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.
In addition to mitigating risks to the 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 the hospital’s position and commitment to promote the highest quality and ethical conduct of research. The courses are free of charge to St. Michael’s Hospital 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 St. Michael’s Hospital research activities 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, volunteers and visitors. All new research staff joining St. Michael’s Hospital 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 SMH 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 St. Michael’s Hospital staff listed on the REB submission have completed their training. The Office of Research Administration and the Research Ethics Office at St. Michael’s Hospital track the completion of the applicable training courses.
If a required research training course was completed while at another organization and within the last two years (for GCP and Division 5 training), please provide Dina Coronios (email@example.com) in the Office of Research Administration with a copy of the training certificate for St. Michael’s Hospital records.