Regulations

Which regulations are investigators required to follow with respect to responsible conduct of research? 

It is a Sunnybrook Health Sciences Centre (Sunnybrook) policy to have a Research Ethics Board (REB) that ensures all health research activities involving human subjects or human materials, being conducted within or on behalf of Sunnybrook, meet current scientific, regulatory and ethical standards for the protection of human research subjects.

The principal investigator assumes full responsibility for the scientific and ethical conduct of the study as described in the REB application and submitted protocol, and agrees to conduct the study in compliance with the regulations (outlined below). The principal investigator assures that all investigators, researchers and other personnel involved in the study are appropriately qualified and will undergo appropriate training to fulfill their role in the study.

All research studies submitted to the Sunnybrook REB must be conducted in compliance with:

• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2); and
• The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004.

All clinical trials filed with Health Canada or the Food and Drug administration (FDA) and phase IV trials (i.e., post-marketing), must also comply with the following, as applicable:

• International Conference on Harmonization (ICH) Guidance E6: Good Clinical Practice (GCP): Consolidated Guideline;
• Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations of Health Canada 2001; 
• Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003;
• Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Device Regulations of Health Canada;
• International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects - Good Clinical Practice 2020 (ISO 14155); and
• United States Code of Federal Regulations Title 21 Part 50 and Part 56, and CFR Title 45 Part 46