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Interim changes to JRO process for reviewing Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø/Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH GMO trial risk assessments

24 June 2020

There is a new interim process for submitting risk assessment documents for GMO-IMP trials (clinical trials which use an investigational medicinal product considered to be a genetically modified organism) at Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø or Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH.

Investigators should now submit documents to the JRO via uclh.randd@nhs.net and mark this as a 'GMO risk assessment'.

Alternatively, Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø investigators – or investigators on Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø sponsored trials – can complete the GM risk assessment form via Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø RiskNet. Further details are here.

Previously documents were sent directly to the Ïã¸ÛÁùºÏ²ÊÖÐÌØÍø/Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH/RFH Genetic Modification Safety Committee chair Professor Emma Morris, but she has now stepped down from the post.

The Approval of hosted clinical trials using IMPs which are considered to be GMOs Ïã¸ÛÁùºÏ²ÊÖÐÌØÍøH Policy will be updated in due course.