Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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20 TABLE 3. Clinical Trials Support Units (cont’d) Facility (URL if available) Types of Trials * PHCRI and the Centre for Health Evaluation and Outcome Sciences (www.cheos.ubc.ca) VCHRI Clinical Research Unit (www.vchri.ca/s/CRU.asp) VIHA Research Department (www.viha.ca/rnd/) Hospital/ Agency (Health Authority) * II, III, IV St. Paul’s (Providence) II, III, IV Institutes and communities within VCH, including VG, UBC, Lion’s Gate and Richmond hospitals II, III, IV Hospitals within the VIHA Investigators Contact • 45 affiliated clinical investigators • Supports all PIs at VGH, UBC and other VCH hospitals and clinics • Supports 30 clinical investigators at Vancouver Island hospitals * Also support investigator-initiated, cooperative research group, and grant sponsored studies. BRITISH COLUMBIA Orr, John. Director of Operations T: 604-806-2294 johnorr@mail.cheos.ubc.ca Feschuk, Connie. Manager. T: 604-875-5886. connie.feschuk@ vch.ca Patel, Anika. Acting Regional Manager. T: 250-370-8764 anika.patel@viha.ca. Contract and Regulatory Support As indicated in Appendices 1 and 2, individual CTUs, centres, study sites, and Clinical Trials Support Units employ study nurses and other staff who liaise between sponsors and services that provide expertise in negotiating and developing contracts. For clinical trials facilities affiliated with VCH, Providence, BCCH, B.C. Women’s Hospital, and Fraser Health, the expert facility is the UBC University-Industry Liaison Office (www.uilo.ubc.ca). For BCCA CTUs and centres, services are provided by the Technology Development Office (www.bccancer.bc.ca). A number of the investigators on Vancouver Island use the services of the VIHA Research Department (www.viha.ca/rnd/); otherwise, contracts are generally handled in-house or by other external facilities. The majority of sites, if not all, provide support for REB submissions and regulatory documentation to, and coordination with, Health Canada and the U.S. Food and Drug Administration (FDA). Quality Control/ Assurance All B.C.’s CTUs, centres, and study sites have Quality Control (QC) and Quality Assurance (QA) measures in place, as indicated in Appendices 1 and 3. Standard Operating Procedures (SOPs) comprise an integral part of each unit’s quality systems. SOPs cover study-related functions (including consent, collection of blood and other biological samples, data management, confidentiality, reporting and management of adverse events, study termination/ closure, and archiving), responsibilities, and training requirements. In the absence of SOPs, facilities ensure standardization by the use of other documents, such as checklists, or closely follow in-house guidelines. As required for clinical trials, SOPs or in-house guidelines are compliant with Health Canada, .FDA.), and ICH Good Clinical Practices (GCP) regulations and guidelines. Quality is also assured by the fact that all staff and investigators are trained in their site-specific SOPs as well as GCP. Furthermore, all projects have to be approved by stringent REBs prior to initiation.
CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP There is generally no requirement for standardized SOPs within a health authority or hospital. However, CTUs affiliated with the BCCA follow that agency’s SOPs. For industry sponsored trials, the sponsor generally provides a procedures manual specific to the study under investigation. QA annual audits are generally conducted for the REB and/or the clinical facility. For industry sponsored trials, audits are conducted by the study sponsor and may also be conducted by regulatory authorities. In addition, the UBC Office of Research Services, which manages the ethics review process for hospitals affiliated with UBC (see below), conducts internal reviews of randomly selected studies that have received REB approval. Research Ethics Boards 11 Regulatory Guidelines Followed by Research Ethics Boards in B.C. The responsibility for ethics in research involving human subjects in B.C. lies primarily with institutional REBs that follow and interpret sets of international and national guidelines, codes of ethics or policy statements to protect human subjects through risk/benefit evaluation, assurance of informed consent, and monitoring of ongoing studies 12 . Investigators intending to conduct human subject research in B.C. must seek REB approval from the involved institution(s) to satisfy funding and regulatory requirements, institutional policy requirements, and to meet criteria for publication in peer-reviewed journals. The 1998 Tri-Council 13 Policy Statement (TCPS): “Ethical Conduct for Research Involving Humans” established ethical principles as well as requirements and prohibitions for REBs in Canada. The TCPS is widely accepted as the gold standard to which Canadian REBs aspire for ensuring efficiency and fairness to both human subjects and researchers. In 2006, B.C. REBs reviewed a total of 13,593 research protocols, including 4,465 new applications, 6,473 amendments, and 2,655 renewals. B.C.’s Ethics Review Structure B.C. has 23 REBs that review research involving human subjects, representing 21 academic institutions, health authorities, and community-based organizations (see Appendix 4). In addition, the for-profit Canadian Western Institutional Review Board (WIRB) located in Vancouver B.C. and based in the U.S., provides independent REB services to national multi-centre and international clinical trials (see Appendix 11). Through an initiative sponsored by the Michael Smith Foundation for Health Research (MSFHR), the harmonization of REB processes is in progress. 14 Each of B.C.’s six health authorities is responsible for ensuring ethics review of all research protocols to be carried out at or by an investigator affiliated with a health care facility within its jurisdiction. Geographically dispersed REBs provide opportunities to bring local perspectives to the review process, incorporating knowledge of rural communities, ethnic cultures, and other issues of local concern. Four of the six health authorities have established their own REBs, the other two (VCH and PHSA) have reached agreement with UBC to carry out ethics reviews on their behalf except for the PHSA’s adult oncology protocols, which are reviewed by the BCCA REB. 11 Extracted from The Ethics Review Process in British Columbia: An Environmental Scan. Michael Smith Foundation for Health Research. October 2007. www.msfhr.org/resources/public/Reports/BC_Scan.pdf. Accessed October 21, 2009. 12 Include: the Nuremberg Code (1948), the Helsinki Declaration (1964), the Belmont Report from The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979), and the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines established in 1990 by the European Union, Japan and the U.S. 13 Tri-Council refers to Canada’s three federal research funding agencies: the Canadian Institutes of Health Research (CIHR), the Social Sciences and Humanities Research Council (SSHRC), and the Natural Sciences and Engineering Research Council (NSERC). 14 http://www.msfhr.org/special_initiatives/ethics_harmonization. Accessed October 21, 2009. 21
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Page 6 and 7: 2 EXECUTIVE SUMMARY BRITISH COLUMBI
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APPENDIX 5. CLINICAL TRIALS TRAININ
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APPENDIX 5. Clinical Trials Trainin
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Pediatrics INSTITUTION EMAIL URL DI
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Pediatrics (cont’d) INSTITUTION E
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248 APPENDICES 7-13 TABLE OF CONTEN
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APPENDIX 8. PROVINCIAL AND NATIONAL
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312 B.C. Centre for Disease Control
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314 University of Victoria Brenda D
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