Anonymity and Organ Donation: Ethical and Policy Implications After the Opinion Released by the Italian Committee for Bioethics.

According to Law 91/1999, art. 18, in Italy, health care professionals and administrative staff involved in the process of organ collection and transplantation are required to ensure anonymity of both the donor and the recipient. Against this backdrop, in 2018, the Italian Committee for Bioethics (ICB) released an official opinion titled "Opinion on the preservation of the anonymity of donor and receiver in the transplantation of organs" that offers a new perspective on the topic, effectively opening the possibility of anonymity ending at certain conditions. The relevance of anonymity within the transplant network is a globally recognized principle with a strong ethical value. In this article, based on the experience of one author directly involved in the ICB opinion drafting, we examine the document and discuss how such a proposal could be implemented at the legislative level.

[Laws regulating transplantation should express the contemporaneity. Questions to the constitutionalist Francesco Paolo Casavola and to the philosophers Remo Bodei and Aldo Masullo about the possibility deciding the destiny of one's own organs at the time one decides on how to die and on contacts between donor families and recipients.]

Transplantation represents modernity thus the laws regulating the procedure should be continuously renovated and remodeled in order to take full advantage of progress. The debate is about Law no. 219, December 22, 2017 and on Law no. 222, April 1, 1999. The quests are a) about the possibility to modify the first so that people deciding on how they want to die, may also decide about their willingness to allow the removal of their organs for transplantation and b) the possibility for donor families and recipients to have contacts after transplantation in the case both sides agree. Questions were emailed to the constitutionalist Francesco Paolo Casavola, immediate Past President of the National Committee for Bioethics, and to the philosophers Remo Bodei and Aldo Masullo. Their answers received by September 16, support the idea a) to include in the Law no. 219, 2017 the possibility to decide not only on the modality one wants to die but also on the possibility to allow his own organs to be removed for transplantation and b) to liberalize contacts between donor families and recipients when both side agree. For both changes there is enough evidence of their feasibility-necessity. The answers related to contacts between donor families and recipients support the decision of the National Committee for Bioethics on September 27, 2018. Professor Casavola also suggests that contacts should organized and supervised by the ethical committees of the hospitals where the transplantation procedure is accomplished.

Are Transplant Recipients Human Subjects When Research Is Conducted on Organ Donors?

Interventional research on deceased organ donors and donor organs prior to transplant holds the promise of reducing the number of patients who die waiting for an organ by expanding the pool of transplantable organs and improving transplant outcomes. However, one of the key challenges researchers face is an assumption that someone who receives an organ that was part of an interventional research protocol is always a human subject of that same study. The consequences of this assumption include the need for oversight by an institutional review board and for research-level informed consent from transplant recipients, all within the complex practical realities of the organ donation and transplantation process in the United States. The current national focus on this issue provides an opportunity to think critically about the policy goals of the human subjects regulations and their application to the nascent field of deceased organ donor intervention research. We propose that for donor research where the transplant recipient does not fall under the definition of human subject, the clinical consent model-rather than the consent model used for human research subjects-best facilitates the policy objectives of balancing clinical innovation, transparency, and protection of patients in an ethically responsible and legally compliant manner.

Multicenter evaluation of a national organ sharing policy for highly sensitized patients listed for heart transplantation in Canada.

BACKGROUND: Transplantation of sensitized recipients has been associated with increased risk of post-transplant complications. In 2010, the Canadian Cardiac Transplant Network (CCTN) created a unique status listing for highly sensitized heart transplant candidates. Status 4S listing requires calculated panel-reactive antibody (cPRA) level >80% as the sole listing criteria and enables geographic expansion of the donor pool by providing national access. In this study, we describe patient characteristics and outcomes of those transplanted as Status 4S in Canada. METHODS: Patients' characteristics and clinical outcomes were retrospectively collected from all 11 adult heart transplant centers in Canada. RESULTS: Ninety-six patients were listed Status 4S from January 2010 to September 2015. Fifty-two were transplanted as Status 4S. Of these 52 transplants, mean cPRA level was 93.4%, mean age was 47 years, 46% were male, 44% had dilated cardiomyopathy and 17% were re-transplanted for cardiac allograft vasculopathy (CAV). Blood group O comprised 42% and 53% had a left ventricular assist device as a bridge to transplant. Desensitization therapy occurred in 9 patients (17%). Over a mean follow-up period of 28 months (1 week to 5.3 years), 9 patients died (17%). Kaplan-Meier 1-year year survival is 86%. Two patients were treated for antibody-mediated rejection (AMR) in the first year post-transplant and 33% of patients had at least 1 ISHLT Grade ≥2R cellular rejection in the first year. Twenty-nine percent of patients developed de novo door-specific antibodies and demonstrated no correlation with AMR. Freedom from CAV at 1 year is 88.5% and at 5 years is 81.0%. Fifty-two percent of donor hearts originated from outside the recipients' geographic and organ donation organization. CONCLUSIONS: A national strategy of prioritizing highly sensitized heart transplant recipients has demonstrated effective expansion of the donor pool, acceptable short-term survival, freedom from CAV and low rates of clinically relevant AMR. However, we observed significantly higher rates of cellular rejection and de novo donor-specific antibody development in this population. It is currently unknown whether this will translate into poorer long-term outcome.

Age limitation for organ transplantation: the Israeli example.

In 2013 the Israeli Ministry of Health appointed a public committee to examine the policy of placing an age limitation on candidates listed for organ transplantation. The committee rejected the use of an age limit criterion for listing candidates for transplantation and recommended to abolish it. However, opinions differed regarding the use of recipients' age in shaping a fair organ allocation policy. The committee's recommendations were adopted and put into force as of April 2014. This article unfolds the committee deliberations on accommodating values of formal equality for optimising the use of organ transplantation.

Effectiveness of Visual Methods in Information Procedures for Stem Cell Recipients and Donors.

OBJECTIVE: Obtaining informed consent from hematopoietic stem cell recipients and donors is a critical step in the transplantation process. Anxiety may affect their understanding of the provided information. However, use of audiovisual methods may facilitate understanding. In this prospective randomized study, we investigated the effectiveness of using an audiovisual method of providing information to patients and donors in combination with the standard model. MATERIALS AND METHODS: A 10-min informational animation was prepared for this purpose. In total, 82 participants were randomly assigned to two groups: group 1 received the additional audiovisual information and group 2 received standard information. A 20-item questionnaire was administered to participants at the end of the informational session. RESULTS: A reliability test and factor analysis showed that the questionnaire was reliable and valid. For all participants, the mean overall satisfaction score was 184.8±19.8 (maximum possible score of 200). However, for satisfaction with information about written informed consent, group 1 scored significantly higher than group 2 (p=0.039). Satisfaction level was not affected by age, education level, or differences between the physicians conducting the informative session. CONCLUSION: This study shows that using audiovisual tools may contribute to a better understanding of the informed consent procedure and potential risks of stem cell transplantation.