What are the funding sources for CARTaGENE?

CARTaGENE is financed by Genome Quebec and Genome Canada, two public organisations that provide funding for scientific research in genomics in Canada.

What exactly is meant by: “CARTaGENE is a public resource for research”?

The CARTaGENE project is an initiative by academic researchers.

It is a non-profit project financed by Canadian and Quebec funding agencies (Génome Québec and Genome Canada).

CARTaGENE also works in partnership with governmental organisations: the Régie de l’assurance maladie du Québec (RAMQ) (Quebec Health Insurance Board) and the Institut national de santé publique du Québec (INSPQ) (Quebec Institute of Public Health).

CARTaGENE data and samples will be transmitted to researchers who submit requests for access and whose projects meet CARTaGENE’S scientific and ethical requirements.

Has there been any public consultation concerning the CARTaGENE project?

Focus groups and surveys have been done to identify concerns people might have regarding the CARTaGENE project (Community Genetics, 2007).

Furthermore, workshops have also been held with professionals involved in ethics, law and public policy.

The project leaders took the results of these consultations into consideration when developing the CARTaGENE project.

What institutions collaborate with the CARTaGENE Project?

The Université de Montréal is the academic institution in charge of the project.

The Régie de l’assurance maladie du Québec (RAMQ) (Quebec Health Insurance Board) is involved in the selection and the recruitment of individuals who are potential participants, through its unit called «the CARTaGENE Service of the RAMQ» (CaG-RAMQ Service).

Blood and urine samples transmitted to CARTaGENE will be stored in The Genome Quebec - Centre hospitalier affilié universitaire régional de Chicoutimi Biobank in Saguenay that is located at the Centre hospitalier universitaire régional de Chicoutimi.

Thanks to the Institut national de santé publique du Québec (INSPQ) (Quebec Institute of Public Health) and the Régie de l’assurance maladie du Québec (RAMQ) (Quebec Health Insurance Board), CARTaGENE will be able to grant access to the information contained in government databases to researchers who meet the required scientific and ethical criteria.

What is the role of the Régie de l’assurance maladie du Québec (RAMQ) in the CARTaGENE project?

Direct communication with potential participants has been entrusted to the CARTaGENE Service of the Régie de l’assurance maladie du Québec (CaG-RAMQ Service), a public governmental organisation.

The CaG-RAMQ Service keeps the consent forms as well as the participants’ personal information in a secure location.

The CaG-RAMQ Service is the only organisation who can re-contact the participants in the future.

The CaG-RAMQ Service will only re-contact participants who have consented to being re-contacted for future research projects.

Participants must contact the CaG-RAMQ Service if they want to withdraw from the CARTaGENE Project.

What governance organisations oversee CARTaGENE’s activities?

The Research Ethics Committee (REC) of the Faculty of Medicine of l’Université de Montréal will be in charge of the ethical evaluation and supervision of CARTaGENE. This committee has approved the CARTaGENE project.

The CARTaGENE Project data and sample collection phases will be supervised, evaluated and approved by the research ethics committees (called: «RECs») of each healthcare facility where collection takes place.

The healthcare facility RECs are independent from the CARTaGENE Project and must report to the Ministry of Health and Social Services via the Principal REC and following the multicentric process established by this Ministry. The CHUM’s REC is the Principal REC.

The Commission d’accès à l’information du Québec (Commission for Access to Information of Québec, CAI) authorizes the use of information contained in government databases and occasionally verifies this use.

CARTaGENE’s Sample and Data Access Committee (called: «SDAC») will examine and approve the requests from researchers who wish to have access to CARTaGENE’s data and samples.

What is a research ethics committee?

The role of a research ethics committee (REC) is to evaluate research activities involving human participants to ensure that they will respect the ethical rules of the institution to which the REC is attached. The MSSS as well as the other federal funding organisations (CRSH, CRSNG and IRSC) also impose ethical rules to the institutions and the REC assures that they are respected.

Amongst other tasks, RECs also review confidentiality and consent procedures.

All research projects, including those that are made possible by the use of CARTaGENE’s banks, and CARTaGENE itself, must receive approval from a REC before starting to recruit participants.

What is free and informed consent?

Before an individual agrees to participate in a research project, the researcher responsible for the project must make sure that this person is informed of the nature of the research project, of the participation that is expected, of the benefits and advantages of participation as well as the risks and inconveniences that may be associated with participation in the project.

The researcher must also make sure that the individual understands the information that is given to him/her, answer questions about the project and the individual’s participation and offer any required additional explanations.

The individual can then decide whether to participate or not in this research project and remains free to withdraw his/her participation at any time.

What is the role of the Commission d’accès à l’information du Québec (Commission for Access to Information of Québec, CAI) in the supervision of the CARTaGENE Project?

Data stored by CARTaGENE is supervised by CAI and falls under the Loi sur l’accès aux documents des organismes publics et sur la protection des renseignements personnels (Act respecting access to documents held by public bodies and the protection of personal information).

The CAI is an organisation of the government of Quebec whose goal is to ensure the protection of personal identifying information (called «personal information») stored by public or private organisations.

Within the CARTaGENE Project, the CAI will authorise the CARTaGENE Service of the Régie de l’assurance maladie du Québec (CaG-RAMQ Service) to use the names and addresses of participants for recruitment purposes and for re-contact in the case of future research projects. The CAI will also authorise the requests from researchers using the CARTaGENE banks when they need to obtain government-held data regarding participants.

The CAI additionally has the power to investigate and inspect, in order to verify that the collection, use, communication and conservation of personal information are done in accordance with the Act.

Under what conditions will researchers have access to the CARTaGENE data and samples?

Researchers whose studies have received all required ethical and scientific approvals will be able to request to have access and use CARTaGENE’s data and samples as well as information contained in government databases if the use of this data is scientifically justified.

Requests from these researchers will be submitted to evaluation by the concerned RECs. Their research projects will also be examined for their scientific validity by the Sample and Data Access Committee that is independent from CARTaGENE (called «SDAC»).

If a researcher also wants to use data contained in government databases, the request will have to be approved by the Commission d’accès à l’information (Commission for Access to Information CAI), a public organisation that is independent from CARTaGENE and from the government. The CAI will decide on the scientific relevance and whether the researcher has taken adequate measures to respect the confidentiality of these data and prevent them to be linked to any participant.

What is the link between CARTaGENE and the P3G consortium (Public Population Project in Genomics)?

The P3G Consortium is a public organisation that brings together several institutions or researchers who are in charge of large population databanks or biobanks like the CARTaGENE banks and that wish to establish international research collaborations.

CARTaGENE is a member of P3G.

What is the role of CARTaGENE within the P3G consortium?

The P3G consortium ensures worldwide leadership in health and genetic population genomic research.

It harmonizes research and promotes tools and methodologies developed by CARTaGENE. This makes CARTaGENE a worldwide leader and ensures scientific outreach.

Through collaboration with other P3G member projects, the statistical power of the analyses in increased. In this way, national efforts and investments in research are maximized.

Any request for the use of CARTaGENE banks, whether from a member of P3G or not and whether the research project is from Quebec or elsewhere in the world, will have to meet CARTaGENE’s standards and will have to obtain appropriate ethical and scientific approvals.

How is CARTaGENE collaborating with the Canadian Partnership Against Cancer Project ?

The Canadian Partnership for Tomorrow Project is a national endeavour aimed at creating a research platform (including four other provincial biobanks).This national cohort of participants will be followed through time (a longitudinal cohort). The objective of this platform is to foster research that seeks to reduce the number of new cancer cases and other chronic diseases in Canada while improving the quality of life of people with these diseases.

The methodology of the CPAC biobanks is harmonised to allow the pooling of data from the different provincial cohorts. Ultimately, the Canadian cohort (divided into provincial cohorts) will contain about 300 000 Canadians. The provinces of Alberta (50 000), Ontario (150 000), Atlantics (30 000), British-Colombia (40 000) and Quebec (20 000) have cohorts in development.