The Principal Investigator (PI) is responsible for the implementation of the research study, its scientific and ethical conduct and the protection of each research participant.
The PI must conduct the research study in compliance with the Tri-Council Policy Statement; relevant regulations (i.e. ICH Good Clinical Practice: Consolidated Guidelines; Division 5, Canadian Food and Drug Regulations; Ontario Personal Health Information Protection Act admits applicable Regulations) and all other applicable laws and regulations of Ontario.
The PI must ensure that the Research Team (all co-investigators, researchers and other personnel) involved in the research study are qualified and experienced to conduct the study. The PI must also ensure that the Research Team adheres to the protocol and consent form(s) as approved by the Research Ethics Board (REB).
All REB review materials (REB application(s), correspondence with the REB, approved consent(s), and REB approval letter) must be reviewed by the PI. Responses to the REB review letter must be signed off by the PI to confirm their review and agreement with the response.
For “clinical studies” as defined by Health Canada (i.e. involving an investigational drug or medical device), the Principal Investigator must be a Qualified Investigator (a physician/psychiatrist or, where applicable a dentist, and a member in good standing of a professional medical or dental association).
External Principal Investigator:
For studies originating from outside of Ontario Shores, a qualified staff member from Ontario Shores must be involved as the institutional liaison (local Principal or Co- Investigator), who will accept complete responsibility for the research activities at the institution. The institutional liaison will also serve as the administrative contact with Ontario Shores’ REB. The role of institutional liaison applies only for studies where the PI initiating the study is not a staff member and external to Ontario Shores.