Acts, Regulations, Guidelines & Policies
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) 2022
Describes the standards and procedures for governing research involving human participants
Application: All research studies submitted to the Sunnybrook research ethics board must be conducted in compliance with the TCPS
The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004
Establishes rules for the collection, use and disclosure of personal health information that protect the confidentiality and the privacy of individuals with respect to that information
Application: All research studies submitted to the Sunnybrook research ethics board must be conducted in compliance with the Ontario PHIPA.
A Guide to the PHIPA 2004 (PDF)
Gives health information custodians (HIC) a basic understanding of how the PHIPA applies in the course of day-to-day activities and help HIC understand their rights and obligations under the legislation
Application: The interpretation of PHIPA in this guide should not be relied upon as a substitute for the legislation.
Provides a unified standard to facilitate the mutual acceptance of clinical trial data by the regulatory authorities
Application: All clinical trials filed with Health Canada or the Food and Drug Administration (FDA), and phase IV trials (i.e., post-marketing), must comply with ICH GCP.
Defines specific clinical trial application (CTA), and clinical trial application amendment (CTA-A) requirements for the sale and importation of drugs for use in human clinical trials in Canada
Application: All clinical drug trials filed with Health Canada must comply with part C division 5.
This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in human subjects in Canada to comply with Part C, Division 5 of the Food and Drug Regulations and to understand the International Council for Harmonisation (ICH) Guidance Document: Good Clinical Practice in the Canadian context.
This guide describes how inspectors classify clinical trial inspection observations based on risk and how the overall rating is assigned to an inspection, when applicable, and includes situations that may result in a non-compliance (NC) rating. It promotes consistency in assigning risk ratings of inspection observations and in the overall inspection rating and also provides examples of inspection observations.
Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003
Defines specific clinical trial application (CTA) and clinical trial application amendment (CTA-A) requirements for the sale and importation of natural health products for use in human clinical trials in Canada
Application: All clinical natural health product trials filed with Health Canada must comply with part 4.
Defines specific investigational testing authorization (ITA) requirements for the sale and importation of class II, III and IV medical devices for use in human clinical trials in Canada
Application: All clinical medical device trials filed with Health Canada must comply with part 3.
International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects - Good clinical practice 2020 (ISO 14155)
Addresses good clinical practice for the design, conduct, recording and reporting of clinical trials that assess the safety or performance of a medical device.
Application: All clinical trials of medical devices conducted at Sunnybrook and filed with Health Canada or the Food and Drug Administration (FDA) must comply with ISO 14155.
Note: Access to this document is restricted by copyright license. Contact Quality Assurance and Education for user access and more information.
The Personal Information Protection and Electronic Documents Act (PIPEDA) 2000
Rules for the collection, use and disclosure of personal health information that protect the confidentiality and the privacy of individuals with respect to that information
Application: Although Ontario has its own privacy laws, PIPEDA continues to apply to personal information in inter-provincial and international research studies submitted to the Sunnybrook research ethics board.
