Useful Links

BC UNIVERSITIES

• University of British Columbia
• Research at University of Victoria
• Royal Roads University
• Simon Fraser University
• University of Northern British Columbia

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CANADIAN GRANTING COUNCILS (TRI-COUNCIL)

• Canadian Institutes of Health Research
• Natural Sciences and Engineering Research Council of Canada NSERC
• The Social Sciences and Humanities Research Council of Canada (SSHRC)

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CLINICAL TRIAL RESEARCH

• ADR Expedited Reporting Summary for ADRs Occurring During Clinical Trials
• Government of Canada, Minister of Public Works and Government Services Canada (1997) Guidance for Industry: Good Clinical Practice: Consolidated Guideline. ICH Topic E6.  Health Products and Food Branch  Guidance Document
• Government of Canada, Department of Justice Food and Drugs Act: Food and Drug Regulations (C.R.C., c. 870, January 8, 2007), Part C: Drugs - Division 5 Drugs for Clinical Trials Involving Human Subjects
• Medical Devices Regulations (P.C. 1998-783 May 7, 1998),  Part 3: Medical Devices For Investigational Testing Involving Human Subjects
• Clinical Trials.gov
• Data and Safety Monitoring Board (DSMB)
• Health Canada
• Health Canada Guidance Document on Clinical Trials
• Medical Research Council (UK)
• Office of Patient Protection
• Society of Clinical Research Associates
• Therapeutic Products Directorate (TPD)

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ETHICAL GUIDELINES

• Tri-council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) (1998, and updates May 2000, September 2002, and October 2005)
• International Conference on Harmonisation; Good Clinical Practice (ICH GCP): Consolidated Guideline (CPMP/ICH/135/95 July 2002)
• Declaration of Helsinki
• Belmont Report
• Nuremberg code

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HEALTH AUTHORITIES

• Fraser Health
• Interior Health
• Northern Health
• Vancouver Coastal Health
• Provincial Health Services Authority

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HEALTH RESEARCH IN ABORIGINAL COMMUNITIES

• CIHR Guidelines for Health Research Involving Aboriginal Peoples
• Schnarch, B. 2004. Ownership, Control, Access and Possession (OCAP) or self-determination applied to research: A critical analysis of contemporary first nations research and some options for first nations communities, J. Aboriginal Health, 80.

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PRIVACY LEGISLATION

• Personal Information Protection and Electronic Documents Act
• The Office of the Information and Privacy Commissioner (OIPC)
• CIHR Best Practices for Protecting Privacy in Health Research (September 2005). Ottawa ON: Canadian Institutes of Health Research. Public Works and  Government Services Canada
• Freedom of Information and Protection of Privacy, Policy and Procedure Manual Section 35 – Disclosure for research or statistical purposes. Victoria BC: Ministry of Labour and Citizens’ Services.
• Q & A’s The Freedom of Information and Protection of Privacy Amendment Act, 2004: A Response to the USA Patriot Act (November 17, 2004). Victoria BC: Information Policy and Privacy Branch, Strategic Policy and Planning Office of the Chief Information Officer, Ministry of Management Services.
• Health Insurance Portability and Accountability Act (HIPAA) OF 1996, Public Law 104-191. Standards for Privacy of Individually Identifiable Health Information: Research (45 CFR* 164.501, 164.508, 164.512(i), 164.514(e), 164.528, 164.532) (December 3, 2002, Revised April 3, 2003). United States Department of Health and Human Services, Office for Civil Rights (OCR). (*Code of Federal Regulations)

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PROFESSIONAL ASSOCIATIONS

• Association of Clinical Research Professionals
• BC Cancer Agency
• BC Medical Association
• Canadian Medical Association
• National Council on Ethics in Human Research (NCEHR)
• World Medical Association

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UNITED STATES REGULATIONS AND GUIDELINES

• United States Department of Health and Human Services. Code of Federal Regulations Title 45, Public Welfare, Department of Health and Human Services Part 46 Protection of Human Subjects. (Revised June 23, 2005, Effective June 23, 2005)
• United States Food and Drug Administration
• United States Food and Drug Administration -Center for Devices and Radiological  Health Search Link
• U.S. Food and Drug Administration Information Sheet Guidances: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

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