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  1. Research
  2. Ethics, integrity and practice
  3. NHS, Social Care and Criminal Justice Policy and Procedures

NHS, Social Care and Criminal Justice Policy and Procedures

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) guidance document (PDF, 202 KB).

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

  • comply with the Health Research Authority (HRA) Procedures
  • seek approval from NHS HRA Research Ethics Committee and Research Governance Approval via the online IRAS system
  • seek sponsorship and indemnity cover from the University Research Support Team
  • maintain an investigator site file

Research involving Offenders must follow the procedures laid down by the National Offender Management Service (NOMS)

The NHS IRAS system handles NOMS 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 their quality assurance processes (research@justice.gsi.gov.uk) Prison Governors have the final say on allowing research in their prisons.

Sponsorship and Indemnity at Sheffield Hallam for NHS, Social Care and NOMS 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. obtain Sheffield Hallam University ethical approving using the IRAS pathway of Converis
  2. seek sponsorship and indemnity cover from the University Research Support Team
  3. maintain an investigator site file for the life of the project (DOC, 99KB)

More guidance on the intersection between Sheffield Hallam University and NHS ethical and governance requirements can be found in this flowchart (PDF, 205 KB).

Not all of the projects undertaken within the NHS are research. 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.

The NHS clearly make a difference between project research, audit or service evaluation. 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.

Applying to the NHS for ethical and/or governance review

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 and social care/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 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

Free NHS training on good clinical practice can be accessed here.

Safety Reporting in Research Trials (Clinical and Healthy Volunteers)

It is a requirement for researchers to produce a protocol to describe procedures for monitoring for any adverse events that occur to participants/patients in research trials. Researchers should familiarise themselves with Sheffield Hallam's Reporting of Serious Adverse Events protocol (PDF, 235 KB) and complete the proforma 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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