Research using genetically modified organisms
Study preparation requirements when using genetically modified organisms
An overview of working with genetically modified organisms is provided on the website of the Health & Safety Executive.
The use of genetically modified organisms for clinical research on University or Oxford University Hospitals Foundation Trust (OUHFT) premises, usually through preparation and administration of GMO agents to volunteers or patients (and known as Advanced Therapy Medicinal Products (ATMPs)), must be covered by either an approved risk assessment for contained use work, or a licence for deliberate release work. This is in addition to any other permissions required for clinical research.
University researchers working on University premises should contact the appropriate departmental biological safety officer or the University Biological Safety Officer for guidance (see the Safety Office's website for details).
Clinical research or trials with GMOs on OUHFT premises, or where University research is likely to lead to the admission of volunteers to OUHFT premises and care from clinical staff, must submit a risk assessment to the OUHFT Genetic Modification Safety Committee (GMSC) for review and approval.
Alternatively, the use of GMO-based agent(s) in a multi-site trial may already be covered by a deliberate release (DR) licence awarded to the sponsoring body. Such a DR licence must be submitted to the OUHFT GMSC for review and approval.
Clinicians/researchers should submit completed assessments or copies of deliberate release licences to the chair of the OUHFT GMSC in the first instance, by emailing email@example.com. Where required, advice on classification of a GMO or applying for a deliberate release licence can be given by the University Biological Safety Officer.
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 OUHT GMSC and/or departmental GMSC. Deliberate release licences are granted by DEFRA and may take up to six months to obtain. Both notifications and licence applications incur fees.