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

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.

Have we reached the limits in altruistic kidney donation?

Altruistic donation (unspecified donation) is an important aspect of living donor kidney transplantation. Although donation to a stranger is lawful and supported in many countries, it remains uncommon and not actively promoted. Herein, we ask the question if we have reached the limit in altruistic donation. In doing so, we examine important ethical questions that define the limits of unspecified donation, such as the appropriate balance between autonomous decision-making and paternalistic protection of the donor, the extent of outcome uncertainty and risk-benefit analyses that donors should be allowed to accept. We also consider the scrutiny and acceptance of donor motives, the potential for commercialization, donation to particular categories of recipients (including those encountered through social media) and the ethical boundaries of active promotion of unspecified kidney donation. We conclude that there is scope to increase the number of living donation kidney transplants further by optimizing existing practices to support and promote unspecified donation. A number of strategies including optimization of the assessment process, innovative approaches to reach potential donors together with reimbursement of expenses and a more specific recognition of unspecified donation are likely to lead to a meaningful increase in this type of donation.