NHS Related

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 (NHS REC) for any research proposal (including PhD student projects) which involve:

• 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.
• NHS staff - recruited as research participants by virtue of their professional role.

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

• A clinical trial of an investigational medicinal project (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 methodologies.
• 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 any of the below, then you will not need HRA Approval but may still need approval from an NHS REC.

• A research tissue bank.
• A research database.
• Is taking place in a non-NHS setting (e.g. a Phase 1 clinical trial in health volunteers).

Please refer to the IRAS tile on the previous page.

Please see below for further information and guidance:

Health Research Authority

HRA Approval: The new process for the NHS in England

Please include this Northumbria-specific Privacy Notice link in your participant information sheets.

NHS Trust R&D Approvals Process

If your research project is a clinical trial of an investigational medicinal project, then you may be able to apply for Pharmacy Assurance, which is currently going through a phased roll out.

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

The CTT 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 trails 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 involves accessing confidential patient information without consent in England and Wales, you will also need to apply to the Confidentiality Advisory Group (CAG).

Please find the relevant guidance below:

Human Tissue Authority- HTA

Human Tissue Authority - FAQs

Northumbria University Tissue Bank Operational Manual

What is the NHS Data Security Protection Toolkit?

The NHS DSPT is an online self-assessment tool that allows organisations to measure their performance against the National Data Guardians 10 data security standards.

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

Enrolling on the NHS DSPT at Northumbria

Northumbria University completed the NHS DSPT assessment for the first time in June 2022, and again in June 2023. To managed researchers access to NHS data under the DSPT restrictions, researchers must contact the Research Ethics and Integrity Manager at ethicssupport@northumbria.ac.uk to enrol on the Northumbria DSPT 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 with to apply for a research passport, please submit a ticket to AskHR in NU People and Finance.

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 a postgraduate taught student, please follow the guidance here. If you have any queries, please contact the Specialist Student Support Team and sl.studentsupport@northumbria.ac.uk.