Research and Innovation in Organ Donation: Recommendations From an International Consensus Forum

Manuel Escoto; Fadi Issa; Florence Cayouette; Henrietta Consolo; Prosanto Chaudhury; Sonny Dhanani; Wenshi Jiang; Gabriel C Oniscu; Nicholas Murphy; Karen Rockell; Matthew J Weiss; Mélanie Dieudé

doi:10.1097/TXD.0000000000001446

Research and Innovation in Organ Donation: Recommendations From an International Consensus Forum

Transplant Direct. 2023 Apr 28;9(5):e1446. doi: 10.1097/TXD.0000000000001446. eCollection 2023 May.

Authors

Manuel Escoto¹, Fadi Issa², Florence Cayouette³, Henrietta Consolo⁴, Prosanto Chaudhury^{5

6}, Sonny Dhanani^{1

7}, Wenshi Jiang⁸, Gabriel C Oniscu⁹, Nicholas Murphy¹⁰, Karen Rockell¹¹, Matthew J Weiss^{1

5

12}, Mélanie Dieudé^{1

13

14

15}

Affiliations

¹ Canadian Donation and Transplantation Research Program, Edmonton, AB, Canada.
² Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, United Kingdom.
³ Pediatric Intensive Care Unit, Great Ormond Street Hospital, London, United Kingdom.
⁴ School of Law, University of Glasgow, United Kingdom.
⁵ Transplant Québec, Montréal, QC, Canada.
⁶ McGill University Health Centre, Montréal, QC, Canada.
⁷ Children's Hospital of Eastern Ontario, University of Ottawa, Canada.
⁸ Shanxi Provincial Organ Procurement and Allocation Center, People's Republic of China.
⁹ Edinburgh Transplant Centre, Royal Infirmary of Edinburgh, United Kingdom.
¹⁰ Departments of Medicine and Philosophy, Western University, Canada.
¹¹ Liver Transplant Recipient/Co-Director and PPIE Lead, United Kingdom Organ Donation and Transplantation Research Network, Peterborough, Cambridgeshire, United Kingdom.
¹² Division of Critical Care, Department of Pediatrics, Centre Mère-Enfant Soleil du CHU de Québec, QC, Canada.
¹³ Department of Microbiology, Infectiology and Immunology, Faculty of Medicine, Université de Montréal, Montreal, Canada.
¹⁴ Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
¹⁵ Hema-Quebec, Québec, QC, Canada.

Abstract

This report provides recommendations from the Research and Innovation domain as part of the International Donation and Transplantation Legislative and Policy Forum (hereafter the Forum) to provide expert guidance on the structure of an ideal organ and tissue donation and transplantation system. The recommendations focus on deceased donation research and are intended for clinicians, investigators, decision-makers, and patient, family, and donor (PFD) partners involved in the field.

Methods: We identified topics impacting donation research through consensus using nominal group technique. Members performed narrative reviews and synthesized current knowledge on each topic, which included academic articles, policy documents, and gray literature. Using the nominal group technique, committee members discussed significant findings, which provided evidence for our recommendations. The Forum's scientific committee then vetted recommendations.

Results: We developed 16 recommendations in 3 key areas to provide stakeholders guidance in developing a robust deceased donor research framework. These include PFD and public involvement in research; donor, surrogate, and recipient consent within a research ethics framework; and data management. We highlight the importance of PFD and public partner involvement in research, we define the minimum ethical requirements for the protection of donors and recipients of both target and nontarget organ recipients, and we recommend the creation of a centrally administered donor research oversight committee, a single specialist institutional review board, and a research oversight body to facilitate coordination and ethical oversight of organ donor intervention research.

Conclusions: Our recommendations provide a roadmap for developing and implementing an ethical deceased donation research framework that continually builds public trust. Although these recommendations can be applied to jurisdictions developing or reforming their organ and tissue donation and transplantation system, stakeholders are encouraged to collaborate and respond to their specific jurisdictional needs related to organ and tissue shortages.