General advice from the Regulator on coverage of new technologies

IBCs provide on-site scrutiny of low-risk contained dealings that do not require case-by-case consideration by the Regulator through independent assessment of NLRD proposals pursuant to regulation 13B – and on behalf of their organisation ensuring compliance with legislative requirements. IBCs are required to comprise a range of suitable experts and an independent person.

More information about the role and formation of IBCs can be found in the Explanatory Information on the Guidelines for Accreditation of Organisations and the Guidelines themselves.

IBCs are required to assess NLRDs and make a Record of Assessment (RoA) (as required by regulation 13B of the Gene Technology Regulations 2001 as amended 1 September 2011).
The OGTR has prepared a 'model' RoA form. IBCs have the option of using this 'model' form or alternatively, IBCs can make a RoA using another recording system. It is strongly recommended that the guidance document is used when preparing NLRD proposals and making RoAs.

Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives (PDF 124 KB)
Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives (DOCX 57 KB)

Guidance for making Records of Assessment of NLRDs (HTML)

Model Form - Records of Assessment Notifiable Low Risk Dealings (NLRDs) (HTML)

Requirements under the Gene Technology Act 2000 for clinical trials in humans involving GMOs –Guidance for clinical trial sponsors

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