CARTaGENE Governance Policies
CARTaGENE banks policies
This policy is intended to establish the rules under which CARTaGENE establish, conserved and managed banks, and under what circumstances and how they cease their activities in accordance with the commitments made to participants. This policy especially states that the collection of data and samples by CARTaGENE should be made from participants who have given free and informed consent, respecting the dignity and privacy. In addition, the recruitment of participants, the collection, the processing, the storage and the subsequent use of this data and samples should preserve confidentiality so that at any time no participant can be identified.
Data and Sample Access and use Policy
This policy is intended to regulate the demands that will be made by researchers who wish to use data and / or samples of CARTaGENE. To be approved, an access request must go through a rigorous authorization process. Indeed, the research project must be approved by the local ethics committee of the institution where the researcher is attached. In addition, the access request must be approved by the CARTaGENE ethics committee as well as the independent Sample and Data Access Committee (SDAC).
To get the SDAC scientific committee approval, the access request must meet certain criteria, including compliance with the conditions of use, the scientific quality of the research proposal, reliable security measures for storage and transport, and a project that targets new knowledge in areas such as genomics, biomedical sciences, clinical medicine, epidemiology and public health. In addition, CARTaGENE must be informed of the results arising from the research projects that use CARTaGENE data or samples. Researchers using data or samples are invited to publish the results of their research to allowing the scientific community and the general public to benefit from them.
The use of CARTaGENE data and samples is made in respect of the dignity and the protection of the privacy of participants. Indeed, the information transmitted to the researcher are always encoded and do not identify the participant. The researcher access contract provides that s/he agrees to keep confidential any personal participant information whose s/he could learn by mistake.
Laws and ethical norms
- Canadian Charter of Rights and Freedoms (Schedule B to the Canada Act 1982 (U.K.) 1982, c. 11)
- Québec Charter of Human Rights (R.S.Q., c. C-12)
- Civil Code of Québec (L.Q., 1991, c. 64.)
- Act respecting Health and Social services (R.S.Q., c. S-4.2)
- Act respecting Access to documents held by public bodies and the Protection of personal information (R.S. Q., c. A-2.1)
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010)(EPTC2)
- Best Practices for Protecting Privacy in Health Research (2005) issued by the Canadian Institutes of Health Research (CIHR)
- Statement of Principles: Human Genome Research (2000) (RMGA)
- Rapport du groupe-conseil du FRSQ/MSSS sur l’encadrement des banques de données et de matériel biologique à des fins de recherches en santé (2007)
- Helsinki Declaration of the World Medical Association (revised in 2008)
- Universal Declaration on the Human Genome and Human Rights (1997)
- International Declaration on Human Genetic Data (2003) and the Universal Declaration on Bioethics and Human Rights (2005), UNESCO
- Plan d’action ministériel en éthique de la recherche et en intégrité scientifique from the MSSS (1998)
- Guide d’élaboration de normes de gestion des banques de données also from the MSSS (2004)
- Document de gestion des banques de données constituées ou utilisées pour des fins de recherche (2006) and the Politique de la recherche avec des êtres humains (2004)
Ethical and legal monitoring
CARTaGENE remains, throughout its existence, subject to a rigorous ethical review. Originally approved by several ethics committees, it is now the CHU Sainte-Justine ethic committee that is responsible of CARTaGENE project. The establishments of CARTaGENE, the mechanisms and the documentation relating to its governance and the management, including the management policy were subject to ethic approval in accordance with the policies and regulations.
CARTaGENE is also subject to the supervision of the Commission d’accès à l’information du Québec (CAI), an organization that has the power to authorize information transfer from the RAMQ to the call center that contacts the participants. All personal information held by CARTaGENE are subject to the supervision of the CAI and the Loi sur l’accès aux documents des organismes publics et sur la protection des renseignements personnels. The CAI is an organism that seeks to ensure the protection of personal information held by public or private organizations. It also has the authority to conduct audits and inspections to CARTaGENE to ensure that the collection, retention, use and disclosure of personal information should be made in accordance with applicable laws.
Management of CARTaGENE
Management and financing
CARTaGENE is managed by the CHU Sainte-Justine Research Centre. The CHU Sainte-Justine ethic committee is currently responsible for ethical oversight of CARTaGENE in accordance with the policies and regulations. The financial support of CARTaGENE is currently provided by Genome Quebec and the Canadian Partnership against Cancer (CPAC).
The executive director is responsible for all operational aspects of CARTaGENE. The executive director’s responsibilities include the redistribution of resources when and where needed to ensure that the objectives are met. She is also responsible for ensuring that measures are in place to protect the identity of participants and confirm the withdrawal of any participant. Finally, she negotiates service agreements with consultants and suppliers.
Scientific Steering committee
A committee of genomics researchers and potential users of CARTaGENE banks was established. It brings together established and emerging scholars in various fields of biomedical research and with a strong interest in human genomics in Québec and elsewhere. This committee purpose to inform the CARTaGENE Project about the perspective of researchers and thus ensure that the resource is developed for optimal scientific use.
Scientific Advisory Board
The scientific advisory committee has been mandated by Genome Quebec, the granting agencies of CARTaGENE. It was created to provide guidance to help define the milestones and deliverables, and to assess the progress of the project. Its functions include the following: make recommendations regarding the establishment of strategic priorities, suggest changes in the scope and direction of activities, provide advice on policies, trends and best practices and the development of cohort or for new technologies.
Sample and Data Access Committee
The Sample and Data Access Committee (SDAC) is responsible for the scientific evaluation and decisions issued with respect to requests for sample and data access in accordance with the Sample and Data Access Policy (SDAP).
Governance structure and roles of CARTaGENE within the Canadian Partnership for Tomorrow Project
CARTaGENE is the Quebec part of the Canadian Partnership for Tomorrow Project (funded by CPAC). Its activities are supervised by members of the International Scientific Advisory Board appointed by the Board of Directors of CPAC and other entities established to coordinate and provide specific services to guide regional cohorts in achieving their business and scientific objectives.
- Board of Directors: This committee makes recommendations on the distribution of funding from the Canadian Partnership against Cancer (CPAC), oversees the development of a long-term strategy for funding, monitoring the progress of regional projects and approves budgets accordingly.
- International Scientific Advisory Board: This committee has a similar mandate to the scientific advisory committee of GQ. It reports to the Board of Directors.
- National Coordinating Centre: This committee has a mandate to facilitate the coordination of regional activities to achieve the objectives.
- Working groups: Four committees or working groups have been established to provide services on various subjects such as biological samples, ELSI (Ethical, Legal and Social Implications), harmonization and communication.