Comments – Queen University, Office of Research Ethics Compliance
Comments are posted in the language in which they were received.
October 4, 2021
Tri-Council Panel on Research Ethics
Tri-Council Secretariat on Responsible Conduct of Research
Submitted by email to: firstname.lastname@example.org
Thank you very much for the opportunity to provide feedback on the proposed changes to the TCPS2. I am submitting amalgamated comments for the TCPS 2 Consultation on behalf of the Queen’s University Office of Research Ethics Compliance, the Queen’s University General Research Ethics Board (GREB) and the Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB).
Review of multi-jurisdictional research;
- This policy should not be mandatory until an accreditation process/qualification process is implemented for REBs, as not all REBs may abide by applicable regulations/guidelines consistently. Concerns have been noted in the past at our institution with respect to multi-site reviews not being adequate in comparison to local reviews regarding compliance with regulations/guidelines (e.g., externally approved application lacking in required consent form elements). Additionally, a qualification/accreditation process may help to alleviate any REB/institutional concerns with respect to the delegation of the ethics review to an external REB. Clinical Trials Ontario (CTO) does utilize a qualification process whereby REBs undergo a two day review process involving the review of policies/procedures and interviews with staff/REB members to ensure compliance. If sites do not meet the minimum criteria, as outlined in the CTO Qualification Checklist, corrective action must be implemented to ensure compliance prior to getting designated as a Board of Record. A standard participation agreement is also utilized by all BOR sites, which negates the requirement for individual institutional agreements, and does contribute to streamlining the REB review process for multi-site research. CTO also utilized a re-qualification process, whereby all BORs must undergo another re-qualification visit to ensure they are still reviewing in compliance with applicable policies/procedures.
- The idea of one centralized REB may be concerning for participants, but the absence of local qualified boards who have connections with local participants may have a contrary effect. For CTO/OCREB models, they do have one centralized contact for ethics concerns, but there is always a local contact/local site information on the centre consent forms. This does not appear to be inclusive with the proposed guidance. Multisite templates and tools may assist with streamlining this process.
- If the majority of applications are only reviewed at major sites (e.g., Toronto, Montreal, Vancouver) concerns were raised that it could impact the quality of REB reviews at smaller/lower volume institutions with respect to local expertise/ethics reviews.
- Concern are noted with respect to differences across institutions regarding conflicts of interest policies.
- Considerations/guidance should be made regarding if one institution is not comfortable signing off on the research, event though it has already been approved by another REB.
- Considerations need to include how REBs will distribute the confidential information related to the REB review process. OCREB/CTO have very robust administration processes, systems, tools and templates to help facilitate the review of multi-site research. Who will pay for the infrastructure and the resources to manage this across multiple sites, particularly for paper based REBs? Additional resources may be necessary to manage this additional administrative responsibility.
- More guidance is needed regarding who will determine the level of risk associated with the research study. What if different REBs have different interpretations? How will this be handled if one site requires full board review as a standard process, where at another site it may qualify for delegated reviews?
- Considerations need to be made if other institutions bring up issues/concerns with another REB(s) review. Without an accreditation process/qualification program, this may put REBs in a difficult situation to navigate.
- Pan-Canada barriers such as differences in the mandatory age for consent and with respect to privacy legislation may cause difficulties operationalizing this mandatory multi-site review process.
- Queen’s has had experience with applications being submitted locally and then withdrawn and then being submitted through CTO in hopes to get a ‘different review result’. Guidance should be included to mitigate the risk of any ‘REB shopping’. For example, we now ask a question it the ethics review process if the application was submitted to another REB and subsequently withdrawn and the reasons for withdrawal.
- The policy does not address quality assurance/monitoring/auditing/Health Canada inspections/FDA inspections that may be related to multi-site research, which vary across institutions.
- Considerations should me made regarding the Office for Human Research Protections (OHRP) to ensure mandatory multi-site review will not impact FWA registration status.
- The current policy is also lacking in definitions such as what constitutes, ‘Under the auspices’ of an institution/use of institutional resources. More robust terminology should be included.
Broad consent in research;
- Lines 66-67: It might be good to have references to Indigenous peoples, in addition to including First Nations, Inuit, and Metis, as it seems sometimes just indigenous identity is appropriate, but other times it’s important to have clear delineation between groups and not amalgamate.
- Lines 70 – 78: Ethics must be sought for future use of data; however, if explicit consent was not initially sought (e.g., institutions that are not required to abide by the TCPS2, institutions that have an opt-out policy for secondary use of data/biologicals, justification for a waiver of consent), communicating limitations regarding the withdrawal of data would not be possible. Currently Line 78 states, ‘These limitations must be explained to participants during the consent processes’. We recommend that additional guidance be included to navigate these types of situations or suggest that the language is softened from ‘must’ to ‘should/as applicable’.
- Line 49-50- 51: What about situations where consent is not sought for deposit into data repositories (i.e. opt out process rather than opt in for secondary use of discarded biological samples/chart reviews data entered into repository)?
- Lines 98-100: In situations where broad consent is obtained from a parent/guardian/substitute decision maker, processes should be in place to obtain consent once capacity is regained as applicable, particularly ‘...when little is known about the nature of the future research, there is a risk that the participant’s contributions could be used for a purpose that the participant might not agree with or support.’
- Lines 109 – 115: It may be impossible to provide this information as an addendum in the event that the participants’ contact information changes. Also, if consent was not obtained/opt out consent policy, future contact with participants may also not be possible.
- Line 125: It is not clear when information related to the repository would not be known at the time of obtaining consent. Could examples be provided?
- Line 137-140: Should the potential for linking this information to any other types of information/data also be communicated and confirmation provided that no identifiable information will be generated during the linkage of this information?
- Line 175: Communication of material incidental findings may not be possible if a passive consent/opt out consent process is being utilized. Perhaps considerations should be made to include guidance that no attempt to re-identify participants should be made, similar to the cell line guidance. Or alternatively, could additional guidance be created to address repositories using biologicals/data that were implemented using waivers/opt out consent processes.
- 199-200: By placing the onus on the participant to update their contact information could cause significant participant burden. Could a guideline/policy be developed that would require repositories to send an annual ‘update’ via letter/email that would help minimize the occurrence of ‘lost to follow up’. While it would still be on the participant to update researchers, the researchers would initiate the follow up.
- 202-203/208: A one-time consent process may be a concern when initial consent is obtained by a parent/guardian/substitute decision maker and contradicts what line 208 suggests, i.e. Mechanisms should be in place to accommodate such changes.
Review of research involving cell lines
- Additional guidance/considerations should be made for cell lines that were collected in advance of guidance implemented > 20 years ago, as researchers may need to seek REB review if they are unaware of consent procedures utilized to obtain this information (i.e. Line 43, ‘ the researcher will comply with known consent terms’). Additionally, cell line companies don't always provide information related to consent. This may cause an influx of requests for exemptions/inquiries to REBs if further guidance is not provided in these circumstances.
- It would be good to see some additional guidance or a separate article in relation to the collection of biological materials with the intent to create a cell line for re¬use. Similar to the guidance in Article 12.13 but specific to somatic cell lines (i.e. maintaining the consent template with the cell line to provide to any subsequent researchers or repositories to ensure all future research complies with original consent terms).
- Line 158 - In situations where a primary cell line is transferred to another institution, an agreement (e.g., MTA/DTA) should be in place. Where an agreement is in place, should the agreement include the consent template in the appendices?
- Should guidance specify that researchers should not further distribute a cell line unless permitted by the sender, as this is a common practice and can contribute to the ‘known consent terms’ issue?
- Line 149 - With the advances in genetics, how should researchers handle potential incidental findings that could have clinical impact? This feeds into the original consent conditions. For example, a researcher provides a de-identified primary cell line to a collaborator at another institution. The collaborator finds a mutation that could have clinical impact on the disease of interest. The collaborator has no REB clearance because they were exempt, how do they proceed? Can guidance be added to address this?
Research involving totipotent stem cells.
- No additional feedback, as this is mainly updated terminology.
If you have any questions or require further clarification please do not hesitate to reach out to Jennifer Couture, Manager, Research Ethics Compliance, Queen’s University at email@example.com.
Andrew Winterborn, DVM DACLAM
Director, Research Ethics Compliance
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