Human Research SOPs
The Standard Operating Procedures (SOPs) for Clinical Research at the MUHC were created by the RI MUHC to promote the responsible conduct of research with human subjects at the MUHC. Compliance with the SOPs serves to protect human subjects participating in research, as well as to present the responsibilities and tasks expected of each member of the research team involved in the conduct of a study. Depending on the nature of the study, not every SOP applies to every study involving human subjects.
The generic SOPs were the result of a successful collaboration among the Fonds de Recherche en Santé du Québec (FRSQ), McGill University, Université de Montréal, Université de Sherbrooke, Université Laval and the 19 FRSQ-funded research centres. The goal of the collaboration was to harmonize the approach to conduct clinical research in publicly funded institutions in Quebec. The MUHC SOPs standardize the expectations for conduct of both academic and industry sponsored clinical research reflecting the best practices for human research in Canada.
The MUHC Clinical Research SOPs were adapted from generic versions by the RI MUHC Administration in consultation with the MUHC Research Ethics Office, Pharmacy, Medical Archives and Environmental Health and Safety; as well as RI MUHC Investigators and Study Coordinators. The SOPs incorporate the standards and practices required by:
- The International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices, 1996;
- Health Canada Therapeutic Products Directorate Food and Drug Regulations for Clinical Trials. Division 5. Canada Gazette Part II, Vol. 135, No. 13, June 2001;
- The Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans; Medical Research Council of Canada; Natural Sciences and Engineering Council of Canada; Social Sciences and Humanities Research Council of Canada, August 1998;
- The US Food and Drug Regulations, Code of Federal Regulations Chapter 21 Part 11, April 2003;
- Quebec Laws and Regulations;
- Quebec Standards proposed by the Ministry of Health (MSSS) and the FRSQ; and
- Regulatory Framework in Health Research at the MUHC, updated November 2008.
The SOPs will be revised from time to time by the groups noted above to reflect the evolution of clinical research conducted at the RI MUHC.
All questions and comments regarding the current SOPs are welcome and will be considered in future revisions by contacting marwan [dot] samia [at] muhc [dot] mcgill [dot] ca at the RI MUHC Clinical Research Core Service.
