Data Access procedure

Eligibility

Any scientific researcher working in a public or private organisation at the national or international level may apply for access to CARTaGENE samples or data.

A valid account is required in order to proceed with a new data access request.

Relevant research areas

To accommodate CARTaGENE's overreaching goals in health and genomics, applications that propose projects in areas such as, but not limited to: population genomics, biomedical research, epidemiological research and public health research may be considered for access.

Processus

Step 1 : Evaluation of feasibility and informatics security measures

The application form must be completed online by all researchers requesting CARTaGENE data and/or samples. CARTaGENE is responsible for evaluating the feasibility of proposed projects as well as whether security requirements are met. Application forms may be submitted by researchers at any time. Two weeks are needed to inform researchers of its decision. Written reviews will be provided with recommendations concerning the feasibility of proposed projects, associated security measures, and estimated costs for data and sample access (where applicable).

Please note that all access requests involve a one time, non-refundable 500$ (CAD) fee. This fee is applicable to all access registrations and applications whether access is granted or not and is not refundable. We will process your application once payment has been received in full. Please address the cheque to the CHU Ste-Justine (CARTaGENE) indicating directly on the cheque (on the back or at the bottom): "registration fees" and the name of researcher/PI.

Mailing address:

CARTaGENE
c/o Maria Barone
3333 Chemin Queen Mary, suite 490/493
Montreal, Quebec
H3V 1A2

Step 2 : Submission of required documents to the SDAC Committee

Researchers who have received a positive response from CARTaGENE will be invited to continue the access procedure. The access application must contain all documents and information required for a full assessment of the project.

A complete application submission will include the following documents:

  1. A fully-developed research proposal. Applications can only be evaluated if a complete and well-argued proposal includes background information, research objectives, research plan and methods, expected outcomes and benefits, and a general timetable and total proposed budget.
  2. Consent forms (if applicable)
  3. CV of the proposed project’s principal investigator (PI)
  4. Certificate of approval from the PI’s institution’s Research Ethics Board (REB)

Step 3: Verification of submitted documents by CARTaGENE

CARTaGENE verifies the documents provided by the researcher at step 2 before transfering the application for the scientific review by the SDAC.

Step 4: Scientific review by the SDAC

An independent committee called Sample and Data Access Committee (SDAC) evaluates all complete applications. SDAC members are appointed to the committee by the Director of the CHU Sainte-Justine. The expertise of these members covers the following fields: population genomics, epidemiology, public health, and environmental health from institutions across Quebec. The SDAC’s mandate is to evaluate the scientific aspects of the project and make sure its objectives are aligned with those outlined by CARTaGENE. Decisions are taken by absolute majority rule.

The following criteria are taken into account in the review process:

  1. Scientific merit;
  2. Potential impact of the project;
  3. Appropriateness of the budget, resources, and timelines; Security measures;
  4. The applicant’s track record and the research team’s competence.

SDAC meetings are scheduled at a minimum of four (4) times a year. Completed applications must be submitted at least two weeks before a meeting. The written decision of SDAC will be communicated to applicants two weeks after the meeting.

Note: SDAC will not eval​uate any access request if the project has not received a certificate of ethical approval from the principal investigator’s local Research Ethics Board.

Step 5: Ethical review

Sample and data access will be finalized once approval from the “Comité d’éthique de la recherche” board at the CHU Sainte-Justine has been granted. Please contact Geneviève David for more details about your project submission to REB.

Note: CHU Sainte-Justine REB will not evaluate any access request if the project has not been reviewed by a recognized scientific peer review committee (eg: CIHR, FRSQ, SDAC).

Step 6: Sample and Data Access Agreement and Transfer of Data and/or Samples

Once the sample and data access application has been approved, the researcher will be required to sign a Samples and Data Access Agreement which outlines the terms of use, duration of the project, samples and data security, reports, results, publications, and costs.

Reporting and publications

Researchers using CARTaGENE data and/or samples are required to complete annual reports as well as a final report at the end of the project. A summary of the project’s results as well as brief biographies of the principal investigators must also be made publically available through CARTaGENE’s web site.

Information extracted from the Access Policy

The information contained in an Access Request communicated by the Investigator to CARTaGENE, the SDAC or CER shall be kept confidential by the CARTaGENE staff members and members of SDAC and CER. However, once the Access Request has been received favourably by the SDAC and CER, the following information will be distributed to the public via the CARTaGENE website or by any other method of communication deemed relevant by CARTaGENE:

  • Title and brief lay summary of the research project
  • Names of researchers and a brief description of their academic credentials and professional experience
  • Name of employer and/or institution to which they are attached
  • Source of funding for the research project
  • Scheduled project start date and end date
  • Once the research project is completed, a summary of the project's results and potential results benefiting the general population and public health.