Mandate and procedures
The Institutional Review Board (IRB) of the Faculty of Medicine is a registered University IRB that works in accordance with the published guidelines of the Tri-Council Policy Statement, the Plan d’action ministériel en éthique de la recherche et en intégrité scientifique, (MSSS, 1998) and the Food and Drugs Act (17 June 2001). The McGill IRB acts in accordance with the U.S. Code of Federal Regulations that govern research on human subjects and holds a Federal Wide Assurance approved by the Office for Human Research Protections (OHRP) that includes an Inter-Institutional Agreement between the University and its affiliated hospitals. The IRB working procedures are consistent with internationally accepted principles of good clinical practice. Deliberations of the Committee must conform with applicable laws, including, where relevant, the Quebec Civil Code and the Loi sur les services de santé et les services sociaux des établissements.
The Minister of Health and Social Services has designated the McGill IRB to carry out the review, approval and follow-up for research to be conducted with children and cognitively impaired individuals as referred to in Article 21 of the Civil Code of the Province of Quebec.
According to the working procedures, certain research activities may be exempt from review or qualify for expedited review. The Committee, however, may elect to review a study regardless of the status of proposed research or changes in ongoing research. All questions regarding the review status should be addressed to the IRB Chair.
Investigators must report planned changes in the conduct of previously approved research. Although minor changes proposed to the study may be reviewed in an expedited manner, changes deemed not to be minor by the Chair, require full board approval before the change may be implemented. The only exception is the rare circumstance where a change is necessary to eliminate an immediate hazard to the subject. Unanticipated risks to subjects or new information that may affect the risk/benefit assessment must be reported promptly. Continuing review of research involving human subjects must be carried out at intervals appropriate to the degree of risk but not less than once per year from the date of initial IRB approval. The investigator should contact the IRB office to determine the requirements for continuing review. Continuing review may require modification of the written consent.