1. Multi-Jurisdictional Research: The Need For New Approaches & Educational Initiatives
Farid Pesteh, Danielle Christie, Zakiya Atcha, Patrizia Albanese & Asher Alkoby
CAREB Workshop (w3), April 10, 2019

2. Session Agenda Introduction (10 minutes) Breakout questions at tables
Group discussion
(15 minutes)
Concluding remarks & recommendations (5 minutes)

3. What is Multi-Jurisdictional Research Under TCPS2 Chapter 8?

4. TCPS2 Chapter 8

5. Application of Article 8.1
Institutions are accountable for research conducted under their auspices
Institutions may create their own review models. The ultimate responsibility for approving alternative review models remains with individual institutions

6. Additional Direction from PRE
If a researcher is involved in collecting data relevant to a small component of the overall research project, should that researcher’s REB review the entire project or only a limited component?
Each institution’s REB is responsible for reviewing the entire research project

7. Multi-Jurisdictional Research Involving Canadian REBs Only
Under Chapter 8, review arrangements should aim to ensure that research involving humans is designed, reviewed and conducted in a way that is informed by the core principles of TCPS
Complying with this requirement is further complicated when the research involves jurisdictions abroad, with different approaches regarding the ethical acceptability of research
Our focus today is on research involving multiple TCPS-compliant institutions, who all follow the same core principles

8. Why This is a Timely Discussion
Cross-institutional research collaborations have many obvious benefits for extending knowledge
There is lack of awareness among researchers regarding the complex rules pertaining to multi-jurisdictional research
Well informed researchers, in turn, are increasingly frustrated with:
the amount of time and effort required to obtain multiple REB approvals
the inconsistency and variation in review models and exemption practices between institutions
What can we learn from each other about streamlining the approval process and finding the right balance between compliance and efficiency?

9. Hypothetical Case
Researcher X at your institution is part of a team of researchers from other universities
The other researchers are at institutions that have formal review agreements with a local hospital
The team will be recruiting and collecting data at the hospital
REB approval at the hospital is sought and granted; recruitment and data collection begin
Researcher X has an affiliation with the hospital but is using your institution’s name in the hospital REB application and for dissemination
Your institution does not have a formal review agreement with the hospital
Researcher X mistakenly believes that since she will not be directly involved in data collection, she does not need ethics approval at your institution. She was also told by other members of the team that they did not have to seek ethics approval at their institutions.
The matter is discovered by your REB after data collection has already begun.

10. Our Approach to Reviewing Multi-Jurisdictional Research (Within Canada)
REB approval is 1st sought and granted at the PI’s home institution
Ryerson researcher who is a member of the research team submits to Ryerson’s REB an expedited (short) form application for review
This includes:
the original protocol in its entirety (including all attachments);
any/all amendments requested by the home institution
letter of approval
Review is typically completed within 2 weeks

11. Other Approaches?
How does your REB review multi-jurisdictional research?
At your table, consider the following questions for discussion

12. Table I: Review Mechanisms for Multi-Jurisdictional Research
Institutions are accountable for research conducted under their auspices, irrespective of the location where it takes place
How do you treat REB applications that have been reviewed and approved by other TCPS compliant REBs?
What are the benefits and drawbacks of your approach?

13. Table II: Compliance
Have you encountered instances of researchers failing to seek approval for research approved elsewhere?
How were these situations handled by your institution?
How would your institution respond to the violation described in the hypothetical case above?

14. Table III: Communication & Education/Awareness
You review a protocol involving external researchers. What responsibility does your REB have in communicating to those external researchers the need to communicate with their home REBs about whether REB review is required there?
Does your REB have guidelines for internal and external researchers? How does your REB ensure that both internal and external researchers are informed about their responsibilities?

15. Table IV: Review Agreements With Other Institutions
The TCPS provides for the creation of formal agreements across institutions and REB’s to help reduce the number of reviews required in the case of multi- jurisdictional research.
Does your institution have such agreements? If yes, with which types of institutions; how do these agreements work; are they effective? If not, is this worth considering? What are the potential benefits and drawbacks?

16. Discussion

17. Reconvene

18. Addressing Compliance Issues
The Panel on Research Ethics (PRE) provided some guidance with respect to compliance challenges in multi-jurisdictional research:
Document the situation in writing
Consult with REB chair(s) at other affected institution(s) and advise them of the issue
Review the facts with your university’s research integrity authority, while taking into account the following considerations:
Was the study properly approved by another TCPS-compliant REB prior to data collection?
Is it reasonable that the research would have been approved at your institution?
Was there any indication that failure to obtain REB approval had an impact on participant welfare?
Based on the above considerations, determine whether a research misconduct complaint is warranted

19. Concluding Remarks & Recommendations

20. Thank you!
Patrizia Albanese (Chair), Asher Alkoby (Vice-Chair) Zakiya Atcha (REB Coordinator) Farid Pesteh (REB Administror) Danielle Christie (Research Ethics Intern)