An overview of working with genetically modified organisms is provided on the website of the Health & Safety Executive.
Safety of all clinical studies performed on University of Oxford (OU) or Oxford University Hospitals NHS Foundation Trust (OUHFT) premises and involving administration of an ATMP, or GMO or a wildtype microbe to a human participant requires review and approval by the Joint OUHFT/OU Advanced Therapy Medicinal Product and Genetic Modification Safety Committee ('OUHFT/OU ATMP & GMSC), contactable by email to atmpandgmsccommittee@ouh.nhs.uk.
Application documents are available to staff with an OU Single Sign-On (SSO) through the links in the 'application documents' section of this page, and to OUHFT staff through the Pharmacy intranet site. The use of GMO-based agent(s) in a multi-site trial may already be covered by a deliberate release (DR) licence granted by DEFRA to the sponsoring body, in which case a new risk assessment is not required, but a DR licence must be submitted to the OUHFT/OU ATMP & GMSC for review.
University researchers should discuss their plans and application with their departmental safety officer, who may advise discussion with the University Biological Safety Officer (BSO) prior to an application to the Joint ATMP & GMSC. Applications to the OUHFT/OU joint committee should be copied to the departmental safety and GM committees responsible for the relevant university premises to ensure awareness. Laboratory work by university staff on university premises in connection with clinical studies is not reviewed by the Joint OUHFT/OU committee and should be reviewed through local processes.
If in doubt about which aspects of a project require review by the joint committee, advice can be sought from the biological safety office or the joint committee email address.
Assessments assigning work to a higher risk classification, usually Class 2, must be notified to the Health & Safety Executive. This will be undertaken by the University BSO in parallel with approval from the OUHFT/OU ATMP & GMSC and/or departmental GMSC. Deliberate release licences may take up to six months to obtain from DEFRA. Both notifications and licence applications incur fees.
Application Documents
