Multijurisdictional FAQs (Workshop Stream 3) Case Studies Multijurisdictional FAQs (Workshop Stream 3) April 10, 2019 Catherine Paquet Susan Zimmerman

Scenario 1 Dr. Cooper is a health care professional at a University-affiliated hospital and holds adjunct status at the Faculty of Medicine of University A. He is collaborating on a project conducted by a PI at University B. His role in the project is limited to recruiting his patients and sending the results of their blood work to a researcher at another institution for analysis. We have often referred to the following interpretation for guidance on ‘under the auspices’ for the purpose of multi-jurisdictional research:

Questions for Scenario 1 Is ethics review required at University A? Explain why / why not If yes, what level of review is required (FB, delegated)? If yes, what documents would your REB request from the researcher Is ethics review required at the hospital? If yes, what level of review is required (FB, MR)? Is ethics review required at the site where the blood is being analyzed? Research Ethics Board (REB) review is not required at the health care professional’s institution in this case so long as: the health care professional is not on the research team; and any participation in the research is initiated by the patient. The individual in question would not be required to submit the research for research ethics board (REB) review within his/her institution so long as the individual is not a member of the research team,   he/she does not benefit from authorship on publications, and his/her contribution is limited in nature to a service that does not in and of itself constitute research involving humans as defined in TCPS 2 (see application of Article 2.1). If the service provider meets the above criteria, or falls within an exception set out in his/her institution’s policy, it would be sufficient for the individual to get confirmation from the principal investigator (PI) that this research has been reviewed by the PI's institutional REB so long as it is compliant with TCPS 2.  Alternatively, the individual can make the provision of his/her services conditional on receiving evidence of an REB review and approval in accordance with TCPS 2.   In making the patient aware of the research project, the health care professional’s actions are analogous to those of a service provider (see governance # 4). It is not uncommon that a health care professional would, on the advisement of the patient, communicate directly or share patient information with the research team. This may be the case, for example, to facilitate the assessment of the patient eligibility to participate in the research. Interpretation # 1274 – modified to generalize it for the purpose of this document. Original is in our interpretation log.

Scenario 2 Professor X works at University A. He is leading a research project on treatment of depression in teenagers. The study, which involves questionnaires and interviews, is focused on the efficacy of various treatment methods for depression, as well as how depression has influenced the parents’ and children’s daily lives. Participants will include parents and youth. The project is being run at four sites; 2 in Canada 1 in the U.S. 1 in England There are co-researchers leading the projects at the other sites. They will conduct recruitment and data collection, as well as participate in the design and analysis of results. The issue to consider is whether the research is being conducted under the jurisdiction or auspices of the other institutions as well, which would necessitate REB review at the other institutions. The determining factors include (1) the extent and nature of the other institutions’ involvement, and (2) whether it is necessary for the researcher to collaborate with the other institutions in order to carry out the research. If the researcher is seeking the collaboration of staff of other institutions and/or using the resources of those the institutions (e.g., bulletin boards, email lists, meeting rooms, equipment) to recruit members of the institution or for the purposes of data collection then the research would be under the auspices of these other institutions.  The research would require ethics review by REBs of the other institutions in addition to the researcher’s REB (see Article 8.3). The level of REB review may be adjusted in accordance with a proportionate approach to research ethics review (see Article 6.12). However, if recruitment and/or data collection involving an institution’s members as prospective participants is done through other means that do not involve the resources of the institution, the research would not fall under its auspices and would not be subject to review by its REB. For example, if names and emails of faculty or department heads are publicly available on websites or through some disciplinary association and the researcher uses this information to recruit them as participants, then REB review at the researcher’s institution would suffice. Similarly, if the researcher approaches members of the institution in a public space outside the institution for recruitment and/or data collection (e.g., on-the-street survey), the researcher would only need approval from his/her home REB. Note that research that involves members of the institution for the purposes of critical inquiry does not require the permission of the institution (Article 3.6).

Questions for Scenario 2 Is ethics review required at the co-researchers’ institutions? Explain why / why not If yes, What level of review is required at each of the institutions (FB, delegated)? What is the best review model for the various sites? Would it be worth having a research agreement in place? Would you consider joint REB review for such a project? What should the be order of review (i.e. who goes first, second, concurrent, etc.)? What documents should the REBs request from the local researchers (non- PI)?

Scenario 3 Professor X works in the Faculty of Health Sciences at University A. She is included as a co-researcher on a large CIHR grant but is not the PI. The project is looking at comparing treatments for adults dealing with the effects of lyme disease. Personal health information will be accessed and individual interviews will be conducted at various sites. Professor X will not be recruiting participants or be involved in the data collection. She will be accessing raw data and helping with the analysis and will be included as a co-author on publications.

Questions for Scenario 3 Is ethics review required at the Professor X’s institution? Explain why / why not Does this change if she does not have access to the raw data? If yes, What level of review is required at each of the institutions (FB, delegated)? What is the best review model for the review? Would it be worth having a research agreement in place? Would you consider joint REB review for such a project? What should be the order of review (i.e. who goes first, second, concurrent, etc.)? What documents should Professor X’s institutional REB request from her?

Scenario 4 A doctoral student received ethics approval from their institution to study volunteer activities of graduate students (minimal risk research). The student approaches deans and the graduate student association at your institution, asking for their assistance in distributing information about his/her study to current students. The invitation contains a link to an online anonymous survey. A multi-site minimal risk project involved case studies at different locations, each site with a lead investigator. A was the PI. B was the lead investigator at one of the sites. Not all site investigators were ready to submit their applications for ethics review of their case studies to the PI’s institution at the same time. The institution agreed to a multi-stage approach: it would review the overall study design and review each case study as it received the applications from the  co-investigators at the various sites. The PI asked that all case studies be approved by the site investigators’ home institutions, as well as by the PI’s institution, before commencing their interviews. One site investigator was of the firm view that review by their home institution was sufficient, and proceeded to conduct interviews after receiving ethics approval from his/her home institution, without submitting an application for approval to the PI’s institution.   What issues does this raise? How would you address this situation?

Questions for Scenario 4 Does this require review at your institution? What should those who have been contacted do when they receive the request? If review IS required, what type of review (FB, delegated) would you conduct? Who would be involved in the review (chair, delegate, chair + delegate, ethics office personnel)? What documents would you ask for? What kind of feedback would your REB provide to the researcher? If they disagree with part of the protocol (e.g. consent document), would they ask for it to be revised?