Commentaires – Health Data Research Network Canada

In recognition that REBs will need to extend time and resources to implement this guidance, we propose that the requirement extend beyond minimal risk where there are initiatives or formal agreements for centralized REBs.

Many harmonized and centralized REB initiatives already in place in Canada are not limited to minimal risk research. These initiatives are the results of a great deal of effort and collaboration seeking to address the concerns of overworked REBs and the variation in approaches to project review/approval by different REBs leading some researchers to preferentially apply to given REBs. These initiatives have resulted in formal agreements that provide standards that can be emulated.

While the need for multiple reviews will be eliminated, it must be acknowledged that the local REB review often serves as a platform used to fulfil other institutional requirements concerning grants, institutional reviews, etc.

Accommodating for local processes will require adjustment.

A more streamlined approach to the acknowledgement process is recommended. While the recommendation to have the acknowledgement completed by an REB member or experienced administrator reduces the demand of the boards themselves, the number of administrative steps remain the same.

What expectations are there for the content of the letter of ‘acknowledgement’?

What does ‘acknowledgement’ mean in this context? If it is about transparency or other, it should be said directly.

Recommendation: Spot audits can be done time-to-time to ensure process is working correctly.

Recommendation: A template should be provided for what is envisioned to be included in the letter of ‘acknowledgment.’

Clarification is required on the management of site-specific variations to multi-site protocols.

How will differences be operationalized and captured? Ideally it would be within an existing centralized process/platform.

Centralization can help avoid conflict when there are multiple REBS in an area - there is an inherent redundancy when different universities or boards are going over the same thing.

Recommendation: Bodies with specific areas of expertise could lead/establish a centralized REB review panel for multi-region (multi-jurisdictional) research.

It must be acknowledged that when limited by their local REBs, researchers are going to go to boards that provide more supportive reviews and process, while perceived as “difficult’ REBs will be avoided.

Recommendation: Tri-Council Panel support the further development of and encourage researchers to use centralized REBs able to address these considerations such as the initiatives stated in Section 2, Paragraph 2.

Recommendation: A network supporting research involving the secondary use of administrative data, HDRN Canada could step forward to establish a centralized body, including representation from all jurisdictions as a board of record for data intensive research.

The administrative process for the communication and document flow between multiple REBs does not facilitate or remove the current concerns expressed by researchers navigating multiple jurisdiction research work

Additionally, there may be institutional requirements and processes such as a privacy requirement at the local level beyond the review to be completed.

These requirements will also need navigation when modifications may be required during the lifetime of the research project.

Recommendation: Provision of a template directing researchers on where to begin and how to address these administrative requirements and resource demands.

Is the 3-week timeline realistic, considering researchers must facilitate all document distribution and the need to address considerations identified by the local REB?

Is there a standard for the ‘complete package’ and who monitors the ‘completeness’ of a package?

Although the guidance suggest work can begin where acknowledgements have been received, what if there are considerations identified that are in conflict?

Are two choices enough? Can there not be a middle ground such as conditional broad consent?

Recommendation: Consent options beyond Project Specific Consent or Broad Consent should be permissible such as usage of Conditional Broad Consent, or use case consent e.g., allowing specific uses/users to use the data, or allowing entire programs of exploration and research, if appropriate governance is established.

Shared responsibility to protect participants “See Articles 9.1 and 9.11 on research involving First Nations, Inuit and Métis Peoples [of] Canada.”

All references to “First Nations, Inuit and Métis Peoples [of] Canada” to be edited to “First Nations, Inuit and Métis Peoples in Canada.”

We ask that the Indigenous data sovereignty be specified and given distinct recognition.

3. Shared responsibility to protect participants - “This guidance can be applied to other communities when appropriate (Article 2.11).”

Clarification is needed with respect to “other communities when appropriate”; what is considered a group that needs more consultation?

Regard must be given to the changing nature of the standards of the day; understanding and definitions of ‘other communities will evolve.

Governance of biobanks should state what is required for working with ‘other communities.’

5. Informed broad consent

There is a blending throughout the guidance of what information could inform potential participants of the use of their personal and personal health information vs. the details of a repository’s governance.

Participants must be able to educate themselves. If not provided for in the consent form, information on where to access details of a repository’s governance including governance mechanisms, sharing of data, and uses of data must be included in the form.

Important information must be communicated such as incidental findings and the governance model behind it. Governance information must be made readily available and accessible over time giving consideration for participant population, the changing nature of technology, connectivity challenges, and web formats.

Recommendation: A template including why content areas are necessary and lay language examples would serve as an invaluable tool. HDRN Canada is available to lead in the development of a guidance template.

5.3 Risks and potential benefits of storage and participation in unspecified research

5.4 Information about the repository and its governance

Many projects indicate they will keep data for XX years. For example, in many cases for RCTs this period is 25 years. Consideration should be given to the long-term storage and the potential for operational changes of repositories over time, including the need for a transfer of custodianship. Planning for succession of both researchers and repositories is needed.

While we continue to identify and marvel at the potential for data usage, we must equally strive to identify the means of ensuring the protection of these data and to implement safeguards that will protect individuals. Repositories and researchers should be aware of what steps are required to safeguard data.

Recommendation: Globally data stewards are working together to identify mechanisms such as “data trusts” that can provide “timely, fair, safe, and equitable” access to data. This includes identifying the minimum specifications (i.e., min specs) that will ensure these principles are upheld. We draw attention to the work of Paprica et al., 2020, and ongoing work at HDRN Canada and the CIO Strategy Council Advances National Standards for Responsible Data Sharing.

6. Ongoing broad consent

There is limited knowledge of the ongoing nature of REBs and REB review may not be required in all regions/jurisdictions or for all entities; potential participants must be informed that data may be made available to researchers not subject to the TCPS.

A clear directive that this uncertainty exists must be made stated- i.e., cannot say they will be ongoing review if this is not known.