Research training is mandated for anyone who conducts, or is involved in, human research activities at Providence St. Joseph’s and St. Michael’s Healthcare.
Training in, and implementation of, accepted ethical and regulatory guidelines in human research helps to ensure that studies are conducted according to the highest ethical, scientific and safety standards.
All individuals (e.g., investigators, coordinators, and any other personnel conducting research activities including students, trainees, fellows, etc.) involved in conducting human research activities at Providence St. Joseph’s and St. Michael’s Healthcare (i.e., any involvement at a site, on behalf of a site, with site participants/ charts/ identifiable data, etc.) are required to complete mandatory research training depending on the type of research being conducted.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Conducting research according to Good Clinical Practice (GCP) provides public assurance that the rights, safety and well-being of human research participants are protected and that the study data are credible.
The Tri-Council Policy Statement (TCPS-2) is a Canadian guideline for the ethical conduct of research involving humans and/or human biological materials. Training in the Tri-Council Policy Statement (TCPS-2) helps to ensure the ethical conduct of research involving humans.
Health Canada’s Food and Drug Regulations (FDR), Part C, Division 5 applies to all clinical drug trials requiring Health Canada authorization. Part C, Division 5 regulations stipulate the application for authorization, amendments/notifications and sponsor obligations.
In addition to mitigating risks to each institution should there be audits by regulatory agencies, such as Health Canada or the U.S. Food and Drug Administration, making these courses mandatory supports our position and commitment to promote the highest quality and ethical conduct of research. The courses are free of charge to Providence St. Joseph’s and St. Michael’s Healthcare staff and affiliates.
Additional benefits of taking these courses include, but are not limited to:
It is the principal investigator’s responsibility to ensure that anyone who conducts or is involved in research activities at Providence St. Joseph’s and St. Michael’s Healthcare completes the training required for the study. This may include, but is not limited to: the principal investigator, co-investigators, scientists, research staff, postdoctoral fellows, students (graduate, co-op and summer), medical residents and clinical fellows, research volunteers and visitors. All new research staff joining Providence St. Joseph’s and St. Michael’s Healthcare must complete applicable research training courses within three months of their start date.
Given that all research involving human participants, including research involving human biological materials (e.g., organs, tissues, blood, urine, saliva) requires review and approval in advance by the Providence St. Joseph’s and St. Michael’s Healthcare Research Ethics Board (REB), REB approval or renewal of a research project will be tied to course completion. This means that REB approval or renewal of a study will be withheld until all Providence St. Joseph’s and St. Michael’s Healthcare staff listed on the REB submission have completed their required training. The Office of Research Administration and the Research Ethics Office track the completion of the applicable training courses.
If an individual has completed a required research training course under the affiliation of another organization (within the last two years for GCP and Division 5 training), a copy of the training certificate must be provided.
For Providence Healthcare and St. Michael’s Hospital, submit to:
Dina Coronios (firstname.lastname@example.org), Office of Research Administration (ORA)
For St. Joseph’s Health Centre, submit to:
Laura Tomat (email@example.com), Medical Education and Scholarship Department