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The Medical Sciences IDREC (MS IDREC) utilise a number of ‘CUREC Approved Procedures’, which are essentially documents approved by CUREC for how to approach certain types of study or intervention.  The main function of such Procedures is to reduce the need for researchers to apply for ethical review using a full CUREC 2 application form.  By agreeing to conduct research within the scope of a CUREC-approved procedure, researchers may apply for ethical review and approval using the process for lower-risk research.  The Central University Research Ethics Committee (CUREC) has recently approved revisions to several Approved Procedures (see https://researchsupport.admin.ox.ac.uk/governance/ethics/resources/ap).

If you are a researcher who utilises any of the above CUREC Approved Procedures as part of an ethically-approved project, it is important that you read the new document to ensure you can still meet with requirements.  In particular, your attention is drawn to the following changes:

Approved Procedure (AP) 25 (Non-invasive methods with children as participants in institutional and non-institutional settings)

  • Title change from ‘Studies using non-invasive methods with children’ to ‘Non-invasive methods with children as participants in institutional and non-institutional settings’;
  • The General Data Protection Regulation (GDPR) will be implemented throughout the EU from 25 May 2018 to replace the Data Protection Act (DPA).  This stipulates that people should be actively asked (i.e. they should `opt in’) to consent to their personal data being stored and processed, if consent is to be used as the legal basis for the processing of personal data.  In view of this, the sections on ‘opt-in’ and ‘opt-out’ recruitment have been updated.  This is to clarify that an ‘opt-in’ approach to recruitment and consent is the preferred method for use when personal data will be collected and stored as part of the research study (if the research is to remain within the frame of this Approved Procedure);
  • Clarification that where parents do not ‘opt-out’ their child from participating in a study, then active assent should be sought from the child, and must be obtained from those aged 13 years upwards where personal data will be collected;
  • Substitution of the legal term ‘duty of care’ with ‘responsibility’, as there is a distinction between a ‘legal duty’ versus a researcher’s ‘ethical duty’;
  • Use of broader terms, such as ‘residential’, ‘non-institutional’ and ‘institutional’ research settings, rather than very specific examples, in order to cover a broad range of care/ educational settings. Specific references to e.g. non-NHS care facilities, youth groups, orphanages, and places of worship have been removed (requested by SSH IDREC);
  • Clarification that the procedure cannot be used for:

×          research conducted in places that would raise more complex ethical issues, such as detention centres, prisons or refugee camps;

×          cognitive brain training (this would classify as  a medical intervention);

  • Clarification that the research setting should not automatically qualify children as ‘vulnerable’, depending on the cultural context.  In order to avoid unnecessary CUREC 2 (higher risk) applications, it has been suggested to refer researchers to the relevant IDREC Secretariat (via ethics@socsci.ox.ac.uk / ethics@medsci.ox.ac.uk) in cases where research settings are likely to define the child participant as ‘vulnerable’. The Secretariat can then help determine whether a full CUREC 2 application should be completed.

AP20 (Non-invasive measurement of blood pressure in the arm)

  • Added the use of pulse volume plethysmography

AP17 (Non-invasive MRI in healthy volunteers)

  • Oxford Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB) has changed its name to the Wellcome Centre for Integrative Neuroimaging (WIN) – documents updated to reflect this
  • Removed statement that previously excluded claustrophobic participants from taking part, asking them instead to let someone know before the scan if they think they are claustrophobic

Revised supporting documents for the Approved procedure for Magnetoencephalographic (MEG) recordings (AP08)

  • There is no straightforward procedure for confirming diagnosis of a possible abnormality.  Documents updated to remove statements suggesting participants would be informed if there was suspected abnormal brain activity