Health and Social Care Research Governance
Research Governance is a requirement of the UK Policy Framework for Health and Social Care.
All health and social care research projects MUST be authorised to commence by a Research Governance Sponsor (this should not be confused with the term 'sponsor', which is often used to mean research funder). The research governance sponsor is ultimately responsible for the healthcare or social care research project, and will need to carry out checks before it can grant a project authorisation to commence research activities and release funding for the project.
Healthcare research is any project involving the NHS/UK Health Department Services in any way (for example, involves NHS staff, NHS patients, takes place on NHS premises, takes place during NHS staff work time, requires NHS ethics or HRA Approval.
The Department of Health’s Research Governance Framework, which defines ‘health care research’ as:
'research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS, and research undertaken by or within social care agencies. It includes clinical and non-clinical research; research undertaken by NHS or social care staff using the resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services.'
Please see http://www.sheffield.ac.uk/rs/ethicsandintegrity/governance/definition for more information on the definition of health care research.
Social Care Research
Social care research is any project involving staff, carers and/or service users of social care services that are provided by a local authority (including any organisations providing services under contract on behalf of a local authority) or a prison health service.
Please see https://www.sheffield.ac.uk/rs/ethicsandintegrity/social/socialcare for more information on the definition of social care research.
All Health Care and Social Care Research Projects MUST follow the Research Governance Procedure.
For further information on the Health Care Research Governance Procedure, please see the following:
For further information on the procedure, please see the pages from Research Services: http://www.sheffield.ac.uk/rs/ethicsandintegrity/governance/rgp
The contact person for University Sponsorship (IRAS) is Dr Jennifer Burr - Chair of ScHARR Ethics Committee firstname.lastname@example.org ext. 20792
Human Interventional Studies/Clinical Trials
The University's definition of a human-interventional study is:
'These are research studies designed to answer specific questions about intervention(s) in human participants, whose purpose is to investigate the effectiveness of the intervention(s) & to assess clinical or physiological outcomes.'
Human-Interventional Studies are a special type of health care research project and, as such require the University's healthcare research governance process. Clinical trials and Human Interventional studies must meet new transparency requirements, such as registering the study publicly and reporting results within certain timescales.
Special approvals must be sought for higher risk clinical trials and human interventional studies.
Please contact: http://www.sheffield.ac.uk/ris/contacts/qgt
The University will usually sponsor (provided that there is not a more appropriate research governance sponsor)
For further information please see the pages from R&IS concerning human-interventional studies:
Do I need an NHS Research Passport?
A Research Passport is designed to allow non-NHS staff to obtain an Honorary Research Contract or Letter of Access in order to do research in the NHS. The Research Passport system establishes a common system of pre-engagement checks which conform to the standards required by all NHS bodies, so are therefore transferrable across NHS Trusts.
For full details please see: www.sheffield.ac.uk/ethicsandintegrity/governance/passport