Dr. Ma'n H. Zawati

1. Allogenic dermis to accelerate the production of a tissue-engineered skin substitute to treat Canadian burn patients - Stem Cell Network (2023 - present)

Expanding on tissue engineering techniques established in Dr. Moulin’s lab (Université Laval) this project will continue to look assess the use of Autologous Self-Assembly Skin Substitutes (SASS) to cover greater than 50% of the total body surface area of burn victims. Health Canada had approved this early-stage clinical trial, and this project will serve as a model treatment approach. This trial’s objective is to assess this cutting-edge therapeutic strategy for treating Canadian patients with extensive burns to promote skin regeneration. Preliminary findings have shown that treatment reduces morbidity brought on by current treatments and improves patients’ quality of life, suggesting that treatment should have economic and societal benefits. Dr. Moulin’s lab will be the first in Canada to routinely treat patients with autologous rebuilt skin after the clinical trial and approval by Health Canada. The CGP will help with the preparation of the requirements needed for research ethics coordination and approval (including preparing standardized recruitment procedures and protocols, consent forms and information pamphlets). Documentation for the clinical trial application meetings and for regulatory approval with Health Canada will be prepared by the CGP.

2. Canadian Paediatric Cancer Consortium - Canadian Institutes of Health Research (2022 - present)

The Canadian Pediatric Cancer Consortium (CPCC) is the largest-ever Canadian pediatric cancer research project. It is performing a broad array of distinct research activities, including both clinical data generation, and public policy work in areas such as health economics, law, and other fields. The Centre of Genomics and Policy leads its ethical-legal and data governance work-package, which includes the development of policies and procedures to enable the stewardship of the data that the CPCC generates. The CPCC raises a plethora of public policy challenges that lie at the intersection of pediatric bioethics and data governance. Building on prior research in the PROFYLE project, governance proposals arising from this initiative could serve as a template for future Pan-Canadian efforts to generate and share pediatric oncology data.

3. Explaining the Right to Explanation: Data Protection Legislation and Clinical Automated Decision-Making - Fonds de recherche du Québec (FRQ) (2022 - present)

Quebec’s National Assembly adopted a right to explanation for automated decision-making in late 2021. This is the first such right implemented in Canada, with as yet unknown consequences for the practice of medicine. Automated decision-making tools for the diagnosis, management, and treatment of disease are being applied across the healthcare system, and these newly adopted rights might have significant legal consequences for clinicians. This project will address how statutory rights to explanation for automated decision-making adopted in Quebec and elsewhere are likely to affect the legal obligations of clinicians providing care that is facilitated by automated medical devices. We are conducting a comparative legal analysis to understand the effects of rights to explanation adopted in other jurisdictions, with particular focus on European Union member states. We will also define the potential scope of rights to explanation by surveying automated decision-making tools presently being used in Canada, hold a virtual deliberative exercise with relevant stakeholders (including clinicians and patient representatives), and prepare policy tools outlining how rights to explanation will affect the use of clinical automated decision making.