This provides an overview of the changes to the REB processes that resulted from the REB integration and the formation of the Unity Health Toronto Research Ethics Board (Unity Health REB or REB).
In June 2018, the Research Ethics Boards of Providence Healthcare, St. Joseph’s Health Centre and St. Michael’s Hospital integrated under our new network, Unity Health Toronto. All human subject research taking place at the three sites is now reviewed by a single REB.
To account for research studies that take place at multiple sites, we established two new study team roles for use within the Unity Health REB. The first, Unity Health Lead Applicant, is the person who is taking responsibility for the ethical and scientific conduct of a study across all Unity Health sites. Every study must designate a Unity Health Lead Applicant, even if the study is only occurring at one site. The Unity Health Lead Applicant must be an employee of, or have an active appointment at, any Unity Health site. The second, Site Investigator, is the person who oversees the ethical and scientific conduct of a research study at a Unity Health site. They must be an employee of, or have an active appointment at, the site where they will be Site Investigator. There must be one Site Investigator for each Unity Health site at which research activities are taking place.
All existing studies that were approved by the Providence Healthcare, St. Joseph’s Health Centre and/or St. Michael’s Hospital REBs now fall under the jurisdiction of the Unity Health REB. REB approved documents and annual renewal dates remain unchanged. In order to harmonize the file number across all sites, the REB file numbers for studies that were approved at Providence Healthcare and St. Joseph’s Health Centre were modified slightly to be compatible with the St. Michael’s Hospital numbering system. For studies that were submitted prior to the REB integration, we converted the person who was listed as the PI on the original application to be both the Unity Health Lead Applicant and the Site Investigator. Studies that are currently approved at more than one site remain separate and are handled as separate files. This means that they have their own renewal dates and require separate submissions for amendments, etc. At this time, the REB integration does not have any impact on the CTO process or on any existing studies that were approved through CTO.
All REB submissions for new and existing studies at any site should be submitted to the Unity Health REB.
Please keep the following in mind when applying to the REB to conduct research at multiple sites:
To expand your existing study, including recruitment to other Unity Health sites, you will need to submit an Amendment to the REB to add the site.
To conduct research activities at a site, research staff must meet two criteria. The first is to be listed in the REB study file as a research team member who will be conducting research activities at that site. You must let the REB know that you will be conducting research activities at another Unity Health site before beginning such activities. The second is to be an employee of, have an appointment at, or be registered as a student or research visitor at that site. If you need to register as a research visitor, please see the instructions on the Research Employment webpage.
All individuals involved in conducting human research activities are required to have training in Good Clinical Practice (GCP) and the Tri-Council Policy Statement (TCPS-2). In addition, all individuals conducting Health Canada regulated clinical drug trials are required to have training in Health Canada’s Food and Drug Regulations Part C, Division 5. Please refer to our Research Training page for additional information.
