulators, and other system stakeholders who aim to create or reform OTDT legislation and policy. Methods: This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. Seven domains were identified by the scientific committee' and domain working groups identified specific topics for recommendations: 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. Patient, family, and donor partners were integrated into every stage of the planning and execution of the Forum. Sixty-one participants from 13 countries contributed to recommendation generation. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by participants. Recommendations were presented at a hybrid in-person and virtual forum in Montreal, Canada, in October 2021. Output: Ninety-four recommendations (9-33 per domain) and an ethical framework for evaluating new policies were developed during the Forum proceedings. The accompanying articles include the recommendations from each domain and justifications that link the consensus to existing literature and ethical or legal concepts. Conclusions: Although the recommendations could not account for the vast global diversity of populations, healthcare infrastructure, and resources available to OTDT systems, they were written to be as widely applicable as possible.

A Program of Research to Evaluate the Impact of Deceased Organ Donation Legislative Reform in Nova Scotia: The LEADDR Program.

BACKGROUND: This is the first time deemed consent, where the entire population of a jurisdiction is considered to have consented for donation unless they have registered otherwise, will be implemented in North America. While relatively common in other regions of the world-notably Western Europe-it is uncertain how this practice will influence deceased donation practices and attitudes in Canada. METHODS: We describe a Health Canada funded program of research that will evaluate the implementation process and full impact of the deceased organ donation legislation and the health system transformation in Nova Scotia that includes opt-out consent. RESULTS: There is a need to evaluate the impact of these changes to inform not only Nova Scotia and Atlantic Canada, but also other provincial, national, and international stakeholders. CONCLUSIONS: We establish a rigorous academic framework that we will use to evaluate this significant health system transformation.