External Approvals

If your study will involve the exposure of ionising radiation to participants, you may be eligible to apply for Radiation Assurance which is currently going through a phased roll out. Exposure of ionising radiation to participants requires submissions to an external Research Ethics Committee (REC) as well as specialist expert input. Further guidance is available by contacting ethicssupport@northumbria.ac.uk.

The Ministry of Defence Research Ethics Committee (MoDREC) ensures that all research involving human participants either undertaken, funded, or sponsored by the MoD meets national and international ethical standards.

MoDREC is comissioned to review research projects involving human participants in research studies.

The committee is an independent body comprising of non-MoD (expert and lay) members and is supported by MoD advisers.

Prior to final review by MoDREC, scientific and technical rigour is assured through assessment by a Scientific Advisory Committee (SAC).

For further information, please click here to read about MoDREC on the government website.

Research undertaken in prisons, with offenders, or the probation services must be reviewed by the relevant REC via the IRAS system.

Information on the process can be found on the government website, Research and His Majesty's Prison and Probation Service.

Researchers should approach the prison's Governing Governor at whichever prison is involved, in order to gain their consent and support before beginning the ethical approval process.

The Mental Capacity Act (MCA) 2005, provides a comprehensive framework for decision making on behalf of adults aged 16 or over who are unable to make decisions for themselves, i.e. they lack the capacity to consent.

The MCA applies in England and Wales only. It applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research.

The MCA is accompanied by a statutory Code of Practice providing guidance on how it should be used. Researchers and others making decisions involving people lacking capacity have a legal duty to regard the guidance in the Code of Practice.

The Health Research Authority (HRA) provide a free eLearning module on research involving participants lacking mental capacity, which you can access here.

Does the Mental Capacity Act apply to my research?

The MCA applies to any intrusive research within England and Wales, wherever it takes place, except for clinical trials of investigational medicinal products. This may include research in healthcare, social care, criminal justice, and other settings. It is not limited to research undertaken within NHS organisations or other public bodies.

What is 'intrusive research'?

Under Section 30 of the MCA, research is intrusive if it is of a kind that would be unlawful if it was carried out "on or in relation to a person who had capacity to consent to it, but without this consent". Therefore, intrusive research means research that would legally require consent if it involved people with capacity. Intrusive research is not limited to trials of clinical interventions.

It includes non-interventional research where consent is legally required, for example involving the processing of personal data or the administration of questionnaires, interviews, or observations. Intrusive research involving a person who lacks capacity is unlawful unless it is approved by an appropriate body.

What research is not intrusive?

Consent is not a legal requirement, and therefore the research is not intrusive, if it is limited to one or more of the following:

• The processing of non-identifiable data.
• The processing of identifiable patient data with the approval under Section 251 of the NHS Act 2006 (or formerly under Section 60 of the Health and Social Care Act 2001).
• The use of tissue samples (cellular material) held prior to the coming into force of the Human Tissue Act (HTA), on the 1st September 2006 - called 'existing holdings'.
• The use of tissue samples (cellular material) taken from a living person, provided that the person is not identifiable to the researcher and the research project has ethical approval.

What is the role of the appropriate body?

The appropriate body is responsible for approving intrusive research involving adults lacking capacity. It must be satisfied that all the criteria in Section 31 of the MCA are met, including that arrangements are in place to satisfy the requirements of Sections 32 and 33.

Who can act as the appropriate body?

All NHS RECs established under the Governance Arrangements for Research Ethics Committees (GAfREC) in England and Wales, and the Social Care REC, are appropriate bodies for the purposes of approving research under the Mental Capacity Act (England and Wales) 2005. The Ministry of Defence RECs are also recognised for research withing their remits.

Although, legally, any REC established under GAfREC in England and Wales may approve research under tha MCA, a panel of flagged RECs for research involving adults unable to consent for themselves has been established.

University ethics committees are not recognised as appropriate bodies under the MCA.

Applications under the MCA relating to research outside the NHS will be accepted for review by NHS RECs.

Which REC should I apply to?

The government Research Ethics Service has flagged a number of NHS REcs in England and Wales to review new applications for approval under the MCA. Members of these RECs have had additional training in issues relating to the MCA.

Applications should be booked with the Online Booking Service so they can be allocated to an appropriate NHS REC.

Are there any specific requirements for applications under the MCA?

The application form, which is available via the Integrated Research Application System (IRAS), incorporates specific questions about compliance with the Act in Part B, Section 6 of the form.

The study protocol should describe the procedures for recruiting people lacking capacity, including arrangements for identifying and consulting consultees.

If appropriate, procedures should be described for seeking consent from participants who may regain capacity during the study.

For student studies that involve research with the NHS, and undertaken primarily for the purpose of obtaining an educational qualification, there is additional information on the government 'Student Research' page, here. Please note the most Undergraduate and Postgraduate Taught students cannot apply for NHS REC approval or to undertake research as defined by the Health Research Authority (HRA) with the NHS.