Research-related Legislation

BC Privacy Legislation

• FOIPPA: Freedom of Information and Protection of Privacy Act.  See Part 3 - Protection of Privacy: Division 2:  Use and Disclosure of Personal Information by Public Bodies - Articles 32 and 35.  
• PIPA: The complimentary legislation for the private sector is the Personal Information Protection Act. 

TCPS

Fraser Health complies with the Canadian Tri-Council Policy on the Ethical Conduct for Research Involving Human Subjects.  This policy which sets the Canadian standard for research involving human subjects is adhered to by academic and health care delivery organizations across Canada.   

For more information on the current ethics requirements of the Tri-Council and for research ethics tutorials, visit Canadian Institutes of Health Research: Research in Ethics.  

Regulated Clinical Trials

Researchers conducting clinical trials that are regulated by Health Canada must also adhere to the guidelines of the International Conference on Harmonization: E6 - Good Clinical Practice: Consolidated Guideline [ICH GCP] and the respective regulations under Canada’s Food and Drug Act which govern drug, device and natural health product trials.  

• Health Canada: Food And Drug Act:  Regulations Amending The Food And Drug Regulations (1024 - Clinical Trials) For Clinical Trials  
• Health Canada: Food And Drug Act: Medical Device Regulations Part 3 Medical Devices For Investigational Testing Involving Human Subjects 
• Health Canada: Food And Drug Act: Natural Health Products Regulations

U.S. Funded/Regulated Research

Researchers who conduct research funded either by the United States Department of Health and Human Services or other U.S. government agencies OR regulated by the United States Food and Drug Administration must comply with the following regulatory requirements for any of the funded research.

• U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research: Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
• Department of Health and Human Services funded research regulated under 45 CFR 46.109 (e)
• Other U.S. government funded research or sponsored research regulated under 21 CFR 56.110

Other

• World Medical Association (WMA):  Declaration of Helsinki (1964) 
• Canadian Institutes for Health Research (CIHR): Guidelines for Protecting Privacy and Confidentiality in the Design, Conduct and Evaluation of Health Research: Best Practices Consultation Draft (2004) 
• CIHR:  Procedures for Addessing Allegations of Non-compliance with Research Policies 
• CIHR:  Final Report of the National Placebo Working Committee on the Appropriate Use of Placebos in Clinical Trials in Canada
• Canada:  Personal Information Protection and Electronic Documents Act