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Interim changes to JRO process for reviewing °×С½ãÂÛ̳/°×С½ãÂÛ̳H 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 °×С½ãÂÛ̳ or °×С½ãÂÛ̳H.

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

Alternatively, °×С½ãÂÛ̳ investigators – or investigators on °×С½ãÂÛ̳ sponsored trials – can complete the GM risk assessment form via °×С½ãÂÛ̳ RiskNet. Further details are here.

Previously documents were sent directly to the °×С½ãÂÛ̳/°×С½ãÂÛ̳H/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 °×С½ãÂÛ̳H Policy will be updated in due course.