Research Ethics Board
Links
The following are links to important resources, references, educational materials, guidance documents, regulations and legislation and others.
Education – Online Tutorials
Ethics Documents
- Belmont Report
- Nuremberg Code
- World Medical Association Declaration of Helsinki
- United Nations Universal Declaration of Human Rights
Regulations and Legislation
Canadian
Health Canada
- Therapeutic Products Directorate (TPD)
- Medical Device Bureau
- Biologics and Genetics Therapies Directorate (BGTD)
- Natural Health Products Directorate (NHPD)
Ontario Personal Health Information Protection Act (PHIPA)
- A Guide to the Personal Health Information Protection Act
- Fact Sheet #01 - Safeguarding Personal Health Information
- Fact Sheet #12 - Encrypting Personal Health Information on Mobile Devices
Personal Information Protection and Electronic Documents Act (PIPEDA)
United States
Food and Drugs Administration (FDA)
Guidance and Policy Documents
International Conference on Harmonization (ICH)
- Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
- Ethnic Factors in the Acceptability of Foreign Clinical Data
- Studies in Support of Special Populations: Geriatrics
- General Consideration of Clinical Trials
- Statistical Principles for Clinical Trials
- Choice of Control Group and Related Issues in Clinical Trials
- Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
Food and Drugs Administration (FDA)
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Guidances, Information Sheets, and Important Notices
University of Toronto (UofT) Research Policies
CIHR (Canadian Institutes of Health Research)
CIHR is a major federal agency responsible for funding health research in Canada. They are very active in providing guidance and policy documents to researchers and the public. These documents include:
- Conflict of Interest and Confidentiality policy
- CIHR Best Practices for Protecting Privacy in Health Research
- Compendium of Canadian Legislation Respecting the Protection of Personal Information in Health Research
