MIREC Data Access Portal

Register and request access to data.

MIREC Biobank

The MIREC Biobank contains data and specimens from the MIREC Research Platform Studies, which include the original MIREC Study, Follow-Up Studies, and Biobank Projects. This Application is used to request data and/or specimens for research purposes from the MIREC Biobank, as administered by the MIREC Biobank Management Committee. The objectives of the MIREC Biobank are to provide a basis for future research on: * Maternal and child exposure to priority environmental chemicals. * Fetal growth, pregnancy and the health of mothers and their infants/children. * Health risks, if any, that are associated with various measures of chemical exposures. * Potential mechanisms of toxicity and markers of susceptibility for adverse pregnancy and child outcomes. The criteria for granting access include: feasibility, scientific value, minimal risk, availability of specimens, contribution to the MIREC Research Platform Studies, and public health importance to Canadians. The MIREC Biobank operates on a cost-recovery basis. The fees to access the MIREC Biobank are determined by the MIREC Biobank Manager and will be used to cover the operating costs of the MIREC Biobank as well as its maintenance over 30 years. The MIREC Biobank does not allow access by insurers or employers.

Process for Applying to Access the MIREC Biobank

Step 0

Create an account

Before initiating a request for data access, all researchers must [create a user account](/signup).

Step 1

Complete and submit the preliminary access request application form

New data access requests are to be created from the [Data Access](/data-accesses) page. The applicant must fill and submit the preliminary application form online and attach all the required access documentation.

The **MBMC reviews** the preliminary application and provides **comments to the Applicant**.

If needed, the **Applicant revises the preliminary application**, in response to the comments from the MBMC.

If the **MBMC approves** the *preliminary application*: 1. The Knowledge Transfer (KT) Representative determines if there is an **overlap** between the proposed project and past or ongoing work. Note: If that is the case, the KT Representative will inform the MIREC Research Platform Studies Investigator responsible for the existing or past work, so they can discuss with the Applicant and agree on a revision of the preliminary application. If an agreement cannot be reached, the KT Representative will join discussions to harmonize the Data Analysis Plans. 2. The Biobank Manager provides a **provisional support letter**, including the cost estimate for the project. Note: preliminary cost estimates cannot be provided before the review of the preliminary application.

Step 2

Complete and submit the access request full application form

If the preliminary application was approved and once funding has been secured, the Applicant submits a full application.

The **MBMC reviews** the full application and, based on its merit, either: 1. Approves the proposed project as submitted, 2. Asks for clarifications and/or revisions, prior to approving, 3. Refuses the proposed project, providing reasons.

If the **MBMC approves** the *full application*: 1. If there are substantive changes to the objectives of the preliminary application, the KT Representative re-confirms that there is no **overlap** between the proposed project and past or ongoing work. 2. The Biobank Manager provides a **letter of provisional support**, confirming the **availability of the requested specimens** and the cost estimate.

Step 3

Complete and submit an ethics application to Health Canada’s research ethics board (REB)

The Applicant **submits an ethics application** to Health Canada’s research ethics board (REB). 1. Health Canada’s REB requests 2 peers reviews, once obtained, the Applicant shares them with the Biobank Manager and completes a “Biobank full application amendment”, if needed (see “Step 3: FINAL STEPS” at the end of this document for more details). 2. The Applicant submits the Health Canada REB bundle to the Biobank Manager, for review, and then submits to the REB.

Once approved by Health Canada’s REB, the Applicant submits the Health Canada’s approved bundle to **their institution’s REB**.

Once approved by the 2 REBs: 1. The Biobank Manager identifies the **Theme Leaders** and sends a consultation email. 2. The Biobank Manager identifies the **MIREC Studies Site Investigators and Co-PIs** and sends a consultation email.

Step 4

Complete and submit the access request end-user acknowledgement forms

The **Applicant and all Team Members** complete and sign the **MIREC Biobank End-User Acknowledgement for Biobank Applicants**.

An **inter-institutional agreement** is signed between CHU Sainte-Justine and the Applicant’s institution.

The Biobank Manager sends the requested **data and specimens**.

To modify an approved project, including request for additional data, the Applicant must submit an Amendment Form and obtain approval of the MBMC and the REBs (if needed) prior to implementing these changes.