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A Research Ethics Board for the Independent Review of Clinical Research Conducted in Private Practice Setting.
In Canada REBs are usually associated with hospitals or universities where
academic research is the focus of their review. Guidance for federally funded
research is founded in the TriCouncil Policy Statement (TCPS), similar to the US
45 CRF 46. However, the regulations adopted by Health Canada for clinical
research of investigational drugs as carried out by pharmaceutical companies
differ from the TCPS (Health Canada GCP - ICH – GCP E.6). Hence there is a gap.
There is an increasing trend by the pharmaceutical industry to support research
“closer” to the primary care giver, which tends to be the private practice
physician. Canadian SHIELD Ethics Review Board was formed to expedite clinical
trials conducted in private practices across Canada. The administrative staff of
Canadian SHIELD has extensive experience both within the pharmaceutical industry
and at the research site. The Board Administrator understands the needs of study
sponsors based on more than 18 years of drug development experience and has
implemented procedures to minimize the administrative burden to both the sponsor
and the Investigator. Likewise the support staff have extensive on site
experience and are uniquely qualified to assist the Investigator and their study
co-ordinators with REB interactions. The Board itself is composed of active
researchers including primary care physicians, private practice specialists and
hospital / university based academic researcher physicians. They can provide
in-depth review and comments based on their extensive clinical research
experience. Canadian SHIELD understands the needs of the pharmaceutical sponsor
as well as the Investigator and their staff helping to expedite high quality
reviews of proposed research from a sound knowledge base. The administrative
burden on both the Sponsor as well as the site staff has been carefully reviewed
to ensure the focus remains on the review of the proposed study and not the
paperwork.
The Administrator of Canadian SHIELD Ethics Review Board has extensive
experience dealing with the regulatory issues impacting clinical research in
Canada and worldwide. Based on this broad understanding, Canadian SHIELD
provides a guarantee to the Canadian government Therapeutic Products Directorate
(TPD) of Health Canada, to the USA government Department of Health and Human
Services and the FDA as well as the European Union (EU) and the European
Medicinal Evaluations Agency (EMEA) that it will follow procedures, which will
assure the protection of all human subjects involved in research projects. In
order to comply with this assurance, Canadian SHIELD has established a Board
competent to review research projects that involve human subjects under the
provisions of the ICH Regulations (GCP E.6 section 3) as adopted by TPD,
Canadian Food & Drug Regulations, Division 5 (1024 Clinical Trials) and HHS
Regulations for Protection of Human Subjects (21 CFR 50 & 56 and 45 CFR 46).
Canadian SHIELD Ethics Review Board is an independent body not associated with
any research site, SMO, CRO or study sponsor. All Board members are active
researchers and understand the issues facing Investigators and their staff. In
order to ensure true independence of the Board, all members have signed
Confidentiality Agreements, Recusal Agreements and Financial Conflict of
Interest Agreements. |
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