About Brain-CODE

Brain-CODE was designed with best-practice privacy strategies at the forefront to enable secure capture of sensitive participant data in a manner that abides by government legislation while fostering data sharing and linking opportunities. Privacy and security features have been incorporated into the foundation of Brain-CODE’s infrastructure, and are reinforced by comprehensive guidelines and state-of-the-art approaches to keep participant data safe. As a result, OBI has been named a “Privacy by Design” Ambassador by the Office of the Information and Privacy Commissioner of Ontario. By embedding the 7 foundational principles of Privacy by Design into the core of Brain-CODE, we can ensure that researchers have the information they need, and that participants are protected.

Access to Data

OBI is a supporter of the international open data movement. As such, it aims to make brain related research datasets available to a broader research community for greater outcomes with positive impact on patient care. To achieve this goal, data on Brain-CODE will be available to recognized academic and non-academic researchers. While Public Data will be immediately available to registered individuals, Controlled Data will require a formal data access request and committee review. More information is available in our Data Sharing Policy which can be accessed at www.braincode.ca/content/governance.

Participant Privacy

The number one priority when sharing data on Brain-CODE is ensuring participant privacy. The safe-guarding of participant identity begins before any data sharing on Brain-CODE. Brain-CODE will only share data in accordance with participant informed consent and adequate research ethics board approval. Through Brain-CODE, inter-institutional collaborators can share their raw study data. Further sharing with external researchers takes place after all data are stripped of identifying information to the extent possible using advanced de-identification tools. These tools are designed to both assess and consequently minimize the risk posed to a participant’s privacy.  The tiered approach to data organization on Brain-CODE enables granular access permissions to ensure only authorized users may access sensitive datasets.

All technical staff working with Brain-CODE are trained on how to respond to any unauthorized attempts at accessing data. Should any such attempts occur, procedures have been put in place to identify, report and manage any threats to data in Brain-CODE. More information on this can be found in our Privacy Breach Policy at available at www.braincode.ca/content/governance

Security Practices

To ensure that data in Brain-CODE are safe and secure, a number of measures have been implemented:

• Continuous monitoring of software tools to identify any unauthorized attempt to access or interfere with data in Brain-CODE
• Systematic user role validation and data de-identification before release to parties requesting data for analysis
• A strict containment process as defined in the Brain-CODE governance policy
• Regular Privacy Impact Assessment and Threat Risk Assessments to ensure that the infrastructure and data manipulation abide by high security standards
• Regular meetings of a Brain-CODE Information Security Committee that oversees the privacy and security practices for all Data on Brain-CODE

If you have any questions, please contact governance@braincode.ca

Governance Structure

A robust governance structure has been developed to ensure that Brain-CODE maintains a high level of quality and security that is consistent with OBI’s vision and mandate. The following committees were formed to ensure the success of Brain-CODE:

Brain-CODE Informatics Steering Committee: provides insight on all issues relating to the establishment and management of Brain-CODE, ensuring that all progress is timely, of high quality and remains in line with the vision of OBI.

Brain-CODE Advisory Committee: advises on the direction and progress of Brain-CODE, ensuring the platform meets international best practices for data organization, sharing and analysis.

Brain-CODE Data Access Committee: develops data access and sharing policies and make recommendations to the Informatics Steering Committee regarding the release of data to third parties.

Brain-CODE Information Security Committee: recommends appropriate information security framework for the Brain-CODE platform, and work with the service group to implement and maintain privacy standards for all data and infrastructure in the platform. 

Brain-CODE Analytics Advisory Committee: advises on the analytics direction of Brain-CODE, ensuring the platform meets international best practices on data curation and integrated data analysis for discovery and sharing. 

Governance Policies

The Ontario Brain Institute has worked with a team of experts to develop clear and comprehensive guidelines on privacy and the use of participant research data. Our governance documents outline how the data are collected, stored, and accessed by Brain-CODE users.

To ensure clarity for study participants, we have developed standard informed consent language outlining how sensitive data will be collected, entered, de-identified, and shared using Brain-CODE.    

Governance Policies

 For any questions, please contact governance@braincode.ca

Zone-Based Infrastructure

OBI's highly secure three zone-based infrastructure for Brain-CODE (Figure 2) maximizes data sharing potential while minimizing risk to participant privacy.

Figure 2. Brain-CODE’s zone-based infrastructure. Three zones exist with distinct purposes and data access parameters to maximize data sharing while minimizing risk to participant privacy and their personal health information (PHI).

Zone 1: Data Management & Analysis

A repository of raw data and your personal data management solution.

Zone 2: Long-Term Storage of De-identified Data

The long-term secure storage of data.

Zone 3: Interface for Third-Party Data Access

Third-party access and analysis of processed data.

Learn more about our Brain-CODE Zones here.

To obtain information on Brain-CODE security and privacy measures, or to report any concerns, please e-mail help@braincode.ca.

Defining Data on Brain-CODE

Two types of data can be entered into Brain-CODE:

Two types of data access on Brain-CODE in Zone 3:

Learn more about data sharing here.

Data Management Tools

Brain-CODE features a comprehensive set of data management tools that allow researchers to securely upload, store, and manage research data electronically. In addition to providing a single point of access to data management tools, the Brain-CODE portal features private file repositories and discussion forums that researchers can use to facilitate sharing and collaboration.

For general inquiries or information about the portal, please e-mail help@braincode.ca.

The Brain-CODE Registry

REDCap

SPReD/XNAT

LabKey

Training and Support

Training, tutorials, reference manuals and user support are availabe for all of the data management tools in our Knowledge Base. 

Accessing Data

There are three general types of Users for Brain-CODE:

Data Access Committee (DAC)

The Data Access Committee reviews requests for data. Learn more about data access and sharing are managed here.

Brain-CODE Operates Under Informed Consent

The expressed written consent of study participants, from whom data have been collected, is required to transfer data, which may include PHI, into Brain-CODE. 

The Brain-CODE standard consent language must be used in studies that are conducted in collaboration with OBI and for which data will be uploaded to Brain-CODE. 

Learn more about Brain-CODE consent language and other standards.

Please contact governance@braincode.ca for additional standard consent templates and procedures for other participant ages.