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 Joint Research Ethics Board (JREB).
All JREB review materials (JREB application(s), correspondence with the JREB, approved consent(s), and JREB approval letter) must be reviewed by the PI. Responses to the JREB review letter must be signed off by the PI to confirm their review and agreement with the response.
For details on “clinical studies” as defined by Health Canada (i.e., involving an investigational drug or medical device), please refer to Ontario Shores Research Ethics Board website (https://www.ontarioshores.ca/research/reb
External Principal Investigator:
For studies originating from outside of Abilities Centre or Ontario Shores, a qualified staff member from Abilities Centre or 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 for research taking place at Abilities Centre site will be a qualified Abilities Centre staff. The institutional liaison will also serve as the administrative contact with the JREB. The role of institutional liaison applies only for studies where the PI initiating the study is not a staff member and external to Abilities Centre.