Tuesday May 02, 2023 - 11:00 to 12:30
Research and innovation in organ donation and transplant - Recommendations from an international consensus forum
Manuel Escoto 1, Fadi Issa 2, Florence Cayouette3, Henrietta Consolo4, Prosanto Chaudhury5,6, Sonny Dhanani 1,7, Wenshi Jiang8, Gabriel C Oniscu9, Nicholas Murphy1,10, Karen Rockell11, Matthew J Weiss 1,5,12, Mélanie Dieudé1,13,14,15.
1Canadian Donation and Transplantation Research Program, , Edmonton, AB, Canada; 2Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Oxford, United Kingdom; 3Pediatric Intensive Care Unit, Great Ormond Street Hospital, London, United Kingdom; 4School of Law, University of Glasgow, Glasgow, United Kingdom; 5Transplant Québec, Montreal, QC, Canada; 6McGill University Health Centre, Montréal, QC, Canada; 7Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, ON, Canada; 8Shanxi Provincial Organ Procurement and Allocation Center, Shanxi , People's Republic of China; 9Edinburgh Transplant Centre, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom; 10Departments of Medicine and Philosophy, Western University, London, ON, Canada; 11UK Organ Donation and Transplantation Research Network, London, United Kingdom; 12Department of Pediatrics, Centre Mère-Enfant Soleil du CHU de Québec, Québec, QC, Canada; 13Department of Microbiology, Infectiology and Immunology, Faculty of Medicine, Université de Montréal, Montreal, QC, Canada; 14Research Center, Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada; 15Héma-Québec, Québec, QC, Canada
Background: This work 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 (OTDT) 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.
Method: We identified topics impacting donation research through consensus using Nominal Group Technique (NGT). Members performed narrative reviews and synthesized current knowledge on each topic, which included academic articles, policy documents, and grey literature. Using NGT, 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 three 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 non-target organ recipients, and we recommend the creation of a centrally administered donor research oversight committee, a single specialist institutional review board (IRB), and a research oversight body to facilitate coordination and ethical oversight of organ donor intervention research.
Conclusion: 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 OTDT system, stakeholders are encouraged to collaborate and respond to their specific jurisdictional needs related to organ and tissue shortages.
The authors acknowledge that this work stems from the International Donation and Transplantation Legislative and Policy Forum that was co-Hosted by Transplant Québec and the Canadian Donation and Transplantation Research Program. The Forum received financial support from the Ministère de la Santé et des Services sociaux du Québec and Canadian Blood Services. The Transplantation Society has also provided significant in-kind logistic support.