HRA/NHS and University Approval

The HRA have developed a decision tool to help you determine whether NHS ethical review is required. 

Some research projects are exempt from REC review, but still need to be approved by the HRA, these can include:

• Projects limited to the use of samples/data samples provided by a Research Tissue Bank (RTB) with generic ethical approval from a REC, in accordance with the conditions of approval;
• Projects limited to the use of data provided by a Research Database with generic ethical approval from a REC, in accordance with the conditions of approval;
• Research limited to the use of previously collected, non-identifiable information;
• Research limited to the use of previously collected, non-identifiable tissue samples within terms of donor consent;
• Research limited to the use of acellular material;
• Research limited to the used of premises or facilities of care organisations (no involvement of patients/service users as participants);
• Research limited to the involvement of staff as participants (no involvement of patients/service users as participants).

Once you have identified that your research requires HRA approval, please log into EthOS and create a new full application form. In question A11, select that you ‘need to apply for ethical approval from a particular recognised approving body or are in the process of being reviewed for ethical approval by such a body’. Then select which recognised body you require approval from.

Once you have completed all the questions, please complete the form and submit the application. This will alert the Research Ethics and Governance team (REG) that you require ethical approval from an external body.

You must also email the Research Ethics and Governance team informing them of this. Please include your EthOS ID in the email. The team will then be in touch with you to advise of the next steps. 

All NHS applications require authorisation by the academic sponsor. The University has one designated person who can confirm sponsorship of the research study.

A sponsor is the person or institution who takes responsibility for the initiation, management and financing (or arranging financing) of that study. For research conducted by staff and students within the University, Manchester Metropolitan will, on most occasions, be the sponsor.

Research sponsorship is required under the UK Framework for Health and Social Care Research for all studies that involve the NHS or Social Care Organisations (e.g. patients or those involved in the care of patients). It is also required for studies of medical devices, human tissue (when it is obtained from the NHS), invasive research involving prisoners or adults lacking capacity. All of these types of research require an NHS Research Ethics Committee (REC) Review.

Before the research can be submitted for REC review, the Research Ethics and Governance team will determine whether Manchester Metropolitan can sponsor your study, and if so, will conduct a thorough review before confirming sponsorship.

You cannot start identification and recruitment of participants / data collection until all approvals are in place and the REG team have given the ‘green light’ to start.

If you have any questions or need any further information, please contact the REG team on [email protected].

• Protocol template for HRA approval
• Consent form template for HRA approval
• Participant Information template for HRA approval
• CI Agreement
• Insurance checklist

If your research does not include health or social care aspects, applications are submitted directly to the HMPPS.