The 3-T Model of Informed Consent for Nonstandard Risk Donors: A Proposal for Transplant Clinical Practice

Abstract

Background. The risk of disease transmission from nonstandard risk donors (NSRDs) is low, and outcomes are similar or better relative to transplants performed with standard criteria donors. However, NSRDs have posed new ethical challenges to the informed consent (IC) process. Based on the shared decision-making model, coinciding with the 3 main timings of the IC process ([1] pretransplant assessments and waiting list registration, [2] time on the waiting list, and [3] time of the organ offer), we put forward a model (3-T Model) to summarize the knowledge on IC for NSRDs and to deliver conceptual and practical support to transplant providers on this emergent issue. Methods. We searched PubMed and analyzed data from our area to provide evidence and ethical arguments to promote standardization of the timing of patient information, degree of patient participation, and disclosure of donor risk factors throughout the 3 stages of the time continuum leading to the potential acceptance of NSRDs. Results. Each of the 3 timings carries special ethical significance and entails well-defined duties for transplant providers relative to patient involvement and information of the benefits and risks associated with NSRDs. Based on our framework, experience, and interpretation of the literature, we put forward a list of recommendations to combine standardization (ie, timing, content, and degree of patient participation) and individualization of IC. Conclusions. The 3-T Model may enable the prevention of physicians’ arbitrariness and the promotion of patient-centered care. Future studies will assess the effectiveness of the 3-T Model in transplant clinical practice.

Liver transplantation from active COVID‐19 donors: Is it ethically justifiable?

“…Therefore, although evidence of the outcomes of LT by use of COVID‐19 positive donors remains limited, it is likely that patients had been previously informed that acceptance of a nonstandard risk donor liver would be more beneficial than remaining on the WL in the event of a decline of their clinical condition. 24 …”

“…Therefore, although evidence of the outcomes of LT by use of COVID-19 positive donors remains limited, it is likely that patients had been previously informed that acceptance of a nonstandard risk donor liver would be more beneficial than remaining on the WL in the event of a decline of their clinical condition. 24 Based on these considerations, we contend that, despite uncertainty, IC was ethically appropriate. Yet, because we did not formally assess whether IC was subjectively meaningful to recipients in this study, this accounts as a study limitation.…”

“…Yet, patient preferences relate primarily with the principle of respect for autonomy, 12 which finds its practical application (at the micro-level) in the IC process. 24 When faced with high risk procedures, with low levels of certainty, and when multiple treatment options exist, shared decision-making and IC should coincide so as to allow the integration of clinical options with the patient's subjective preferences and considerations, enabling a valid IC tailored to the patients' individual circumstances. 24,25 Respect for the principle of autonomy is particularly tenuous in an exceptional pandemic context characterized by uncertainty and fear.…”

“…24 When faced with high risk procedures, with low levels of certainty, and when multiple treatment options exist, shared decision-making and IC should coincide so as to allow the integration of clinical options with the patient's subjective preferences and considerations, enabling a valid IC tailored to the patients' individual circumstances. 24,25 Respect for the principle of autonomy is particularly tenuous in an exceptional pandemic context characterized by uncertainty and fear.…”

Cost-effectiveness of Kidney Transplantation From Donors at Increased Risk of Blood-borne Virus Infection Transmission

“…Additionally, physician and patient attitudes that may pose a barrier to accepting kidneys from donors with BBV need to be explored and supported with the highest level of evidence. 14 To our knowledge, there are no studies reporting the economics of accepting donors with an increased risk of BBV transmission of HIV, HBV, and HCV because of risky behaviors. Previous studies have largely focused on the cost-effectiveness of transplanting HCV-positive kidneys in HCV-negative recipients.…”