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

Abstract

Background. 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.

Organ Donation Organization Architecture: Recommendations From an International Consensus Forum

“…As detailed in the Baseline Ethical Principles (Gardiner et al) 32 and Research and Innovation domains (Escoto et al), 33 innovation is not only appropriate but necessary. Furthermore, innovation benefits from coupling with evaluative procedures to ensure efficacy and adherence to ethical standards.…”

Is there a need to reassess the impact of functional donor warm ischemia time in the era of advanced perfusion techniques?

“…There is a need to create a more uniform definition of what constitutes fDWIT based on higherlevel data, which underscores the need for more research in the DCD organ donation space. [4] It is important to acknowledge potential areas of bias in the current study by Lee and colleagues. This is a retrospective study, but really is the best data available at a national level on the subject.…”

“…The clinical reality in practice is that surgeons, transplant programs, and OPOs in the United States vary widely on what is considered the initiation of fDWIT. Some programs begin at the start of WLST; others use blood pressure and SpO 2 thresholds to “start the clock.” There is a need to create a more uniform definition of what constitutes fDWIT based on higher-level data, which underscores the need for more research in the DCD organ donation space 4 …”