Current Research Projects
2019 - 2021
Granting Agency:
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.
Close2009 - 2022
Granting Agency: Canadian Partnership Against Cancer
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 five participating cohorts (Atlantic PATH, CARTaGENE, Ontario Health Study, Alberta Tomorrow Project, and BC Generations Project). Hosted at the Centre of Genomics and Policy, the ELSI Standing Committee built the ELSI infrastructure of the CanPath platform. The 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 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. P3G2 also ran the Access Office of CanPath until 2018, which reviewed access requests from national and international researchers.
Close2019 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR) - Génome Québec
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”.
Close2018 - 2022
Granting Agency: Genome Alberta - Genome British Columbia - Genome Canada - Ontario Genomics Institute (OGI)
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.
Close2019 - 2021
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
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.
Close2020 - 2021
Granting Agency:
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.
Close2020 - 2022
Granting Agency:
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 Que?bec-Universite? 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.
Close2020 - 2022
Granting Agency:
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.
Close2020 - 2024
Granting Agency:
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.
Close2020 - 2022
Granting Agency:
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.
Close2018 - 2021
Granting Agency: Genome Canada - Génome Québec
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.
Close2020 - 2022
Granting Agency:
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.
Close2020 - 2022
Granting Agency:
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.
Close2019 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - Fonds de recherche du Québec - Santé (FRQS)
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.
Close2018 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR) - Fonds de recherche du Québec - Santé (FRQS)
H2020 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.
Close2018 - 2022
Granting Agency: Genome British Columbia - Genome Canada - Génome Québec
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.
Close2018 - 2021
Granting Agency: Qatar National Research Fund
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.
Close2018 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2018 - 2021
Granting Agency: The Chan Zuckerberg Initiative - The Klarman Family Foundation - The Leona M. and Harry B. Helmsley Charitable Trust
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 hosts the HCA ethics policy platform and assists the HCA in the ongoing coordination of its Ethics Working Group (EWG), the development of an ethics and data governance framework, template consent forms, relevant tools (retrospective consent filter, ethics submission guidance), template agreements (material/data transfer agreement templates, data submission agreement template, data use agreement template) and a helpdesk to support the HCA community. The CGP is also in the process of producing specialized guidance relating to holistic international data governance and to pediatric populations and other vulnerable groups.
Close2020 - 2022
Granting Agency:
The CHU de Que?bec-Universite? 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 devel- oped 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.
2018 - 2022
Granting Agency: Genome Canada - Génome Québec
Acute myeloid leukemia (AML) is a leading cause of cancer-related death in young adults and a highly lethal disease in older adults. Most AML patients survive fewer than two years after diagnosis, due primarily to an absence of effective treatment options and an inability to target therapies to genomic risk profiles. 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 prognostic and therapeutic web portal that will make the project’s findings widely available to researchers, clinicians, and patients. The CGP will undertake an extensive review of policy instruments adopted for similar functions as well as significant engagement with patients, caregivers, and healthcare providers. These efforts will 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.
Close2018 - 2022
Granting Agency: Genome Canada - Génome Québec
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.
Close2018 - 2021
Granting Agency: Autism Speaks Inc.
Autism Speaks launched the MSSNG project with the overall goal to store and analyze the world’s largest collection of genomes of people with autism and their families. With the goal of sequencing the DNA of 10,000 families affected by autism, MSSNG will help answer the many questions we still have about the disorder. Thanks to the Google Cloud, this vast sea of information is accessible for free to researchers. Scientists from around the world will be able to study trillions of data points in one single database. Already, MSSNG has led to new discoveries about autism and its associated health conditions.
As part of the MSSNG Database project, the CGP is offering Data Access Compliance Office (DACO) services to the MSSNG project. From January 1st to December 31st 2019, DACO processed 30 applications (including renewals).
Close2017 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2019 - 2023
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
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.
Close2020 - 2022
Granting Agency:
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.
Close2020 - 2021
Granting Agency:
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.
Close2018 - 2022
Granting Agency: Genome Canada - Génome Québec
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.
Close2018 - 2022
Granting Agency: Genome Canada - Ontario Genomics Institute (OGI)
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.
Close2018 - 2021
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
Launched in 2018, the Transforming Autism Care Consortium (TACC) network aims to bring together the autism research community in Que?bec, by improving access and availability of resources and integrating knowledge into practice. The Que?bec 1000 families project (the “Q1K project”) is a TACC network’s flagship project. It provides a platform (database, biobank and registry) to facilitate research by creating a large cohort of ASD family trios (proband participant, and first-degree relatives) in families where a child has been diagnosed with an autism spectrum disorder. The CGP has developed a governance framework (which includes relevant policies on privacy, data access, return of research findings, etc.), template consent forms/assent forms and support to research ethics board submission for the Q1K project and is providing ongoing support with the management of emerging ethical questions pertaining to the implementation of the Q1K project and the TACC network.
Close2020 - 2022
Granting Agency:
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 (Universite? 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.
Close2019 - 2023
Granting Agency: Canadian Foundation for Innovation (CFI)
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 genomics analysis, and implement services that apply new cutting-edge algorithms for the interpretation of cancer genomes. Our design and implementation plans are based on feedback from our Canadian and international user community, and on our own hands-on experience coordinating international genome analysis projects across petabyte-scale data sets. The CGP will be involved in the ethical and policy questions surrounding the sharing of data and the use of e-tools to facilitate adjudication processes.
Close2020 - 2022
Granting Agency:
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, He?ma-Que?bec, 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.
Close2019 - 2021
Granting Agency:
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.
Close2020 - 2023
Granting Agency:
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.
Close2018 - 2022
Granting Agency: Social Sciences and Humanities Research Council of Canada (SSHRC)
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.
Close2020 - 2022
Granting Agency:
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 Que?bec-Universite? 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.
Close2020 - 2022
Granting Agency:
This project aims to create a platform to revolutionize the treatment of heart disease. The project will establish a scientific basis for a nano-vaccine intended to reduce the need for medication that prevents cardiovascular events. It will simultaneously assess the ethical and legal complications raised by the development of such technology. The team at the CGP is engaged in studying the ethical and legal implications of shifting from personalized therapy (medication) to universal therapy (vaccine). Among other things, the team will determine whether the predicted transition will affect the legal responsibilities of health professionals. We focus in particular on the obligations of health professionals engaged in the care of minors and asymptomatic populations.
Close2020 - 2022
Granting Agency:
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.
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