Clinical Trials and Preclinical Infrastructure Asset Map - Life Sciences

CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP
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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.