Animal studies performed on behalf of GlaxoSmithKline (GSK) are expected to uphold the core principles established by Corporate Policy 403, ‘Care, Welfare and Treatment of Animals by GSK’. There are two major considerations that are assessed prior to approval of an external institution; conformance with all 8 principles for animal care and use, and an assurance of a scientific peer review. The diligence reviews are composed of a set of electronic forms that are completed by the GSK scientists and the partnering external institution. These forms include information about the institution, aspects of ethical review and details of the study. Specific review is weighted based on species order, the regulatory oversight in the country of work, the level of pain/distress in the study design and any previous history with the institution. Studies involving unalleviated pain, plus any study involving non-rodent species are forwarded to the team of expert scientists that provide a peer review. The need for a site visit is determined by a risk rating tool that highlights the potential welfare concerns for the company. Partnering these two processes, diligence and scientific review, meets the expectations for quality and risk assessment for external institutions at GSK.
• To understand the perceived animal welfare risks that externalized studies pose for GSK
• To understand the components and process of the diligence and scientific reviews
• To share our risk rating tool for determination of necessary site visits