Relevant Legislation, Guidelines and Institutional Policies
Toronto Rehab researchers conduct their research according to the relevant legislation, guidelines and institutional policies (of both Toronto Rehab and University of Toronto).
Tri-Council Policy Statements
Toronto Rehab, as a recipient of Canadian federal research grants, must follow the Memorandum of Understanding which includes the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
and the Tri-Council Policy Statement: Integrity in Research and Scholarship.
http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/4-Integrity-Integrite_eng.asp
Ontario Privacy laws
Research involving personal health information complies with Ontario Personal Health Information Protection Act (PHIPA).
The Act:
http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_04p03_e.htm
The Regulations:
http://www.e-laws.gov.on.ca/html/regs/english/elaws_regs_040329_e.htm
Health Canada Regulations
Clinical trials of drugs or natural health products are conducted in accordance with Health Canada’s Food & Drug Regulations (Division 5)
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/index-eng.php
Natural Health Products Regulations
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index-eng.php
and also ICH Good Clinical Practice Guidelines
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6_e.html
Medical Device Regulations
http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php
Other Links
University of Toronto Office of Research Ethics
http://www.research.utoronto.ca/for-researchers-administrators/ethics/
Declaration of Helsinki
http://www.wma.net/en/20activities/10ethics/10helsinki/index.html
For US-funded studies, see
21 CFR 50 - Protection of Human Subjects
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50
21 CFR 56 - Institutional Review Boards (equivalent to Canadian REBs)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56
21 CFR 54 - Financial Disclosure by Clinical Investigators
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=54
21 CFR 812 - Investigational Device Exemptions
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/showCFR.cfm?CFRPart=812
45 CFR 46 – Protection of Human Subjects
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html