Research Ethics Board FAQ

To submit data access requests through the Controlled Access Mechanism, External Researchers must possess an affiliation with an accredited academic institution, think tank, company, or other research organization. External Researchers can be local, national, or international members of the general science or health care community.

The request will be reviewed by the Data Access Committee (DAC). The DAC consists of representatives from the Ontario Brain Institute’s (OBI) Integrated Discovery Programs (IDPs) partners and will include members knowledgeable in privacy. A community advocate and/or patient experience representative may also be a member of the DAC.  

The request will also be reviewed by the Brain-CODE Informatics Steering Committee (ISC) to ensure adherence to the Ontario Brain Institute’s Principles. The Brain-CODE ISC will approve or deny the request based on input from the DAC.

The following documents are required for a Data Access Request submission:

• REB approval letter / exemption letter

• REB approved protocol (with matching version number / code)

Under the Brain-CODE Governance Policy, all data access requests for data stored in Brain-CODE must be approved or exempted from review by the External Requester’s local IRB/REC/REB. Approved study protocols should explicitly mention using the specific data set the External Requester is seeking access via Brain-CODE.

If the Brain-CODE data set being requested is being used in addition to an existing IRB/REC/REB-approved study, External Requesters are asked to complete an IRB/REC/REB amendment explicitly mentioning use of said data set. For support on preparing such an amendment, please contact governance@braincode.ca.

Prior to review by the DAC and the ISC, the Informatics Team, which manages the Brain-CODE platform, will review the request and contact the External Researcher if there are any concerns or questions about the application. If upon review of the Data Access Request, the decision is made to deny the request, the Informatics Team at OBI will explain the decision to the External Researcher. The External Researcher who has requested access to the data can email governance@braincode.ca to request further information about why the request was denied and appeal the decision.

The DAC consists of representatives from the Integrated Discovery Programs (IDPs) and will include members knowledgeable in privacy. A community advocate and/or patient experience representative may also be a member of the DAC.  The ISC consists of OBI senior management staff.

Data that was collected that did not previously contain identifiable health information (PHI) can be released via the Public Data Access Mechanism which does not require approval from a Data Access Committee or Research Ethics Board (REB). These data include animal model data, phantom MRI data, or anonymous survey data. Upon submission of the Public Data Access Request, the External Researcher will receive an email with instructions on how to download the Data. Data that is accessed via the Controlled Data Access Mechanism is data that may have contained PHI when it was originally collected and has since been de-identified as outlined in the Brain-CODE Informatics Governance Policy.