1. If a researcher obtains REB approval at his/her own institution to gather data from participants who are members of other institutions, is it necessary to obtain REB approval at each of the other institutions that employ the participating members?
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 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).
2. Three researchers conduct separate but related research that has been approved by their respective REBs. When their separate data collection is complete, they share their results and publish a paper together. Is this considered multi-jurisdictional research requiring REB review based on guidance in TCPS 2?
If the three researchers are intending to collaborate from the start, the research project should be characterized from the beginning as multi-jurisdictional research with procedures set out for safeguarding participant privacy in the context of data sharing/linking/management (Article 5.7), and following guidance in Article 8.3. If the three researchers initially conduct separate research projects and collaboration is only discussed at the results and dissemination stage, the researchers are introducing a change to their approved research (Article 6.16). The researchers should consult their REBs to determine whether the change to the way the research data/results/findings are shared, pooled, stored or disseminated is a change to what the participants agreed to in their initial consent, the ethical implications of that change and what impact it has on the level of risk to participants. The REBs should also decide whether the research would be considered multi-jurisdictional research.
In making this determination, REBs should take into consideration: what information is being shared, in what form (e.g., raw, aggregate, coded, anonymized) for what purpose, whether data linkage is involved, whether the sharing of results has ethical implications and/or introduces risks for participants, whether participants have been or should be informed about the sharing of their data, and depending on the identifiability of the information being shared, whether follow-up consent may or may not be necessary. If the change to the research is substantive, researchers must submit it to their REBs who "shall decide on the ethical acceptability of those changes to the research in accordance with a proportionate approach to research ethics review" (Article 6.16).
3. In multi-jurisdictional research, 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 that limited component?
"Each institution is accountable for the research carried out in its own jurisdiction or under its auspices" (Application of Article 6.1). In multi-jurisdictional research, in the absence of an ethics review agreement between institutions (Application of Article 8.1) each institution's REB is responsible for reviewing the entire research project. By reviewing the research in its entirety, the REB will have sufficient details to fully assess the risks to participants and the potential benefits of the research. This will enable the REB to fully understand the ethical implications of the research, and to make an informed judgement on its ethical acceptability.
4. If a health care professional at an institution makes a patient aware of research being conducted at another institution, is REB review required at the health care professional’s institution? New
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.
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). The health care professional can, 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.
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