Posted on behalf of Research Services
With effect from 1st September 2016, studies that will involve administration of pain, Transcranial Stimulation (TCS), Transcranial Magnetics Stimulation (TMS) or Magnetic Resonance Imaging (MRI) to Healthy Human Volunteers may be submitted directly to the Medical Sciences Inter-Divisional Research Ethics Committee (MS IDREC – a sub-committee of CUREC) for ethical review. Previously, there was a requirement for such studies also to be reviewed by the Clinical Trials and Research Governance (CTRG) team before these could be submitted to the MS IDREC.
To reflect this change, guidance on the CUREC website has been updated, and the CUREC 1 application form revised and re-issued. The current version can be downloaded at https://www.admin.ox.ac.uk/curec/apply/ms-idrec-process/#d.en.169858. Please note that the MS IDREC will not accept any older versions of this form for new applications with effect from 1st October 2016.
CUREC Approved Procedure numbers 17 (Magnetic Resonance Investigations - MRI), 19 (Experimentally Induced Pain), 21 (Transcranial Magnetic Stimulation - TMS) and 22 (Transcranial Stimulation - TCS), and their associated documents (e.g. template Participant Information Sheets and Informed Consent Forms) have also been updated to reflect the new process.
If you are currently working under an existing ethics approval for a study involving MRI, pain, TMS or TCS (that was reviewed by CTRG) you do not need to take any action at present. However, if you wish to make an amendment to any such approval in the future, this may now be sent directly to the MS IDREC for review.
We would like to remind you that CUREC studies involving NHS staff, data or facilities, and CUREC 3 applications (for studies that involve administration of a licensed drug or other (non-drug) substance to healthy volunteers in the EU) must still be sent to CTRG for Sponsorship Approval prior to submission to CUREC for ethics review.