Genetically modified organisms (GMO)
Among Phase 1 clinical research units, HMR is unusual in having been approved by the Health and Safety Executive (HSE) for activities involving GMO at containment level 1. In compliance with the GMO (Contained Use) Regulations 2014, we have a Biological Safety Officer who chairs our Genetic Modification Safety Committee (GMSC). The Biological Safety Officer advises the Medical Director on the containment of biological hazards, and on the safety of staff and trial participants. The GMSC meets to review proposals for trials involving GMO, and to advise on the risks to human health and the environment. The Committee also advises on procedures relating to safety, training, and health monitoring. That infrastructure has allowed us to complete very demanding trials of GMO.
- HMR is approved by the HSE for activities involving GMO at containment level 1.
- We can also do GMO studies at containment level 2, which require notification to the HSE. Our experienced project management team can provide regulatory support, and oversee the notification process.
- We’re very experienced in managing complex trials that fall under the GMO (Deliberate Release) Regulations 2002. Our BSO and regulatory experts manage the application for consent to the competent authorities on behalf of the study sponsor.