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| FEDERALWIDE ASSURANCE (FWA) Under the US Department of Health and Human Services (DHHS) human subjects protection regulations 45 CFR 46.103 every institution engaged in human subjects research supported or conducted by the DHHS must have assurance of compliance approved by the US Office for Human Research Protections (OHRP). OHRP Federalwide Assurance (FWA) and Institutional Review Board (IRB) assurance have been obtained for Providence Health Care and the UBC/PHC REB noted below with links to the OHRP website (IRB's are known as REB's in Canada). Click on the FWA or IRB Assurance Number for more detail. Click on the FWA or IRB Assurance Number for more detail.
ETHICS + REGULATORY WEB RESOURCES FOR PROVIDENCE HEALTHCARE RESEARCHERS + CLINICAL RESEARCH COORDINATORS Please scroll down the page for information regarding Canadian and United States Ethics Resources and Regulatory Guidelines Web Based Tutorials in Human Subject Protection Canadian: Introductory Tutorial for the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. http://www.pre.ethics.gc.ca/english/tutorial/ (English) http://pre.ethics.gc.ca/francais/tutorial/ (French) United States: Human Participant Protection Education for Research Teams Two-hour web based tutorial that satisfies NIH human subjects training requirement for obtaining Federal Funds. Certificate of completion is available for printing. http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp UBC LINKS Clinical Research Ethics Board (CREB) Forms and Guidance Notes http://www.ors.ubc.ca/ethics/clinical/c-forms.htm#app_guide Behavioural Research Ethics Board (BREB) Forms and Guidance Notes http://www.ors.ubc.ca/ethics/behavioural/b-forms.htm UBC Policy #89: Research and Other Studies Involving Human Subjects http://www.universitycounsel.ubc.ca/policies/policy89.pdf CANADIAN RESEARCH COUNCILS AND INSTITUTES TCPS (Tri-Council Policy Statement) http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm (English) http://www.pre.ethics.gc.ca/francais/policystatement/policystatement.cfm (French) Interagency Advisory Panel on Research Ethics (PRE) The mandate of this panel is consultation and revision of the Tri-Council Policy Statement http://www.pre.ethics.gc.ca/ CIHR (Canadian Institutes of Health Research) http://www.cihr-irsc.gc.ca/e/193.html NATIONAL POLICIES Declaration of Helsinki (World Medical Association) http://www.wma.net/e/policy/b3.htm HEALTH CANADA ICH-GCP (Good Clinical Practice Guideline) - Health Canada Regulation as of Sep 2001 Health Canada - HPFB (Health Products and Food Branch) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/index_e.html Health Canada (Regulations Amending the Food and Drug Regulations 1024 Clinical Trials) http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/food_drug_reg_amend_1024_gcp_entire_e.html Health Canada - TPD (Therapeutic Products Directorate) This site includes information on the following Directorates:
U.S. FOOD AND DRUG ADMINISTRATION Code of Federal Regulations, Part 46 Protection of Human Subjects (45 CFR 46) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Code of Federal Regulations, Part 50 Protection of Human Subjects (21 CFR 50) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50 FDA Regulations Relating to Good Clinical Practice and Clinical Trials Site includes information about the development of final rules related to FDA's regulations on good clinical practice and clinical trials. http://www.fda.gov/oc/gcp/regulations.html FDA (Food and Drug Administration - General Site) http://www.fda.gov/ ADDITIONAL U.S FEDERAL INSTITUTIONS OHRP - Office of Human Research Protections (US Dept. of Health & Human Services) http://www.hhs.gov/ohrp/ FWA (Federal Wide Assurance and IRB Registration) http://www.hhs.gov/ohrp/assurances/ DHHS - Dept. of Health & Human Services http://www.hhs.gov/ |
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