Regulatory Guidelines and Law

MUHC and McGill

Regulatory Framework in Health Research at the McGill University Health Centre [.pdf]
Guidelines for the Management of Data and Tissue Banks [.pdf]
McGill University Policy on the Ethical Conduct of Research Involving Human Subjects [.pdf]
McGill University Ethical and Legal Aspects of Research Involving Human Subjects Conducted in the Faculty of Medicine and Affiliated Hospitals Policies and Proc [.pdf]
Appendices to Faculty of Medicine Policy and Procedures [.pdf]
Glossary of Terms for Reviewing Human Subjects Research [.pdf]
Guidelines on Public Advertising for Recruitment of Human Subjects in Research Projects
McGill University Research Regulatory Framework


An Act Respecting Access to Documents Held by Public Bodies and the Protection of Personal Information
An Act Respecting Health Services and Social Services
An Act respecting the Health and Social Services Ombudsman
An Act Respecting the Protection of Personal Information in the Private Sector
Charter of human rights and freedoms
(FRSQ) Background Document on Human Cloning [.pdf]
(FRSQ) Code of Ethics and Professional Conduct [.pdf]
(FRSQ) Guide d'éthique de la recherche et d'intégrité scientifique (2e édition) [.pdf] 
(MSSS) Circulaire 2003-06-19 [.pdf]
(MSSS) Guide d'élaboration des cadres de gestion des banques de données et de matériel biologique constituées à des fins de recherche [.pdf]
MSSS Plan d’action Ministèriel [.pdf]
CMQ code of ethics of physicians [.pdf]
Civil Code of Quebec 


Assisted Human Reproduction Act
CIHR "Best Practices for Protecting Privacy in Health Research"
Clinical Trial Application
Food and Drugs Act
Food and Drugs Act Marijuana Exemption (Food and Drugs Act) Regulations
Food and Drug Regulations - Part C - Division 5 [.pdf]
Health Canada Addendum to the ICH Guidance E11: Clinical Investigation of Medicinal Products in the Pediatric Population
Health Canada Adverse Reaction Information
Health Canada Consolidation of the Food and Drugs Act and Food and Drug Regulations
Health Canada Medical Devices Problem Reporting
Natural Health Products
Health Canada Regulatory Requirements Governing Drugs for Use in Clinical Trials in Canada [.pdf]
Medical Devices Regulations
Memorandum of Understanding - Tri-Councils
Natural Health Products Regulations
Personal Information Protection and Electronic Documents Act (PIPEDA)
PIPEDA Organizations in the Province of Quebec Exemption Order
TCPS 2 - Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

United States

Health Insurance Portability and Accountability Act (HIPAA) 
Guidance for Industry: Acceptance of Foreign Clinical Studies
The Belmont Report 
US HHS Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection [.pdf]
US Federalwide Assurance
US Food and Drug Administration
US 45 CFR 46


Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human Subjects

Council for International Organizations of Medical Sciences (CIOMS)
International Guidelines for Ethical Review of Epidemiological Studies

Council for International Organizations of Medical Sciences (CIOMS)
Human Genome Mapping, Genetic Screening and Gene Therapy

Good Manufacturing Practices Guidelines [.pdf]
(The) Declaration of Helsinki (2008)
International Committee of Medical Journal Editors (ICMJE). Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication 
International Compilation of Human Research Standards 
ICH Efficacy
ICH GCP (Good Clinical Practice) Consolidated Guidelines
(The) Nuremburg Code (1947)


Advertising Standards Canada
Code of Conduct (Canada’s Research-Based Pharmaceutical Companies) [.pdf]