Regulations and guidelines

Ethical Guidelines for Lawson Health Research Institute 

Guidelines for all applicable regulations, guidelines and standard operating procedures to which Lawson research is subject.

Ontario Personal Health Information Protection Act (PHIPA)

Establishes rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care. Read more. 

The Personal Information Protection and Electronic Documents Act (PIPEDA) 

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. Read more. 

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)

A joint policy of Canada’s three federal research agencies including CIHR, NSERC and SSHRC that describes the standards and procedures for governing research involving human participants. Read more. 

Tri-Agency Framework: Responsible Conduct of Research

Describes Agency policies and requirements related to applying for and managing Agency funds, performing research, and disseminating results, and the processes that Institutions and Agencies follow in the event of an allegation of a breach of an Agency policy. Read more. 

Tri-Agency Financial Administration Guide

Outlines the roles and responsibilities of the grantee and the institute related to the use, administration, reporting and monitoring of grant funds received from CIHR, NSERC and/or SSHRC. Read more. 

International Conference on Harmonization (ICH) Guidance E6: Good Clinical Practice (GCP)

Provides a unified standard to facilitate the mutual acceptance of clinical trial data by the regulatory authorities. Applies to all clinical trials filed with Health Canada or the Food and Drug Administration (FDA), and phase IV trials (i.e., post-marketing). Read more. 

Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations

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. Applies to all clinical drug trials filed with Health Canada. Read more. 

Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations

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. Applies to all clinical natural health product trials filed with Health Canada. Read more. 

Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Devices Regulations

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. Applies to all clinical medical device trials filed with Health Canada. Read more.