Health Research Authority governance

NHS or social services ethics committee approval is required for research involving

  • NHS patients or social services clients, people recruited as participants by virtue of current or past contact with the NHS or social services, including those being treated under contract with private sector providers, relatives or carers of past or present users of NHS or social care services
  • access to records of previous or former NHS patients or social services clients
  • 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

Full guidance can be found in the Health Research Authority (HRA) document.

All research which involves NHS or social services patients must, in addition to receiving University approval

  • comply with HRA procedures
  • seek approval from HRA Research Ethics Committee and Research Governance Approval
  • seek sponsorship and indemnity cover from the University Research Support Team
  • maintain an investigator site file

Research involving offenders

When research involves offenders, it must follow the procedures laid down by Her Majesty’s Prison & Probation Service (HMPPS). The NHS IRAS system handles HMPPS applications.

Research involving secure training centres or youth offending teams must gain approval from the Youth Justice Board (research@yjb.gov.uk) and research commissioned by the Ministry of Justice must go through the ministry's quality assurance processes (research@justice.gsi.gov.uk) Prison Governors have the final say on allowing research in their prisons.

Sponsorship and indemnity for NHS, social care and HMPPS ethics applications

Sheffield Hallam will act as a sponsor for research projects and take on the responsibilities of the sponsor as set out in the Department of Health Research Governance Framework.

However, each project is assessed on a case by case basis and must have received Sheffield Hallam University ethical approval before a letter of sponsorship and confirmation of professional indemnity cover can be issued. Follow these steps.

  1. Complete the online IRAS form. Do not submit it online – instead download it as a PDF
  2. Obtain Sheffield Hallam ethical approval through the University's Ethics Review System, by uploading the draft IRAS form to the appropriate pathway
  3. Seek sponsorship and indemnity cover from the University Research Support Team
  4. Submit final IRAS application to the HRA 
  5. Maintain an investigator site file for the life of the project

More guidance on the intersection between Sheffield Hallam University and NHS ethical and governance requirements can be found in the IRAS flowchart.

The NHS makes a clear distinction between project research, audit and service evaluation. Under the Research Governance Framework, projects not classified as research are not managed as research within the NHS. To help you decide if your project is research, please refer to the NHS site.

Projects not classified as research do not require NHS Research Ethics Committee permission for research, but may require other NHS management arrangements. We would recommend seeking the opinion of the NHS Research and Development office where the research will take place. Audit and service evaluation require University ethical approval before the work commences.

IRAS – Applying to the NHS for ethical and/or governance review

The requirements by NHS Research Ethics Committees and other bodies depends on the type of research and where it will take place. The Integrated Research Application System (IRAS) is a single online system for applying for permissions and approvals for health, social care and community research in the UK.

Research Passport

If you have no contractual arrangements with the NHS and will be conducting research in the NHS which has an impact on patient care you will require an NHS Research Passport. This is part of the governance system but not yet included within the IRAS system. The University process for obtaining a Research Passport is detailed in the attached flowchart.

Good clinical practice

The National Institute for Health Research offers free NHS training on good clinical practice.

Safety reporting in research trials

It is a requirement for researchers to produce a protocol to describe procedures for monitoring for any adverse events that occur to participants and patients in research trials. Researchers should familiarise themselves with Sheffield Hallam's reporting of serious adverse events protocol and complete the form at the end of the protocol.

NHS audits and service evaluations

Projects classified as audits and service evaluations by the NHS require University research ethics approval, so should be submitted via the Converis Ethics Review System (staff and doctoral) or a SHUREC 7/8 form (masters and undergraduate), as though they were research projects. They still need to be done ethically and it means that there is ethics approval in place if the researchers want to publish.

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