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. 2023 Apr 28;9(5):e1351.
doi: 10.1097/TXD.0000000000001351. eCollection 2023 May.

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

Affiliations

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

Matthew J Weiss et al. Transplant Direct. .

Abstract

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.

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Conflict of interest statement

The majority of the Forum funding was from the Provincial Government of Québec with additional in-kind or cash funding from nonprofit research and professional organizations (CDTRP, TTS, the LEADDR program of research) and Canadian Blood Services (CBS). No funding was received from for-profit entities. The recommendation generation process did not involve any new research, and ethics approval was not required or sought out. All participants were required to complete a potential conflict of interest form, which was screened by 2 members of the planning committee. Any declaration of a past or present relationship with a for-profit entity was reviewed by the planning committee. No relevant conflicts were discovered.The authors declare no funding or conflicts of interest.

Figures

FIGURE 1.
FIGURE 1.
Actual donors and transplants per million population by country, reproduced with permission of the Global Observatory on Donation and Transplantation. DBD, donation after brain death; DCD, donation after circulatory death; pmp, per million population.
FIGURE 2.
FIGURE 2.
The four-step process of the nominal group technique.,

References

    1. Global Observatory on Donation and Transplantation. Data (charts and tables). Available at http://www.transplant-observatory.org/data-charts-and-tables/. Accessed January 21, 2022. - PubMed
    1. Chandler JA, Connors M, Holland G, et al. . “Effective” requesting: a scoping review of the literature on asking families to consent to organ and tissue donation. Transplantation. 2017;101:S1–S16. - PubMed
    1. European Directorate for the Quality of Medicine and HealthCare/Council of Europe Guide for Quality and Safety. Newsletter transplant: international figures on donation and transplantation. September 2021. Available at https://freepub.edqm.eu/publications/PUBSD-87/detail. Accessed December 11, 2021.
    1. Arshad A, Anderson B, Sharif A. Comparison of organ donation and transplantation rates between opt-out and opt-in systems. Kidney Int. 2019;95:1453–1460. - PubMed
    1. Chatterjee P, Venkataramani AS, Vijayan A, et al. . The effect of state policies on organ donation and transplantation in the United States. JAMA Intern Med. 2015;175:1323–1329. - PubMed

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