RESEARCH PROJECTS
2023
Description
In March 2020, the World Health Organization (WHO) declared the outbreak of the new coronavirus 2019 (COVID-19) a global pandemic. Since then, the rapid spread of the virus and the resulting public health emergency required immediate action on the part of local, regional, national and international and international actors. The state of public health emergency resulting from the COVID-19 pandemic was exacerbated by the many unknown factors surrounding the virus including its origins, etiology, modes of transmission and infection. That said, the implementation of sound governance is one of the crucial elements of any research in times of crisis.
CGP is proposing five specific objectives for this project:
1. Identify research projects and the documents (governance framework, access policies, specifications, consent, etc.) supporting their governance.
2. Analyze and compare these documents in order to identify the basic elements (varying according to the type of project populations (adults, children, etc.)).
3. Validate the basic elements based on a literature review and an analysis of the applicable framework (legislative, regulatory, jurisprudential, policy).
4. Set up study groups with patient partners to gain a better understanding of their perspective on different approaches to research in times of crisis.
5. Develop an electronic resource in the form of a toolbox enabling researchers, patients, ethics committees, institutions and members of the public to better inform themselves about the components of good governance.
Principal Investigators
Funding Organization(s)
Period
2023-12-01 to 2024-11-30
Description
The rise of epigenetic age and aging tests, illustrated by the recent commercial breakthrough of TALLY Health in the USA - a company headed by David Sinclair of Harvard University - represents a significant advance in our ability to understand and quantify the aging process. These innovative tests make it possible to estimate an individual's chronological or biological age with greater precision, based on calculations of DNA methylation rates (a type of epigenetic modification). They thus open up new avenues for the development of "longevity strategies", including, among other things, changes to certain lifestyle habits, or the consumption of health products that can, according to some, slow down or even reverse biological aging.
CGP is has a wealth of experience and knowledge in the field of bioethics and with the Dephi-type mixed method required for the success of the project. This familiarity with the method will be an important asset for the success of the project and the expansion of our community of collaborators in the ethics of aging.
Principal Investigators
Co-Investigators
End-User
Period
2023-11-07 to 2024-03-31
Description
In this project, the CGP will advance the deliverables of the REWS, including the development of consent registry standards, clinical data sharing best practices, integration of Equity, Diversity and Inclusion considerations in the GA4GH Work Streams, developing recommendations for diverse genomic dataset development, development of a genetic discrimination policy, and supporting the coordination of the Global Policy Forum. In addition, the CGP, under Prof. Joly, will provide REWS leadership, strategy, and oversight and will provide guidance to the Work Stream and Clinical Projects Manager.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2023-07-20 to 2024-12-31
Description
The project goal is to develop and pilot data governance, data quality, and digital infrastructure methods and tools to enable the computational analysis of high-dimensional digital trajectories across establishments in Quebec. The developed methods and tools will directly address existing barriers to the secondary use of clinical data within the consortium which includes the Integrated Health and Social Services University Network for West-Central Montreal (CCOMTL), the McGill University Health Center (MUHC) and its Research Institute (RI-MUHC). This will enable a scaling-up in the sophistication and volume of data-driven research and innovation within the consortium and accelerate progress towards a Learning Health System. Moreover, we will translate knowledge and methods and tools generated through this project to other stakeholders in Quebec to enable similar advances in research and innovation throughout the province.
The CGP will assist with the Data Governance to:
1. Develop a data governance framework to clarify the process for sharing trajectory data between establishments for research and innovation, including with and without patient consent.
2. Adapt existing consent processes to facilitate clinical trial recruitment.
3. Identify the requirements for implementing a consent registry to support the use of artificial intelligence to screen for patients eligible for clinical trials across the MUHC and the CCOMTL.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2023-07-01 to 2026-07-01
Description
Canada is in an ideal position to capitalize on the opportunities afforded by big genomic data - we boast world-leading expertise in genomics and in the development of data sharing policies and tools. However, we lack a national strategy to capture, store and access Canadian data in an equitable, secure and sustainable manner. At the same time, the size and complexity of human genomics datasets and their associated clinical data are growing rapidly. The Pan-Canadian Genome Library (PCGL) will establish the strategy for Canada's management and sharing of human genomic data. The PCGL will build upon Canadian-made foundational components and datasets, and utilize international standards to unify Canada's human genome sequencing efforts and set out a federated data management system that respects limitations on the jurisdictional movement of human genetic data. To respectfully support research relying on Indigenous data, we will also work with the Silent Genome Project and others to develop an Indigenous Genetics Circle. The PCGL will lay the groundwork for large-scale genomic data sharing and storage and raise the international visibility of Canadian research as well as lead to more effective and cost-effective healthcare delivery for all members of Canadian society.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2023-07-01 to 2028-06-01
Description
The COVID-19 pandemic has brought back to the forefront the inequities that exist in access to patented medicines and vaccines worldwide, while reaffirming the primordial role of research and development (R&D) and access to data for the international health community. The practices observed over the past two years testify to the shortcomings of the normative framework underlying patents, within which institutional and pharmaceutical players operate. Initiatives stemming from international efforts and aimed at equitable access worldwide have unfortunately proved insufficient to achieve this goal.
The project aims to identify and propose the elements (agreements, laws, policies, practices) of a normative patent framework that maximize R&D and access to patented medicines and vaccines, particularly in the context of a pandemic.
Two concepts in particular, namely the notion of technological non-discrimination, which underlies patents, and the notion of Corporate Social Responsibility (CSR) applicable to the pharmaceutical sector will be utilized. More specifically, we want to assess the extent to which the use of these two concepts can or cannot maximize R&D and access to patented medicines and vaccines in the context of a pandemic. To achieve this, we will draw on neo-institutionalism and the stakeholder preference theory approach. A Delphi survey (iterative survey) will be used to identify elements of a normative framework (hard law, soft law, including contractual practices) relating to patents that are viable and realistic from an institutional and political point of view for all stakeholders.
Our work will also lead to the development of a bilingual guide, in the form of a tutorial, aimed at pharmaceutical companies, which could be adapted to other industries, such as the agri-food sector.
More specifically, Dr. Joly will draw on his expertise in the Delphi method, supported by his multidisciplinary team at the Centre de Génomique et Politique (CGP). In carrying out this method, as well as in analyzing the responses it generates, the CP will accompany him and draw on its expertise in pharmaceutical policy, in taking preferences into account in policy-making, and its skills in the co-construction of knowledge.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2023-05-01 to 2027-03-31
Description
Genetic ancestry (GA) refers to inferences about an individual's ancestral origin and lineage of descent or the geographic history of an individual's ancestors according to signatures in their genome. In precision medicine, GA constitutes an additional layer of genomic information about a study population that can contribute to stratifying individuals' health and risk of developing diseases. GA has also been used to infer individuals' race composition and ethnicity in the context of research, precision medicine, and Direct-to-Consumer genetic services. Continental ancestry (the continental association of GA) can be used to determine the geographic origins of a person from a genetic admixture of people, where it serves as an important reference and control in using genomic data in precision medicine.
The CGP will conduct a systematic literature review (SLR) covering literature published over the last 15 years in English about GA-related ethical and data misuse issues tied to race information in precision medicine in both research and the clinical context. This research will focus on the identification of ethical issues, evidence, and a complete set of published guidance models that will help us improve policies and practices associated with GA in precision medicine. The review will also consider published recommendations and best practice guidelines. An additional co-citation mapping analysis on the SLR data addressing key authors, specialty clusters (expertise, institutions), and trends (timeline) will identify crucial associations with the perceptions of the specific knowledge users in the field.
Principal Investigators
Funding Organization(s)
Period
2023-05-01 to 2025-04-30
Description
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.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2023-04-01 to 2025-01-31
Description
Prescription drugs play an expanding and essential role in preventing and treating chronic health problems. Despite the benefits of modern drug therapy, the full potential of medications to improve population health has not been realized due to limited capacity to assess real-world safety and effectiveness, personalize treatment, and influence use in practice. Drugs are often prescribed to populations in which they were not tested, with 5%-20% of patients experiencing potentially preventable adverse drug events, and 30%-50% not adhering to therapy due to side-effects, costs, or attitudes towards medication. To achieve high value pharmacare, we must optimize medication use in ways that address patient priorities, maximize benefits, and minimize risks. Digital advances in computerized prescribing and dispensing, electronic medical records (EMRs), artificial intelligence (AI), computerized decision support, and patient-centered mobile apps and portals have created opportunities to catalyze the science of high value pharmacare. The purpose of this research program is to develop a new family of predictive algorithms for predicting benefit, risk, and adherence to a drug for a specific patient through AI-enabled analysis of real-world data, implement them as clinical decision-support tools in computerized prescribing systems, and determine if they improve patient outcomes.
Principal Investigators
Collaborators
Co-Applicant
Funding Organization(s)
Period
2023-04-01 to 2029-03-31
Description
One child diagnosed with cancer on ten has an underlying cancer predisposition syndrome. In the majority of children, the cancer arises before the cancer predisposition syndrome is recognised (i.e., the cancer predisposition syndrome goes unrecognised until a child develops a first cancer or worse, when the child develops a subsequent cancer or when their sibling or parent develops cancer). Cancer predisposition syndrome evaluation is now considered a necessary part of the holistic care in pediatric oncology, as such a diagnosis can lead to concrete actions in children and families. MIPOGG is a pediatric focused eHealth solution. Healthcare providers who evaluate and treat children and adolescents with cancer (any type of cancer, any type of setting, anywhere in the world) is MIPOGG's target population with direct impacts on patient and family care. The essence of this proposal aligns with the knowledge translation and mobilization mandates of the Canadian Pediatric Cancer Consortium (CPCC). The MIPOGG project deliverables are anticipated to be useful for various CPCC related activities.
Centre of Genomics and Policy will contribute to elucidating questions on the responsible development of eHealth technology and AI including topics of fairness, explainability and transparency in machine learning, as well as liability and responsibilities of clinicians and researchers who use these technologies in clinical care and research.
Principal Investigators
Collaborators
Co-Applicant
Funding Organization(s)
Period
2023-04-01 to 2028-03-31
Description
Previously unrelated emergent technologies like artificial intelligence, gene editing, nanotechnology, neurotechnology, and robotics are now deeply entwined. As a consequence of the globalization, the socio-technical novelty, the cross-disciplinary nature and the disruptive potential, of digital nanotechnologies necessitates the development of adapted policies harmonized with that of Canada’s economic and research partners. In collaboration with our Korean colleagues at Yonsei University Bioethics Department we will research and develop the foundations for a more coherent international regulatory framework between our two countries. The project will solidify existing bonds through collaborative research and knowledge translation activities. Lastly, the regulatory framework should allay public fears towards the integration and societal impact of nanotechnologies and help to re-build public trust in science.
Principal Investigators
Funding Organization(s)
Period
2023-03-31 to 2024-12-31
Description
While new avenues for gender diversity are opening, politically motivated legal battles are increasingly impeding access to gender affirming care (GAC) for trans and non-binary (TNB) youth. These legal developments will have substantial repercussions for the wellbeing of TNB minors and implicate many stakeholders including their families and clinicians, community organizations, health and social services, schools, researchers, policymakers, and legislators. This seed project will be a critical interdisciplinary legal and social-scientific analysis to capture an overview of current trends and biases in the legal arena and their influence on the provision of and access to GAC TNB youth in Canada and the U.S. over the past five years. We will conduct and integrate three modes of analysis: (1) Network analysis of key actors in cases and legislation; (2) Thematic analysis of values presented implicit to GAC; (3) Comparative analysis of the approach to GAC in Canada and the US. This seed project will lay the foundation for a larger interdisciplinary research program on ELSI in access to and provision of GAC for youth.
Principal Investigators
Funding Organization(s)
Period
2023-01-15 to 2024-03-31
2022
Description
Hypertrophic scars (Hsc) are very common sequelae of deep wounds in general but especially following burns. However, treatments of these pathological scars show a low efficacy whereas the level of research in Canada is low. To stimulate research in this field, access to the human tissues or cells is needed. Our goal is to set up the conditions to create a biobank dedicated to Hsc. We are therefore requesting funds to carry out the administrative work to set up the conditions for a biobank including Hsc samples as well as normal skin samples from the same patients. This project will be carried out in 4 main steps:
1. Determine the area and number of biopsies that can be taken to allow for maximum studies;
2. Obtain ethical and administrative approval to begin biobanking;
3. Develop a protocol and train research staff to process, store and ship samples;
4. Perform the first biopsies to evaluate the process. The ability for researchers to have access to a biobank is a factor that will encourage them to focus on this condition and find a way to treat it.
Co-Applicant
Funding Organization(s)
Period
2022-12-01 to 2023-11-30
Description
A consortium of Canadian innovators, led by Toronto-based DNAstack, has created a platform allowing researchers to access and analyze massive networks of data without moving it, through a process called federated learning. This will allow scientists to make discoveries on larger and more diverse datasets than is currently possible. Thanks to an unprecedented collaboration, and co-investment support from Canada’s Digital Technology Supercluster, the project will create an open innovation ecosystem, where sequencing providers, data custodians, diagnostic developers, pharmaceutical companies, researchers, governments, individuals, families, and others can digitally interconnect over a common goal of driving better health care outcomes for Canadians.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-10-01 to 2024-03-31
Description
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.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-07-01 to 2025-06-30
Description
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.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-06-01 to 2024-06-01
Description
The COVID-19 outbreak has highlighted the need for genomic data standards in order to enable the rapid sharing of high quality genomic and health data. Researchers have shared viral and host sequence data at an unprecedented pace, a first step in creating vaccines in record time. Simultaneously, the cost of genome sequencing continues to decrease, yielding millions of samples in the coming years from both research and healthcare. Sharing of this data is necessary to understand human diseases and eventually help patients. Strengthening international standards over time will prepare us to more effectively respond to future outbreaks as well as advance basic biology and inform clinical care across a range of disease areas. Doing so requires the community to agree on common methods for collecting, storing, transferring, accessing, and analyzing data. The Global Alliance for Genomics and Health (GA4GH) was established in 2013 to accelerate progress in genomic research and human health by cultivating a common framework of standards and harmonized approaches for effective and responsible data sharing. GA4GH brings together 1,000+ individual contributors and 660+ organizational members across 35+ countries working in the areas of healthcare, research, patient advocacy, life science, and information technology to deliver genomic data sharing standards and frameworks. This proposal will provide support for the GA4GH to bring in additional personnel, support the existing team, and drive engagement with the Canadian COVID research community. GA4GH will develop, refine, and adapt GA4GH standards and open-source tools to facilitate research data sharing for COVID applications and the greater infection disease community. Collectively, these efforts will ensure the rapid and timely research response to the current phase of the COVID-19 pandemic in Canada and around the globe, which will be heavily impacted by emerging variants of concern.
CGP will build on expertise and tools developed within REWS. For example, the overall VirusSeq data sharing approach is grounded in the GA4GH Framework for Responsible Sharing of Genomic and Health-Related Data.
Principal Investigators
Collaborators
Funding Organization(s)
Period
2022-05-01 to 2024-03-31
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-04-01 to 2024-03-31
Description
Skin autografts are used to treat burn wounds, but they take on a strategic role when the area that needs to be covered is greater than 50% of the total body surface area. Autologous Self-Assembly Skin Substitutes (SASS) can be made from just a little skin biopsy using tissue engineering techniques established in Dr. Moulin’s lab (Université Laval), and they might be used to permanently cover all the patient’s wounds. Health Canada had approved this early-stage clinical trial, and only a small number of patients have received care in Quebec. By extending the study to burn units in other Canadian provinces, 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.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-04-01 to 2025-01-31
Description
Recessive dystrophic epidermolysis bullosa (RDEB) is a disease affecting the skin and mucosa. RDEB patients have very fragile skin due to a mutation in the collagen 7 gene. There is no cure for EB. The only option is to treat the recurrent wounds with daily care and bandages. Patients experience pain, suffering and poor quality of life. The LOEX/CHU de Québec-Université Laval, a leader in the autologous self-assembled skin substitute (SASS) therapy, using cultured stem cells for the treatment of burn patients, has initiated research studies to find a treatment for RDEB. Our interdisciplinary team brings together experts in: stem cells and tissue engineering; gene therapy; socio-ethical and legal issues; a pediatric dermatologist directing the largest Canadian EB clinic and many research professionals. The objective of the present proposal is to complete the steps necessary for the translation, from the laboratory to the clinic, of our new therapeutic approach combining gene therapy and tissue engineering. Ultimately, our goal is to develop a definitive treatment for RDEB. Without a cure, RDEB patients have recurrent wounds. The annual costs for specialized bandages is very expensive. This rare disease impacts on the quality of life of patients and their families. Therefore, this new treatment, if proven successful, could change lives of Canadian patients by improving skin stability and preventing recurring wounds.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2022-04-01 to 2024-03-31
Description
Clinical genome-wide sequencing (GWS), which includes exome and genome sequencing, has become standard of care for the diagnosis of complex rare genetic disease (RD). Until recently, all provinces across Canada have been sending clinical GWS to private, mostly US-based, labs for sequencing, analysis and interpretation. With the support of Genome Canada’s Genomics Applied Partnerships Program (GAPP), provinces are patriating clinical GWS and integrating it into the diagnostic care pathway for complex RD. Six GAPP projects (British Columbia, Alberta, Prairie, Ontario, Québec, Atlantic) share a vision to deliver on the promise of precision health for RD. To realize this vision, the GAPP projects identified two goals: facilitate high-quality clinical GWS as standard-of-care and provide access to precision health research for Canadians with RD.
Principal Investigators
Funding Organization(s)
Period
2022-04-01 to 2024-09-30
Description
Modern cancer therapies increasingly rely on antibody-based drugs or genetically engineered immune cells that are programmed to recognize specific proteins on the surface of cancerous cells while not attacking their healthy counterparts. The goal of this project is to better target leukemia cells while sparing the normal blood by engineering blood stem cell grafts as a next-generation therapy for treating aggressive blood cancers. Further, establishing an improved delivery method for genetically engineered anti-leukemia immune cells into leukemia patients by completely modifying blood stem cells would allow for the regeneration of engineered immune cells for life. Overall, this research has the capability to vastly improve therapeutic prospects for leukemia patients.
Our role is to investigate potential liability for race-associated precision medicine interventions. We will review and document how North American courts have considered medical liability when adjudicating claims of medical negligence for the race-disparate effects of clinical interventions. We will also engage in a systematic review of legal scholarship on race-based or race-influenced medical care and document the degree to which academic legal commenters predict that such interventions will affect the professional and clinical obligations of individuals engaged in providing care of this kind.
Furthermore, CGP will investigate the social-economical assessment studying the viability of this approach in the Canadian context.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2022-04-01 to 2025-01-31
Description
This project will address the lack of guidance for researchers designing cell therapy clinical trials, especially at the first-in-human stage, the lack of guidance and educational resources for REBs and regulatory bodies assessing such trials, and the lack of guidance for research participants considering the risks and benefits of their participation, as well as the ethical, legal and social issues associated with these gaps, in order to facilitate the ethical and responsible clinical translation of cell therapies, via ethically conducted clinical trials, with a specific focus on minors and their parents / families. Issues addressed by this project will include: criteria to be used by researchers / clinicians, REBs and regulatory bodies to select which potential therapies should move towards clinical trials; review criteria for REBs to assess such proposals; clarification of the legal and ethical duties and professional liabilities of researchers / clinicians; specific considerations regarding the participation of minors in clinical trials; and concerns perceived as important by minors, their parents / families, and their pediatricians, regarding cell therapies. Addressing these issues will allow us to better understand how to overcome challenges and barriers to clinical translation.
Our role is to analyze the legal roles and ethical responsibilities of researchers/clinicians in the context of clinical trials using cell therapies, with an emphasis on first-in-human trials in minors, and to understand the perspectives of clinicians and researchers on how to operationalize the high-level principles of the Charter for Regenerative Medicine relevant to their practice and covering their interactions with participants.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2022-04-01 to 2025-01-31
Description
Psilocybin is the psychoactive element found in hallucinogenic mushrooms or “magic mushrooms”. Although the production, possession, and sale of these mushrooms are illegal in Canada, the potential therapeutic uses of psilocybin are attracting growing interest internationally. Randomized clinical trials have demonstrated that a moderate single dose of psilocybin combined with psychotherapy produces rapid, robust, and long-lasting anxiolytic and antidepressant effects in patients with advanced cancer and suffering from cancer-related psychological distress.
This project aimed to 1) assess the social and professional acceptability of psilocybin-assisted therapy to relieve existential distress at the end of life, 2) identify the issues to consider for access to this innovative therapy and 3) propose recommendations establishing guidelines for the use of psilocybin for therapeutic purposes in the Quebec forensic context. In addition to the recommendations that were presented to decision-makers in the form of a memorandum, this work laid the foundations of a community resource that, together with the care settings, will have the mission of informing and supporting patients considering using assisted therapy with psilocybin to alleviate their existential distress.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2022-04-01 to 2025-03-31
Description
The Genetic Discrimination Observatory (GDO) is a unique international network of researchers and stakeholders from more than 27 countries dedicated to researching and preventing genetic discrimination worldwide. Genetic discrimination (GD) involves the differential, negative treatment or unfair profiling of an individual relative to the rest of the population based on actual or presumed genetic characteristics that can infringe upon or have the effect of infringing human rights, fundamental freedoms, and human dignity. For decades, it has been a global problem associated with genetic testing, data-intensive genetic research, and direct-to-consumer DNA testing services. With rapid technological advancements in today’s postgenomic era, GD is a persistent issue associated with the use of genetic and genomic data. Many countries have adopted legal frameworks to prevent GD that offer a certain degree of protection. However, many legislation and policies overlook essential aspects of GD, and vulnerable individuals may remain at risk of discrimination. Furthermore, genetic information from patients, data-sharing research, and genetic services (such as 23andMe, Ancestry.com) are increasingly moving across national borders or transcending them, thus limiting the effectiveness of protections built solely around national approaches.
It is vitally important to advance the debate and research regarding novel solutions to counter GD at the national and international level by building on both foundational international ethics and human-rights texts. The GDO was launched in 2020 and has since achieved a significant presence on a global scale. The GDO is looking to have a two-day in-person international conference on genetic discrimination. This conference will be invaluable to gather together a group of interdisciplinary experts in law, bioethics, genetics, sociology and economics from different world regions. The GDO conference will address recent normative framework developments worldwide and the many novel forms of GD deriving from today’s rapidly evolving genetics and biotechnology.
The GDO conference will be instrumental in generating the following deliverables in 2022-2024: publications of the conference proceedings in an open-access journal, lay summaries adapted for healthcare professionals, genetic counsellors, patient associations and the lay public, and video capsules. The GDO online platform (https://gdo.global/en) and its international team of expert collaborators will provide a unique edge in disseminating the GDO conference outputs to researchers and knowledge users (KUs) in Canada and draw the international community’s attention to recent developments in the field of GD.
Principal Investigators
Funding Organization(s)
Period
2022-03-22 to 2024-03-21
Description
Non-harmonized data access processes are a barrier to the cost-effective use of existing oncology data to derive population-level insights. To this end, CanFED was launched as a common effort across multiple cancer and population health data repositories that operate Data Access Committees (DACs). It explored technical, organisational, and private law measures that increase the interoperability and scalability of DACs and generated empirical evidence of the distinct data governance processes that different repositories have implemented. Participating infrastructures included the International Cancer Genome Consortium (ICGC), the Canadian Partnership for Tomorrow`s Health (CanPath), the Marathon of Hope Cancer Centres Network, and dbGaP. Ana Bonilha and Alexander Bernier are leading the drafting and development of a policy document to provide actionable guidance to new data stewards that are developing their own data access processes. This document described the established best practices in the operation of data access committees, and assessed the relative merits of distinct approaches to achieving further standardisation and automation of access processes.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-03-15 to 2023-03-14
Description
The Centre of Genomics and Policy along with the MUHC Data Governance Task force will develop an MUHC/MUHC-RI Data Governance Framework encompassing the use of clinical and administrative data from MUHC information systems and other sources by researchers at the RI-MUHC. The Framework will clearly define the ethical and legal foundations for, and limits on, the use of clinical and administrative data for research within and outside of the MUHC in the province of Quebec. The Framework will facilitate legal and ethical conformity in domains including privacy, data access, research ethics and information systems. The Framework will also consider, when possible, the use of these data by clinicians and administrators for quality assurance of healthcare. The use of clinical and administrative data for research and quality assurance are well aligned under the concept of a learning healthcare system, in which science, informatics, incentives, and culture are aligned for continuous improvement and innovation with new knowledge being captured as an integral by-product of care delivery.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2022-01-01 to 2024-12-31
2021
Description
The CGP has developed an expert report delivered to the Public Health Agency of Canada (PHAC), detailing how Canadian data protection law, Canadian public health legislation, and biomedical research ethics guidance affect the potential to share health-related information for public health purposes, amongst distinct Canadian health-sector institutions. This report helps the Public Health Agency of Canada, and the Expert Advisory Group on the development of a Pan-Canadian Health Data Strategy, to propose recommendations to facilitate the sharing and stewardship of biomedical information to enable improved healthcare delivery and inform public health efforts.
Principal Investigators
Funding Organization(s)
Period
2021-08-24 to 2022-03-31
Description
The Centre for Genomics and Policy will serve as the secretariat and academic partner for the International Best Practices for Genomic Data Sharing project. The Centre for Genomics and Policy (a) will draft the International Best Practices for Genomic Data Sharing document, (b) seek, organize, and incorporate feedback on the International Best Practices for Genomic Data Sharing drafts from Industry Core Group members, (c) schedule and facilitate discussions between Industry Core Group members and other relevant stakeholders regarding the International Best Practices for Genomic Data Sharing content, ( d) ensure agendas are distributed for and take minutes at International Best Practices for Genomic Data Sharing-related meetings and (e) synthesize pre-existing Global Alliance for Genomics and Health guidance and assess its applicability to the International Best Practices for Genomic Data Sharing, among (f) other tasks necessary to create the Work Product.
Following completion of the Work Product, the Centre for Genomics and Policy will introduce the International Best Practices for Genomic Data Sharing document to the GA4GH Regulatory & Ethics Workstream and facilitate its socialization among the broader GA4GH membership.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2021-07-21 to 2024-07-20
Description
The Centre of Genomics and Policy (CGP) at McGill University is a multidisciplinary team working at the crossroads of law, medicine, and public policy. The CGP in this collaboration will carry out a review of the applicable institutional, ethical and legal guidance and policy options to contribute to the development of the OncoBrCaDrive Biobank Framework. The policy options identified for inclusion in the Framework will form the backbone that will contribute to identifying and managing ethical concerns and foster patient and participant trust. The CGP will assist in the development of policy documents related to initiating and maintaining the biobank and establishing and supporting its Data Access Committee (DAC). Further, a member of the CGP with expertise in bioethics (Dr. Nicole Palmour) will sit on the DAC for the first two years of the Biobank operations. Building on the experience of the pilot phase, a revised and updated version of all documents will be developed and made available (Q4 of 2021-2022 or Q1-2 2-2022-2023). All documents will be evaluated and refined in accordance with the OncoBrCaDrive Biobank specifications.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2021-07-01 to 2023-06-30
Description
The Quebec SmartCare (Soins intelligents) Consortium is an innovative research project centred on the Opal patient portal (opalmedapps.com) at the Research Institute of the McGill University Health Centre (RI-MUHC) that is designed to address the challenges caused by the siloing of data in the Quebec healthcare system. It comprises a unique group of public and private partners with expertise and interest in patient-centered care, mHealth technology, and AI research. Working together, the consortium partners will strengthen the patient-centered technology of the existing Opal patient portal, enable secure data flow from wearable devices into Quebec hospitals, and collect real-world data for artificial intelligence and real-world evidence research.
The Centre for Genomics and Policy will: (1) examine specific ethico-legal issues associated with access to data, (2) develop a governance framework for access, (3) develop with stakeholders a “Collaboration with Industry” policy, a Code for Collaboration with Industry, and a go/no-go checklist for agreements with industry, and (4) implement an Access system and coordinate review/adjudication of access requests by researchers.
The work will put in place solid frameworks for data governance and commercialization/ technology transfer that are expected to persist well beyond the lifetime of the QSCC and will help foster continued collaboration amongst the partners.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2021-07-01 to 2024-06-30
Description
Rapid advances in stem cell research and tissue engineering have put regenerative medicine at the forefront of innovation in the area of patient-oriented therapeutic applications. Combining stem cells cultured from patient biopsies with tissue engineering has the potential to revolutionize grafting practices by offering viable and feasible solutions not only to healing complex wounds but also to the shortage of donated organs. However, the clinical translation, from bench to bedside, of these personalized tissue engineering products is slow and often hampered by both a lack of resources and access to appropriate facilities that meet the safety and quality standards required for clinical research. Therefore, the aim of this project is to provide Canada with the certified Good Manufacturing Practice (cGMP) facility required to conduct the clinical research essential in concretizing the applications of personalized tissue engineering for regenerative medicine.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2021-06-01 to 2025-07-31
Description
Innovations in digital technologies and the onset of the COVID-19 pandemics have accelerated the implementation of new approaches to the conduct of clinical trials. Funded by the MEI’s Fonds d’accélération des collaborations en santé (FACS) initiative, the "Paradigm Shift in the Conduct of Clinical Trials" project aims to develop and deploy a multi-faceted informatics framework to support the conduct of high-quality, low-cost digital and virtual clinical trials using innovative strategies for patient recruitment, retention, and follow-up at performance thresholds well beyond conventional approaches. The CGP is responsible for drafting access policies to facilitate the sharing of clinical trial data is providing ongoing support with the management of emerging ethico-legal questions, including informed consent, participant confidentiality, and the responsibilities of nurses and physicians when remotely monitoring patients.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2021-04-01 to 2024-03-31
Description
The Distributed Infrastructure for Genomics Data Sharing and Analysis project is divided into four activities. In Activity 1, the CGP will develop a broad Canadian data sharing framework, using the APIs developed under the auspices of the Global Alliance for Genomics and Health (GA4GH). Activity 2 continues the development of GenAP: a computational gateway for data analysis in life sciences that is configured to take advantage of Compute Canada infrastructure. Activity 3 builds a data-sharing platform to allow for the collection of standardized clinical data, dynamic cohorts, and the performance of genome analytics across datasets stored on various Compute Canada nodes, and to enable genome-guided clinical trials across Canada. Finally, Activity 4 will establish the Canadian Molecular Profiling in Cancer Trials (CAMPACT) Interchange. Together, the four activities will utilize Compute Canada infrastructure to build a distributed and secure computational framework for the analysis of genomic datasets relevant to human diseases and beyond. The CGP will also contribute to the implementation of the data sharing and privacy policy framework of the International Human Epigenome Consortium (IHEC) as well as that of the GA4GH.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2021-04-01 to 2025-03-31
Description
Advances in regenerative medicine challenge both traditional legal classifications and professional ethics norms. The development of a Regenerative Medicine Charter by the CGP, founded on both international human rights and recent policy guidance, seeks to frame the future conduct of research in regenerative medicine. To do so, we examine the current international ethical and legal landscape concerning cellular genomics, bioengineering, human genome editing, and stem cell research in order to propose key pillars for the Regenerative Medicine Charter. In particular, we posit that the respect of the human right to science, to health, and to non-discrimination as well as the principles of quality/safety, integrity/accessibility, and transparency/accountability could guide the ethical future of regenerative medicine. Hopefully, the Charter will bring together and inspire the diverse communities of policymakers, scientists, clinicians, as well as patients and their families as they face the challenges of regenerative medicine.
Principal Investigators
Funding Organization(s)
Period
2021-04-01 to 2022-03-31
Description
Smartphone applications for health are being increasingly used as a platform to collect and share large volumes of crowdsourced personal health data for biomedical research and algorithm training. Consumer genetics products are similarly allowing individuals to have direct access to their own genetic data and to share such data with researchers. Using smartphone and genetic data in these ways presents numerous opportunities to expand biomedical knowledge, though it also raises certain risks. Some of these include risks to personal privacy and risks associated with unclear ethical and legal obligations on the part of app developers and researchers. In this project, the CGP collaborates with Belgian partners to mitigate these risks. We do so by determining how smartphone applications and other mobile tools that collect health data work in practice and by addressing legal, ethical, and regulatory uncertainty in both Canada and the European Union. We will use this evidence to develop health policy guidelines that will enable smartphone data to be used safely, in a manner that protects users and the public. In doing so, we will assure that such data will contribute to improved health outcomes by expanding biomedical knowledge and making health more effective and efficient.
Principal Investigators
Funding Organization(s)
Period
2021-01-01 to 2024-12-31
Description
The concept of “serious / severe disease” is a key element in the ethical and policy analyses of emerging regenerative and cell and gene therapies. It is used to define those considered ethically appropriate and/or legally permissible across a spectrum of possible interventions, such as pre-implantation genetic testing of embryos, prenatal testing, and newborn screening. It is also used to justify interventions in contexts such as access to last resort medications / treatments (“right to try” / expanded access program) or disclosure of a genetic condition to family members over the objection of the patient. Most recently, it has resurfaced in the debate surrounding human genome editing.
Exploring this notion is timely relevant to the evolving debates regarding regulation and governance of emerging and non-standard of care medical interventions, including the growing options for unproven stem cell-based interventions. Unpacking this concept has direct and important implications for policy and the clinical translation of existing and emerging technologies, including cell and gene therapies.
A workshop to consider, challenge, and unpack the notion of “serious” disease or condition, was conducted in June 2023 at the Brocher Foundation, to move towards greater definitional clarity and utility in research, clinical and policy decision-making.
The expected outputs include:
- An academic publication outlining the findings from the deliberation (i.e. peer-reviewed, open access publication);
- lA policy brief (white paper) on the recommendations stemming from the workshop regarding the need to define, which will be targeted towards policy-makers.
Principal Investigators
Funding Organization(s)
Period
2021-01-01 to 2021-12-01
2020
Description
The Réseau québecois de diagnostic moléculaire (RQDM) is an initiative that aims to meet the current and future needs of the health and social services network in the field of molecular diagnosis and personalized medicine, particularly in the areas of rare disease diagnosis and cancer. It also aims to repatriate analyses performed in private national and international laboratories into the Québec public health and social services network. The CGP works on the development of an ethical and legal framework for the implementation of RQDM’s activities and to harmonize consent for patients that are prescribed a molecular analysis in genetics or oncology. Accordingly, the CGP is developing template consent forms that address the following elements: compliance with ethical standards, management of incidental findings, storage and sharing of sequencing data and clinical information, storage of samples for future clinical use, and access to samples and data resulting from clinical analyses for research purposes.
Principal Investigators
Funding Organization(s)
Period
2020-11-16 to 2023-12-31
Description
Data has the potential to dramatically transform biomedical research and health care. In particular, we are now in an era where genomes can be systematically sequenced and provide fundamental insights into our predisposition to diseases, our response to therapies and how our health can be affected by our environment. Recognizing this, Canada has been at the forefront of the genomic revolution, making a combined investment of more than $2.4 billion in this field. However, as a global scientific community, our ability to interpret and utilize this type of information is still only at a nascent stage. Specifically, to fully realize the benefits of genomic and health data, we need infrastructure to securely store, analyse and employ this information without compromise. Moreover, when appropriately consented, we need tools to share these data both nationally and internationally, since a critical mass of samples is needed for advanced machine learning approaches and to enable key biomedical discoveries. Our SecureData4Health proposal will create within Canada the computational and software infrastructure needed to safely store, interpret and share the genomic and health information that is rapidly expanding within our centres and hospitals. It will also facilitate access to the wealth of complementary information being made available across the world. The SecureData4Health infrastructure will be deployed within the existing host sites of Compute Canada, allowing our team of scientists and users easy access to the technologies needed to reap the full benefits of their data, without the need to duplicate resources. Finally, our project will provide innovative data sharing modalities where the security and confidentiality of participants’ data will be paramount. It will enable Canada to play a leading role in the challenging but critically important movement towards international health data sharing.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-11-01 to 2026-03-31
Description
The Quebec 1000 Project (Q1K), a flagship project of the Transforming Autism Care Consortium (TACC), aims to develop a platform to facilitate research by creating a large cohort of family trios (proband participant and family member participant(s)) in families where an individual has been diagnosed with autism spectrum disorder (‘ASD’) or a related neurodevelopmental condition. To do so, the Q1K project will create coordinated biobank(s), a database and a participant registry, to be made available as resources to the autism research community.
Building on the collaborative development of the Quebec 1000 families (Q1K) Governance Framework and related policies, as well as the ongoing discussion with stakeholders, there is a clear need to maintain discussions to address emerging ethical questions related to ASD research, particularly with respect to genomic research and governance of data sharing.
Principal Investigators
Funding Organization(s)
Period
2020-10-01 to 2024-03-31
Description
The CHU de Québec-Université Laval has developed a “collaborative oncogenetic model” (COM) aimed at improving access to genetic counseling services and minimizing delays for genetic tests for patients. The Oncopole project seeks to understand the context in which the COM was developed and implemented, and to document the lessons that can be drawn from it to optimize the delivery of local and regional oncogenetics services in Quebec.
CGP missions:
- Review of the literature on legal, regulatory and ethical issues related to the extension of the role of non-genetic health professionals and the establishment of a register of patients benefiting from genetic counseling and testing for cancer hereditary breast and ovary.
- Comparative law analysis to identify the main legal variations and promote better coordination of the legal texts of the different national systems.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-09-01 to 2022-10-01
Description
The aim of this project is to demonstrate through a clinical trial that autologous tissue-engineered skin substitute, produced with fibroblasts and epithelial stem cells previously corrected ex vivo by gene therapy, offers an efficient strategy to treat Canadian patients suffering from dystrophic epidermolysis bullosa (DEB). As one of the leading organ reconstruction laboratories in the world, LOEX, CHU de Québec-Université Laval will be the first to launch a clinical trial using a bilayered human skin substitute (instead of a single cell type) in which the adhesion of epidermis to the dermis is functional in vitro before grafting on patients, thus possibly providing a curative treatment for the recurring wounds of many Canadians. The CGP (CGP) will assists in preparing the necessary requirements for research ethics approval (including preparing standardized recruitment procedures and protocols, consent forms and information pamphlets). The CGP will also be involved preparing documentation for the pre-CTA meetings and for the regulatory approval with Health Canada.
Principal Investigators
Funding Organization(s)
Period
2020-09-01 to 2023-01-31
Description
The COVID-19 Immunity Task Force (CITF) is collecting blood samples and survey data for the purposes of assembling a national repository of data relating to seroprevalence and immunization, as well as vaccine surveillance. The CITF is coordinating numerous local and multi-centre seroprevalence studies, and is collaborating with Canadian Blood Services, Héma-Québec, and the National Microbiology Laboratory, among other partners, to collect and interpret data in a harmonized manner.
The CGP is responsible for creating ethico-legal deliverables for the CITF and for guiding the data governance initiatives thereof.
To this end, the CGP has produced a data governance framework, template informed consent materials, and retrospective consent guidance for legacy datasets and samples. Further, the CGP has been actively involved in the CITF’s efforts to ensure the normative interoperability of its cohorts, through direct engagement with study coordinators and CITF leadership.
Principal Investigators
Funding Organization(s)
Period
2020-07-01 to 2023-09-30
Description
As COVID-19 continues to spread globally, there is an urgent need to understand the DNA footprint of this rapidly evolving virus. Led by DNAstack, the COVID Cloud Project harnesses Canada’s genomic research capabilities to rapidly sequence, share and analyze the genomic profile of COVID-19 and the people who have contracted it in Canada and around the world. This information will help inform the development of public health policies, diagnostics, therapies and vaccines. The team at the CGP will map relevant provincial, federal, and international data privacy laws and research ethics regulations and will work to determine how their application is affected in emergency situations. We will further work to design a streamlined access model based on the international GA4GH research passport standard, allowing credentialed researchers to access data and search networks for specific purposes, including COVID-19 research. We will promote these efforts through online videos and workshops.
Principal Investigators
Co-Applicant
Funding Organization(s)
Period
2020-07-01 to 2021-06-01
Description
In response to the ongoing COVID-19 pandemic, CGen has received federal funding to sequence the genomes of thousands of Canadians, in order to better understand the variable clinical response to COVID-19, and share resulting genomic and sequencing data through the HostSeq databank. In doing so, HostSeq will leverage existing biobanking and sample collection efforts, as well as invite interested researchers to launch their own site-specific recruitment protocols to contribute to this Canadian COVID-19 resource. The CGP developed a governance framework for the HostSeq databank, which identifies ethical, operational and oversight mechanisms governing the databank. Additionally, the CGP has prepared a list of core consent elements to assist investigators in sites across Canada in collaborating in this effort and submitting their local projects to their research ethics committees or for determining the adequacy of already-existing projects to contribute to this effort. The CGP team will also perform a pre-assessment of existing informed consent forms of contributing collections in order to assess their compatibility with the HostSeq core consent elements (or identify items that may impede use, such as data storage limitations or international sharing limitations) and will provide ongoing policy consultation to the HostSeq databank.
Principal Investigators
Funding Organization(s)
Period
2020-06-01 to 2023-03-31
Description
The Canadian COVID-19 Genomics Network (CanCOGeN) was launched to coordinate and upscale the existing genomics-based research efforts to study the SARS-CoV-2 virus and COVID-19. The CanCOGeN project is organized into components focusing on human-disease component (HostSeq) and virus (VirusSeq) to address topics unique to each.
CanCOGeN-VirusSeq has multiple goals such as tracking viral transmission and exploring a multitude of pressing topics, such as the variability across patient outcomes, with each better informing both research and Public Health.
Currently, Prof. Yann Joly serves as the chair of both the CanCOGeN-VirusSeq Ethics and Governance Committee and the CanCOGeN Data-Sharing Committee, while also acting as an active member the VirusSeq Implementation Committee. Lingqiao Song and Hanshi Liu are also members of the CGP (CGP) who actively contribute to the various ethical and legal topics in the project. Overall, as a part of CanCOGeN-VirusSeq, the CGP team addresses essential ethical and legal issues derived from the CanCOGeN project.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-05-01 to 2022-06-30
Description
The COVID-19 pandemic has demonstrated the on-going need for scientific cooperation and re- sponse at a global level. Recent research has already brought several vaccines to market, as well as possible therapeutics to combat the disease. COVID-19 specific biobanks and data repositories have been positioned at the forefront of these biomedical developments, providing researchers tools to study the novel virus at unprecedented speeds. Still, important ethical, legal, and social tensions arise between the need for rapid collection and the clinical realities faced on the ground by professionals responsible for both patient care and recruitment into research.
The goal of this project is to provide policy evidence – as well as ethical and legal guidance – to inform newly created COVID-19 research infrastructures. The CGP plans to conduct a comparative analysis of existing COVID-19 international biobanking policies and launch a national survey on the lived experiences of health professionals involved in participant recruitment during the pan- demic. In co-ordination with the Biobanque Que?becoise de la COVID-19 and researchers in the UK, Italy, Australia, South Africa, and Hong-Kong, the CGP will ensure this work can provide objective evidence for policy development.
Principal Investigators
Funding Organization(s)
Period
2020-05-01 to 2022-04-30
Description
Epigenetics refers to heritable or non-heritable changes to the DNA structure and gene activity that can occur in response to exposure to various environmental or social factors. This project aims to identify opportunities and challenges in using epigenetic technologies in the context of defense and security, with a focus on four applications: 1) exposure to nuclear, chemical or biological weapons; 2) epigenetic age (e.g., proving child soldiers’ age through DNA methylation analysis); 3) mental health monitoring (e.g., PTSD); and 4) enhancement of bodily functions (memory, cognition, muscle strength) through epigenome editing.
The CGP has carried out trailblazing research on the opportunities and technical, ethical and legal challenges associated with epigenetics. In this project, the CGP will undertake extensive documentary research (funded research, military directives and orders, laws and government policies) that would yield a peer-reviewed article on epigenetics’ anticipated uses. This research will complement a one-day workshop with US and Canada experts on epigenetics, DARPA researchers in epigenetics and DND/CAF staff. The workshop’s outcomes will be translated into a policy brief and briefings for interested DND/CAF officials, highlighting paths to effectively implementing epigenetic technologies in defense and security contexts.
Principal Investigators
Master's Student
Funding Organization(s)
Period
2020-04-01 to 2022-03-31
Description
This study aims to explore the potential ethical, legal and social implications (ELSI) associated with the use of artificial intelligence (AI) within WADA’s anti-doping strategies. This will be accomplished using a three-round, consensus-building online survey method (Delphi study) whereby the perspectives of experts and stakeholders with varied expertise and experiences will converge to inform a forward-looking approach for the ethical application, regulation and design of AI within a sport anti-doping context. These include (but are not limited to): anti-doping organization administrators; anti-doping laboratory administrators; bioinformatics experts with knowledge about AI; ELSI scholars (e.g., ethicists, social scientists, legal scholars) working on AI and/or anti-doping; and advocates of elite athletes’ rights and interests.
Ultimately, this will assist in better informing and facilitating the translation of the relevant ELSI into normative guidance (i.e., ethical principles and legal norms), as well as shape regulatory and governance approaches in the applications of AI within anti-doping strategies. This will foster coherence and provide overarching ethical guidance to effectively navigate and address the issues and challenges identified.
Principal Investigators
Collaborators
Funding Organization(s)
Period
2020-04-01 to 2023-06-30
Description
This project aims to develop and implement a plan that raises awareness in Healthcare professionals, key opinion leaders, the Canadian public and Funding Agencies about the DOvEEgene screening test that will be made available to the public, initially in the context of a trial and following successful validation as a clinical test. Our milestone is an effective DOvEEgene Awareness Campaign developed on evidence-based strategies. Methods/Tools will be developed after analysing the literature on barriers and promoters that are relevant to implementation of a screening test and taking into account contextual factors, such as the healthcare system itself, providers, and patient groups, as well as economic impact. We will use a variety of television, newspaper, magazines, radio, features & interviews, our website, and social media. We will send an information letter to gynecologists and general practitioners to inform them about the trial using lists obtained from the College Des Me?decins. This will be repeated every six months. We will invest in Continuing Medical Education of Healthcare Professionals (general physicians, gynecologists, nurses) and in lectures and events aimed at middle-age and mature women, who will be the target population.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-04-01 to 2023-03-31
Principal Investigators
Funding Organization(s)
Period
2020-04-01 to 2021-01-01
Description
The present project proposes a new technology at the crossroads of this issue: we aim to democratize cardiovascular prevention through the development of a nano-vaccine to prevent and treat atherosclerosis. Breaking with the current approach, we aim to teach the body to use its own defense mechanisms to combat the leading cause of cardiovascular disease in this country (and the world). Just as flu vaccines enable the body to fight viruses, the innovation here is to teach it to fight the development of atherosclerotic plaques. This approach contrasts with the drugs currently used to prevent coronary heart disease, which must be taken daily and have numerous side effects. Ultimately, this vaccine could have considerable repercussions, potentially preventing a public health problem that kills over 38,000 Canadians every year, with direct and indirect costs estimated at $22 billion a year. In concrete terms, the aim of this project is to induce the production of cardioprotective antibodies in patients by injecting nanoparticles prepared from oxidized phospholipids. Drawing on the unique properties of nanotechnology and the way vaccines work, we aim to prevent the development of coronary heart disease, thus making a complete break with the current pharmacological paradigm. Ultimately, we believe that this technology could provide a single, universal vaccine to rival the current model of personalized therapy.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-04-01 to 2024-03-31
Description
This project aims at creating a knowledge-based platform and electronic medical record (EMR) that will integrate clinical and genomic information into clinically actionable reports for clinicians. Such platform will be flexible and adaptable to different biomarkers independently of their “omics” origin. The CGP will work to develop privacy and confidentiality policies to facilitate this integration of genomic and clinical data. Ultimately, this work will culminate in best-practice documents that will be shared with the Qatar team for local and territorial use.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2020-01-26 to 2024-04-22
Description
This study examines the ethical and legal issues regarding the use of internet-based Direct-to- Participant (DTP) recruitment and provides guidance for its practice in stem cell research. The main objective of this project is to fill the ethical and policy gap by: 1) examining the ethical/legal issues of international DTP recruitment (for adult and minor participants) and 2) yielding concrete, practical ethical guidance and tools for Canadian researchers and REBs. In collaboration with the Program for Individualized Cystic Fibrosis Therapy (CFIT) at SickKids, the CGP will first build a case study to examine the feasibility and utility of international DTP recruitment, while producing practical, context specific governance framework and recruitment tools. Knowledge and pragmatic experience gained from the CFIT case study, along with consultations with national stakeholders (REB representatives, researchers, and policy makers), will contribute to the development of Canadian Best Practice Guidelines for DTP recruitment. As innovative and fundamental resources for Canadian REBs and researchers, the guidelines and practical tools will directly address an immediate need for clear policy and guidance for international DTP recruitment in stem cell research. They will also set the standards for Canada and internationally, consolidating Canada’s position as a leader in policy development.
Principal Investigators
Funding Organization(s)
Period
2020-01-01 to 2023-01-31
Description
Treatment for burn wounds is based on skin autografts, but when the surface that needs to be covered is more than 50 percent of one’s total body surface area, autografts becomes strategic. With tissue engineering methods developed in Dr. Moulin’s lab (Université Laval) , autologous Self-Assembly Skin Substitutes (SASS) can be produced from only a small skin biopsy and could permanently cover all the patient wounds. This early phase clinical trial has now been accepted by Health Canada and few patients have been treated in Que?bec. This project will allow expanding the trial to burn units in other Canadian provinces. The aim of this trial is to evaluate this novel therapeutic approach, treating 17 patients to help skin regeneration. Dr. Moulin plans to recruit at least seven patients during the next two years and evaluate graft take and post-grafting scarring over a two-to-three-year period. Her aim is to treat most Canadian patients that have been burns over more than 50 percent of their body. SASS treatment should have economic and social benefits, as our preliminary results have demonstrated that treatment decreases morbidity caused by standard treatments and increases quality of life for patients. At the end of the clinical trial and acceptance by Health Canada, Dr. Moulin’s lab will be the first in Canada to routinely treat patients with autologous reconstructed skin.
Our interdisciplinary team is composed of four internationally known researchers in regenerative medicine from two universities and of plastic surgeons working in major Canadian burn unit sites. The CGP (CGP) will assist in preparing the necessary requirements for research ethics approval (including preparing standardized recruitment procedures and protocols, consent forms and information pamphlets). This will require coordination of REB approval. The CGP will also be involved preparing documentation for the pre-CTA meetings and for regulatory approval with Health Canada.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-01-01 to 2023-01-31
Description
The aim of this project is to demonstrate through a clinical trial that autologous epithelium tissue, engineered from corneal limbal stem cells, offers an efficient strategy to treat Canadian patients with visual deficits due to limbal stem cell deficiency. As one of the leading organ reconstruction laboratories in the world, LOEX, CHU de Québec-Université Laval, will be the first to launch a multicentre trial using a human fibroblast feeder layer (instead of a murine feeder layer) to expand and preserve human stem cells in vitro, thus possibly improving vision for many Canadians. The CGP provides consultation on the socio-ethical and legal issues and assists in developing the necessary documentation for approvals from Health Canada and research ethics boards.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2020-01-01 to 2023-01-31
Description
The International Cancer Genome Consortium (ICGC) represents international cancer research projects who share the common aim of elucidating genomic changes in a range of cancers. ICGC has gathered mass volumes of data since its inception culminatory in the PCAWG publication in Nature (February 5, 2020). Data is shared with 1300 researchers from 37 countries. The CGP houses the consortium’s Data Access Compliance Office (DACO). International researchers have obtained access to controlled data for use in genomics, bioinformatics, and related research. The CGP manages the data access process in order to ensure that cutting edge cancer research progresses efficiently and with as broad a reach as possible. To date, DACO has processed over 2000 applications for ICGC Controlled Data Access (including resubmissions and renewals). This project has been realized at the CGP in collaboration with members of the P3G/P3G2 project.
Principal Investigators
Funding Organization(s)
Period
2020-01-01 to 2021-12-01
2019
Description
The McGill Clinical Genomics program (McG) aims to implement hospital-based genomic medicine building on robust research to improve clinical care. McG seeks to improve disease diagnosis and risk-stratification, the efficiency of test ordering and prediction of drug responses that will deliver benefits to person-centered patient care and value to the wider healthcare system and across the CIUSSS du Centre-Ouest-de-l’I?le-de-Montre?al/Center West Montreal. As part of this project, members of the Centre of Genomics and Policy will lead the Ethics and Governance Pillar and develop a set of ethics policies and templates to ensure that the Project will be able to recruit participants as well as use and share their data and samples for research purposes in an ethical and efficient manner, which complies with international best practice. Special focus will be put on COVID-19 related recruitment in light of the pandemic.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-10-01 to 2022-08-31
Principal Investigators
Funding Organization(s)
Period
2019-09-01 to 2024-09-01
Description
In recent years, genetic testing available to consumers online through private companies, also known as direct-to-consumer (DTC) genetic testing, has increased significantly. A growing number of individuals now have access to information about their genome, which represents a person’s complete set of genes. With this information, people are able to discover information about their ancestors, genealogical links with other people and, in some cases, genetic risk factors.
DTC genetic testing has enabled the assembly of large cohorts, which represent a group of people that can provide valuable information for scientific research. However, this information remains mostly under the control of private companies, limiting opportunities for research.
The objective of CopaQ is to develop a platform for the collection, sharing, and simplified interpretation of population research results. This platform will collect genetic, genealogic and basic demographic information from individuals who have already performed a genetic test with a private company (e.g. 23andMe, Ancestry, etc.) in order to securely share this information with members of the research community that agree to protect its confidential nature. The CGP is developing the consent form for this project and also advises on ethical and legal issues.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2019-05-01 to 2021-04-30
Description
Over the past few years, epigenetic and microbiomic tests have been commercialized by private companies, some of which are currently being advertised and offered to the Canadian public online. The collection and use by private companies of such biological information raises serious legal and ethical privacy concerns. The privacy implications raised specifically by the increase in diversity of these new forms of biological data – and their integration with genomic datasets – have not been seriously addressed yet. This project will investigate the privacy issues emerging from the rapid scientific development and commercialization of what the researchers call “postgenomic biometrics.”
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2019-04-01 to 2020-03-31
Description
As genomic medicine is increasingly used in the clinic, demand for genetic counselling is growing. Genetic counselling, however, is not regulated in most Canadian provinces, including Quebec. Understanding the potential impacts of this lack of regulation on the provision of health services, on the clinical uptake of genomic research findings, and on the risks incurred by the public is essential. The existence of frameworks regulating the practice of a medical profession is one of the options for safeguarding the protection of the public by reserving the acts and titles of specific health professionals. To determine how the activities of a genetic counsellor could be translated into legal duties, our project aims to categorize the main tasks of genetic counsellors and the risks associated with these tasks in the context of Quebec. To do this, we combine our legal expertise, the expertise of an Expert Advisory Committee composed of RMGA members and a broader stakeholder consultation (e.g., genetic counsellors, medical geneticists, and other medical specialists). Understanding the scope, limits and possible overlap of genetic counselling with acts currently reserved for other health professionals will optimize the integration of genetic medicine applied to the practices and policies of the Quebec health system.
Principal Investigators
Funding Organization(s)
Period
2019-04-01 to 2020-03-31
Description
Epidermolysis Bullosa (EB) is a genetic disease manifested by a lack of adhesion between the dermis and the epidermis. It causes detachment of the mucous membrane and epidermis, which can lead to serious complications such as ulcers, infections and cancer (carcinoma). Currently, the treatments offered are palliative, mainly with bandages to protect epithelial wounds. EB is characterised by mutations in different genes. The aim of the project is to develop an effective gene therapy treatment for two types of EB: dystrophic EB (D) and junction EB (J). Skin substitutes (reconstructed skin) will be produced from EB patient cells, grown in vitro and corrected by gene therapy. The efficacy of this treatment will be tested on reconstructed human skin in the laboratory. The CGP will be reviewing ethical and legal issues associated with this project.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-04-01 to 2020-03-31
Description
ARCHI is the pilot phase of a national platform (PRECINOMICS) for centralized access and exchange of genomic and administrative health data for health research purposes. As a project, ARCHI aims to 1) integrate data from 20,000 participants enrolled in two separate research cohorts (the Montreal Heart Institute and the Canadian Partnership for Tomorrow Project); and 2) enrich these data with (gen)omics data. In addition, doubling as a proof-of-concept, the completion of ARCHI will demonstrate the maturity of data processing and sharing technologies as well as the feasibility of data sharing for precision medicine research.
In this project, the role of the CGP is twofold. First, it is to develop the access and consent governance policy for the platform. To do so, the CGP will survey existing and proposed biobank consent forms and access policies in order to identify regulatory, ethical and governance-related issues and barriers in the access model of the platform. Second, the CGP will develop the privacy and security policy for the platform. Similar to the access and consent governance policy, the CGP will sequentially survey current and proposed best practices in the data sharing ecosystem and propose recommendations matching the profile and orientation of the platform
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-04-01 to 2020-06-30
Description
With rare diseases (RD), sufficient patient numbers are not available at any one site. Data needs to be centralized, integrated and broadly accessible to drive RD research for gene identification and understanding. Harmonized policies, an overarching governance framework and the sharing of data through a nation-wide data sharing resource would make a significant impact on research and treatment of RDs. The Canadian Genomics Partnership for Rare Diseases (CGP4-RD) Policy Toolkit aims to address disparities between current institutional, provincial and federal regulatory frameworks to foster sharing of research and health data. Building from a stakeholder engagement process, a set of broad, inclusive and actionable policy resources are being developed for implementation by Genome Canada funded Genomic Applications Partnerships Program (GAPP) projects. This policy toolkit also aims to enable pan-Canadian data sharing by projects funded by the Genome Canada GAPP initiative that would incorporate the data sharing principles and practices as well as the protection of patient interests particular to rare diseases. Though tailored to the rare disease clinical research community, the tools developed by the CGP4- RD Policy Toolkit can be adapted and used as models for common diseases as we move towards precision medicine.
Principal Investigators
Funding Organization(s)
Period
2019-04-01 to 2024-03-31
Description
The goal of this project is to create a dynamic, leading North American centre for oncology research and innovation. Formed by the Goodman Cancer Research Centre, the Jewish General Hospital, the Centre hospitalier de l’Université de Montréal (CHUM), the Maisonneuve-Rosemont Hospital, the Institute for Research in Immunology and Cancer (IRIC) and the Research Institute of the McGill University Health Centre (RI-MUHC), the consortium’s mission to double enrollment in oncology clinical trials and to create a dynamic biobank of samples collected during clinical trials of new drugs will have a major impact on the advancement of science for the benefit of patients. The team at the CGP will assist in the development of project governance tools and will advise the consortium on its legal and ethical obligations. In doing so, the Centre will draw on its extensive expertise in the biobanking field. The team will likewise draw on its background in the adoption of mobile health technologies for facilitating largescale genomic oncology research.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-04-01 to 2023-03-31
Description
Our research question aims to validate, specify and prioritize the potential ethical, legal and social implications (ELSI) associated with the introduction of artificial intelligence (AI) within the World Anti-Doping Agency’s (WADA) anti-doping strategies. This will be accomplished using a consensus-building approach whereby the perspectives of a group of experts with varied expertise will converge onto a forward-looking approach for the ethical application, regulation and design of AI within an anti-doping context.
Our study’s main objective, as stated earlier, is to assess the potential benefits of, challenges with and solutions for an ethically responsible implementation of AI within anti-doping strategies, according to experts from around the world engaged in related administrative, professional, research and advocacy activities. This main objective will be attained by: a) validating existing theoretical expectations and concerns surrounding AI with expert opinion; b) specifying the ELSI raised by the introduction of AI in the particular context of anti-doping; and c) prioritizing the ELSI based on their level of importance, according to our panel of experts.
Ultimately, we aim to better inform and facilitate the translation of the relevant ELSI into normative guidance (i.e. ethical principles and legal norms), as well as shape regulatory and governance approaches in the applications of AI within anti-doping strategies. This will foster coherence and provide overarching ethical guidance to effectively navigate and address the issues and challenges identified.
Principal Investigators
Collaborators
Post-Doc Fellow
Funding Organization(s)
Period
2019-04-01 to 2021-03-31
Description
The Cancer Genome Collaboratory (CGC) is a unique Canadian cloud compute facility that holds the world’s most comprehensive public collection of cancer genomes and associated clinical information. The proposed work will extend the CGC’s data holdings, improve accessibility to the data, add a series of high-quality vetted pipelines for standardized cancer genomic analysis, and implement services that apply new cutting-edge algorithms for the interpretation of cancer genomes. The CGP is drafting a code of practice for the international sharing of cancer genomic data. The CGP has also performed research concerning data identifiability standards, data protection law, and international data transfers with a particular emphasis on data transfers between Canada and the European Union.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-04-01 to 2023-03-31
Description
EUCanCan aims to federate existing European and Canadian infrastructures to analyze and manage genomic oncology data. The CGP is co-leading the development of guidance and ethico- legal tools regarding international sharing of clinical and research oncology data. The aims include: 1) to perform a legal, policy, and normative interoperability analysis to develop guidance aimed at Canadian oncology projects when sharing personal health data with European countries and within Canada; 2) to analyze the requirements Canadian projects will have to satisfy pursuant to the EU General Data Protection Regulation when receiving personal health data from European partners; 3) to deliver a Report these first two topics; 4) develop overarching guidance for the project on the use and sharing of clinical cancer-related genomic and other health related data; and 5) describe generalized compliance tools to be used by future international collaborations, whether they are studying cancer or other diseases. Thus far, the CGP has compiled guidance and research related to the pan-Canadian and Canada-EU sharing of data. The CGP intends to produce further research and guidance relating to the use of centralised platforms to store health data across Canada and the European Union.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-04-01 to 2024-09-30
Description
The Canadian Partnership for Tomorrow’s Health (CanPath) has enrolled 300,000 Canadians between the ages of 35 and 69 years, who have agreed to be followed for their adult lifetime, to explore how genetics, environment, lifestyle, and behavior interact and contribute to the development of cancer and other chronic diseases. This pan-Canadian project has seven participating cohorts (Atlantic PATH, CARTaGENE, Ontario Health Study, Healthy Future Sask, Manitoba Tomorrow Project, Alberta’s Tomorrow Project, and the BC Generations Project). The project’s Ethical, Legal, and Social Issues (ELSI) Committee is hosted at the CGP and is responsible for developing ELSI infrastructure for the CanPath platform. Its goals are to bring together ELSI experts and develop relevant policies, documents, and procedures that are needed either by CanPath or by a specific cohort and to ensure the conformity of the platform with legislation and ethics guidelines so as to prospectively guide the cohorts. The ELSI Standing Committee’s mandate is broad, ranging from developing interoperable recruitment, access policies, and procedures to dealing with ethical issues surrounding consent, privacy, data sharing, and proposing governance structures for CanPath.
Principal Investigators
Funding Organization(s)
Period
2019-04-01 to 2023-03-31
Description
In partnership with numerous universities and colleges, and with the support of 88 research centres, non-governmental organizations, businesses, government players and various groups in Quebec, Canada and abroad, Université Laval proposes to set up the International Observatory on the Societal Impacts of Artificial Intelligence and Digital Technologies (OBVIA). The ambition of this innovative institution is to distinguish itself internationally through the quality of its research, its ability to federate various types of expertise and its ability to foster collaboration among all parties concerned by the challenges posed by the development of artificial intelligence (AI) and digital technology. OBVIA is based on four different but interdependent functions. It will conduct intersectoral and interdisciplinary research and creative activities on several priority themes. Members from the CGP will be involved in the “Éthique, gouvernance, démocratie et responsabilité sociale des organisations” Pillar within OBVIA.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-03-01 to 2023-04-30
Description
The Global Alliance for Genomics and Health (GA4GH) is an international consortium that frames policy and establishes standards for the international exchange of genomic and health related data. Data sharing between institutions, sectors and countries is essential for accelerating research, ensuring databases are ethnically diverse, and improving health care. To guide effective and responsible data sharing, the GA4GH formed a foundational Regulatory and Ethics Work Stream (REWS). “CanSHARE Connect” will support the continued Canadian leadership and coordination of the REWS by the CGP. A central responsibility of the REWS is to develop a forward? looking policy “tool?kit” addressing ethical and legal issues consistent with the Framework for the Responsible Sharing Genomic and Health-Related Data that is developed inn 2017. This tool?kit addresses consent, privacy & security, accountability, and coordinated ethics review of international collaborative research. The tool?kit must continue to expand and evolve in order to address the changing needs of open science as well as shifting legal and ethical requirements. The goal is to promote harmonization of policies and protections across countries and settings, to improve certainty and foster the trust that data sharing protects the rights and interests of participants, researchers, and society. The REWS also supports the implementation of the tool?kit by 22 real world genomic data sharing “Driver Projects”.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2019-01-01 to 2023-03-31
Description
The Canadian Open Neuroscience Platform (CONP) aimed to bring together many of the country’s leading scientists in basic, translational, and clinical neuroscience to form an interactive network of collaborations in brain research, interdisciplinary student training, international partnerships, clinical translation and open publishing. The platform provided a unified interface to the research community, so as to propel Canadian neuroscience research into a new era of open neuroscience research with: the sharing of both data and methods; the creation of large-scale databases; the development of standards for sharing; the facilitation of advanced analytic strategies; the open dissemination to the global community of both neuroscience data and methods, and the establishment of training programs for the next generation of computational neuroscience researchers. CONP aimed to remove the technical barriers to practicing Open Science and improve the accessibility and reusability of neuroscience research to accelerate the pace of discovery.
The CGP hosted the Ethics and Governance Committee for the CONP to ensure neuroscience data are shared in a respectful and responsible manner. The Committee is Chaired by Prof. Knoppers and managed by Michael Beauvais. The Committee has generated an Ethics and Data Governance Framework, as well as Publication and Commercialization Policies to promote responsible open neuroscience and a Portal privacy policy to ensure the responsible use of portal users’ data by CONP. The Committee’s Open-Science consent clauses and retrospective filter are soon to be completed, with authentication policies and other novel outputs in the pipeline.
Principal Investigators
Funding Organization(s)
Period
2019-01-01 to 2021-05-01
2018
Description
The Human Cell Atlas (HCA) is a global biomedical research collaboration to create a reference map of all human cells – an international, public resource for better understanding human health and disease. The HCA’s success relies on the expertise of researchers across several countries, undertaking work in different research domains and settings. The CGP leads the development of its ethics tools, including an ethics and data governance framework, template consent forms for adult and pediatric populations, relevant tools (retrospective consent filter, ethics submission guidance), template agreements (material/data transfer agreement templates, data submission agreement template, data use agreement template). The CGP further coordinates the HCA Ethics Working Group (EWG), and hosts an ethics helpdesk to support the HCA community. The CGP supports the governance activities of the HCA’s Data Coordination Platform (DCP), including the implementation of its Data Access Compliance Office (DACO) and Data Access Committee (DAC).
Principal Investigators
Funding Organization(s)
Period
2018-11-01 to 2023-10-31
Description
As genomic medicine and personalized healthcare become increasingly prevalent in the Gulf region, the public and policymakers face difficult ethical questions. Since 2003, there has been a great deal of institutional emphasis on developing genomic medicine and personalized healthcare in the Gulf. As healthcare systems increasingly emphasize these emerging fields, the public should be exposed both to the science of genomic medicine and to associated issues in Islamic ethics. The latter, being a crucial element of the public’s ‘moral world,’ underscores how ethics and policy norms may be developed for the regulation of genomics practices within the Islamic tradition.
There has been little scholarly or public debate on the implications of genetics on Islamic ethics. To address these gaps, this project attempts to develop an understanding of public engagement for the development of policies and regulations in the genomics and personalized medicine contexts that is both religiously and culturally sensitive. As a long-term objective, the project aims to lay the foundation for a Qatar-based consortium of experts and specialists interested in fostering public understanding and engagement with science. This project’s research team will be composed of experts in such fields as Islamic ethics, genomics, international bioethics, medical social sciences, translation, and interdisciplinary and intercultural communication. The Centre of Genomics and Policy will perform a comparative analysis of international genomics norms that will provide the team with international perspectives they can emulate.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-10-01 to 2021-09-30
Description
Advances in next-generation sequencing have led to a vast increase in available human epigenetic data, including transcriptomic data (via RNA-seq) and chromatin data (via ChIP-seq). These epigenetic datasets have led to the development of expression-wide association studies (EWAS) and chromatin-wide association studies (CWAS). This may lead to improved biomedical applications by providing mechanistic explanations and key insights into the interpretation of genome-wide association studies (GWAS). However, obtaining the raw data stored at multiple controlled access repositories can be a very challenging task, because access needs to be controlled in order to protect research participants’ right to privacy.
We need mechanisms to make the process of analyzing epigenomic data more flexible, while addressing the ethical and privacy aspects of data sharing. The Global Alliance for Genomics and Health (GA4GH) has developed tools and standards to address these issues for genomic data. Such tools are now also needed for epigenomic data. The EpiShare framework will provide a user-friendly web resource for scientists to access and visualize large epigenomics datasets, alongside privacy and confidentiality assessment tools to ensure that the methods with which the data will be stored, accessed and analyzed meets requirements set by international laws and standards.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2018-10-01 to 2022-09-30
Description
The euCanSHare aims to build the first one-stop-shop platform for multi-cohort cardiac data integration and exploitation, integrating within a unified ecosystem metadata catalogues, computational tools and data models for facilitating data sharing and re-use in cardiovascular research. Through this consortium, the platform will build upon existing collaborative initiatives on both sides of the Atlantic, namely the Canadian Alliance for Healthy Hearts and Minds (8 cohorts), the European BiomarCare project (>30 cohorts), and other large cohorts such as the UK Biobank (500,000 participants). Addressing their current limitations and exploiting the accumulated know-how and experience, euCanSHare will provide new possibilities for personalised medicine research in the field of cardiology. As the leaders of WP1 (Socioethical and legal interoperability analysis) (and in collaboration with P. Borry (KU Leuven)), P3G2 coordinates the ELSI research activities regarding the legal and ethical implications of implementing blockchain technology, and associated smart contracts, in a Canadian-European data sharing context. The Centre of Genomics and Policy has contributed to this initiative by translating patient consents into automatable profiles for machine reading and providing guidance on Canadian privacy law and research ethics.
Principal Investigators
Funding Organization(s)
Period
2018-10-01 to 2024-09-30
Description
As our scientific understanding of intersex conditions increases, and as we increase the frequency of testing that can detect intersex conditions prenatally via genetic testing, we will increase awareness of intersex conditions in otherwise asymptomatic individuals. As is true of other biological differences with the potential for prenatal diagnosis, this has the potential to increase pathologization, particularly given the option to terminate affected pregnancies. Genetic counselling is one avenue through which parents might be helped to understand the full spectrum of intersexuality and realistic expectations for their children. Despite a pressing need, policies and regulations for genetic testing and genetic counselling in the context of intersex conditions are severely lacking, and there has not been a commensurate rise in training and education for genetic counselors on this subject. Of the five genetic counseling training programs available in Canada, two are currently located in Quebec, at McGill University and Université de Montréal. For this research, we investigated the training available for genetic counselors on intersex conditions, as well as the content of genetic tests that permit testing for intersex conditions. Simultaneously, we undertook a scoping review of existing literature and applicable policy recommendations on the communication of prenatal test results involving intersex conditions to parents. Out of this, we have developed a discussion paper drawing attention to the implications of the rise of prenatal genetic testing for intersex individuals.
Principal Investigators
Funding Organization(s)
Period
2018-09-01 to 2019-08-31
Description
NAC Bio is a health information company aiming to advance clinical research into the medicinal benefits of cannabis in the treatment of chronic disease and illness, by using the latest developments in data-science, human genomics and digital health. Headquartered in Vancouver, British Columbia, it was founded by National Access Cannabis Corp. and by Dr. Tyler Wish. As part of this project, P3G2 assisted the team in establishing their recruitment process in order to ensure the respect of ethical guidelines. Support on governance, data storage and data sharing issues was also provided.
Principal Investigators
Funding Organization(s)
Period
2018-09-01 to 2019-09-30
Description
As part of the Open Science Policy Knowledge Mobilization project, P3G2 has developed an international comparative research brief with a focus on consent. It also designed a consent form seeking to increase patient awareness of and promote data sharing according to open science principles and in line with international best practices.
Principal Investigators
Co-Investigators
Period
2018-09-01 to 2019-12-31
Description
Genome-wide sequencing (GWS; whole genome or exome sequencing) is a powerful new tool that analyzes a person’s entire genetic make-up. However, the information garnered from this type of testing can be overwhelming and may be misinterpreted by non-experts. Genetic counsellors are health professionals that aid patients and families in making informed decisions for this type of testing. However, due to the small number of genetic counsellors in Canada and lack of legal recognition, access to their services is extremely limited. As access to GWS improves and cost decreases, the use of this technology will increase along with the need for genetic counselling. As a result, further exploration of the possible legal recognition of genetic counsellors and key related strategies is necessary. The CGP oversees policy development for the future legal recognition of genetic counsellors in Canada. Specifically, the CGP will (1) research models of legal recognition available to genetic counsellors; (2) categorize the main tasks performed by genetic counsellors and assess how they translate into legal duties; and (3) convene a pan-Canadian working group comprised of key stakeholders to discuss the feasibility of and potential pathways toward legal recognition.
Principal Investigators
Co-Investigators
Master's Student
Funding Organization(s)
Period
2018-07-01 to 2024-03-31
Description
Epigenetics is the study of molecular mechanisms for the regulation of gene expression, such as DNA methylation, that switch genes off or on without altering the DNA sequence. The Building Blocks of Life project ‘Cut out for the future!’ is developing a novel assay (MeD-seq technology) for genome-wide DNA methylation profiling in colon and cervical cancer. This new technology will help to understand the role of DNA-methylation in the pathogenesis of cancer, and may ultimately improve the ability to predict disease progression and treatment outcome in colon and cervical cancer and potentially a variety of other cancers. Due to its unique features epigenetic technology - uncovering potentially modifiable risk factors at high resolution and very low cost - may increase individual autonomy, health and wellbeing by offering personalised preventive interventions. However, these features also give rise to pressing ethical, legal and societal issues regarding autonomy, informed consent and unsolicited findings, harms & benefits of screening tests, privacy, personal responsibility and solidarity.
Through close cooperation with the BBoL project, the CGP will identify and address ethical, legal and societal issues arising in the early phase of research and development of MeDseq technology. Moreover, we will anticipate and explore issues that may arise in the future when epigenetic technologies may be introduced into the domain of population screening. We will develop practical guidelines to help investigators, test developers and policy makers to consider these issues in the phase of research & development and in anticipation of its potential implementation in population screening.
Principal Investigators
Collaborators
Funding Organization(s)
Period
2018-07-01 to 2020-04-30
Description
MSSNG and AGRE are the world’s largest databases of genomic information collected from individuals with autism spectrum disorder (ASD) and their families. MSSNG in particular advances the goal of sequencing 10,000 families affected by ASD to answer significant remaining questions about autism, its causes, and effects. Scientists from around the world may access trillions of data points in a single database. The CGP hosts the Data Access Committee for MSSNG and AGRE, adjudicating access on the part of external researchers to these valuable resources. CGP manages the review of data access applications and grants access to qualified researchers. In 2021, the Data Access Committee approved 17 new applications.
Principal Investigators
Applicant
Funding Organization(s)
Period
2018-07-01 to 2025-12-31
Description
Open Science is among the most recent branches of the various open content movements to attract widespread attention and significant investment on both sides of the Atlantic. In Canada, the 2017 launch of the Tanenbaum Open Science Institute came with a commitment to forgo intellectual property claims on the data associated with their research, and otherwise make their data broadly available. These initiatives correspond with the lead-up period to the enforcement of the European Union’s new General Data Protection Regulation (GDPR), whose rules on the transfer of personal data to countries outside the EU are part of a network of data protection frameworks including Canada’s Personal Information Protection and Electronic Documents Act. Because open content movements, including Open Science, have rarely engaged with the implications of data protection on their overarching mission, the risk of contradictory, incoherent, and ill-suited practice and frameworks looms large in this area. The CGP was involved in research aimed at tracing how the values underlying Open Science and data protection might be harmonized in the context of data transfer, and in particular with key transfer frameworks sketched out in the GDPR: adequacy decisions, model contractual clauses, and codes of conduct.
Principal Investigators
Co-Investigators
Period
2018-04-18 to 2019-03-31
Description
This project aims to provide evidence that can significantly expand the benefits of current agebased population breast cancer screening programs by supporting the transition to a risk-based approach. This will enable individualized risk assessment and improve the counseling process by health care providers for women. A large population-based cohort will be assembled to evaluate the acceptability and feasibility of using a new comprehensive risk prediction web tool and a genomic profiling test. The cohort will be followed to determine behavioral, psychosocial and clinical outcomes. Policies will be developed to address the socio-ethical and legal challenges for women, health professionals and decision makers associated with implementing risk-based breast screening. The CGP will provide health authorities with acceptable policies that address emergent socio-ethical and legal issues of the implementation of a personalized risk-based screening approach in Canada. To achieve this, the CGP will examine five issues via a legal and sociological transdisciplinary analysis: 1) Extension of the roles of health professionals; 2) Integration of information technologies to provide timely clinical and informational support; 3) Management of privacy when using BOADICEA with electronic health records; 4) Compliance with federal and provincial regulatory requirements and technology transfer options, and; 5) Information of women on the risks of genetic discrimination and existing protections to mitigate them. The CGP will also support the research team in regard to the ethics approvals required and specific ethical issues associated to the establishment of the research cohort.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-04-01 to 2024-03-31
Description
Cystic fibrosis (CF) is the most common fatal genetic disease, affecting 4,000 Canadians and 80,000 people throughout the world. The debilitating disease causes difficulties in breathing, lung infections, and digestive disorders and those affected die at a median age of 35 in Canada. Treatments can ease symptoms, but there is currently no cure. Newer drugs can address the underlying genetic defect that causes CF, but only some patients respond positively to them, while others do not. Given the side effects and the high cost of these drugs, there is a pressing need for robust predictors of who will respond to what treatment. Dr. Felix Ratjen (Hospital for Sick Children) and his team are developing predictive tools to help clinicians determine the right medicine for the right patient. The team will examine how genetic factors can help predict individual treatment responses and examine if drug testing on tissue samples can be used to inform the potential clinical response to drugs by each patient. The team will work with industry partners, patient organizations and the Ontario Ministry of Health to integrate these strategies into patient care. The result of the team’s work will be a shift toward individualized treatment for CF, assistance for clinicians in making treatment decisions, guidance for policymakers on reimbursement and better health outcomes for patients.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-04-01 to 2024-03-31
Description
To understand unsolved rare diseases (RDs), C4R-SOLVE explores new sequencing technologies and seeks to improve data sharing world-wide, enabling the discovery of new causes of RDs. The goal of C4R-SOLVE, aligned with Canada’s national RD strategy, is to fully understand the molecular pathogenesis of unsolved RDs and facilitate timely access to clinical genome-wide sequencing. As part of its activities, C4R-SOLVE will develop a pan-Canadian RD repository (Genomics4RD) to optimize data sharing and analysis. P3G2 developed a governance framework to oversee the Genomics4RD database.
This framework outlines the policies with respect to the creation, management, and use of the Genomics4RD repository. It includes, amongst others, provisions on the identification of eligible participants, core consent requirements (prospective/retrospective), terms of the collection and integration of data from different sources (e.g., genomic data, clinical data, cost data, patientcontributed data, etc.), re-contact options and, where relevant, mechanisms for the return of results. Furthermore, an assessment of legacy (retrospective) datasets to be shared with Genomics4RD and PhenomeCentral was undertaken.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-04-01 to 2024-03-31
Description
The McGill University and Génome Québec Innovation Centre is a world class research facility for genomics and proteomics. Founded in 2002, the Centre has developed a world-renowned expertise in complex genetic disorders such as cardiac disease, asthma and Type 2 diabetes, and has become a resource and a networking site for various research initiatives in human health, forestry, infectious diseases, agriculture and environment.
Ambitious projects in recent years are a testimony of the ability of Génome Québec to provide data of exceptional quality in the pursuit of various genomics studies. The Innovation Centre provides complete DNA and RNA analysis services, from a few samples to several tens of thousands per week. Large-scale genomics and proteomics services at the Innovation Centre are articulated around sequencing (including massively parallel sequencing), genotyping, functional genomics and extraction supported by a solid infrastructure, tools (Nanuq), unique expertise in bioinformatics and nucleic acid extraction. The Innovation Center also hosts the Canadian Center for Computational Genomics (C3G) which offers bioinformatics services. All services work in parallel to provide comprehensive, reliable services to the Québec, Canadian and international scientific community. Located on the campus of McGill University in the heart of Montreal, the Innovation Centre acts as a vast resource of knowledge and technology to the academic and industrial sectors. The CGP provides ongoing ethical and policy consultation on this project.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-04-01 to 2022-03-31
Description
The development and implementation of an ethically and legally robust governance structure for research biobanks and databases is a pre-requisite to building and maintaining the trust of funders, research participants, research ethics boards, and collaborators. A comprehensive governance framework and related policies not only provide immediate guidance for the managers, researchers, participants and other stakeholders involved in the project, but also fosters a continuous and uniform management of the resource for future prospective uses. Since the financial support of AllerGen to the Canadian Healthy Infant Longitudinal Development (CHILD) Study will soon come to an end, time is of the essence to develop and implement a governance framework to ensure maintenance of the scientific utility, validity and usability of the datasets and biospecimens generated by the CHILD Study, for the future. Currently, datasets and samples collected as part of the CHILD study are heterogeneous and vary across different recruitment sites. The Governance Framework provides a common ethical and policy structure for the future use of these datasets and samples so that the voluntary participation of Canadians is respected. The purpose of this Governance Framework is to provide a general overview of the core elements related to the management, operations and ethical governance of a health database and, where applicable, an associated biobank. Detailed policies and procedures also accompany this guidance.
Principal Investigators
Funding Organization(s)
Period
2018-04-01 to 2020-03-01
Description
Cancer is the leading cause of disease?related death in children, adolescents, and young adults (CAYA) beyond the newborn period. While the overall survival rate in Canada approaches 88% for all CAYA patients (0-29 years old), the prognosis for those with refractory, relapsed or metastatic (‘hard-to-treat’) disease is grim, and progress has stagnated for many disease groups over the last three decades.
To address this gap, and to make new therapeutic for CAYA patients with hard-to-treat childhood cancers, we participated in the PRecision Oncology For Young peopLE (PROFYLE) program. Overall, the program aims to transform the care of CAYA patients by using next-generation molecular tools and cancer model systems to identify disease and patient-specific biomarkers. The core of PROFYLE consists of real-time molecular profiling to personalize cancer treatment with either existing oncology drugs or repurposed drugs. The project includes the incorporation of new technologies and an emphasis on the evaluation and development of minimally invasive patient-specific biomarkers that can track the patient’s molecular profile over time. The Centre of Genomics and Policy studies questions surrounding access to genetic data by parents and the use of mobile health applications when streamlining recruitment processes.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2018-04-01 to 2023-03-31
Description
Acute myeloid leukemia (AML) is a leading cause of cancer-related death in young adults and a highly lethal disease in older adults. The Leucegene project aims to contribute to the more effective targeting of AML treatment according to genomics risk profiles, especially in the case of patients in intermediate risk categories for whom no reliable curative treatment measures exist. Alongside its genetics research objectives, the Leucegene project team will also assemble a ground-breaking web portal that will make the project’s findings widely available to researchers, clinicians, and patients. The CGP undertook an extensive review of policy instruments adopted for similar functions as well as significant engagement with patients, caregivers, and healthcare providers. Notably, in-depth interviews were conducted with healthcare providers to assess their expectations for using a web portal for accessing and sharing information about AML research, which, in turn, informed the development of the portal. These efforts will also contribute to the drafting of internal policy guidance for managing the Leucegene portal. At the same time, the CGP will draw on international policy and case law to produce a Good Practices document for informing the development of prognostic and therapeutic web portals in other healthcare contexts. The center will also organize several focus groups with patients to better understand their expectations in terms of online services to access health information and help the leucegene webportal to be more user-friendly.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-04-01 to 2024-03-31
Description
Scientific developments and their expanding scope demonstrate the need to continue socio-ethical and policy discussions surrounding the fields of stem cells, and genetic and reproductive technologies. Reform of the Assisted Human Reproduction Act (AHRA) remains uncharted. Yet, there is a critical need for policy guidance adaptive to the complexities of “cellular genomics.” In 2016, the Canadian Government announced its intention to strengthen and clarify the policy frameworks regulating assisted human reproduction. Consequently, from 2016-2017, the CGP, together with the SCN and other collaborators (the “Policy Group”), sponsored four workshops to assess the adequacy of existing regulatory frameworks. The outcome was a series of peer reviewed publications leading to a Consensus Statement to guide reform of the AHRA. Another outcome was future agenda setting highlighting the necessity to move from policy development to consultation and validation.
We proposed a critical series of interactions with Canadian stakeholders with the objective of consulting and validating our recommendations, to propose effective policy translation. This approach was supported by organizations such as the Canadian Medical Association (CMA), the Canadian College of Medical Geneticists (CCMG-CCGM), governmental agencies (e.g. Health Canada), and academic-industry organizations such as the Centre for Commercialization of Regenerative Medicine (CCRM).
Principal Investigators
Funding Organization(s)
Period
2018-04-01 to 2019-02-28
Description
About 1.7% of the population falls under the umbrella of “intersex”, with bodies that develop along a spectrum of sex differences. Intersex individuals face egregious human rights violations, discrimination, and stigmatization. In healthcare, this includes unnecessary surgical interventions, the withholding of accurate health information, and an overemphasis of incidental health risks. Qualitative research on which best practices and policies can be based, and which would make it possible to put an end to these prejudices, remains underdeveloped. At present, there is a lack of Canadian-specific guidance or explicit legal protections to guide healthcare providers in their professional relationship with intersex patients. This project engages two communities of stakeholders: intersex individuals and healthcare professionals (HCPs). The core objectives are to generate qualitative evidence on the experiences of intersex individuals in the healthcare system, and to use this evidence to develop improved standards of care. Following a comparative review of relevant laws and policies, we will conduct a series of semi-structured interviews with intersex adults and their HCPs. From these, the CGP will develop: 1) a guidance document for healthcare practitioners; 2) an issues paper on person-centered research with vulnerable populations; and 3) information sheets for intersex individuals navigating the Canadian healthcare system.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2018-03-15 to 2024-03-31
Description
This study aims to understand and document the regulation of Direct-To-Participant (DTP) genomic research around the world. We developed and distributed a survey to law and policy experts in 31 countries in order to clarify the law, regulation, and policy governing this novel and emerging approach to research recruitment in the genomics context. Our team at the CGP played a central role in research design, participated in expert working groups to identify and prioritize the key issues for the standard questionnaire, identified and recruited potential expert participants, and analysed final research results. We played an active role in the formulation of conclusions and recommendations for the future governance of DTP genomic research. We also coordinated the preparation of a special issue of the Journal of Law, Medicine, and Ethics detailing our findings and presenting the team’s recommendations. The special issue was published in 2020. We have further disseminated our findings in several international conference presentations.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2018-03-01 to 2022-01-01
Principal Investigators
Funding Organization(s)
Period
2018-03-01 to 2018-10-01
Description
The HeLTI program was developed by the Canadian Institutes of Health Research (CIHR), Institute of Human Development, Child and Youth Health. The program represents a partnership between CIHR, the South African MRC, the Department of Biotechnology, India, the National Natural Science Foundation of China and the World Health Organization. HeLTI was developed to address the increasing burden of non-communicable diseases (including obesity, diabetes, cardiovascular disease and poor mental health) around the world. There are four separate but harmonized projects that are commencing in Soweto (South Africa), Mysore (India), Shanghai (China), and across Canada. All projects are focused towards developing evidence-based interventions that span from pre-conception across pregnancy and into the postnatal period with a goal improving maternal, infant and child health. The CGP is involved in the development of governance tools to foster international data sharing.
Co-Investigators
Funding Organization(s)
Period
2018-01-01 to 2022-03-01
2017
Description
The epidemics of obesity and metabolic syndrome related disorders are a major public health concern. Increasing evidence points to the role of early life adverse factors in the developmental origins of the vulnerability to such metabolic disorders. Reducing the risk of overweight and obesity (OWO) from early life stages will produce substantial benefits to decrease population burdens of metabolic diseases. However, current intervention measures remain insufficient to halt the increasing OWO epidemics. Building on large birth cohort studies, clinical trials and studies on the development of metabolic disorders, our transdisciplinary Chinese-Canadian team will conduct a multi-site and community-based randomized controlled trial. This trial will test the effect of a family-mother-child intervention package (incorporated into routine patient care) on childhood OWO rates in children aged one through six. The CGP is developing the policies and tools to facilitate the use of the cohorts included in this project. More specifically, the CGP develops the governance framework as well as the data access and biospecimen sharing policy. The tools created by the CGP aim to facilitate policy interoperability and access authorizations as well as streamline the ethical and legal aspects of international collaborative research.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2017-11-01 to 2024-03-31
Principal Investigators
Funding Organization(s)
Period
2017-05-01 to 2019-04-01
Description
To join global efforts, the International Human Epigenome Consortium (IHEC) has established an Epigenome Mapping Centre (EMC) at McGill University that applies epigenome mapping in order to understand interactions between environment and genome in human blood cells, interprets diseases impacting metabolism using tissue samples, and studies how epigenetic changes can alter function of the brain. The large-scale generation and sharing of human epigenome data present challenges to the informed consent process that are managed first through the integration of existing cohort data with EMC McGill, using a special template developed in conjunction with the Public Project in Genomics and Society (P3G), and subsequently by prospectively developing a model consent template that ensures all IHEC consent, policy, and ethics requirements are met. Throughout this, we will continue to actively participate in discussions on the development of a more comprehensive ethical policy framework at the IHEC level. Both the EMC and Epigenomic Data Coordination Centre (EDCC) projects also involve the development of and support for a bioethics workgroup for the IHEC.
Principal Investigators
Co-Investigators
Collaborators
Funding Organization(s)
Period
2017-02-01 to 2024-03-31
2016
Description
This project will complete our clinical trial and allow us to seek Health Canada approval for a new modality of treatment for corneal limbal stem cell deficiency (“LSCD”) using cell therapy. LSCD is a severe disease caused by damage or depletion of the corneal stem cells in the limbal region of the eye following trauma/disease. The epithelial tissue of the cornea can no longer regenerate resulting in chronic inflammation, conjunctivalization, and vision loss. To treat LSCD patients, we developed a tissue engineering technique involving massive expansion of epithelial cells in vitro to produce epithelial sheets for autologous transplantation (cultured epithelial corneal autografts – “CECA”). After twenty-five years of experience with skin substitutes using cultured epithelial autografts (“CEA”) on burn patients, we successfully demonstrated the effectiveness of CECA (pre-clinical studies in animal models), reconstructed human corneas in vitro (CECA), and initiated a clinical trial of a new treatment for which Health Canada approval will be sought with the help of the Centre of Genomics and Policy. Our team of scientific researchers, clinicians, and ethical/legal experts – with extra funding support from CHU de Québec Hospital Foundation, FRQS ThéCell Network – will be the first in Canada to offer CECA treatment for unilaterally blind or vision impaired patients suffering from LSCD.
Principal Investigators
Period
2016-09-01 to 2017-10-01
Description
The 2012 Genome Canada Large-Scale Applied Research Project Competition, Genomics and Personalized Health (GAPH), funded 17 projects. Each project integrates technology assessment and social science and humanities research under the banner of the signature Genome Canada GE3LS initiative (i.e. Genomics and its Ethical, Environmental, Economic, Legal and Social aspects).
In 2016, Genome Canada announced funding for a network to bring together GE3LS researchers from all 17 projects. The Network will enable the projects to share best practices; improve and prime future collaborative research; accelerate the progress to market of GAPH technologies; and maximize the impact of investment in the GAPH projects.
The Network will address four priority GE3LS themes: research ethics review; health economics and health technology assessment; knowledge transfer and implementation in health systems for ‘omics technologies; and intellectual property and commercialization.
This $2 million initiative is designed to accelerate the translation of research results into practical applications in healthcare for the benefit of Canadians. The Government of Canada, through Genome Canada, is investing $1 million in the Network, with the balance of funding to be secured from co-funders.
Objectives for each Network theme were outlined by GE3LS and science representatives from each of the 17 projects at a workshop in April 2015. A Network Management Team (Network co-leads and theme leads) will monitor progress on each objective.
By identifying and directing research to overarching issues that emerge from the GE3LS components of the 17 projects, the Network will accelerate their common goal of transforming research results into practical applications adopted by health systems for the benefit of patients.
Co-Investigators
Period
2016-04-01 to 2018-03-01
Description
Evidence suggests that the majority of breast cancers develop in a small proportion of women with susceptibility to the disease. The identification of these is a determining factor in the effectiveness of prevention. Currently, high-risk women are mainly identified on the basis of a family history of cancer and screening for mutations in BRCA1 and BRCA2 genes. However, recent breakthroughs in genomics have led to the identification of a large number of genetic variations associated with breast cancer. These include variations/rare mutations in new genes or predisposition/rare mutations in novel susceptibility genes, conferring a range of moderate to high risks, as well as common variations (SNPs) associated with the risks of cancer <1.5 times the risk of the general population. Knowing that SNPs act multiplicatively, they can be combined into a polygenic risk profile in order to stratify women, with or without family history, according to their individual risk. A much more accurate risk prediction could be obtained by combining data from all genetic variations (frequent and rare) with other recognized risk factors. It is imperative to conduct studies using large international cohorts in order to obtain reliable estimates of individual risk in order to improve models of prediction of risk of breast cancer/risk prediction models and better adapted therapies, facilitating the identification of women who can benefit the most (substantially) from the approaches of prevention, reduction of risk and of the best adapted therapy/ treatments. This is why two major projects were set up: PERSPECTIVE, led by the Quebec team, and BRIDGES, funded by the European Commission-Horizon 2020 (09/2015-08/2020), of which University Laval is a partner without funding. Professor Simard’s participation was determining/decisive (had been determined) considering that the results of PERSPECTIVE will be very useful for the realization of several BRIDGES objectives. The funding of the MEIE for the project will come at a pivotal time, permitting/providing consolidation or consolidating the leadership of the Quebec team in the BRIDGES project, which will be all the more critical since the financing of PERSPECTIVE will end in March 2017. Our results will improve targeted disease prevention in the context of oncogenetic/oncogenic clinics and the breast cancer screening program in Quebec.
Principal Investigators
Co-Investigators
Period
2016-04-01 to 2019-03-01
Description
The aim of this project is to improve knowledge of the molecular dysfunctions associated with certain rare diseases. This project aims to : 1) Identify the genetic causes associated with certain rare diseases in children and young adults whose genetic cause has not yet been identified; and 2) obtain a better understanding of the molecular mechanisms involved in the development of these rare diseases. In addition, this project aims to establish a biobank for future research at the national and international levels. In a framework of scientific collaboration, the Centre of Genomics and Policy (CGP) oversees and prepares the ethical documents required for initial approval by the Research Ethics Committee of CHU of the Québec-Université de Laval. Subsequently, the CGP provides support on ethical and legal issues, including changes/ modifications to ethical documents or preparation of documents arising from the evolution of the project and the initiation of new collaborators with groups of international research
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2021-03-01
Description
Increasingly, Canadians are affected by chronic diseases such as cancer, cardiovascular disease, chronic obstructive lung disease, diabetes, and mental illnesses. Many of these conditions have their origins in early life (conception, pregnancy, infancy, and childhood). Canadian pregnancy and birth cohort studies have been implemented to explore hypotheses related to the Developmental Origins of Health and Disease (DOHaD).
The Research Advancement through the Cohort Cataloguing and Harmonization (ReACH) initiative was formerly established in 2016 to provide the Canadian research community with the means to leverage and carry out leading-edge collaborative research. The ReACH initiative provides resources in the form of a comprehensive web-based catalogue and a harmonization platform to optimize and expand the use of Canadian pregnancy and birth cohort data and biological samples. The CGP’s role is to study the existing processes addressing sharing, access and data linkage and by performing a comprehensive analysis of the ethical and legal clauses included in the documents used by these cohorts (i.e. consent forms, data sharing policies, governance framework, etc.). The CGP will compare the different clauses and processes to identify similarities and divergences and has notably developed a Points-to-Consider document from an ethical and legal point of view, for access to research databases.
Ultimately, the ReACH initiative will enhance the capacity for collaborative and cross-disciplinary research (outputs generated faster and at a lower cost); expand research perspectives (leverage national and international collaborations); improve quality of research practices; and foster the development of innovative and reliable evidence-based research on the Developmental Origins of Health and Disease.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2021-03-01
Description
The gender dimorphic effects of prenatal stress are well demonstrated. Girls may be more susceptible to the effects of fetal adversity on fearful temperament, emotional reactivity and internalizing problems. Little research has examined whether gender differences in the case of fetal adversity are maintained in the prediction of anxiety and depression in older children. A landmark study reports that maternal prenatal depression is associated with an increased risk of depres- sive symptoms in 18-year-old female offspring. It suggests the need to consider the interaction between gender and prenatal adversity and the role of genotype and postnatal environments. Accordingly, gender considerations will be approached as follows: 1) careful examination of gender-based age-specific trends in the development of anxious and depressive psychopathology from preschool through pre-adolescence; 2) the moderation of gender effects for anxious and de- pressive psychopathology by genetic susceptibility; 3) the role of early maternal care; and 4) early temperamental signals of vulnerability to anxious and depressive psychopathology. The CGP’s role is to design ethical and legal guidelines for: 1) the safeguarding of pediatric genomic data; and 2) the consent for data use from children as they become adults.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2022-06-01
Description
The advanced and chronic course of depression makes it the disease with the leading cause of disability, an effect marked by a 2-fold difference in the rate for girls and women as of early adolescence. Precise knowledge of how risk factors interact to predict those at higher risk is lacking. For instance, gender differences in stress response are well documented in early emotional development, but not in later development. Genetic differences in susceptibility to prenatal events are also important. The project gives the opportunity to collaborate in four prolific international longitudinal cohorts to communicate, share and reproduce models and findings about early factors in the prediction of early-age psychopathology. The cohorts in Canada, the United Kingdom, the Netherlands and Singapore include and share measures of genes, maternal care, child psychopathology, and sensitive data with different consent forms, measures, access approaches, laws and regulations. The CGP acts as a collaborator-consultant, supporting the project with analysis, reflections and recommendations that pertain to the ethics and legality of: 1) safeguarding child genomic data, and 2) addressing issues of consent and the need to re-contact child participants once they become adults.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2022-03-01
Knowing and communicating your family history to better fight breast cancer in Quebec: implementatio
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2019-03-01
Development of a knowledge dissemination strategy on familial cancers in palliative care based on an
Description
This project aims to propose a strategy for the dissemination of knowledge in cancer genetics applied to the context of palliative care in order to help stakeholders address the needs of dying patients and their family members on issues related to their family history of cancer, all in an appropriate legal and ethical framework. To achieve this, three activities will be implemented and are aimed at: 1) identify with doctors and nurses in palliative care priority issues associated with family history of cancer in their work context, as well as the barriers and facilitating factors to address, if any, ethically with the patients end of life and members of his family; 2) identify needs and concerns related to palliative care cancer patients about their family history and how to address them properly in the context of the end of life; 3) identify the legal and ethical guidelines applicable to the communication of family history of cancer in the family members of a patient in palliative care. Ultimately, the goal is to develop knowledge dissemination activities, including a toolbox to ensure the dissemination and accessibility of information for healthcare professionals working in palliative care who have to deal with issues related to a family history of cancer.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2016-04-01 to 2018-08-01
2015
Description
Each year, there are an estimated 88,000 cases of foodborne illnesses related to the consumption of fresh produce contaminated with Salmonella. The health impacts vary, from minor effects to serious infection requiring medical care or even causing death. Salmonella infection is estimated to cost the Canadian economy as much as $1 billion annually in terms of medical costs, work absenteeism, and economic losses. Using whole genome sequencing, the research team will develop new tools that will: (1) allow public health officials to better determine the source and treatment of Salmonella illnesses; (2) enable stakeholders along the food supply chain to more rapidly identify and remove contaminated fresh produce from grocery stores and restaurants; and, (3) control the presence of Salmonella on fresh produce. An anticipatory governance approach integrates a consideration of the evidentiary requirements, the economic, legal, ethical, and regulatory implications of supporting such a paradigm shift. More precisely, the CGP team will assess the perspectives of key stakeholders regarding the development, adoption and implementation of the subtyping testing method and the biocontrol. This includes integrating the perspectives of experts (Delphi survey), the general public (national public opinion survey), and a series of interviews with key stakeholders.
Co-Investigators
Funding Organization(s)
Period
2015-10-01 to 2020-09-01
Personalized Medicine, Biobanks and Translational Research: Developing a Governance Framework for th
Principal Investigators
Funding Organization(s)
Period
2015-07-01 to 2019-06-01
Description
Despite decreasing sequencing costs in the wake of the Human Genome Project, wide scale data sharing is still a distant reality both in Canada and internationally. Ensuring interoperable policies and procedures across provinces in Canada and between jurisdictions remains a challenge, often due to socioethical and legal issues. Innovations in the biomedical sciences and in information technologies (IT) inspired Canadian leaders of the Global Alliance for Genomics and Health (GA4GH) to create Can-SHARE in amis of advancing the goals of the GA4GH within Canada and internationally. GA4GH’s mission is to enable rapid progress in biomedicine by working to develop policies, tools ,and guidelines for harmonization while engaging stakeholders across disciplines (http://genomicsandhealth. org/). In this context, Can-SHARE will advance Canadian leadership by developing data access and sharing policy as well as more specifically tools in Canada, within the GA4GH and other international research consortia. The Can-SHARE team will support prominent Canadian leaders in GA4GH ensuring and enabling innovation in health care for Canadian patients in the decades to come
Principal Investigators
Funding Organization(s)
Period
2015-06-01 to 2019-12-01
2014
Description
This project aims to compare and analyze national and international privacy frameworks applicable to genomic databases and biobanks. A series of articles will be prepared on the privacy frameworks in place in a wide sample of countries and regions. Each article will survey the privacy instruments and legal and policy materials in place in a given jurisdiction, and will provide a legal analysis and critical evaluation of those instruments and materials. The general political and research contexts of the country or region will be introduced, and a description of its biobanking ecosystem will be provided. This will be followed by a comprehensive description of the legal and regulatory privacy framework applicable to genomic databases / biobanks in the country or region. Each article will conclude with a critical evaluation of the national privacy framework as it relates to genomic research privacy, security, and governance. The project will have an International Advisory Board (IAB) consisting of three internationally recognized scholars to provide oversight and guidance of the project throughout its development and advancement. The series of articles will be published in two dedicated special issues in the Journal of Law, Medicine & Ethics.
Principal Investigators
Co-Investigators
Period
2014-10-01 to 2015-03-01
Description
The goal of the Regenerative Cell Therapy Network (RCTN) will be to standardize RCT by sharing the data generated at each participating center, by accelerating the implementation of novel cell therapy applications, and by reducing operational costs, consequently enabling more rapid technological advances. The RCTN will also promote the implementation of innovative cell therapy approaches in patients by disseminating knowledge to: 1) clinical centers with the expertise to identify suitable patients and administer the cells; 2) industrial partners to further develop and commercialize cell therapy strategies; and 3) patients to discuss treatment opportunities and implications. The RCTN will enable Canadian investigators to share information and engage with scientific collaborators, cell therapy organizations, and regulatory bodies from around the globe. Through RCTN’s unique collaborative approach with non-profit organizations, the knowledge capacity and access of patients to cutting-edge care will be enhanced.
Principal Investigators
Co-Investigators
Period
2014-05-01 to 2017-04-01
Description
This project aims to broaden and deepen the existing Q-CROC Network which has developed internationally recognized expertise in designing and executing biopsy-driven studies to identify biomarkers in metastatic cancers. Moreover, it will use a program in which all new cancer patients are asked to consent to having their primary tumor biobanked and profiled, to having their entire clinical course anonymously recorded, and to being re-contacted for additional studies. Consistent with its prospective population-based approach, the new trans-national global network will help generate the large scale of profiled patient numbers and build an enormous biological and clinically annotated database.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2019-03-01
Description
The OPTI-THERA project will implement Optimized Therapeutic drug responses and Optimized Theranostics strategies through the creation of a Knowledge and Information Integrating Node (KIIN). The Centre of Genomics and Policy will conduct research concerning: 1) the legal aspects surrounding insurance and the use of genetic information; 2) the role of a trusted third party; 3) the conflict of interest issues in public-private partnerships for personalized medicine. Collaborating closely on this project, the Population Projects in Genomics and Society (P3 G) will: 1) review and amend of the project’s consent forms; 2) provide ongoing ethics support (i.e., ethics approval); and 3) develop policies and procedures (re. clinical assessment and gate keeping functions).
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2018-03-01
Description
The objective of the project is to create and expand a biomedical ecosystem that overcomes the major rate-limiting steps involved in realizing and expanding biomarker-driven clinical research for personalized medicine in cancer. This will be achieved through: 1) ready access to a collection of engaged patients, their tumors, and clinical data collected in a prospective and longitudinal manner that conforms to the highest standards of ethics and quality; and 2) an advanced program in serial biopsies of metastatic tumors that defines the molecular signature of resistance to new targeted agents allowing the industry to modify the drug or add combinations to overcome or avoid resistance and greatly expand the clinical benefit to patients. The Centre of Genomics and Policy provides a review of the ethical and legal issues while ensuring that consent respects the federal and provincial legal requirements (on re-use of samples, governance, confidentiality, data-sharing, e-consent, risks, etc.). Other considerations reviewed by the Centre concern public-private partnerships.
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2020-03-01
Description
This project comprises three synergistic research objectives: 1) Identifying the existing environment and gaps in the Canadian legal and policy framework applicable to the use of cloud computing for genomic research; 2) Documenting and analyzing the policies currently used by several significant cloud providers to address privacy issues; and 3) Developing tools and strategic recommendations to assist Canadian policymakers fill the policy gaps and guide Canadian privacy professionals and genomics researchers in developing privacy-enabled cloud-based genomics research.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2015-03-01
Description
The Sino-Québec Perinatal Initiative in Research and Information Technology (SPIRIT) was created to fulfill three main objectives: 1) Promote collaboration in epidemiological and fundamental research concerning the intra-uterine determinants of health and child development as well as research on perinatology health services in Shanghai and in Quebec; 2) Reinforce strategic positioning of our academic and industrial partners in Quebec, China, and internationally by accentuating access to new markets/ expertise and by developing harmonized products adapted to perinatal research; and 3) Consolidate infrastructures allowing transfer and application of knowledge among users and partners, ultimately reinforcing China-Quebec collaborations. By doing so, SPIRIT will set forth updated guidelines, health policies, and transfer activities in the clinical setting.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2017-03-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-04-01 to 2018-03-01
Description
In Canada, Citizenship and Immigration Canada (CIC) representatives increasingly resort to DNA testing to confirm biological filiations in the realm of immigration sponsorship, specifically concerning immigrants originating from Africa, Asia, and the Caribbean. This project proposes a Canadian-specific analysis to: 1) determine the legal and ethical issues arising from the use of DNA testing in the context of immigration sponsorship in Canada; and 2) propose a legislative and political reform in response to this emerging problematic.
Principal Investigators
Funding Organization(s)
Period
2014-01-01 to 2014-12-01
Description
The project’s main objective is to study the legal and ethical issues that arise from the use of Whole Genome Sequencing (WGS) in minors. Our results will contribute to: 1) developing two policies on the use of WGS in minors – one for the research setting and the other for the clinical setting; and 2) elaborating a prospective analysis detailing the implications associated to the eventual use of WGS in paediatrics within the realm of direct-to-consumer (DTC) testing and neonatal screening.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2014-01-01 to 2016-09-01
2013
Description
The Personalized Medicine Partnership for Cancer (PMPC) projects, lead by Caprion Proteome, are expected to have a measurable impact on clinical diagnosis and therapeutic management of various cancers as well as on the efficiency and costs of the healthcare system by developing an integrated clinical platform to validate new biomarkers, develop new diagnostic tests as well as improved therapies. The CGP is leading the sub-project “Insurance and personalized medicine”, which aims to account for the legislative, regulatory, and normative changes needed to maximize societal benefits related to the use of genetic data in clinical cancer research in Quebec. Our main objectives include: 1) analyzing the normative insurance framework in Quebec; 2) reviewing insurance proposition form requirements; and 3) analyzing consent forms (for diagnostic tests in clinical and research contexts).
Collaborators
Period
2013-11-01 to 2016-01-01
Description
The aim of this project is to collect and analyze facts and figures to assess the current legislation on the therapeutic use of somatic cells, and to bridge it with the research infrastructure capacity building. The project is based on a coherent consortium of experts in the fields of cell therapies, cell banks and translational biomedicine, having strong expertise in law and / or in governance issues to provide evidence about the contemporary practices around cells and design a picture of the “market” and its distribution between the public and private sector. The CGP’s role in the project is to examine and enhance the understanding and interpretation of national, regional, and international legal and ethical issues surrounding umbilical cord blood (UCB) research and provide recommendations. This is a critical and logical step towards building a robust implementation process for the ethical and legal frameworks governing UCB research, banking and clinical applications in Europe, so as to harness its potential for novel therapeutic applications. The project will thus help the Commission in the regulatory choices covering the use of human cells for therapeutic purposes and to foster the innovation potential of related research activities.
Co-Investigators
Period
2013-10-01 to 2016-09-01
Description
CARE for RARE is a collaborative pan-Canadian project configured to improve the diagnosis and treatment of rare diseases. Powerful new DNA sequencing methods such as wholegenome (WGS) and whole-exome sequencing (WES) will be used to discover 60 new genes, each of which causes a rare disease. The identification of new genes provides useful biological information, giving us insight into cellular pathways significant in human health. It is hoped that the research will lead to the implementation of WES as an effective and reliable diagnostic tool for clinical use. However, in order to facilitate the integration of WES into the clinical setting, the GE3 LS component of this study, which will be conducted at the Centre of Genomics and Policy, will include: 1) the drafting of clinical exome trial consent forms; 2) a qualitative analysis of the clinical utility of WES as a diagnostic tool for patients with rare diseases (from the patients’ and clinicians’ point of view); 3) the drafting of a national position statement and best practices outlining professional and ethical standards for the reporting of incidental findings found using WES; and 4) the development of clinical integration tools for use by clinics offering exome sequencing to patients with rare diseases.
Principal Investigators
Co-Investigators
Period
2013-04-01 to 2017-03-01
Description
This project intends to implement two novel tests in the healthcare system: 1) a chemogenomic model for the development of a prognostic test in Acute Myeloid Leukemia (AML); and 2) an integrated detection kit for Minimal Residual Disease (MRD). Our first objective is to highlight the strengths and weaknesses of Canadian federal and provincial regulatory test approval models. To this end, we will undertake a comparative analysis of US and EU models. Our second objective is to develop recommendations based on an ethical and legal analysis of the duty to inform in the context of lab directors (i.e., whether these directors are under an obligation to inform treating physicians of clinically-valuable information resulting from AML research).
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2013-04-01 to 2017-03-01
Description
The project is designed to significantly extend the benefits of the current highquality population screening program, particularly for younger women (35 to 49) by implementing a risk stratification approach targeting screening at an identifiable subset of women with relatively high risk of breast cancer (BC) who are missed by the current standard age-based screening program. This personalized risk-based approach to breast cancer screening will detect cancers at an earlier stage. Significant socio-economic and health benefits will be achieved since a woman’s survival prospects will be increased and the burden of disease and costs of treatment will be reduced. Knowledge of the genetic basis of BC and its risk factors will allow stratification of individuals into different risk groups for screening and personalized followup with appropriate preventive and clinical measures. However, a strategic approach is needed to facilitate the acceptance and adoption of risk-based stratification BC screening models in clinical settings, healthcare services and policies. At the end of our project we will deliver a web-based risk stratification and communication toolbox for use by health professionals and women to facilitate the implementation of a personalized risk-based approach in BC screening and management.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2013-04-01 to 2017-03-01
Description
In Canada, Citizenship and Immigration Canada (CIC) representatives increasingly resort to DNA testing to confirm biological filiations in the realm of immigration sponsorship possibly leading to genetic discrimination as documented in Canadian case law. In collaboration with the Canadian Council for Refugees and Immigration Canada, this project proposes a multidisciplinary analysis (qualitative research, systematic review, and consensus conference) to: 1) determine the social, cultural, and ethical issues associated with the use of DNA testing in the family sponsorship process; and 2) propose a legislative and political reform in response to this emerging problematic.
Principal Investigators
Funding Organization(s)
Period
2013-04-01 to 2017-03-01
Description
The Canadian Alliance for Healthy Hearts and Minds is a project that aims to build on the Canadian Partnership for Tomorrow Project (CPTP), a pan-Canadian research platform, by expanding efforts to identify the early root causes that lead to chronic diseases of the brain, the heart and the cardiovascular system. To do so, the Alliance will gather detailed information from about 10,000 Canadian participants on their environments, lifestyle and behaviors that could affect their cardiovascular health. Participants will also be assessed by magnetic resonance imaging (MRI) of the brain, blood vessels, heart and liver. Adding this to the health and biological information assembled over many years within CPTP will allow researchers to explore how these factors contribute to the development of chronic disease leading to heart failure and dementia. In partnership with the Public Population Project in Genomics and Society (P3 G), the Centre of Genomics and Policy will support the project in its development of consent forms and policies.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2013-04-01 to 2017-03-01
Description
The goal of this project is to develop an integrated information campaign that aims to sensitize the population to the importance of considering family history to fight effectively against breast cancer. The campaign also aims to better equip health professionals to evaluate the risk of breast cancer on the basis of family history. This campaign will be realized through a rigorous process that will partner diverse professional and community associations. Information and sensitization tools will be developed and compiled into information toolkits. These toolkits will respond to three needs: to effectively collect, use, and share information on family history of breast cancer. The tools will allow users, for example, to answer the following questions: From whom should I obtain information? What kind of medical information do I need? How can I obtain this information from my family? With whom should I share the information I gather on breast cancer risk? The present team is a group of experts in genetics, epidemiology, public health, psychosocial evaluation, ethics, and public law, all of whom possess a specific expertise in breast cancer.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2013-04-01 to 2017-03-01
Description
Research on rare diseases raises special issues regarding the privacy and confidentiality, notably due to the low number of people affected by each of these rare diseases that makes that indirect identification of participants often remains possible despite the usual measures of protection of privacy and confidentiality. Moreover, research on rare diseases requires concerted action and transnational (and even international) data sharing. This fact may exacerbate concerns relating to the protection of privacy and confidentiality. The goal of this pilot-project is to examine whether the legal and ethical rules on protection of privacy and confidentiality can be a barrier to research on rare diseases and to provide, if needed, practical solutions to rectify the situation. This involves an analysis of provincial laws, and national and international policy and guidelines on the protection of privacy and confidentiality of human research participants, as well as a review of the literature. These analyses will culminate in the production of a green paper, i.e. a prospective report containing a set of proposals to be discussed for the development of a policy. This green paper will inform policymakers, researchers and REB on the specific issues of research on rare diseases and outline the strategic measures (legislative, normative or administrative) that could be implemented to not impede research in this area.
Principal Investigators
Funding Organization(s)
Period
2013-04-01 to 2014-03-01
Principal Investigators
Funding Organization(s)
Period
2013-04-01 to 2014-03-01
Description
This project will develop cell therapies for the treatment of corneal limbal stem cell deficiency (“LSCD”). LSCD is a severe disease caused by damage or depletion of the corneal stem cells in the limbus region of the eye following trauma or disease. Once the corneal stem cells are destroyed, the epithelial tissue on the surface of the cornea can no longer regenerate or heal spontaneously, resulting in chronic inflammation, conjunctivalization, and vision loss. To treat LSCD patients, we have developed a tissue engineering technique involving massive expansion of epithelial cells in vitro to produce epithelial sheets for autologous transplantation (cultured epithelial corneal autografts – “CECA”). After twenty years or more of experience using epidermal cultured autografts (“CEA”) on burn patients for skin grafts, we have successfully demonstrated the effectiveness of CECA (animal models) and reconstructed human corneas in vitro (CECA). We are ready to obtain approval from Health Canada to begin CECA trials for the cornea. Our team of researchers, clinicians and ethical/legal experts will be the first in Canada to offer treatment for unilaterally blind or vision impaired patients suffering from LSCD.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2013-01-01 to 2013-12-01
2012
Description
The main objective of this project is to develop tools for optimizing access to ethically sourced umbilical cord blood (UCB) for research. UCB is considered a valuable source of stem cells for research and clinical applications. Furthmore, UCB transplantation is standard practice for the treatment of blood disorders and studies suggest their potential use for the development of novel blood and immune-based therapies. Canadian Blood Services (CBS) will establish and operate the national OneMatch Public Cord Blood Bank (OMPCBB) that will be accessible to Canadian and international patients. The OMPCBB will promote efforts that contribute to research and improved clinical care by making non bankable units available for research. In this context, the development of harmonized tools for UCB collection and uses that meets the needs of all stakeholders is critical. In partnership with CBS and other stakeholders, we will develop practical tools to enable ethical provenance of UCB stem cells as well as policy recommendations for UCB research (e.g. informed consent protocols, information pamphlets for donors and ethics review boards) to facilitate the interpretation of ethical guidelines and ensure research is performed within a strong ethical and legal framework.
Principal Investigators
Funding Organization(s)
Period
2012-08-01 to 2013-07-01
Description
The main objective of this project is to develop tools for optimizing access to ethically sourced umbilical cord blood (UCB) for research. UCB is considered a valuable source of stem cells for research and clinical applications. Furthmore, UCB transplantation is standard practice for the treatment of blood disorders and studies suggest their potential use for the development of novel blood and immune-based therapies. Canadian Blood Services (CBS) will establish and operate the national OneMatch Public Cord Blood Bank (OMPCBB) that will be accessible to Canadian and international patients. The OMPCBB will promote efforts that contribute to research and improved clinical care by making non bankable units available for research. In this context, the development of harmonized tools for UCB collection and uses that meets the needs of all stakeholders is critical. In partnership with CBS and other stakeholders, we will develop practical tools to enable ethical provenance of UCB stem cells as well as policy recommendations for UCB research (e.g. informed consent protocols, information pamphlets for donors and ethics review boards) to facilitate the interpretation of guidelines and ensure research is performed within a strong ethical and legal framework.
Principal Investigators
Funding Organization(s)
Period
2012-05-01 to 2012-12-01
Description
CCRM is a Canadian, not-for-profit organization supporting the development of foundational technologies that accelerate the commercialization of stem cell- and biomaterials-based products and therapies. CCRM is supported by the Centres of Excellence for Commercialization and Research (CECR) Program.
The CCRM Ethics and Policy Unit is housed at the Center of Genomics and Policy, McGill University. The overall objective of the Ethics and Policy Unit is to provide gold standard policies on Socio-Ethical and Legal Issues (ELSI) related to commercialization for CCRM core activities as well as on communication strategies.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2012-05-01 to 2014-04-01
Description
Scientific collaboration is a key aspect of the globalization of research. It is essential for the feasibility of any international collaborative project such as the International Stem Cell Forum (ISCF). The ISCF is composed of twenty-one partners and research funding institutions from around the world. It faces the challenge of conflicting regulatory and policy approaches regarding the exchange of materials and data adopted by its various partners. The divergent policy frameworks and governing regulations affect the permissibility of conducting stem cell research (i.e. procurement, derivation, banking, distribution and use of stem cell lines) and thus, they could potentially inhibit collaboration at the national and international level.
The Ethics Working Party (EWP) initiative was set up on behalf of the International Stem Cell Forum by its Canadian member organization, the Canadian Institutes of Health Research (CIHR). The EWP is comprised of independent experts in the area, which are appointed by each of the Forum's member organizations. It is chaired by Dr. Bartha Maria Knoppers and its Secretariat is housed at the CGP in the Genome Innovation Centre of the Faculty of Medicine of McGill University. The primary purpose of the Ethics Working Party is to assist member countries to undertake stem cell research within a transparent and well-considered ethical framework. The EWP seeks to identify prospective strategies to foster the scientific and ethical integrity of research in a global context.
Principal Investigators
Funding Organization(s)
Period
2012-04-01 to 2015-05-01
Description
As our understanding of diseases and how to treat them evolves, so too must our decision making procedures for providing fair and cost-effective treatments for those living with an illness. Today, one area of policy and decision making in particupal lags behind, that for treating rare diseases. At present there is no policy framework to help decision makers navigate the complex factors involved when making decisions about pyaing for orphan drugs. This project brings togeth a multidisciplinary team of experts in matters relating to treatment for rare diseases, and will incorporate input from the public and key stakeholders to develop such a framework. It will facilitate priority settings for orphan treatment decisions constrained by a limited budget, that considers the relevant developmental, clinical and economic factors and ethical principles, as well as being consistent with the values of society at large.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2012-02-01 to 2017-03-01
Description
To join global efforts, the International Human Epigenome Consortium (IHEC) has established an Epigenome Mapping Centre (EMC) at McGill University that applies epigenome mapping in order to understand interactions between environment and genome in human blood cells, interprets between environment and genome in human blood cells, interprets diseases impacting metabolism using tissue samples, and studies how epigenetic changes can alter function of the brain. The large-scale generation and sharing of human epigenome data presents challenges to the informed consent process that are managed first through the integration of existing cohort data with EMC McGill, using a special template developed in conjunction with the Public Project in Genomics and Society (P3G), and subsequently by prospectively developing a model consent template that ensures all IHEC consent, policy, and ethics requirements are met. Throughout this, we will continue to actively participate in discussions on the development of a more comprehensive ethical policy framework at the IHEC level. Both the EMC and Epigenomic Data Coordination Centre (EDCC) projects also involve the development of and support for a bioethics workgroup for the IHEC.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2012-01-01 to 2017-12-01
Description
This project proposes an integrative Epigenomic Data Coordination Centre at McGill, which will be a national hub to support data collection, processing, storage and dissemination for projects funded under the CEEHRC initiative and facilitate integration with the IHEC. The ouctome will include data pipelines and tools using standardized formats and vocabularies for verification, validation, and analyses across the CEEHRC network. The EDCC McGill will also develop a framework that leverages Compute Canada national resources to supoort large-scale processing, sharing and visualization of epigenomics data. The platform will enable epigenetic researchers on a national level to query and exploit this valuable research.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2012-01-01 to 2017-12-01
Description
The Public Population Project in Genomics (P3G) is a non-for-profit international consortium to promote collaboration between researchers in the field of population genomics.
It has been launched in order to provide the international population genomics community with the resources, tools and know-how to facilitate data management for improved methods of knowledge transfer and sharing. Its main objective consists in the creation of an open, public and accessible knowledge database. The motto is transparency and collaboration.
Principal Investigators
Funding Organization(s)
Period
2012-01-01 to 2013-12-01
2011
Description
Intellectual property (IP) is perceived as playing an important role in the commercialization process, and the role of patents in particular has received a considerable amount of attention in the literature (Golden 2010). Our focus in this phase will be on the relationship between translation and commercialization pressure (including IP policies), and data access policies. We will investigate current restrictions to access, as reflected in (for example) international stem cell banking policies, including restrictions to future IP claims, and compare them with existing open access policies (e.g., UK Stem Cell Initiative and the CIRM iPS biobank). This work will include an analysis of whether certain commercialization policies, and concomitant IP approaches (such as restrictive patenting practices) do in fact conflict with emerging open access approaches and policies, as reflected, for example, in the UK Stem Cell Bank (Joly 2010; George 2010).
Funding Organization(s)
Period
2011-10-01 to 2015-03-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-10-01 to 2016-03-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-09-01 to 2013-01-01
Description
This project, in partnership with research groups in the United States, aims to determine what criteria should govern return of individual results in paediatric genomic research, using analysis of US law and international guidelines regarding decision making for and by minors as the foundation. This issue, which has received remarkably little attention, must be resolved if this research, which is vital to understanding the contributions of genetic variation to the health of children, is to proceed. In order to develop these criteria, the project will draw upon a host of ethical, legal, and sociocultural sources, as well as empirical data. The Centre of Genomics and Policy is analyzing international (including Canadian) policies and guidelines on the return of pediatric research results, and the US PI’s are analyzing US legislation and case law that may impact on the return of pediatric research results.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-09-01 to 2013-09-01
Description
Do the current ethical and legal policies applicable to research with genomic databases sufficiently account for the new reality of open biotechnology? How could the current policy framework be improved to facilitate the transition to a more transparent, collaborative research context? Our research will investigate the impact of open biotechnology on research ethics and legal policies with a particular focus placed on informed consent (scope of consent, privacy, data ownership) to large open database projects. We will use a combination of quantitative and qualitative research strategies that will offer complementary applied legal and ethical data on the impact of open biotechnology on the governance of genomic research. The use of a common research methodology in all streams of the project will facilitate comparisons and integration of our results. Our methods will include comparative legal and ethical research (policy review, legal research), questionnaire analysis and focus group interviews. To validate our findings, we will engage stakeholders at the annual meetings of two major organizations involved in research with open databases: The Public Population Project in Genomics (P3G) and the International Cancer Genome Consortium (ICGC).
Principal Investigators
Funding Organization(s)
Period
2011-07-01 to 2015-06-01
Description
Water quality is primarily assessed at the tap using coliform bacterial species as indicators of microbial pollution, a paradigm which reflects an anthropocentric focus on drinking water and human health. Metagenomics is a "culture-independent" method for analysis of multiple microbial genomes, for example, in the drinking water. Importantly, water safety and genomics together create a highly volatile postgenomics innovation trajectory for metagenomics applications in public health and ecosystem health.
This study comprises three stages. First, we will identify the metagenomics stakeholders for water safety in consultation with the water and metagenomics experts and through metagenomics and water safety document analyses and interviews. Second, the issues associated with a new watershed test that may impact each stakeholder group will be identified through complementary social science methodologies including document analyses, literature reviews, surveys, focus groups and interviews. Third, we will hold a multi-stakeholder workshop to present, negotiate and validate the identified social, legal, ethical and policy issues in the form of a "points-to-consider" document to inform prospective policy.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-07-01 to 2014-06-01
Description
Making Connections est un réseau qui réunit des experts pour aborder les questions relatives à la gouvernance des biobanques. En 2011, le quatrième atelier de Making Connections s'est tenu à Montréal les 10 et 11 octobre, juste avant la réunion du Congrès international de génétique humaine.
L'atelier avait quatre objectifs :
Une déclaration de principe sur la restitution des résultats de la recherche et des découvertes fortuites dans les études de population - élaborée en collaboration avec le Public Population Project in Genomics - a été discutée lors de la réunion et est publiée par P3G :
- Poursuivre l'expansion du réseau international de gouvernance des biobanques.
- Examiner les voies possibles vers une utilisation efficace des biobanques dans la recherche translationnelle et les applications cliniques.
- Publier un document d'orientation sur les défis et les solutions en matière de recherche translationnelle à l'intention des parties prenantes nationales et internationales et le diffuser largement.
- Identifier les possibilités de recherche financée et de projet politique.<http://www.p3g.org/secretariat/news/P3G%20 Return%20of%20Results.pdf>
Principal Investigators
Funding Organization(s)
Period
2011-06-01 to 2012-03-01
Description
One of the biggest current challenges in human genetics is the identification of genes and variants responsible for phenotypic variability and susceptibility to common genetic disorders. We postulate that rare Mendelian disorders should be used as a tool to identify phenotypically important genes. Historically, such disorders have been neglected, both because of their rarity and because of the difficulty in identifying the underlying genes and mutations. Current sequencing technologies have drastically altered the playing field. We can now sequence individual genomes at manageable costs. In this project, we propose to set up a high throughput sequencing platform to detect mutations underlying rare Mendelian disorders. We will also establish a bioinformatics pipeline for annotation, prioritization, and selection of the genetic variants that are most likely to be responsible for the observed phenotype. Our initial approach will rely on isolating and sequencing only the coding portions of the human genome, but we anticipate that within this funding period, the rapidly decreasing cost of sequencing will render our pipeline operational at a whole-genome scale. The goal is to create a seamless technology and informatics platform allowing us to detect disease causing mutations within a week of obtaining DNA samples. We will also create cell and animal models to validate and understand the causative role of selected mutations. We aim to establish a reputation and extend a network of collaborations to position McGill as a centre for mutations detection, screening, and - in the future – genetic testing.
Applicant
Co-Applicant
Funding Organization(s)
Period
2011-06-01 to 2012-12-01
Description
MICYRN brings together the 17 Canadian academic child/ child-maternal health centres and research institutes in a multi-disciplinary national initiative committed to removing barriers and building capacity for the conduct of safe and high quality health research. The CGP is involved in several projects with MICYRN, including: Practices for Health Research Involving Children and Adolescents, Paediatric Consent Best Practices, Research Harmonization, Newborn Bloodspots/Biobanks, Newborn Screening/WGS, and creating policy tools for a Paediatric Biobank Research Platform. • Developing Best Practices in Pediatric Consent Forms: The analysis provides valuable insight and evidence into how consent forms address current ethical issues, reducing gaps and facilitating harmonized, yet contextualized, approaches to pediatric health research ethics. • Evaluating a novel model for Canadian National Federated Ethics Review: Expert review of 5 new research protocols in order to test new ways of doing ethics review for pediatric research. • P3G International Psediatric Biological Research Platform: The Pediatric Platform is meant to develop an online platform, hosted by P3G, providing research tools for researchers and REBs concerned with pediatric biobanking. Using model documents in informed consent, data sharing, and biobank governance, the platform facilitates harmonization, provides practical value for researchers, works to improve ELSI management in pediatric biobanking, and facilitates REB review.
Period
2011-03-01 to 2013-03-01
Description
FORGE Canada (Finding of Rare Disease Genes) is a national consortium of clinicians and scientists using next-generation sequencing technology to identify genes responsible for a wide spectrum of rare pediatric-onset disorders present in the Canadian population.
The Consortium brings together clinicians from all 21 Clinical Genetics Centres (representing every province) and internationally-recognized Canadian scientists with expertise in gene identification, with the infrastructure of the Genome Canada Science and Technology (GC S&T) Innovation Centres. International collaborations have been established with clinicians in 16 countries. Two nation-wide requests for proposals have resulted in 175 disorders that met FORGE criteria; 70 of these rare disorders have been selected for study over the 18 months of this project. These disorders range from those affecting single families, to disorders with 20+ patients from across Canada and internationally recruited through the FORGE network. We are establishing a national data coordination centre to streamline and improve existing large-scale sequence analysis tools and our GE3LS team is working toward national ethical guidelines for analyzing sequence data from entire genomes and for sharing results with families.
Gene discoveries made by the FORGE Canada Consortium will have immediate and long-term benefits for the health of Canadians through translation to diagnostic tests, including the development of new methodologies and algorithms for the use of this technology. Within the first three months, we have identified 9 genes; 6 of these are novel genes that were previously not linked to human disease thereby providing insight into the molecular pathogenesis of these disorders. Successful completion of the activities of the FORGE Canada project will yield a coordinated and sustainable Consortium focused on the investigation of the genetic basis of human disease.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-03-01 to 2012-08-01
Description
The objective of this study is to create Canadian recommendations and other resources for electronic consent for future research use of data and biological materials. Informed consent signals the primary duty to inform and protect research participants. Providing consent is based on the right of research participants to exercise full autonomy in decisions affecting their health and personal privacy. As technologies in medical research improve and research questions become increasingly complex, there is a need to recruit new participants, as well as use previously-collected data and biological materials to increase statistical power and minimize the burden on research populations. This application addresses the need for guidance in the use of research data and biological materials to answer questions that were not planned or known at the time of collection.This guidance will provide recommendations for the use of data and biological materials that have already been collected and provide recommendations and a model electronic consent process for data and biological materials that will be collected in the future. Specifically we will: 1. Evaluate the feasibility of creating a digital governance system in Canada by identifying the legal and ethical issues relating to the use of an electronic approach to consent for future research use of data and biological materials; 2. Draft an Electronic Consent Governance Framework Report with actionable recommendations, and validate it with pertinent stakeholders (ethics boards, patient organizations); 3. Develop a model form for electronic consent, which could be adapted to different types of research and sites, across disease groups, and across populations with an emphasis on the needs of the aging population.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-02-01 to 2014-07-01
Description
This project aims to develop and make available real-time PCR technology at point-of-care for rapid detection of infections. Our research concentrates on the legal and ethical issues associated with the use of such a diagnostic tool. More precisely, we undertake two research objectives. The first is to examine whether healthcare institutions in Québec have a duty to integrate effective new technologies - such as real-time PCR - into their services, especially in regard to the growing problem that are nosocomial infections. The second aims to study how the use of real-time PCR technology at point-of-care will affect the legal duties of healthcare professionals.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2011-01-01 to 2012-09-30
2010
Description
BioSHaRE-EU has assembled a consortium of leading international researchers from all domains of biobanking science. These experts are working to develop and apply methods and tools that will provide a foundation for an ambitious program of harmonization and standardization in European biobanks and major biomedical studies. This facilitates the full participation of European bioscience in the next phase of international aetiological research that demands access to studies that have 3 complementary characteristics: 1) participants must be comprehensively assessed not only for genotype, but also for phenotype; 2) measurement quality must be high; and 3) because no single study will provide adequate numbers of subjects for certain questions, biobanks must therefore be harmonized and standardized so that studies can pool biobank data in valid and effective ways. The CGP is involved in the development of ethical, legal and social guidance in order to harmonize the treatment of environmental risk and personal life-style data in and from different European biobanks. The CGP also offers BioSHaRE its ethical expertise in issues of privacy and retrospective access to samples and data.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-12-01 to 2015-06-01
Principal Investigators
Funding Organization(s)
Period
2010-12-01 to 2011-03-01
Governance and Use of Previously Stored Human Biological Material in the Public Health Context: Lega
Principal Investigators
Funding Organization(s)
Period
2010-11-01 to 2011-03-01
Guidance for Biobanking: Anonymisation and Disposal of Human Biological Materials from Existing Coll
Principal Investigators
Funding Organization(s)
Period
2010-10-01 to 2011-02-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-10-01 to 2016-03-01
Description
The rules and policies of collaborative oncological gene-environment studies (COGS) as well as the laws and public policies applicable to the international exchange of genetic samples in the United Kingdom, Australia, Canada, Europe (confidentiality), and France (material transfer agreements and broad consent) will be systematically identified and analyzed by this project. Findings will be validated by consultation (teleconference or email) with experts from each of the selected countries or regions. Our analysis, complemented by a critical literature review, will allow us to outline the central similarities and differences between norms and produce recommendations aiming to harmonize the rules of EI-RFCS with those of COGS. Our second objective concerns the communication of information to third parties. We will carry out a review of the relevant law, regulations, and guidelines concerning medical liability and genetic discrimination in Quebec. This review is necessary to identify the actual practices of insurance companies in Quebec and to compare them to legal and ethical norms. We will analyze the forms available on the web-sites of personal insurance companies in Quebec (Desjardins, La Capitale, Groupe Promutuel, etc.). Norms will be organized according to the emergent issues, such as confidentiality, access, and discrimination. The contextual legal analysis of these issues will serve to identify those elements that would benefit from the issuance of recommendations addressing medical liability and genetic discrimination in Quebec.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-10-01 to 2013-09-01
Applicant
Funding Organization(s)
Period
2010-09-01 to 2011-03-01
Principal Investigators
Funding Organization(s)
Period
2010-09-01 to 2011-08-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-07-01 to 2011-06-01
Principal Investigators
Funding Organization(s)
Period
2010-06-01 to 2011-05-01
Description
The scientific objectives of this project are to evaluate in a nonhuman primate (NHP; vervet monkey) model differences in the microbiome of the gastro-intestinal tract at different locations, determine whether stool is a relevant material for microbiome studies, and assess how age, sex, genetics and diet influence the diversity of the microbiome at points along the gastrointestinal tract. Microbiome based therapies, namely fecal transplantation (FT) therapeutics, are thought to hold great potential for treatment of a number of disorders. However, potential FT based therapeutics raise GE3LS issues that are unique to microbiome research and implementation. The project aims to investigate the regulatory hurdles of FT based therapies, namely: 1) How would FT based therapeutics, as they are currently prepared and administered, be treated under Canadian and International legislative and regulatory regimes? 2) What are the legislative, regulatory, and/ or local administrative hurdles that both current, and anticipated FT based therapeutics face in Canada and Internationally?
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-06-01 to 2014-09-01
Description
From the Lab to the Clinic: ELS Issues in Cancer Stem Cell Research is a project key to a larger Cancer Stem Cell Consortium (CSCC) funded initiative that aims to identify, characterize and develop methods of destroying leukemia stem cells (LSC). This latter research project involves three key phases of the innovation process: the use of a large tissue bank (basic research), the engagement of industry partners (commercialization) and the development of valuable therapeutics (translation) for patients with intractable leukemia. The ELS initiative led by HeaLS Research Director Timothy Caulfield explores the ethical, legal, social and policy issues affiliated with each realm of research associated with the innovative process. The team will be investigating ELSI challenges that characterize tissue banking and the commercialization process, in addition to those associated with the marketing of therapies. This latter component is being done through the lens of medical tourism.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-05-01 to 2014-04-01
Principal Investigators
Funding Organization(s)
Period
2010-04-01 to 2010-12-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2010-04-01 to 2011-02-01
2009
Description
The International Cancer Genome Consortium (ICGC) represents international cancer research projects who share the common aim of elucidating genomic changes in a range of cancers. ICGC has gathered mass volumes of data since its inception culminatory in the PCAWG publication in Nature (February 5, 2020). Data is shared with 1300 researchers from 37 countries. The CGP houses the consortium’s Data Access Compliance Office (DACO). International researchers have obtained access to controlled data for use in genomics, bioinformatics, and related research. The CGP manages the data access process in order to ensure that cutting edge cancer research progresses efficiently and with as broad a reach as possible. To date, DACO has processed over 2000 applications for ICGC Controlled Data Access (including resubmissions and renewals). This project has been realized at the CGP in collaboration with members of the P3G/P3G2 project.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2009-07-01 to 2013-05-30
Description
Q-CROC is developing a provincial-wide network of collaborators which includes oncologists, surgeons, pathologists, clinician-scientists and basic researchers. Q-CROC has the objectives of improving and developing translational and clinical research.
Q-CROC aims to identify and validate biomarkers specific to clinical resistance to FOLFOX and bevacizumab, in the development of a standardized first line treatment for metastatic colorectal cancer. The aims are to 1) create a unique and unprecedented clinical resistance biobank, and 2) use these biospecimens to identify biomarkers that can be rapidly translated to the clinical setting. The project starts with identification and validation of biomarkers from candidates drawn from the literature or from the research labs of Q-CROC scientists. It continues with a search for new biomarkers and functional validation of the most promising of these in order to obtain insights into mechanisms of resistance. The ultimate goal is to speed the development of personalized medicine through better patient and treatment selection, and to generate new knowledge on therapeutic resistance in the clinical context.
The CGP oversees the legal and ethical aspects of Q-CROCs translational project including patient protection, the drafting of consent forms, and the outlining of rules that govern access to bio-specimens. Dr. Knoppers also acts as Chair of the Q-CROC Ethics Committee.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2009-07-01 to 2012-06-01
Description
The objective of the RMGA is to develop the four key goals of its program: training workshops, Genetics Days, training scholarships, and a multi- and transdisciplinary educational program through collaborative supervision. RMGA hopes to widen its scope and access to its training in specific domains that the scientific community and the general population both recognize as essential.
Applicant
Co-Applicant
Funding Organization(s)
Period
2009-04-01 to 2014-12-31
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2009-04-01 to 2010-03-01
Principal Investigators
Funding Organization(s)
Period
2009-01-01 to 2012-01-01
2008
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-12-01 to 2009-12-01
Description
CanGeneTest is an international knowledge and research network studying the challenges posed by healthcare treatments and policies, including those related to genetic laboratory services. Its general objective is to improve technological transfer of clinically useful genetic innovation having an interesting cost/ efficiency ratio for the healthcare system, and to promote healthcare policy development in light of probative statistics. Using a multidisciplinary approach, the CGP studies the development of the genetic screening test and its discovery in the fundamental research lab, up to its use in the clinical context. Furthermore, with the help of an electronic newsletter and a website, we contribute to the dissemination of relevant and accurate information to all our colleagues interested in this research field. This work downstream from gene discoveries is necessary to translate clinically relevant and useful studies into innovative health care.
The CGP specifically addresses two major legal, ethical and social issues for this project: 1) intrafamilial issues; and 2) false-positive results in newborn screening.
Principal Investigators
Co-Investigators
Applicant
Funding Organization(s)
Period
2008-11-01 to 2015-03-01
Description
The overarching goal of this project is to thoroughly evaluate the prediction of breast cancer risk and its communication to individuals with a family history of breast cancer. The 4 components of the program are designed:
This program is identifying specific genetic factors contributing to breast cancer susceptibility, in particular, yet poorly explored, uncommon or rare intermediate-risk variants that potentially explain a significant proportion of missing familial risk of breast cancer. Some of these could enter clinical cancer genetics practice in the foreseeable future.
- To determine the contribution of uncommon or rare intermediate-risk variants in selected candidate genes to the genetic population attributable fraction and the familial relative risk of breast cancer, and to assess the robustness of their risk in women ascertained through clinic-based and population-based studies.
- To improve estimation of breast and ovarian cancer risks associated with mutations in BRCA1 and BRCA2 genes by identifying the genetic and environmental modifiers that may influence these risks.
- To integrate the knowledge on newly identified genetic an environmental factors, as well as biologic markers, in breast cancer risk prediction models providing individual risk estimates.
- To assess communication of risk prediction information by health professionals and the impact of such information on women at moderate to high risk of the disease.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-10-01 to 2013-10-31
Description
The RMGA is a network of multi- and trans-disciplinary researchers. Its objective is to support and develop basic and applied human genetic research by creating, managing, and promoting scientific infrastructures and knowledge transfer through health services and interventions, for the benefit of the Quebec population.
The Network has close to 350 members, representing the majority of human genetics researchers in Quebec. The RMGA includes a Legal and Socio-Ethical Issues Infrastructure at the CGP that considers those issues arising from secondary use of biological materials and data in health research.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-04-01 to 2016-03-01
Description
ECOGENE-21 est une initiative cohésive et transdisciplinaire guidée par les besoins spécifiques des communautés. ECOGENE-21 s'appuie sur des projets locaux, nationaux et internationaux antérieurs, en cours et émergents, ainsi que sur des réseaux d'expertise en génétique communautaire. Ses objectifs sont de développer, valider, appliquer et reproduire de nouvelles technologies rentables et des stratégies de dépistage pour prévenir les maladies récessives dans les communautés fondatrices et les maladies courantes au niveau communautaire. ECOGENE-21 s'efforce également de développer l'expertise et les plateformes nécessaires pour générer, appliquer, valider et reproduire, au sein des communautés et entre elles, les nouvelles connaissances issues de la recherche en génomique.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-03-01 to 2012-06-01
Description
This project analyses how ethical, legal and social issues (ELSI) affect the conduct and direction of stem cell research (SCR), as well as the translation of the research into public policy.
In this phase of studies, we utilize new and existing legal and social science research tools to carry out a more nuanced analysis of the complex institutional and social structures that have emerged around SCR – from the research networks to special funding and regulatory mechanisms. The immediate goal of this work is to inform research policy, such as the upcoming review of Canada’s embryo research legislation, the Assisted Human Reproduction Act (AHRA). More broadly, this work produces the following: data describing the nature and impact of the research environments; policy recommendations and best practices; innovative research tools to measure the return on investment in SCR and other biomedical research; consensus statements on policy positions; and ELSI guidance to various stakeholders including members of the Stem Cell Network, research ethics boards, clinical trial committees, and the public.
Specific Project Objectives include:
• Provide a detailed description and analysis of the international SCR environment, thus informing international collaboration and policy development while serving as a research resource;
• Provide an analysis of the impact of various variables (e.g., research ethics rules, IP policy, availability of funds) on the nature and direction of SCR, thus informing the development of best practices, commercialization policy and measurements of return on investment;
• Provide an analysis of and recommendations about public representations of SCR. This will inform the development of best practice guidelines for the communication of developments in SCR as well as for the reception of popular messages about the research by policymakers;
• Proactively inform regulatory reaction to emerging SCR processes by developing normative ethical guidelines for resolving challenges to and controversies posed by emerging SCR processes and techniques, and
• Directly inform the review of the AHRA in 2009.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-01-01 to 2012-09-01
Description
The ENGAGE consortium unites 22 research organizations and two companies from the biotechnology sector to improve interoperability in some of the most complete cohorts in Europe. ENGAGE aims to translate the richness of information obtained from some of the most important genetics and genomics research projects on European cohorts (and others) to information relevant to clinical applications. In order to do so, ENGAGE is regrouping close to 80,000 association studies of genomic characteristics to identify new medical susceptibility variants that are presently unidentifiable through individual studies. The CGP specifically addresses societal issues raised by molecular epidemiological studies that translate retrospective data and analysis.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2008-01-01 to 2012-12-31
Principal Investigators
Funding Organization(s)
Period
2008-01-01 to 2009-06-01
2007
Principal Investigators
Funding Organization(s)
Period
2007-11-01 to 2009-06-01
Principal Investigators
Funding Organization(s)
Period
2007-10-01 to 2011-12-01
Description
The identification of mutations in the BRCA1/2 genes or other new breast cancer susceptibility genes in an individual implies that other family members may be affected. Presently, there is no consensus about the responsibilities of family members to communicate this information to relatives. Given the sensitive nature of genetic information, the variety of modern-day families, the geographical and social proximity issues and the complexity of genetic risk information, individuals receiving BRCA1/2 test results face a number of moral choices and challenges. The study follows previous research on the legal and ethical obligations around communicating genetic information. It will investigate whether family members have different obligations than those of other individuals (e.g. doctors or third parties interested in the results but not directly involved) in communicating breast cancer information. The team will evaluate current legal obligations in Canada, host two round tables to validate findings and make suggestions about this communication and whether it can or should take place.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2007-10-01 to 2010-04-01
Description
The main objective of this project is to facilitate access to ethically and legally appropriate UCB samples for basic and clinical research so as to ensure that Canadian researchers are competitive in the increasingly active environment of adult stem cell research. It builds on a previous SCN Catalyst Project entitled “The Future of Cord Blood Banking in” that successfully fostered a collaborative relationship between individuals and organizations, including public and private cord blood banks, with highly diverse interests. This second catalyst project, led by Bartha Maria Knoppers and Jacques Galipeau, aims to further exploit the team’s momentum so as to enhance Canada’s competitiveness in the area of UCB stem cell research.
Principal Investigators
Funding Organization(s)
Period
2007-06-01 to 2009-05-31
Description
This research project explores the relevance of the current framework for the regulation of nanomedicine products falling under the purview of Health Canada’s Health Products and Food Branch. The main objectives of this project are to: (1) Identify the salient issues and statutory and regulatory gaps associated with the current approval process for nanomedicine products (e.g. drugs, medical devices, natural health products and cosmetics); (2) Identify, describe and analyse the legal and regulatory requirements considered and/or employed in other jurisdictions to address these issues and gaps identified in (1); (3) Compare the legal and regulatory requirements considered and/or employed in other jurisdictions with the Canadian framework; and (4) Identify and frame policy options for the regulation of nanomedicine for consideration by Canadian policy-makers; (5) Communicate the themes and goals of this research to the broader publics.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2007-04-01 to 2010-03-31
Description
CARTaGENE creates a resource for the advancement of genetic research, with the aim of improving the health of Quebecers. This public resource operates under a governance framework and consists of a databank and a biobank of 20,000 individuals in Phase A and 30,000 individuals in Phase B. The database contains environmental, demographic and health data. The biobank contains DNA, blood and urine samples.
Principal Investigators
Funding Organization(s)
Period
2007-01-01 to 2010-12-31
Description
The Chair’s mission is to examine ethical and legal issues in the field of genetics and to assist in defining national and international policies to guide industry, research and government conduct in this area.
The final sprint in the genome race can be likened to a gold rush, with thousands of researchers working day and night to identify humanity’s genetic inheritance, while as many others multiply the ways to apply this new knowledge. One voice has risen above the tumult to speak of the need for a genetics code of ethics. In order to support and maintain this research, the Genetics and Society Project has developed and implemented a database of international, regional and national normative texts and guidelines accessible to the public through the www.humgen.umontreal.ca website.
What’s more, the Chair contributes to the activities of the International Institute of Research in Ethics and Biomedicine (IREB), an organization whose main interests and interventions fall within the following 3 areas: research ethics, human genetics research and clinical care, and finally, healthcare systems.
Applicant
Funding Organization(s)
Period
2007-01-01 to 2009-12-31
Principal Investigators
Funding Organization(s)
Period
2007-01-01 to 2010-07-01
2006
Principal Investigators
Funding Organization(s)
Period
2006-04-01 to 2009-03-01
Description
This project will research, in a series of policy papers and GE3LS meetings, the socio-ethical and legal issues underlying questions like: How do we balance the potential interests of the "at-risk" population in the presence of infectious or communicable diseases against the confidentiality of individual or community genetic information and the security of such databases? Can these databases be used for public interest or for the public good?. The project will also examine and review the results of interviews with health-care professionals and policymakers, a policymakers forum, and the contribution of the public through a citizen’s workshop and two international symposia, one of “consumer-citizens” who are stakeholders in models of public participation and one of health professionals involved in newborn screening. Finally, the project will conclude with a multi-sectored consensus conference on a "Policy Framework: Points to Consider" document developed with national and international collaborators. The “Policy Framework: Points to Consider” will provide a more coherent international response not only to infectious or communicable diseases, but more importantly will translate genomic knowledge into awareness for disease prevention and health promotion.
Principal Investigators
Funding Organization(s)
Period
2006-01-01 to 2008-12-01
Description
The GRID project will not seek to identify new genes but instead will focus on regulatory mechanisms in common human diseases, such as abnormal gene production, assembly and turnover. The project will characterize more than 250 disease genes believed to be associated with diabetes, asthma, inflammatory diseases and some forms of cancer. The team expects to identify a cascade of biological steps initiated by regulatory mechanisms in 25 genes that modify disease risk.
At the same time, the project will also study the ethical implications and dimensions of this research in order to develop an appropriate framework for this and other projects.
The research team is part of the GE3LS (Genomics, Ethics, Environment, Economics, Legal, Social) section of the project and will investigate: conflicts of interest between researchers and private pharmaceuticals sponsors; confidentiality, patents and copyright; and research and patent exceptions
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2006-01-01 to 2009-12-31
2005
Description
The aim of this research proposal is to develop a stem-cell based strategy for treatment of the inherited bleeding disorder, hemophilia A. This project will utilize the combined expertise of the research team to develop a strategy for the advancement of stem cell-based gene therapy for hemophilia from pre-clinical evaluation into early phase clinical trials.
This project raises unique ELSI challenges and calls for a reassessment of traditional ones. Critical socio-ethical and legal analysis of (prospective) clinical trials of stem cell-based therapy for the treatment of hemophilia go beyond conventional ethical assessment of patient recruitment, protection of human research subjects and issues relating to informed consent, privacy and monitoring. The core objective of this project is to develop informed ethical and policy guidelines for the establishment of stem cell-based gene therapy of hemophiliacs in Canada.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-12-31 to 2008-10-01
Description
This research seeks to examine the emerging ELSI issues associated with the integration of stem cell research and technologies into clinical research. This work will be done through four highly integrated projects. Project 1 will bring together an interdisciplinary team of academics, policymakers, researchers and other stakeholders to consider the unique and emerging research ethics issues associated with this research as it moves toward clinical applications. We will also analyze broader social consideration on how research can be conducted in a just and fair manner that serves the interests of all Canadians.
Project 2 seeks to examine public perceptions and popular representations of stem cell research.
Project 3 will explore ethical and policy challenges created by the commercialization pressures (e.g., patenting).
Project 4 is a comparative analysis of the diverse policies and laws throughout the world. This international comparative analysis will include a consideration of stem cell research, banking and patent policies. It will also include the hosting of several international meetings that will bring together representatives from over fifteen countries involved in stem cell research policies (Ethics Working Party of the International Stem Cell Forum).
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-12-31 to 2008-09-01
CAREnet and SCN Partnership Project: A Focus on Translation Application of Cardiovascular and Pulmon
Description
The CARENeT-SCN group was constituted with the focused purpose of advancing the field of cell-based cardiovascular regeneration and repair. This group was formed to capture established Canadian scientific and clinical strengths in cardiovascular disease modeling, stem cell biology and clinical study of innovative cardiovascular therapies. In particular, cell-based technologies will be studied and screened through animal models of hind limb arterial insufficiency, myocardial infarction and chronic ischemic cardiomyopathy As we move from bench to bedside both new and old ethical and legal challenges related to novel cell therapies must be evaluated in a prospective manner. Central to this analysis is the issue of safety of clinical trials considering the demand for efficacious therapies. We propose to: (1) assess the socio-ethical and legal issues specific to transition/translation to the first human clinical trial applying human novel stem cell therapies for cardiovascular and respiratory regenerative medicine, (2)develop model protocols for such trials and (3) respect the specific legal requirements of Quebec’s Civil Code.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-12-01 to 2008-10-01
Principal Investigators
Funding Organization(s)
Period
2005-09-01 to 2008-09-01
Description
The present project is based on ongoing SCN research by the Centre de recherche en droit public (CRDP) and the Health Law Institute (HLI) reviewing scientific, ethical and regulatory implications of cord blood stem cell banking.
We plan to invite representatives from the public sector (Héma-Québec, Alberta Cord Blood Bank, Canadian Blood Services, Victoria Angel Registry of Hope) and private spheres of the cord blood banking industry (Cells for Life, InSception BioSciences, Lifebank, etc.), as well as transplant physicians, cord blood investigators and representatives of international organizations responsible for setting and maintaining regulatory guidelines governing the collection and use of cord blood (e.g., the Foundation for the Accreditation of Cellular Therapy, FACT) along with key governmental stakeholders from Health Canada to a one-day workshop. Prior to the workshop, background papers and relevant documentation will be circulated.
The goal is to set up a task force to discuss the ethics of public and private cord blood banks and to suggest a framework that will allow public policy makers to effectively regulate cord blood banking in Canada.
Principal Investigators
Funding Organization(s)
Period
2005-08-01 to 2007-01-31
Description
This pilot project aims to explore the best methodological approaches in order to investigate the socio-ethical opinions of multicultural communities in the area of genetics. The project will develop an innovative methodology which aims to involve community participation in all the stages of the research project. The analysis will require three main stages. The first stage is to form a literature review based on investigative methods that are effective for multicultural communities. Secondly, a group of ten professionals, all with different expertise in the domain of health and genetics but who also have expertise concerning sickle-cell disease, will be questioned in order to determine which individuals within the community should form a focus group. The third stage will require the representatives of the community that form the focus group to answer the three following questions: 1) Which ethical and social issues of genetic screening are the public concerned about; 2) Which methods of investigation will best explore the opinions of the community; and 3) What are the most effective means to solicit participants. Thereafter, we will try to validate our method by making a comparative analysis of the answers obtained from the focus group with the literature review and interviews with research experts. If there are important differences found through the comparative analysis, we will be able to conclude that it is necessary to develop parameters of investigation in collaboration with the community concerned with research, as we will have done in with this pilot project. The results will enable us to identify the best parameters to be adopted for the investigation that we project to make. From there, we will establish the issues which should be the subject of this future investigation and will chose the techniques of investigation which will appear best adapted to the situation.
Funding Organization(s)
Period
2005-06-01 to 2008-11-01
Description
The RMGA is a Québec network of multi- and trans-disciplinary network of researchers seeking to facilitate both applied research in medical genetics in Quebec and the transfer of new knowledge useful to this population. More specifically, its objective is to support and develop basic and applied human genetic research by creating, managing, and promoting scientific infrastructures and knowledge transfer through health services and interventions for the benefit of the Québec population. The Network has 350 members representing the majority of human genetics researchers in Québec. The RMGA included a Legal and Socio-Ethical Issues Infrastructure at the CGP that considered issues arising from the research activities of the RMGA members and provided ELSI guidance on emerging issues. For example, in 2016, the CGP consolidated a decade of RMGA policies into a prospective Statement of Principles addressing ten different issues raised by research involving human: recruitment of research participants, informed consent, secondary use of data and/or biosamples, privacy and confidentiality, professionalism, conflicts of interest, discrimination and stigmatization, governance of biobank and databases, commercialization and return of results. The Québec Network of Applied Genetic Medicine has also been actively involved in the legal and social debate regarding the federal law on genetic discrimination. The RMGA had notably developed a Position Statement on Genetic Discrimination.
Principal Investigators
Funding Organization(s)
Period
2005-06-01 to 2009-03-01
Description
The overarching goal of this proposal is to define the methods, reagents and cell populations that will make cell therapy for muscle disease a reality. To achieve this goal we plan to gather sufficient preclinical data to bring novel ES-cell derived human progenitor populations to clinical trials.
Clinical genetic research conducted in children creates new ethical and regulatory challenges, including the need to develop safeguards or procedures to protect the best interest of the child. To that end, we propose to study the continuing debate surrounding the inclusion of children in research, and in particular, stem cell therapies.
Within the framework of this project our team will interact closely with this group of researchers to study the ethical implications of long-term immunosuppression in young recipients of cellular therapy.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-03-31 to 2008-04-01
Chimeras and Hybrids in Comparative European and International Research – Scientific, Ethical, Philo
Description
The objective of this project is to make a comprehensive and deepened analysis of fundamental problems of research on chimera and hybrid in the form of reports, workshop-papers, conferences and workshops and thereby to compile concepts, strategies, and suggestions for research practices and decision support for science, society and decision makers in policy.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-03-31 to 2008-04-01
Description
The research team proposes to develop the ethical and legal foundations that will support a protocol for the retrospective compilation, use and disclosure of existing breast cancer tissue samples and relevant clinical information from various medical centres across Canada. The team will suggest an ethically and legally appropriate model that will include an ethics governance framework and data management options for CBCRA’s proposed retrospective microarray resource. The team will then validate the model developed via submission to Research Ethics Boards (REBs).
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2005-01-01 to 2005-08-31
2004
Description
The main objective of this project is to build a framework and a problematic shared between 6 teams on human population genetics and public health. Another objective is to provide multidisciplinary analysis and international comparison of the normative contexts and practices in order to be able to jointly deposit, into 2007, a demand for an international invitation.
Principal Investigators
Funding Organization(s)
Period
2004-12-01 to 2007-11-30
Description
Advances in the fields of genetics and genomics are creating a new paradigm for the practice of medicine, one that could revolutionize the future of healthcare. Pharmacogenomics promises to deliver the right amount of medicine to the right patient at the right time. However, children are at risk of being excluded from the potential benefits of this new therapeutic approach because of ethical, legal and social challenges associated with their participation in pharmacogenomic research trials. To address these issues, this research aims to: (1) identify the legal, social and ethical issues of pharmacogenomic research involving children through an analysis of relevant legislation and guidelines at the international, regional, national, federal and provincial levels and of the relevant literature; (2) conduct qualitative interviews of researchers in the field of pharmacogenomics to identify the most challenging issues; (3) carry out an in depth study of the issues identified in (1) and (2). And finally, (4) to draft recommendations targeted at research professionals, ethics committees and policymakers.
Principal Investigators
Funding Organization(s)
Period
2004-11-01 to 2005-10-31
Description
The recent SARS outbreak has spurred calls for the creation of a national disease surveillance and control agency in Canada. A proposed federal agency of this type would play a key role in responding to infectious disease outbreaks by undertaking surveillance activities and implementing control measures to halt the spread disease. However, the nature and extent of the legal authority of the federal government to establish such a body is a critical question that must be answered. To address this issue, the primary objectives of this research proposal are to: identify and describe the legal foundations necessary to create a national disease surveillance and control body in Canada; and analyse legal issues that may define the mandate and constrain the power of such a body. The first part of this research will identify federal powers in relation to public health and the second part will focus on the legal authority of a federal agency to conduct surveillance and impose control measure such as quarantine orders and mandatory screening. this research will be informed by the recent Canadian experience with SARS and will result in a comprehensive legal analysis that will assist legislators, policy-makers and public health officials make decisions about how to prepare at national level for the next infectious disease outbreak.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2004-06-01 to 2005-05-01
Description
A GE3LS (Genomics and Ethical, Economic, Ecological, Legal and Social) issues component will assure that the nationwide exchange of clinical research data and specimens is done in an appropriate legal, ethical and social context that reflects Canadian and international norms.
Principal Investigators
Funding Organization(s)
Period
2004-04-01 to 2007-03-31
Description
This project will study the roles and powers of the State to ensure public health protection in case of zoonosis. The analysis will focus on the relation between individual rights and collective rights within the powers confered to the State and will also focus on actions and reactions of the State when threats to public health occur.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2004-03-31 to 2007-04-01
Description
The Canadian Molecular Cytogenetics Platform (the CMCP) is an infrastructure partnership of 13 major research facilities. It will include:
- a system for the collection of clinical research data and specimens from 18 centres;
- a national database of clinical and cytogenetic research data on individuals who have undergone cytogenetic testing;
- a national cell and DNA bank;
- a database governance facility; and
- a health technology assessment facility and a statistical support facility.
A distributed set of core technology centres will provide the most powerful molecular cytogenetic tools available, and an international partnership with the HC Forum in France will enable the implementation of a state-of-the-art molecular cytogenetic database platform throughout Canada. The platform will support collaborative research based on clinical research data and specimens from affected patients identified by clinical genetics and cytogenetics investigators at participating CMCP centres throughout Canada.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2004-03-01 to 2007-05-31
Description
The main objective of this project is to anticipate the ethical, economic, environmental, legal and social issues that might be relevant to the use of regenerative medicine technologies in order to maximize its benefits and minimize risks in medical research and practice.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2004-01-01 to 2009-01-01
Description
This project is the result of an interdisciplinary collaboration between epidemiology and genetics with ethics, law and philosophy of science and involves researchers from seven different institutions in Norway, France, Portugal and the UK. The aim of this project is to investigate some of the ethical, legal and social challenges raised by research biobanking in its different modern forms and formats. Besides analyzing current legislation, other forms of regulation and public debates concerning biobanks in European and other relevant jurisdiction, this project also includes an “in-vivo” study of ethical, legal and social issues likely to emerge from two new genomics/functional genomics projects: Biohealth-Norway and Genomeutwin.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2004-01-01 to 2009-04-01
2003
Principal Investigators
Funding Organization(s)
Period
2003-06-01 to 2004-05-01
Description
Both conceptual and practical concerns underlie the issue of the terminology used to explain to research participants the degree of confidentiality of their data. Conceptual, in that the validity of such consent (and thus the autonomy and privacy of the person) can be severely undermined if the protection of samples or data is not fully understood. Practical, in that the use of samples for data mining can be severely undermined if researchers employ contradictory definitions of the types of mechanisms of confidentiality.
This situation has become particularly serious in the already explosive world of genetic research where sampling and data collecting are the norm. If applied to the emerging field of population genomics, it risks totally defeating international collaboration on genotyping and phenotyping mapping efforts. The degree of “identifiability” determines which ethical and legal rules apply. This makes harmonization essential.
The study of the definitions used or proposed to date, the level of protection offered and the need for ethical review or not (depending on the definition) is further coloured by the myriad of laws governing medical, personal or “genetic” data generally. Out of this complexity, some simplicity and possibly harmonization may emerge if common elements can be discerned and a dialogue initiated between institutional contributors on the current contradictory lexicon (Phase I), and, an effort made towards international consensus (Phase II).
Principal Investigators
Funding Organization(s)
Period
2003-01-01 to 2004-12-31
Description
This projects intends to examine health and genetic policies by creating a knowledge network that will bring together academicians, genetic counsellors, and government representatives. Utilizing interdisciplinary research, the goal of this network is to answer questions relating to policy making in the field of genetics. Three main areas for research to be examined were decided : genetic and health services, genetic and public health, and genetic and public relations. We will reach our objective by several means, including : implicating policy makers, writing policy briefs, training researchers, reinforcing existing teams etc. Expected benefits include the acknowledgement of researchers' input in policy making, the improvement of genetic services, the implication of the public, and the instauration of a lasting technological transfer.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2003-01-01 to 2008-12-12
2002
Description
While the mapping of the human genome provides a tremendous tool for genetic research, it is still impractical to test the approximately 10 million common variations in human gene sequences to discover their role in diseases. Recent research suggests that the variations on the human chromosomes are clustered into blocks of DNA, which come in relatively small number of varieties called haplotypes and, which are relatively large in size. Mapping this chromosome structure and generating haplotype maps will provide a valuable tool for biomedical research and for discovering common genetic diseases. The project is an international collaboration among the Montreal Genome Centre, the Wellcome Trust Sanger Institute in the United Kingdom and the Whitehead Institute/MIT Center for Genome Research in the United States.
Social, ethical and legal issues related to consultation, consent and communication with defined ethnic populations are highly relevant to this project. Indeed, the focus on defined populations gives rise to concern about possible stigmatization and discrimination. Informing the public about the science in an effective two way process will be addressed.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2002-10-01 to 2005-09-01
Description
Valorisation recherche Québec (VRQ)
Recent technological advances, carried out in genomics and proteomics, allow us to identify the causes of various digestive diseases. A better understanding of these causes will support the development of new diagnostic tools, early treatment and preventive measures. Conversely, we need be aware of the scope of preventive medicine, given that genetic research results intended to identify genes and to create genetic profiles will have social, ethical and legal repercussions on the population.
In addition to identifying functional polymorphisms, this multidisciplinary project will establish the proteomic map of intestinal cells. It will determine the cellular genotype-phenotype relation and will evaluate their clinical impact through longitudinal studies on children and families suffering from digestive tract diseases.
Within the framework of this project, our team will examine ethical questions raised by genetic research and predictive genetic tests involving children, newborns and adolescents. We will draft a consent form specifically designed for genetic research upon children and adolescents, and will develop genetic information tools, such as information pamphlets about late-onset diseases and/or certain gastro-intestinal diseases (including information about psychosocial risks). The team will analyse ethical policies and existing legal standards on an international level relating to: 1) disclosure of information to the child and family, specifically siblings; 2) communication of incidental and unexpected results to carriers, and; 3) storage and use of collected samples.
It is also planned to create a PedGen module in the HumGen database to allow access to information and to create a discussion forum between researchers and interested parties.
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2002-01-01 to 2006-03-31
2001
Principal Investigators
Funding Organization(s)
Period
2001-12-01 to 2005-08-01
Principal Investigators
Funding Organization(s)
Period
2001-06-01 to 2002-05-01
Principal Investigators
Funding Organization(s)
Period
2001-06-01 to 2004-05-01
Principal Investigators
Funding Organization(s)
Period
2001-06-01 to 2007-05-31
Principal Investigators
Funding Organization(s)
Period
2001-06-01 to 2002-05-01
Principal Investigators
Funding Organization(s)
Period
2001-01-01 to 2001-03-01
Description
The International Institute of Biomedical Ethics Research is an institute without walls, aiming for the international cooperation and collaboration in the field of research in biomedical ethics but also for the establishment of an international inter-disciplinary and inter-institutional network. IREB's mission is educative since it will allow young researchers and professors/researchers to acquire experience through the funding of internships. By sharing its reflections with the community, IREB wishes to encourage society involvement.
IREB functions are to:
- structure and coordinate exchanges between international partners and institutions;
- mobilize collaborators and partners through dynamic interactions;
- encourage the education and formation of students through international projects and internships;
- encourage public awareness on biomedical research ethics issues through accessibility and dissemination of the work done by IREB through its own international website.
Principal Investigators
Funding Organization(s)
Period
2001-01-01 to 2009-04-01
Description
This project involves researchers from six Quebec universities. It examines the socio-ethical, environmental and legal and issues involved in three broad areas: population research, accountability, and transgenics. The first research component includes the study of: DNA sampling and banking, as well as, transfer and confidentiality mechanisms in order to develop and propose standardization and harmonization of approaches. The second research component on accountability examines the issues of professional responsibility and liability for the communication of genetic information for reproductive genetic counselling, for recruitment, confidentiality, follow-up, and communication with the public as well as for oversight mechanisms for all genomic research. The third looks at issues surrounding the creation and use of transgenic animals and plants in research and medical treatment, the preservation of biodiversity, and the protection of the environment. All projects involve comparing international policies and reviews on these issues.
The research team has created four platforms: the French portal of the HumGen website; a GenConsult platform (“think tank format”); a platform called “Generistic” on transgenics; and, a public communication platform.
Principal Investigators
Funding Organization(s)
Period
2001-01-01 to 2004-12-31
Description
Genetic tests to detect familial breast cancer genetics has the potential to facilitate the early detection, prevention and treatment of this type of cancer. However genetic tests can also reveal information which is personal as well as familial, and such personal genetic information could be misused. Moreover, current public policy to protect genetic data lags behind the science. The numerous social, ethical and legal issues posed by genetic research with respect to privacy and confidentiality are not well addressed. Therefore, we are investigating the legal, social and ethical implications of the following issues:
1) genetic research and genetic epidemiology using cancer registries and tumour/tissue;
2) professional disclosure and respect for the rights of individuals and families;
3) public concern about genetic discrimination, particularly access to insurance.
Another important goal of the activities will be to educate professionals, policy-makers and the public about guidelines and information on cancer genetics.
The following questions are being addressed : 1) To what extent do the rules on cancer registries facilitate/prevent genetic research on cancer? 2) How will the confidentiality of data be maintained? 3) What security mechanisms (management) are needed to protect against unauthorised access? 4) Do the current laws permit transborder flow of nominal information, and secondary uses of data?
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2001-01-01 to 2005-03-31
Description
The Office of Science of the Department of Energy (DOE) has designated the storage of genetic information and tissue samples as one of its four priority areas. Study is neededbecause of three features: (1) the focus on the rapid evolution of biobanking, and in particular, the emergence of multiple types of biobanking raising ethical and legal issues that are sometimes identical, sometimes different but related, and sometimes entirely new; (2) the attention to the relationship between ethical and legal considerations in policy responses to biobanking; and (3) the international comparative perspective as a platform for work on the harmonization of standards.
The primary objective of this project is to develop and apply a conceptual framework for understanding the ethical, legal, and policy implications of traditional and emerging forms of biobanking (the solicitation, collections and storage of human biological materials for purposes that include dissemination for research). The fulfilment of this objective will then allow us to construct an analytical framework for the regulation of biobanking.
More specifically this research aims to:
· Review and update the literature on the ethical, legal and policy implications of classical banking (small-scale biobanking in clinical or academic research settings). This review will allow us to develop tools to assist scientists and others in understanding and implementing standards;
· Critically evaluate the progress of population banking (large-scale database-driven biobanking initiatives) and efforts at regulation;
· Contribute to the refinement and harmonization of standards for commercial banking (the operation of a biobank, or the brokerage of human biological materials, by for-profits entities) and;
· Conduct original ethical, legal and policy research on the emerging phenomenon of virtual banking (the solicitation of human biological materials via the Internet), analyzing options for regulation at the state, national, and international levels.
Principal Investigators
Funding Organization(s)
Period
2001-01-01 to 2003-12-31
2000
Principal Investigators
Funding Organization(s)
Period
2000-08-01 to 2001-03-01
Principal Investigators
Funding Organization(s)
Period
2000-06-01 to 2001-05-01
Principal Investigators
Co-Investigators
Funding Organization(s)
Period
2000-06-01 to 2001-05-01
Principal Investigators
Funding Organization(s)
Period
2000-06-01 to 2002-05-01
Inventory of laws affecting the protection of personal information in the health and social services
Principal Investigators
Funding Organization(s)
Period
2000-06-01 to 2001-05-01
The consideration of the community in the acceptability of a technological breakthrough: the case of
Principal Investigators
Funding Organization(s)
Period
2000-06-01 to 2003-05-31
1999
Principal Investigators
Funding Organization(s)
Period
1999-10-01 to 2001-09-01
Principal Investigators
Funding Organization(s)
Period
1999-06-01 to 2000-05-01
1998
Principal Investigators
Funding Organization(s)
Period
1998-06-01 to 2001-05-01