Access to samples and data

Researchers can access the Data and/or material only if:

• They apply to the BioPortal through the formal Data access review and request process.
• They obtain approval for their research project from their REB; and
• They have signed appropriate Data access or sample access agreements.

There are three main mediums of access to the Samples and Data:

• Portal – The purpose of the portal is to let prospective researchers assess the types of variables available and the counts of individuals with such measures. No individual-level will be displayed. Therefore, this Data will not contain personal identifiable Data. Rather it will present only aggregated Data. For example, information presented on the Biobank portal will include a count of the number of people with body mass index over a certain threshold, or the count of people with a certain diagnosis.
• Multivariable summary Data access to aggregated Data. This is similar to the portal but can display the count of individuals fulfilling more than one criterion, such as identify those with a body mass index over 25mg/m2 and a diagnosis of Type 2 diabetes.
• Individual level Data – a controlled access model, which relates to ‘all’ of the coded Data. Access to this will only be permitted after successful application to the Data Access Committee, approval from an REB and signature of Data access agreements.

Further details are set out in the draft Data & Sample Access Committee Terms of Reference. This can be shared with REB if requested.

Access Committee

Mandate: The Data & Samples Access Committee will be responsible for making decisions about access to the Biobank’s Samples and Data through an assessment of the scientific validity of access requests and compliance with the Access Policy.

Composition: The Access Committee will be comprised of 3 individuals who are scientists, but are not directors of the biobank, or employed by the biobank to prevent conflict of interest. Other members will include the Project Manager.

Frequency of Meetings: The Access Committee will convene regularly, as necessary, by any means (e.g., in person, teleconference, shared files) to review access requests depending on the frequency of requests.

Decision-making Processes: The Access Committee will need a minimum of 3 voting members to make access decisions (quorum). Access decisions will be made by majority vote. Voting may be carried out by any means (e.g., email). All meeting discussions and decisions will be recorded in minutes.

Reporting: The Access Committee will deliver annual reports to the Jewish General Hospital REB.

External Advisors: Where the Access Committee lacks specific scientific, analytic (e.g., machine-learning), clinical, ethical, legal, or other expertise to assess an access application, it may seek advice from external advisors on an ad hoc basis.

Change Management: Leaving members will be replaced respecting institutional representation requiring experience in epidemiology, Data management and disease research.

Access Policy

Insurers or employers of participants will not be granted access to any Samples or Data.

The BioPortal will consider requests from academic and/or private sector researchers in a similar fashion. This policy will apply to all users including the BioPortal research team, its collaborators, other researchers at the Jewish General Hospital, and external users.

Access Principles

The following principles will guide access decisions:

• Use of the BioPortal’s resources to maximize scientific, clinical, and societal benefit.
• Supporting broad health and biomedical research, primarily the study of common complex and rare and infectious diseases.
• Providing non-discriminatory access to qualified researchers across countries and sectors (including commercial researchers).
• Data will not be released to researchers in countries where their jurisdictional laws require them to share such information with their government. This will preclude sharing data and samples with investigators from China, given current Chinese legislation.
• Respecting the rights, interests, and expectations of Participants.
• Constantly demonstrating and improving the value, utility, and sustainability of the BioPortal.
• Upholding the reputation of the BioPortal and its supporting institutions and funders.

Access Criteria

Biological material and Data will only be distributed to researchers who register to the BioPortal and whose project(s) have been approved by the BioPortal’s Data & Samples Access Committee and a duly constituted REB.

Biological materials will be dispensed judiciously as they may in many cases be a non-renewable resource. We will favour large-scale programs using a large proportion of Samples to undertake validated assays that meet industry standards.

Applications for Data access must meet the following requirements, which will be reflected in the Material/Data Access Request Form:

1. The proposed project must have subject to approval and oversight by the user’s REB.
2. The project team, aims, and methodology must be described in sufficient detail to allow the Access Committee to assess the potential scientific/medical benefit of the study.
3. Appropriate safeguards must be in place to ensure the privacy, confidentiality, and security of Data.
4. Any Data generated by the project should be returned to enrich the Biobank.
5. Completion of the Material/Data Access Request Form.

Decisions

The Access Committee will issue a decision of approved, conditionally approved, or declined. The Biobank will inform the applicant researcher of the decision in writing (e.g., email). Additional information requested in a conditional approval may be reviewed by one member of the Access Committee.

Once the research project is approved by the Access Committee and the REB from the institution from which the project originates, and the Sample/Data Use Agreement Template has been signed, authorized members of the research team will be granted access to coded research Data through the appropriate platform (REDCap), and will receive Samples by courier, ensuring that Samples are preserved as appropriate, for example by sending them on dry ice. Any coded Data will be shared by standard on-line industry web-based practices.

 Any modifications to the standard Sample/Data Use Agreement Template will be reviewed by the Jewish General Hospital legal & contract office.

Timelines for providing Samples & Data

Whilst every endeavour will be made to share Data and Samples in a timely manner, timelines to deliver Samples to researchers depends on several factors.

• The clarity and completeness of the request (including required REB approval for proposed researcher, evidence of funding etc.).
• The complexity of the cohort and study selection criteria
• The availability of Samples in stock or need to collect Samples prospectively.
• The number of access requests in the Biobank pipeline

Duration of Access and Renewal

Access will be granted for 2 years following approval and completion of agreements. Users may request an extension by submitting a renewal Access Request Form before the end of the approved period. The user will be required by contract to destroy or return any Samples and/or Data upon termination of the approval period and to demonstrate evidence of this. The decision as to whether to destroy or return Samples will be made by the BioPortal PI.

Research projects led by the Biobank research team and approved by this hospital’s REB will not have to additionally seek approval from the access committee but will follow all the other requirements of this access policy (e.g., REB approval, transparency about projects).

Agreements

Generally, two types of agreements will be used for the BioPortal:

1. Data access agreements and Material transfer agreements. A Data access agreement will grant the applicant with access to Data stored in the BioPortal, based on the five access criteria above. A Data access agreement will outline the types of Data to be transferred, the research purpose, and the obligations of each party. In addition, it will accord with the informed consent, ethical approval, and relevant access policies and procedures. The Access agreements will include, among other terms and conditions: restrictions on use, publication clauses, confidentiality and necessary safeguards, intellectual property provisions, termination (including what happens to the Data and Samples).
2. Material transfer agreements will be a contract between the Lady Davis Institute (as provider) and the research users (and their institution & REB), that authorizes the recipient to use Samples preserved in the BioPortal.

Both agreements will be drafted in compliance with Quebec privacy law and the TCPS2.

Access for audit purposes

The source Data/documents will be made accessible to auditors, inspectors, and regulatory authorities such as REB and Health Canada.

All questions will be answered during inspections.

Costs and access fees

Access Fees / Cost Recovery
Given the public nature of the BioPortal, it aims to promote a wide and accessible distribution of knowledge developed using this resource and achieve maximum public benefit. It is therefore the intention of the BioPortal to consider granting access to academic and private sector researchers who meet appropriate scientific and ethical standards and are approved by a responsible REB.

The BioPortal will not in any circumstance sell Participant’s Data or Samples and will only release them as part of a formal adjudicated access process. Participants will be asked to waive any rights to cost recovery as a condition of participation in the consent form.

The BioPortal will ensure equitable sharing of benefits that acknowledges the valuable contributions of the BioPortal, its supporting institutions (Jewish General Hospital), and its funder: the Jewish General Hospital Foundation. The BioPortal will clearly establish the respective rights of users through Data/ material use agreements. Any profits received by the BioPortal will be reinvested in its operations or related scientific research activities.

The following principles will be adhered to:

• The BioPortal will act on a cost-recovery basis, specified in advance of material/Data distribution.

• The BioPortal will operate on a mixed (cost per project and cost for infrastructure maintenance) cost basis. This will consider both the short- and longer-term costs of running the biobank.

• Fees for services will be determined by the steering committee and reflected in the Access Agreement. The BioPortal determines fees using an agreed method as proposed by the Canadian Tissue Repository, to calculate costs and determine user fees to charge to researchers for services involved in accessing the BioPortal.

Percent of cost charged to users will be revised and updated to ensure that the BioPortal is fully recovering costs, fairly and equitably.

Intellectual Property

The BioPortal is an open science initiative. There will be no Intellectual Property (IP) held by the CIUSSS over Data or Samples. Applicants who, through the above-mentioned means, have research projects approved, may file IP upon their discoveries with no licencing, royalties or IP shared with the CIUSSS. However, if a qualified researcher from the CIUSSS uses the Data or Samples to generate IP, this resultant IP will follow the IP policy of the CIUSSS.

Who we have shared data with

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