Research using genetically modified organisms

The use of genetically modified organisms for clinical research on University or Oxford University Hospitals NHS Foundation Trust (OUH) 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.

Oxford University Hospitals premises

Clinical research or trials with GMOs on OUH premises, or where University research is likely to lead to the admission of volunteers to OUH premises and care from clinical staff, must submit a risk assessment to the OUH 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 OUH GMSC for review and approval.

Clinicians/researchers should submit completed assessments or copies of deliberate release licences to the chair of the OUH GMSC in the first instance, by emailing:

atmpandgmsccommittee@ouh.nhs.uk

Where required, advice on classification of a GMO or applying for a deliberate release licence can be given by the University Biological Safety Officer.

Notes

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 OUH 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.