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 (REC) and Research Governance Approval
- (if a doctoral project) seek sponsorship from the University's Research and Innovation Services (see IRAS Applications)
- maintain an investigator site file
Research Involving Offenders
When research involves offenders, it must follow the procedures laid down by His Majesty’s Prison & Probation Service (HMPPS). The NHS IRAS system also handles HMPPS applications.
Research involving secure training centres or youth offending teams must gain approval from the Youth Justice Board (firstname.lastname@example.org) and research commissioned by the Ministry of Justice must go through the ministry's quality assurance processes (email@example.com) Prison Governors have the final say on allowing research in their prisons.
Offender and Prison Research Ethics Approval Guide
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. 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.
Data Sharing Agreement with the Department of Health and Social Care
The University has a Data Sharing Agreement with the Department of Health and Social Care. This has particular relevance to Join Dementia Research. More information about the Agreement can be found here.