Completed Research Projects
2002 - 2004
Granting Agency: Génome Québec
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.
Close2009 - 2012
Granting Agency: Fonds de la recherche en santé du Québec - Pfizer
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.
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2008 - 2015
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
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2005 - 2006
Granting Agency: Canadian Institutes of Health Research (CIHR)
This project is the first step in a multi-phase program that aims to critically examine approaches to considering ELSIs in health technology assessment. In this step, rigorous knowledge synthesis methods will be used to identify and explore both conceptual issues and methodological challenges, with specific reference to genetic screening programs, and with a focus on two case studies: neonatal screening programs for cystic fibrosis and prenatal screening programs for haemoglobinopathies.
Close2015 - 2020
Granting Agency: Genome Canada - Génome Québec
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.
Close2013 - 2016
Granting Agency:
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).
Close2005 - 2005
Granting Agency: Canadian Breast Cancer Research Alliance (CBCRA)
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).
Close2011 - 2012
Granting Agency: International Stem Cell Forum - International Stem Cell Forum, Medical Research Council (UK), Canadian Institutes of Health Research (CIHR) - SSHRC - Social Sciences and Humanities Research of Canada
Whether faced by a new technology, climate change or an environmental and economic crisis, societies -- as individuals, groups and communities -- need to develop a broad capacity early on to prepare for the future impacts of such transformative events. Efforts to control or respond to these ever present societal challenges have tended to focus on "prediction" or alternatively, creation of policies that envision a deterministic future. Yet, social events with long lasting impacts such as environmental change, military conflicts or technology innovations are often unpredictable by their very nature. The traditional "predict-and-control" framework is therefore inadequate for complex social change and transformative innovations. Anticipatory governance is a new approach for managing the uncertainties posed by future(s) of innovations and the prospective understanding of transformative social changes in rapidly moving and dynamic fields. The goal of anticipatory governance is not to predict or forecast a singular future but to develop foresight on multiple possible future(s). It builds on the principles of incrementalism and collective learning, and explores the representations of alternative future(s) in the present as perceived by a diverse set of stakeholders, both expert and lay. As such, it signals a shift towards "looking at" rather than "looking into" the future(s). The aim of this study is to characterize the methodologies used in foresight and anticipatory governance analyses over the past decade and the context in which they have been utilized.
2011 - 2014
Granting Agency: Genome British Columbia - Genome Canada
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.
2020 - 2022
Granting Agency: DNA Stack
The cost of biomedical data generation has decreased exponentially, due to technologies like genome sequencing and biometric tracking devices, with a corresponding increase in the volume and diversity of data. By 2025, there will be more genomic data generated than content uploaded to YouTube. Due to the size, complexity and sensitivity of biomedical data, traditional practices for searching and analyzing large co-located datasets do not work. New technologies must be developed to connect and derive insights in a federated model from networks of heterogeneous datasets translating to clinical and pharmaceutical applications in precision health.
Autism spectrum disorders (ASD) are a set of complex conditions characterized by difficulties in social interactions and communication, as well as repetitive behaviours, which collectively affect ~1% of the population. Today, there are no approved drugs designed to treat the core features of ASD. Those affected are treated with medicines designed for other conditions. There is great promise in resolving the complex causes of ASD (and many other disorders) by sharing large volumes of biomedical data from diverse geographic populations.
In 2019, DNAstack, Autism Speaks, and AIMS-2-Trials co-founded the Autism Sharing Initiative (ASI), with the goal of uniting the world's most ambitious efforts in autism to create the first federated, global sharing network to accelerate discoveries and development of precision therapeutics.
This project will accelerate the mission of ASI by (1) building general-purpose technology to connect biomedical data into knowledge-sharing networks, (2) expanding the network to include new high-value data resources, (3) developing a platform to engage individuals with autism and their families, (4) building applications advancing precision diagnostics and therapies in autism, and (5) creating policies for responsible data sharing in the network.
Close2010 - 2015
Granting Agency: The European Commission
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.
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2018 - 2020
Granting Agency: Allergen - Networks of Centres of Excellence (NCE)
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.
Close2007 - 2009
Granting Agency: Canadian Government
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.
Close2004 - 2007
Granting Agency: Canadian Foundation for Innovation (CFI) - Genome Canada
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.
Close2019 - 2021
Granting Agency: Brain Cancer Foundation - Canadian Brain Research Fund
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 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.
Close2009 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
Adverse drug reactions (ADRs) are in the fifth most frequent cause of death in North America North America. Half of these reactions are likely caused by inherited genetic differences and are currently considered ‘unavoidable’. This project aims to understand why certain drugs are safe for use in some children but not in others and then to create easy to administer diagnostic tests that will predict and therefore prevent specific ADRs in children. To meet their goals, CPNDS is collecting data through a Canadawide surveillance network that operates within nine of Canada’s largest children’s hospitals. They then perform large-scale genomic and proteomic studies to define genes critical for ADRs. These results are being used to help develop diagnostic tests to recognize a child’s genetic fingerprint and allow personalized dosing recommendations to be implemented for commonly used drugs.
Close2016 - 2021
Granting Agency: Canadian Foundation for Innovation (CFI)
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.
Close2018 - 2023
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.
Close2005 - 2009
Granting Agency: Networks of Centres of Excellence (NCE)
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.
Close2007 - 2010
Granting Agency: Genome Canada - Génome Québec
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.
Close2007 - 2009
Granting Agency: Networks of Centres of Excellence (NCE)
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
2014 - 2020
Granting Agency: Canadian Institutes of Health Research (CIHR) - Natural Sciences and Engineering Research Council of Canada (NSERC) - Networks of Centres of Excellence (NCE) - Social Sciences and Humanities Research Council of Canada (SSHRC)
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.
Close2005 - 2008
Granting Agency: Stem Cell Network (SCN)
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.
2013 - 2016
Granting Agency:
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.
Close2012 - 2014
Granting Agency:
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.
Close2005 - 2008
Granting Agency: European Commission
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.
Close2008 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
This CIHR Emerging Team examines two areas where genomics meets every day health care and general populations: 1) using family history information in predicting risk of common diseases and 2) screening newborns for rare but serious inborn metabolic diseases. The team is also engaging with citizen groups and health professional groups to understand their reactions to upcoming developments in ‘genomic profiling’, where DNA is used to assess susceptibility to common diseases in both adults and children.
2008 - 2012
Granting Agency: Canadian Institutes of Health Research (CIHR)
ECOGENE-21 is a cohesive, transdisciplinary initiative driven by the specific needs of communities. ECOGENE-21 builds upon previous, ongoing and emerging local, national and international projects and networks of expertise in community genetics. Its objectives are to develop, validate, apply and replicate new cost-effective technologies and screening strategies to prevent recessive diseases in founder communities and common diseases at the community level. ECOGENE-21 also strives to develop the expertise and platforms needed to generate, apply, validate, and replicate within and across communities, new knowledge from genomics research.
2008 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
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:
- 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.
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.
2007 - 2010
Granting Agency: Canadian Breast Cancer Research Alliance (CBCRA)
The CBCRA is Canada’s primary granting agency for breast cancer research and plays a national leadership role in setting priorities and directions for breast cancer research.
Breast cancer (BC) and cancers "run in families." Diagnosing a breast cancer gene in an individual implies that other members of the family may be affected. During the INHERIT BRCAs project, funded by Canadian Institutes of Health Research (CIHR), we investigated the ethical and legal implications for professionals to communicate research results to participants, to recontact patients and to warn relatives.
This study follows previous research on the legal and ethical obligations around communicating genetic information. It investigates whether family members have different obligations than others (e.g. doctors, "third parties" who are interested in the results but are not directly involved) in communicating breast cancer information.
Using our results, we evaluate current legal obligations in Canada, make suggestions about how (and if) this communication should take place, and determine participants' feeling about these ethical and legal issues.
2021 - 2022
Granting Agency: The Government of Canada Public Health Agency of Canada (PHAC)
TBA
Close2012 - 2012
Granting Agency:
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.
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: Canadian Government - Digital Technology Supercluster
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.
Close2011 - 2012
Granting Agency:
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.
Close2020 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - Natural Sciences and Engineering Research Council of Canada (NSERC) - Networks of Centres of Excellence (NCE) - Social Sciences and Humanities Research Council of Canada (SSHRC) - Stem Cell Network (SCN)
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.
Close2011 - 2014
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2006 - 2007
Granting Agency: UNESCO
Our team has been retained to assist with the preliminary stages of development of a network of databases in bioethics, called the Global Ethics Observatory (GEObs). We are currently working on a pilot phase for the GEObs project, which is the creation of a database of legislation, guidelines and regulations in connection to bioethics.
The goal of this portion of the project is to provide information on the effect of the three UNESCO declarations on bioethics:
1. Universal Declaration on Bioetchics and Human Rights (2005)
2. International Declaration on Human Genetic Data (2003)
3. Universal Declaration on the Human Genome and Human Rights (1997)
The pilot phase involves compiling Canadian legislation, guidelines and case law relating to bioethics under five major themes: medical research with human beings, access to health care and essential medicines, genetic counselling, protection of future generation and freedom of scientific research.
Close2020 - 2022
Granting Agency: Ministère de la Santé et des Services sociaux (MSSS) - Revue Que´be´coise de didactique des mathe´matiques (RQDM)
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 - 2023
Granting Agency: Genome Canada - Génome Québec
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.
Close2005 - 2005
Granting Agency: Canadian Health Services Research Foundation (CHSRF)
This workshop will focus on developing knowledge brokering over internet by bringing onto play two methods of e-brokering: 1) intranets and 2) public websites, to help improve communication tools and networking mechanisms among policymakers and health professionals.
Close2020 - 2022
Granting Agency: Genome Canada
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.
Close2008 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
The goal of this project is to create a multidisciplinary team to develop strategies for uptake of nanotechnology-derived data sets. The scientific interest of this project is the identification and validation of genes that cause or predispose to brain diseases. Our team is developing approaches for interpretation and follow-up of the genetic information arising from nanosequencing in human patients. Tourette Syndrome (TS) is used as the major model of a brain disease disorder for implementation of these goals.
2013 - 2017
Granting Agency:
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.
Close2018 - 2020
Granting Agency: Erasmus Medical Center - Netherlands Organisation for Scientific Research (NWO)
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.
Close2018 - 2022
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 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - Natural Sciences and Engineering Research Council of Canada (NSERC) - Networks of Centres of Excellence (NCE) - Social Sciences and Humanities Research Council of Canada (SSHRC) - Stem Cell Network (SCN)
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.
Close1998 - 2002
Granting Agency:
This project proposes a critical analysis of the different processes by which one may assess the ethical value of research in the field of human genetics. We focus our attention on two main aspects: the participant's consent (identification of the elements of consent specific to research in human genetics and the standardization of some consent clauses ) and the continuing review and monitoring of research, after its approval by an ethics committee (what are the ethical and legal obligation to insure continuing surveillance of ongoing research projects and DNA banks? Who is responsible and how can it be achieved ?). We will set out some possible interpretations and applications which should be useful to ethical review boards and the research community in the field of genetics.
Close2020 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - The Government of Canada Public Health Agency of Canada (PHAC)
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.
Close2020 - 2022
Granting Agency: Genome Canada
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 - 2022
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.
Close2008 - 2012
Granting Agency: European Commission under the 7th Framework Program
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.
2011 - 2012
Granting Agency: European Commission - European Commission under the 7th Framework Program - Genome Canada - Stem Cell Network (SCN)
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.
2012 - 2017
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2011 - 2016
Granting Agency: Networks of Centres of Excellence (NCE)
International initiatives are emerging to address harmonization and standardization processes for SCR and banking (e.g. International Society for Stem Cell Research (ISSCR) and the International Stem Cell Banking Initiative (ISCBI)). Until recently however, these efforts adopted an ‘embryo-centric’ approach, leaving behind other timely and promising sources (e.g. induced pluripotent stem (iPs) cells, cells derived from placentas, etc.).
While certain socio-ethical and legal (ELSI) concerns are specific to the nature of SCBs, can they thrive by applying the lessons learned in biobanking generally? To answer this, we will examine the current national and international SC banking landscape against the biobanking models for human tissues generally, with a view to evaluating existing governance, commercialization and regulatory frameworks and to proposing policy recommendations to increase the upstream understanding of the factors which encourage or hinder SC translation. We will develop "international governance models" and a "Points to Consider" thereby providing a wide range of stakeholders and receptors (e.g. researchers, SC bankers, policy-makers and the general public), with analyses, strategies and solutions for moving towards translational SCR within Canada and on the global stage. Furthermore, we will build capacity by training and mentoring future ELSI researchers.
Close
2010 - 2014
Granting Agency:
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.
Close2021 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR)
The COVID-19 outbreak has highlighted the need for genomic data standards to share high- quality genomic and health data rapidly. Researchers have started to share viral and host sequence data at an unprecedented pace, a first step in creating vaccines in record time. Sharing this data is necessary to understand human diseases and eventually help patients. Doing so requires the community to agree on standard methods for collecting, storing, transferring, accessing, and analyzing data.
The Global Alliance for Genomics and Health (GA4GH) GA4GH brings together 1,000+ individual contributors and 660+ organizational members across 35+ countries 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 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. This project will support the GA4GH to bring in additional personnel, support the existing team, and drive engagement with the Canadian COVID research 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 emerging variants of concern will heavily impact.
Close2016 - 2018
Granting Agency:
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.
2018 - 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 - 2019
Granting Agency:
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.
Close2001 - 2002
Granting Agency:
Department of Energy (United States)
This research will study whether there should be any limits placed on life insurers' use of predictive genetic information in risk classification or medical underwriting. The research will focus on the following issues: 1) the current state of the science on the use of predictive genetic information in mortality risk calculations; 2) the statutory and case law addressing actuarial fairness in life insurance; 3) existing and proposed legislative activity regulating life insurers' use of genetic information; 4) the case law allowing individuals to challenge their denial of life insurance coverage or premium rates under Title III of the Americans with Disabilities Act; 5) antitrust and other legal constraints on cooperation among life insurance companies with regard to their use of predictive medical information in underwriting; 6) consumer attitudes toward life insurance and genetic information; 7) comparative law perspectives on genetics and life insurance; 8) the moral mission and social function of life insurance; and 9) the development of policy options and possible legislative and regulatory strategies.
Close2007 - 2008
Granting Agency: Genome Canada - Génome Québec
The Genetics of Type 2 Diabetes Mellitus project will identify genes that predispose people to develop Type-2 diabetes. To achieve this goal, a team of researchers at both McGill and the University of Montreal will identify genes and proteins whose function is different in the cells of people with diabetes. These will include genes and proteins that prevent the pancreas from producing proper amounts of insulin as well as those that prevent insulin from working properly in other tissues in the body. Because obesity may lead to diabetes in some people, this project will also identify genes and proteins that may link increased body weight to Type-2 diabetes.
2004 - 2007
Granting Agency: Genome Canada
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.
Close2008 - 2011
Granting Agency: Génome Québec
The SARS epidemic in Canada, the emergence of several other viral diseases such as West Nile and Avian flu as well as the threat of a new Influenza pandemic in the near future have highlighted the need to develop a rapid system to produce safe and effective vaccines. Findings emanating from this project contribute to increase the Canadian expertise and ensure its dissemination worldwide and particularly in developing countries. The Genomics and Proteomics platforms brings together a strong team composed of academic researchers in Canada, Africa, Europe and South America clinicians and industrial partners with multidisciplinary and complementary expertise.
Close2006 - 2008
Granting Agency: Génome Québec
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.
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.
Close2009 - 2011
Granting Agency: The Government of Canada Public Health Agency of Canada (PHAC)
GRaPH-Int is a global collaboration of individuals and organizations with an interest in public health genomics. The network helps transform knowledge and technologies into public policies, programmes and services for the benefit of public health. GRaPH-Int is both a Network and an Enterprise with interdisciplinary goals that support dialogue, research, education and training, communication and stakeholder engagement.
The Centre of Genomics and Policy is commissioned by the Public Health Agency of Canada to act as the international Secretariat of the Network.
2014 - 2015
Granting Agency:
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.
Close2018 - 2019
Granting Agency:
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.
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.
Close2016 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2004 - 2007
Granting Agency: Ministère délégué à la recherche, action concertée incitative internationalisation des sciences humaines (France)
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.
2008 - 2011
Granting Agency: Canadian Institutes of Health Research (CIHR)
This project proposes an empirical research in two Canadian jurisdictions that have addressed the challenge of expanded newborn screening quite differently: Ontario and Quebec. The main objectives of this project are: 1) to gain empirical and theoretical insight into the perceptions and expectations of parents and health professionals with regards to the governance of newborn screening programs, the option-provision, and the provision of information and/or decision support to parents; 2) to develop and conduct initial validation of an aid for parents; and 3) to explore ways to enhance the capacity of public health services and clinical and public health professionals to provide information and support to parents prior to the newborn screening test. This project also includes a background literature review on: 1) informed choice in newborn screening; 2) perceptions regarding storage and secondary use of newborn screening dried blood spots for research; and 3) the roles and responsibilities of clinical and public health professionals in the provision of information and decisional support for parents.
Close2013 - 2017
Granting Agency:
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).
Close2020 - 2022
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
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.
2008 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
The mission of this multi-institutional network and its transdisciplinary research programme is to serve as a catalyst:
1) To enhance the quality and impact of perinatal research in Quebec and in Canada;
2) To train the next generation of researchers in an environment that reflects CIHR’s four pillars; and
3) To create an innovative regional/provincial clinical research model ensuring evidence-based care.Important knowledge gaps concerning the long-term impact of various adverse exposures (environmental or genetic) during pregnancy on the health of future generations are due to the lack of prospective clinical research transcending obstetrics (pregnancy) into the neonatal and pediatric years.
2012 - 2017
Granting Agency:
This project proposes an integrative Epigenomic Data Coordination Centre (EDCC) at McGill, which will be a national hub to support data collection, processing, storage, and dissemination for projects funded under the Canadian Epigenetics, Environment and Health Research Consortium (CEEHRC) initiative and facilitate integration with the International Human Epigenome Consortium (IHEC). Protection of data confidentiality will be paramount, and all steps associated with data flow within the CEEHRC network will adhere to current IHEC policy through a reliance on two-tier classification of datasets, where data that cannot be aggregated to generate a dataset unique to an individual is made publicly accessible, while access to data associated with a unique (albeit not directly identifiable) person is controlled. A Centre-specific data access agreement has been developed to ensure that researchers adhere to standards of confidentiality and maintain good IT practices. Developments in the bioinformatics, IT security, scientific, and policy literature are monitored to ensure that the current classifications for “open” or “controlled” data continue to protect patients. Both the EMC and EDCC projects also involve the development of and support for a bioethics workgroup for the IHEC.
Close2012 - 2017
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2001 - 2005
Granting Agency: Canadian Institutes of Health Research (CIHR)
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?
Close2009 - 2019
Granting Agency:
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.
Close2009 - 2013
Granting Agency: Ontario Institute for Cancer Research (OICR)
The International Cancer Genome Consortium (ICGC) has been organized to launch and coordinate a large number of research projects that have the common aim of elucidating comprehensively the genomic changes present in many forms of cancers that contribute to the burden of disease in people throughout the world.
The DACO is responsible for the handling of requests for access to controlled data collected by the ICGC. It reports to both the Data Coordination Centre and the International Data Access Committee. Its objectives are to facilitate ethical, efficient and responsible transfer of controlled data to members of the scientific community who agree to the Consortium terms and objectives.
2001 - 2009
Granting Agency: Canada research Chair in law and medicine - Ministère de l'Économie et de l’Innovation (MEI) - Ministère des relations internationales (France/Québec) - Quebec - Health and Social Services
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.
2012 - 2015
Granting Agency: Canadian Institutes of Health Research (CIHR) - International Stem Cell Forum - Medical Research Council (MRC)
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.
2018 - 2023
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. 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.
Close2002 - 2005
Granting Agency:
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.
Close2004 - 2007
Granting Agency: Ministère des relations internationales (Italy/Quebec)
This project aims to establish a cooperation between Quebec and Italy in the field of bioethics. It also achieves to promote research across disciplines and institutions with the establishement of partnerships and networks between research teams. Thanks to this collaboration, researchers and graduate student will be given the opportunity to share their experiences. This endeavour is endorsed by the IIREB, a multidisciplinary institute bringing together research teams and resources from various disciplines, institutions and countries in an effort to institute partnership on major issues of biomedical ethics.
Close2014 - 2014
Granting Agency:
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.
Close2019 - 2023
Granting Agency: ONCOPOL
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’Universite? de Montre?al (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.
Close2019 - 2020
Granting Agency: Fonds de recherche du Québec - Santé (FRQS) - ThéCell
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.
Close2014 - 2016
Granting Agency:
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.
Close2004 - 2005
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2011 - 2012
Granting Agency: Canadian Institutes of Health Research (CIHR)
Making Connections is a network that brings together expert scholars to address issues surrounding the governance of biobanks. In 2011, the fourth Making Connections’ workshop was held in Montreal on October 10-11, just prior to the International Congress of Human Genetics Meeting. The workshop had four objectives:
- Continue the expansion of the international biobanks governance network.
- Examine possible pathways towards an effective and proficient use of biobanks in translational research and clinical applications.
- Publish a guidance document on translational challenges and solutions for national and international stakeholders and widely disseminate it.
- Identify opportunities for funded research and policy project.
A policy statement on the return of research results and incidental findings in population studies - developed in collaboration with the Public Population Project in Genomics - was discussed at the meeting and is published by P
3G.<http://www.p3g.org/secretariat/news/P3G%20 Return%20of%20Results.pdf>
2004 - 2009
Granting Agency:
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.
Close2008 - 2010
Granting Agency: Canadian Institutes of Health Research (CIHR)
This study focuses on how publicly funded infrastructures (DNA repositories) can use a Uniform Material Transfer Agreement (UMTA) to: 1) better define and respect the rights of participants, funding agencies and potential researchers; 2) preserve the open-source approach of publicly funded infrastructures; 3) preserve patentability and licensing of resulting intellectual property; 4) clearly define research limits in light of public purpose and the participant’s informed consent; 5) establish national and international transfer modalities for biological samples and data; and 6) define related risks and responsibilities. A proper analysis of these aspects may reveal that MTAs can, at least provisionally, in the absence of specific legislation, be used as a flexible and efficient tool in the context of research infrastructures improving predictability, public protection (and incidentally confidence), decreasing negotiation delays and setting important standards in the field. It is hoped that these proposed standards will influence the private sector as well.
Close2011 - 2013
Granting Agency:
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.
Close2006 - 2012
Granting Agency: Canadian Institutes of Health Research (CIHR)
MIREC is a national five-year research study that is recruiting about 2,000 women from the following cities: Vancouver, Calgary, Winnipeg, Sudbury, Ottawa, Kingston, Hamilton, Toronto, Montreal and Halifax. Women will be recruited during the first trimester of pregnancy and followed through pregnancy, up to eight weeks after birth. The main goals of this study are:
• To measure the extent to which pregnant women and their babies are exposed to environmental chemicals, as well as tobacco smoke;
• To assess what pregnancy health risks, if any, are associated with exposure to heavy metals (lead, mercury, cadmium, arsenic and manganese);
• To measure the levels of environmental chemicals and some of the beneficial components (nutritional and immune constituents) of breast milk.
2004 - 2009
Granting Agency: Canadian Institutes of Health Research (CIHR)
The implementation of the research objectives set out in this project and the creation of a research platform and tissue bank cannot proceed until a variety of a legal, ethical and social issues have been considered. The ethical issues we propose to address include: 1) recruitment (consent) and participation of children; 2) biobanking of materials from mothers and children; 3) secondary use of information/tissues; and 4) the return of results.
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.
Close2002 - 2003
Granting Agency:
Seaver Institute
The project, which has been funded by the Seaver Institute, will focus on developing real world case studies of Models of Ethical Decision-Making in Bioscience Firms. The project's objective is to develop a framework for understanding the key factors affecting the attention given to ethical issues in the strategic decision-making of bioscience firms and to identify policies and practices that can be used to enhance these firms' capacity to self-regulate the ethical component of their business decisions.
Close2012 - 2017
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 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.
Close2018 - 2019
Granting Agency:
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.
Close2007 - 2010
Granting Agency: SSHRC - Social Sciences and Humanities Research of Canada
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.
Close2011 - 2014
Granting Agency: Génome Québec
The project proposes to develop a prognostic gene signature and validate a "made in Quebec" clinical test for ER-positive breast cancer patients. The ELSI portion of this project, for which the Centre of Genomics and Policy has primary responsibility, revolves around the barriers to the adoption of new technologies into clinical practice. We are focusing first on the educational factors that might limit uptake or understanding of these tests. That is, does the education received by physicians and nurses as part of primary or continuing education curricula adequately take into account the growth of genetic medicine in everyday medical practice? We will also be pursuing a qualitative study beginning in the spring of this year. For this, we will be interviewing or sending questionnaires to clinical care providers to obtain their input on what barriers exist for them, if any, for the use of genetic testing in their practices. From this we hope to develop a discussion paper on barriers to uptake of new genetic technologies, including educational and any other that arise from the qualitative study.
2019 - 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: MI4 Emergency COVID-19 Research Funding (ECRF) - Social Sciences and Humanities Research Council of Canada (SSHRC)
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.
Close2018 - 2019
Granting Agency:
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.
Close2020 - 2022
Granting Agency: Department of National Defence (Canada) - Mobilizing Insights in Defence and Security (MINDS)
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.
Close2014 - 2018
Granting Agency:
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).
Close2012 - 2013
Granting Agency: Stem Cell Network (SCN)
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.
Close2007 - 2010
Granting Agency: Genome Canada
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.
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.
Close2013 - 2017
Granting Agency:
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.
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.
Close2001 - 2003
Granting Agency: VRQ - Valorisation-recherche Québec
Valorisation recherche Québec Genomics provides the opportunity to design and develop new drugs and to predict responsiveness to drug interventions, since drug response is partly determined by the genetic susceptibility of the individual. In the long term, it promises to individualise practices of prescription by narrowing the target populations exclusively to those for which the medication is safe and effective. In pharmacogenomics, research undertaken to develop new adapted drugs, necessitates frequent manipulation of genetic data. To develop a drug that is effective in a particular sub-group of patients, taking into consideration phenotype and genotype, genetic tests will be necessary for the identification of a specific population. The widespread use of genetic tests in research requires special consideration. Genetic information is a veritable fountain of knowledge with various preventive and therapeutic properties. It embodies very sensitive and intimate pieces of information. Unlike most general medical information, it possesses, an individual, a familial and a collective dimension. Even if genetic material is, by nature, specific and unique to each individual, it can also reveal personal information about blood relatives and indicate some medical trends encountered in a particular population. With the explosion of genetic knowledge comes a plethora of ethical, legal and social issues. The integration of pharmacogenomics into drug development adds new dimensions to the process. The fact that genetic data are manipulated, analysed and stored in this context, calls for the adaptation of legal and ethical standards. Clinical drug trials and biomedical research undertaken in the fields of genetics and genomics and involving DNA banking are both governed by numerous legal and ethical guidelines. The present analysis will look at some of the issues, questions and problems that may arise at different levels of application of pharmacogenomics: during the process of drug development and discovery and the consequences for health care. Investigators at the CRDP will use the HUMGEN database in order to compile and analyze policies related to DNA sampling, banking, consent and data protection in genetic research. This analysis will be used as a basis for the establishment of a legal and ethical framework in pharmacogenomics research.
Close2006 - 2009
Granting Agency: Génome Québec
Genetic differences among patients are believed to account for variations in drug responses. While genomics is opening the way to personalized, predictive and preventive medicine, pharmacogenomics, in particular, uses a patient's genetic information to predict individual responses to medication. Pharmacogenomics is important since adverse drug reactions are a leading cause of hospitalization and mortality in Canada, the United States and Europe.
The team will investigate the toxicity of lipid lowering drugs, especially statins (which are used to treat atherosclerosis) and the concentration of lipids or fats (which narrow or block the arteries). The team will also study the efficacy of new anti-atherosclerotic agents.
The team expects to identify relevant biomarkers, which can then be used to develop diagnostic tests. This will help determine how patients will respond to treatments for cardiovascular disease based on their genetic profile. The project will also develop ethical guidelines to help plan future pharmacogenomic research and will develop models and strategies to integrate genetic knowledge into health care practices.
2004 - 2005
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2013 - 2017
Granting Agency:
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.
Close2018 - 2023
Granting Agency: Terry Fox Research Institute
The PRecision Oncology For Young peopLE (PROFYLE) program aims to transform cancer treatment in children, adolescents, and young adults by using next-generation molecular tools and cancer model systems to identify disease and patient-specific biomarkers. The project emphasizes real-time molecular profiling to personalize cancer treatment and improve outcomes. The CGP studies questions surrounding access to genetic data by parents and the use of mobile health applications when streamlining recruitment processes. Our team proposes policy recommendations for improving access to molecular profiling and associated treatment applications. The team will further identify ethical and legal issues raised by the development of mobile health technologies that facilitate patient recruitment and that promote equitable access to molecular profiling. This research will lead to the development of a points to consider document to guide PROFYLE’s work toward developing a mobile application.
Close2016 - 2019
Granting Agency:
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.
Close2016 - 2021
Granting Agency: Le Centre de recherche du CHU de Québec-Université Laval
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
Close2019 - 2020
Granting Agency: Ministère de l'Économie et de l’Innovation (MEI)
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
Close2014 - 2015
Granting Agency:
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.
Close2019 - 2020
Granting Agency: Office of the Privacy Commissioner of Canada
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.”
Close2004 - 2007
Granting Agency: SSHRC - Social Sciences and Humanities Research of Canada
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.
2018 - 2022
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.
Close2009 - 2015
Granting Agency: Canadian Institutes of Health Research (CIHR)
The QTNPR network is creating a multidisciplinary curriculum on the impact of environmental exposures on maternal and child health. The objectives of QTNPR are to 1) provide trainees the knowledge, skills, and values that will allow them to address the complex interdisciplinary challenges of the current reproductive and perinatal health environment; 2) integrate into a single training network several research groups with complementary expertise in reproductive, perinatal, and infant health research; 3) link state-of-the-art, discipline specific teaching to crosscutting core competencies in the form of a transdisciplinary training grid; and 4) establish and maintain national and international partnerships with relevant complementary training programs.
2011 - 2012
Granting Agency:
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.
Close2011 - 2015
Granting Agency: Fonds de la recherche en santé du Québec
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).
2018 - 2019
Granting Agency:
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).
Close2014 - 2017
Granting Agency:
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.
Close2021 - 2022
Granting Agency: Stem Cell Network (SCN)
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.
Close2004 - 2009
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2001 - 2003
Granting Agency:
Department of Energy (United States)
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.
2018 - 2022
Granting Agency: National Institutes of Health (NIH)
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.
Close2016 - 2021
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2003 - 2008
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2008 - 2016
Granting Agency: Fonds de la recherche en santé du Québec
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.
Close
2014 - 2019
Granting Agency: Fonds de partenariat pour un Québec innovant et en santé (FPQIS)
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.
Close2011 - 2013
Granting Agency: National Institutes of Health (NIH)
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.
2013 - 2017
Granting Agency:
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.
Close2020 - 2022
Granting Agency: Canadian Foundation for Innovation (CFI)
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.
Close2020 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - Natural Sciences and Engineering Research Council of Canada (NSERC) - Networks of Centres of Excellence (NCE) - Social Sciences and Humanities Research Council of Canada (SSHRC) - Stem Cell Network (SCN)
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.
Close2011 - 2012
Granting Agency: Génome Québec
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.
Close2014 - 2017
Granting Agency:
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.
Close2001 - 2005
Granting Agency: Stem Cell Network (SCN)
The Stem Cell Network is a bold new venture for Canada that brings together more than 50 leading scientists, clinicians, engineers, and ethicists, with the mandate to investigate the immense therapeutic potential of stem cells for the treatment of diseases currently incurable by conventional approaches.
The major research themes include:
1) ethical, legal, social, and policy issues
2) biology of stem cells
3) bioengineering of stem cells and
4) clinical applications.
Under the first theme, the CRDP is working with other bioethics researchers in Canada on the issues of : the sources of stem cells (embryos; fetal tissues, adults...); the commercialization of research, animal models, regulatory and policymakers approaches and, the ethics of research.
The HumGen database will be a core facility to ensure accessibility to international, comparative policy statements. A special module (StemGen) on stem cell, cloning and gene therapies has been created.
Close2005 - 2008
Granting Agency: Stem Cell Network (SCN)
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.
2004 - 2005
Granting Agency: Canadian Institutes of Health Research (CIHR)
The aim of the project is to summarize current practices and relevant socio-ethical and legal concerns underpinning the storage, consent, ad access to screening materials leftover from newborn screening programs. We propose the following objectives: - Review the policies and practices for storing DBS internationally - Survey of screening laboratory policies and practices for storing DBS in Canada - Review Canadian legislation and case law to see whether storage, access or further use of stored Guthrie cards has or could lead to infringement of property or privacy rights or to discriminatory practices - Build a Canadian multidisciplinary Newborn Screening Task Force - Host a workshop addressing newborn screening program practices regarding storage.
Close2009 - 2014
Granting Agency: Canadian Institutes of Health Research (CIHR)
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.
Close2011 - 2013
Granting Agency: MDEIE - Programme de Soutien à la Recherche - Volet 2
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.
Close2005 - 2008
Granting Agency: SSHRC - Social Sciences and Humanities Research of Canada
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.
Close2013 - 2017
Granting Agency:
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.
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 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.
Close2011 - 2014
Granting Agency: Génome Québec
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?
2005 - 2006
Granting Agency: Stem Cell Network (SCN)
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.
Close2016 - 2022
Granting Agency: Canadian Institutes of Health Research (CIHR)
The gender dimorphic effects of prenatal stress are well demonstrated. Girls may be more sus- ceptible to the effects of fetal adversity on fearful temperament, emotional reactivity and inter- nalizing 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 gen- der-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.
Close2006 - 2009
Granting Agency: Génome Québec
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
2019 - 2020
Granting Agency: Network of Applied Genetic Medicine
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.
Close2009 - 2019
Granting Agency: University of Glasgow
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.
Close2011 - 2014
Granting Agency: Génome Québec
The project proposes to identify novel prognostic markers and therapeutic targets in acute myeloid leukemia. The ELSI portion of this project, for which the Centre of Genomics and Policy has primary responsibility, analyzes the new Tri-Council Policy Statement requirement that material incidental findings be disclosed to research participants. Of particular interest are how diligent must researchers be in looking for ‘incidental findings’, how should they be disclosed, and how is this obligation funded (or not). We will also be pursuing a qualitative study that will ask researchers about difficulties they have had with this obligation, whether it be know what to disclose, how to disclose it, or how to fund the staff to assist in the disclosure if the researcher is not him- or herself qualified to do so.
2019 - 2022
Granting Agency: Jewish General Hospital Foundation
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.
Close2004 - 2005
Granting Agency: Health Canada
The Project’s objectives are to identify and describe the legislative framework governing infectious and/or reportable diseases for selected jurisdictions, and to create an international comparative table of laws and guidelines addressing selected themes. The following jurisdictions and organisations have been selected: Australia, New Zealand, the United Kingdom, the United States of America, the World Health Organisation and the Pan-American Health Organization.
Close2006 - 2020
Granting Agency: Fonds de recherche du Québec - Santé (FRQS) - Network of Applied Genetic Medicine
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.
Close2008 - 2012
Granting Agency: Stem Cell Network (SCN)
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.
2010 - 2013
Granting Agency: Canadian Institutes of Health Research (CIHR)
This project aims to examine whole-genome sequence variations from a sample of childhood leukemia (ALL) patients with the following aims: 1) to identify novel sequence and structural variants in childhood ALL genomes; 2) to explore changes in gene expression associated with ALL by examining the transcriptome and allelic expression; 3) to assess the impact of selected genes on disease susceptibility and disease outcomes and investigate the functional significance of these genes in vitro; and 4) to translate the genetic discoveries into appropriate health care policy and services. These findings will ultimately lead to the development of powerful research and clinical tools that could improve detection, diagnosis and treatment of childhood leukemia. The CGP aims to identify ethical, legal and social issues in the return of pediatrics research results. More specifically, our Centre is reviewing the ELSI implications of Genome-wide re-sequencing results on children and parents. This involves an analysis of international and national policy statements, the obligations and needs of researchers and health professionals regarding the return of research results, and the needs of families and their children. This analysis will culminate in the production of a comprehensive discussion document. The development of the discussion document also involves literature and policy review, interviews with healthcare providers and families, and collaboration with various stakeholders.
2010 - 2014
Granting Agency:
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?
Close2009 - 2020
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
Created in 2009, the Québec Cell, Tissue and Gene Therapy Network (ThéCell) focuses on the development of novel cell, tissue and gene therapies to improve patient care in an innovative and sustainable manner. It brings together researchers with diverse expertise in the field of regenerative medicine within Quebec to build a multi-disciplinary team. The Network aims to promote and structure translational research and advance knowledge, technological tools and treatments in regenerative medicine. Prof. Knoppers and CGP members support researchers in their reflection on ethical, legal and social issues (ELSI) raised by the transition from bench to bedside of emerging cell and gene therapies. This comprises two components: 1) Assisting researchers in the development of research protocols (sample governance mechanisms, recruitment and participants’ consent processes); 2) Providing support in the regulatory approval process for these clinical trials. The multidisciplinary aspect of the Network makes it possible to consider and integrate ELSI concerning the scientific reality of clinical trials in regenerative medicine.
Close2013 - 2014
Granting Agency: Fonds de recherche du Québec - Santé (FRQS)
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.
Close2009 - 2022
Granting Agency: Fonds de la recherche en santé du Québec
Created in 2009, the Québec Cell, Tissue and Gene Therapy Network (ThéCell) focuses on the development of novel cell, tissue and gene therapies to improve patient care in an innovative and sustainable manner. It brings together researchers with diverse expertise in the field of regenerative medicine within Québec to build a multi-disciplinary team. The Network aims to promote and structure translational research and advance knowledge, technological tools and treatments in regenerative medicine. Prof. Knoppers and CGP members support researchers in their reflections on ethical, legal and social issues (ELSI) raised by the transition from bench to bedside of emerging cell and gene therapies. This comprises two components: 1) assisting researchers in the development of research protocols (sample governance mechanisms, recruitment and participants’ consent processes) and 2) providing support in the regulatory approval process for these clinical trials. The multidisciplinary aspect of the Network makes it possible to consider and integrate ELSI concerning the scientific reality of clinical trials in regenerative medicine.
Close2018 - 2023
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.
Close2003 - 2004
Granting Agency: Canadian Institutes of Health Research (CIHR)
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).
Close2020 - 2023
Granting Agency: Canadian Institutes of Health Research (CIHR) - Natural Sciences and Engineering Research Council of Canada (NSERC) - Social Sciences and Humanities Research Council of Canada (SSHRC) - Stem Cell Network (SCN) - Université Laval Networks of Centres of Excellence (NCE)
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.
Close2011 - 2014
Granting Agency: Fonds de la recherche en santé du Québec
This project focuses on three questions relating to a disease-specific biobank: Given its current ethical framework, can the liver biobank e-contact research participants for updates to enrich the quality of the bank? If so, what measures will need to be taken to meet Canadian and international ethical standards? How can a policy to return incidental findings be developed that takes advantage of a double-coding system of privacy protection but is streamlined and efficient? What is the scientific, ethical, legal and policy framework applicable to the return of results in the context of a personalized medicine biobank project?
Close2005 - 2009
Granting Agency: Stem Cell Network (SCN)
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).
Close2003 - 2008
Granting Agency: Canadian Institutes of Health Research (CIHR)
It will take many years for new genetic discoveries to be fully translated into improvements in health and health care. However, policy makers already have to make decisions about emerging genetic technologies, without evidence of their benefits, costs or other consequences. If we do not evaluate technologies or services, we do not know whether they achieve what is intended, or whether they are a good use of limited resources. However, as well as these technical issues (effectiveness and efficiency), research in genetics needs to reflect wider societal concerns about the potential for harm to individuals and groups, and how we might minimize such harm. In order to begin addressing these issues, this new team is bringing together research expertise and approaches from a broad range of disciplines. The team will focus on identifying and prioritizing the most important research questions, using rigorous research methods to answer them, and communicating what is learnt in effective ways with those who need to know: the general public, providers of health care, and those who make decisions about what and how services should be provided. The team will also aim to train the next generation of researchers, and to enhance understanding and expertise across the disciplinary boundaries.
Close2011 - 2015
Granting Agency: Networks of Centres of Excellence (NCE)
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).
2016 - 2017
Granting Agency:
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.
2020 - 2023
Granting Agency: Fonds de recherche du Québec (FRQ)
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 - 2023
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.
Close2019 - 2021
Granting Agency: Fonds de recherche du Québec (FRQ) - Ministère de l'Économie et de l’Innovation (MEI) - World Anti-Doping Agency (WADA)
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.
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