Normative Documents

Normative Documents

+ Canadian Legislation
Health Canada Food and Drugs Act
Personal Information Protection and Electronic Documents Act (PIPEDA)
 
+ Canadian Regulations
Health Canada Food and Drugs Regulations, Part C, Division 5
Health Canada Natural Health Products Regulations, Part 4
Health Canada Medical Device Regulations, Part 3
 
+ Policies and Guidelines
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)

International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice Guideline

 
+ Other Regulations
US Code of Federal Regulations Title 21
US Code of Federal Regulations Title 45
 
+ Other Related Documents (Informative)

A Systems Approach to Human Research Protection: Innovation in Healthcare, authored by Alexander G. Karabanow, BSc, BAA; Janice E. Parente, BSc, PhD; Jacquelyn Legere, RN, BN,CIPP/C; Ann Munro Heesters, BEd, BA(Hons.), MA, PhD

Institute of Medicine – Preserving Public Trust: Accreditation and Human Research Participant Protection Programs

Report on the Evaluation of Control Mechanisms in Clinical Research in Quebec (The Deschamps Report), authored by Pierre Deschamps, BCL, CM

The Governance of Health Research Involving Human Subjects (HRIHS), authored by Michael McDonald, BA, MA, PhD

World Health Organization – Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants

World Medical Association – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects