EXTERNAL APPROVALS

The Research Governance Framework for Health and Social Care states that independent ethical review is undertaken of all health and social care research. Ethical approval must be obtained from an appropriate NHS Research Ethics Committee (REC) for any research proposal (including PhD student projects) which involves:

• Patients and users of the NHS. This includes all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions
• Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS, as defined above
• Access to data, organs or other bodily material of past and present NHS patients
• Foetal material and IVF involving NHS patients
• The recently dead in NHS premises or facilities; and
• NHS staff – recruited as research participants by virtue of their professional role

If your research project fall into one of the following categories you will need HRA Approval via the IRAS system:

• a Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of Phase 1 trials in healthy volunteers taking place outside the NHS)
• a Clinical Investigation or other study of a Medical Device
• a combined trial of an Investigational Medicinal Product and an Investigational Medical Device
• a Clinical Trial to study a novel intervention or randomised Clinical Trial to compare interventions in clinical practice
• a basic science study involving procedures with human participants
• a study administering questionnaires/interviews for quantitative analysis, or using mixed qualitative/quantitative methodology
• a study involving qualitative methods only
• a study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
• a study limited to working with data (specific project only).

If your project does not fall into the categories above but is:

• a Research Tissue Bank;
• a Research Database; or
• taking place in a non-NHS setting (for example a Phase 1 clinical trial in health volunteers)

Then you will not need HRA Approval but may still need approval from an NHS Research Ethics Committee.

Please refer to the separate section of this web page relating to Integrated Research Application System - IRAS

Health Research Authority

HRA Approval: the new process for the NHS in England

HRA Participant Information Sheets and Informed Consent templates and guidance

Please include this NU-specific Privacy Notice link in your Participant Information Sheets

NHS Trust R&D Approvals process

Integrated Research Application System (IRAS) is a single system for applying for Health Research Authority (HRA) permissions and approvals for health and social care / community care research in the UK. IRAS enables you to enter information about your project once instead of duplicating information in separate application forms and uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required.

If you are unsure whether you should complete an IRAS form, please check with your supervisor in the first instance and then your Departmental Ethics Lead or the Research Ethics and Integrity Manager. This Presentation on HRA and NHS REC applications and IRAS is very informative.  

Before submitting to the IRAS system, please follow Northumbria University’s Internal Approval Process for IRAS submission here and complete Northumbria's IRAS Internal Approval Form which can be found here.

Once internally approved, complete your submission to the NHS Integrated Research Application System here.

New Users to IRAS can find online guidance here.

What is the NHS DSTP?

The Data Security Protection toolkit is an online self-assessment tool that allows organisations to measure their performance against the National Data Guardian’s 10 data security standards.

As data security standards evolve, the requirements of the DSPT are annually reviewed and updated to ensure they are aligned with current best practice. 

Enrolling on the Toolkit at Northumbria

Northumbria University completed the DSPT assessment for the first time in June 2022, and again in June 2023. To manage researchers access to NHS data under the Toolkit restrictions, researchers must contact the Research Ethics and Integrity Manager via ethicssupport@northumbria.ac.uk to enrol on the Northumbria DSTP Framework. 

The Research Passport is the NHS mechanism for non-NHS staff to obtain an Honorary Research Contract/Letter of Access if you propose carrying out research in the NHS. Please refer to the appropriate guidance at the following links:

If you are a member of staff and wish to apply for a Research Passport, please submit a ticket to AskHR

If you are a Postgraduate Research student, please follow the guidance here. If you have any queries, contact the Graduate School at hl.graduateschool@northumbria.ac.uk

If you are an Postgraduate Taught student, please follow the guidance here. If you have any queries, contact the Specialist Student Support Team at sl.studentsupport@northumbria.ac.uk

The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.

The Toolkit is primarily focused on Clinical Trials of Investigational Medicinal Products (CTIMPs) and the regulatory environment and requirements associated with these. However researchers and R&D staff working on trials in other areas will also find useful information and guidance of relevance to the wider trials environment.

ClinicalTrials.gov is a registry and results database of public and privately supported clinical studies of human participants conducted around the world. This web-based resource provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

If you require a User Account, please contact ethicssupport@northumbria.ac.uk

If your research project is a CTIMP then you may be eligible to apply for Pharmacy Assurance, which is currently going through a phased roll-out.

If your research project involves accessing confidential patient information without consent in England and Wales, you will also need to apply to the Confidentiality Advisory Group (CAG).

Human Tissue Authority- HTA

Human Tissue Authority - FAQs

Northumbria University Tissue Bank Operational Manual

If your study will involve exposure of participants to ionising radiation research you may be eligible to apply for Radiation Assurance, which is currently going through a phased roll-out. Exposure of participant to ionising radiation requires submission to an external REC as well as specialist expert input. Further guidance is available from Research and Innovation Services..

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

 MoDREC is commissioned to review research projects involving human participants. It safeguards the rights, dignity and welfare of the individuals volunteering to participate in research studies.

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

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

 For further guidance, please check here.

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

The Act applies in England and Wales only. The Act 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 research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. 

The Act 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 have regard to the guidance in the Code of Practice. 

The HRA provides a free eLearning module on research involving participants lacking mental capacity.

Does the Mental Capacity Act apply to my research?

The Act 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 Act, 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: 

• processing of non-identifiable data
• 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)
• use of tissue samples (cellular material) held prior to the coming into force of the Human Tissue Act on 1 September 2006 (“existing holdings”)
• 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
• use of the results of the analysis of DNA in 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 Act 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 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 2005 (England and Wales) Act. The Ministry of Defence RECs are also recognised for research within their remits.

• Although legally any REC established under GAfREC in England / Wales may approve research under the Act, 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 Act.
• Applications under the Mental Capacity Act relating to research outside the NHS will be accepted for review by NHS RECs.

Which REC should I apply to? 

The Research Ethics Service has flagged a number of NHS RECs in England and Wales to review new applications for approval under the Mental Capacity Act. 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 Act? 

The application form, 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. 

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 here:

Research at Her Majesty's Prison and Probation Service

Researchers should approach the prisons’ Governing Governor (at whichever prison is involved), in order to gain their consent and support before beginning the ethical approval processes.

For student studies that involve research with the NHS, and undertaken primarily for the purpose of obtaining an educational qualification there is additional information available here. Please note that most undergraduate and postgraduate taught student cannot apply for NHS REC approval or to undertake research (as defined by the HRA) with the NHS