We will use traditional methods of legal scholarship (e.g., the systematic and conceptual analysis of relevant case law, legislation, professional norms, legal theory, etc.) to assess how existing norms and obligations may play out when donor-recipient matching tools are used to inform clinicians’ and patients’ decisions concerning acceptance or refusal of organs, deceased donor organ allocation policies, and living donor organ donation. Relevant legal and electronic databases will be searched to find material relevant to this analysis. Beyond the analysis and application of norms, we will consider whether the “rule of rescue” can effectively be addressed such that healthcare providers change their behaviour in a way that is helpful to the implementation of PM-based organ allocation, and what legal and policy action would this require? This work will inform the integration of PM into future allocation policies by clarifying legal and ethical obligations.
We will use traditional methods of legal scholarship (e.g., the systematic and conceptual analysis of relevant case law, legislation, professional norms, legal theory, etc.) to assess how existing norms and obligations may play out when donor-recipient matching tools are used to inform clinicians’ and patients’ decisions concerning acceptance or refusal of organs, deceased donor organ allocation policies, and living donor organ donation. Relevant legal and electronic databases will be searched to find material relevant to this analysis. Beyond the analysis and application of norms, we will consider whether the “rule of rescue” can effectively be addressed such that healthcare providers change their behaviour in a way that is helpful to the implementation of PM-based organ allocation, and what legal and policy action would this require? This work will inform the integration of PM into future allocation policies by clarifying legal and ethical obligations.
Activity 4A
To Translate Legal, Ethical and Societal Considerations Regarding Transplantation
Current Canadian organ allocation policy is built around notions of fairness and equity. However, policies around the world are increasingly embracing evidence-based outcome measures and the use of precision medicine tools for donor-recipient matching in order to maximize utility related to graft survival. This reality has the potential to create a tension between the goals of precision medicine and the legal obligations of healthcare providers and the healthcare system. For example, how will physicians balance their obligations to advocate for patients that fall outside (or on) the margins of precision medicine-determined allocation criteria? And, will this conflict significantly delay, slow or prevent the adoption of Precision Medicine-informed organ allocation in favour of current clinical practices? We will conduct a systematic and conceptual analysis of relevant case law, legislation, professional norms, legal theory, etc. to assess how existing norms and obligations may play out when donor-recipient matching tools are used to inform clinicians’ and patients’ decisions concerning acceptance or refusal of organs, deceased donor organ allocation policies, and living donor organ donation. This work will inform the integration of precision medicine into future allocation policies by clarifying legal and ethical obligations.
Patient and Family Advisory
As part of our commitment to a stronger patient-oriented research approach in this project, we have recruited a Patient and Family Advisory Group to inform, shape and provide feedback to the development and dissemination of the simulation modelling and deliberative dialogue work in Activity 4.
Activity 4B
To Understand and Translate Public Representations of transplantation Policy
Traditional and online media representations have been shown to impact public perceptions of transplantation or organ donation. In some instances, media coverage can be at odds with evidence-informed health policy, including in the context of the allocation of resources. This is an important consideration as social medial is playing an increasingly important role in the dissemination of information including healthcare-related issues. Consequently, this can impact public perception and understanding positively or negatively for organ transplantation. The opinions of social media consumers will depend largely on the quality and reliability of health information. Exploring the manner in which Precision Medicine and organ donation is portrayed on social media will shed light on the public’s perception of the facts surrounding these topics. It will also elucidate which ethical and/or legal, issues are present or absent, and which resonate most with those participating in discussions. Our goal is to conduct analyses of how popular culture (including social media and the news media) represents transplantation policy and organ donation. We also intend to explore the legal tools such as federal truth-in-advertising regulations in order to map the possible legal responses that can be utilized to curb inappropriate public representations.
Activity 4C
To Understand and Translate Public, Patient and Provider Preferences
The implementation precision medicine epitope-based matching may have significant implications on organ allocation. For example, patients with less common HLA alleles may experience delays in access to deceased donor transplants in an epitope-based matching program. In the case of living donor, transplantation currently proceeds if the donor/recipient are blood type compatible and have no pre-formed DSA. Precision Medicine epitope-based matching, however, may change this strategy and encourage closer matching to achieve superior outcomes. This may require expansion of the Canadian living donor exchange program and raise new ethical, operational and economic issues in relation to the living donor paradigm. We plan to conduct research surveys to evaluate providers, public, and patient perspectives on the trade-offs between equity (consideration of wait-times) and utility (superior survival of transplant organs; a rare resource) related to the introduction of evidence-based Precision Medicine tools into kidney allocation policies. We will assess both quantitative and qualitative data (mixed methods approach) the viewpoints of the various stakeholders. Ultimately these findings will help to better inform revisions to organ allocation schemes that incorporate Precision Medicine tools in a manner that is sensitive to public and patient preferences and is also cognisant of existing racial and ethno-cultural diversity in Canada.
Activity 4D
To Understand and Translate the Economic Implications and Healthcare Impact
Precision Medicine tools to prevent AMR offer the potential of major improvements in both short and long-term clinical and patient outcomes. We will perform economic analyses of whether the new technologies developed represent value-for-money to the provincial and territorial health care systems in Canada. Specifically, for the precision medicine tools we will assess the magnitude of benefit they likely deliver (in terms of health gains) and their expected resource/cost implications. This will be captured in a cost-utility analysis, with benefits measured as quality-adjusted life years. The development of this new simulation model of the Canadian renal transplantation system will provide the analytic infrastructure and deliver predictions of the full stream of benefits and costs associated with the Precision Medicine tools.
