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

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.

Health Care Research Governance Procedure

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:

Overview of Process

Identifying Your Sponsor

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 j.a.burr@sheffield.ac.uk ext. 20792

Necessary Approvals

Where the University of Sheffield is the research governance sponsor, before it can start the project needs to be:

  • registered on the Costing Tool as a Student Governance Project (details here)
  • be independently scientifically approved (funding confirmation, ISR Forms or PhD Confirmation)
  • independently ethically approved via the University's ethics review procedure or NHS Ethics
  • HRA or Local Authority Approval

Alternatively, if another organisation has agreed to be the research governance sponsor, you will need to provide evidence from them confirming this and register the project on the Costing Tool.

Submit all necessary approvals to your Departmental Research Governance contact Charlotte Claxton/Jon Woodward who will issue a Research Governance Sponsor Authorisation letter and authorise the project to commence.

Monitoring During Project

Once the health/social care research project has been officially authorised to start by the University of Sheffield, the following monitoring arrangements must be completed:

Assign a 'Study Governance Administrator'who will take responsibility for complicance with governance requirements and carry out the following:

• Set up a site file
• Report progress (for example 3 months after starting, annually, at the end)
• Report Adverse Events

If your project was ethically approved by an NHS Research Ethics Committee (REC) then within 90 days of the project's end (or within 15 days if the project is terminated early) you need to inform the REC of the project's end.





Contacts:

Research Governance: Charlotte Claxton/Jon Woodward scharr-rec@sheffield.ac.uk

Monitoring Site Files: Charlotte Claxton/Jon Woodward scharr-rec@sheffield.ac.uk

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:

http://www.sheffield.ac.uk/rs/ethicsandintegrity/gov-ethics/clinicaltrials/index

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

Useful Documents & Key Contacts

Useful Documents

NHS Research Passport Application Form
Staff Process (Flow Diagram)
Student Process (Flow Diagram)

Departmental Contact for University Sponsorship (IRAS)
Dr Jennifer Burr - Chair of ScHARR Ethics Committee
j.a.burr@sheffield.ac.uk ext. 20792

The Sheffield Teaching Hospitals NHS Trust’s Clinical Research Office
Zoe Whiteley zoe.whiteley@sth.nhs.uk 0114 271 2572
Gaurika Kapoor gaurika.kapoor@sth.nhs.uk 0114 226 5939

Find your Research and Development (R&D) contact in an NHS Trust:
http://www.rdforum.nhs.uk/content/

FAQ

WHAT IS AN NHS RESEARCH PASSPORT FOR?
It is designed to simplify the procedure for obtaining an NHS honorary research contract and designed to facilitate undertaking research at more than one NHS Trust (different NHS Trusts are developing reciprocal arrangements in order that they can accept honorary research contracts which have been issued by different Trusts).

WHO NEEDS AN NHS RESEARCH PASSPORT?
The Research Passport is for researchers who have no contractual arrangements with the NHS but who conduct research in the NHS which can impact on patient care. Postgraduate students who conduct research within the NHS but who are not part of a healthcare placement need to complete a Research Passport.

WHO DOES NOT NEED AN NHS RESEARCH PASSPORT?
Researchers with substantive NHS employment contracts;
- Researchers with honorary clinical contracts (e.g. clinical academics);
- Students conducting research as part of their healthcare placements;
- Students who are employed by the NHS.

WHEN SHOULD I APPLY FOR AN NHS RESEARCH PASSPORT?
If you require an NHS Research Passport then you should start applying for one as early as possible - i.e. at the time you register your health care research project with the University and with the NHS Trust. This is because the nature of your project may mean that you require clearance checks such as Criminal Records Bureau clearance, which can take several weeks.

DOES THE RESEARCH PASSPORT SCHEME ONLY APPLY TO SOUTH YORKSHIRE?
No - The Research Passport scheme applies to the whole of the UK.

WHAT DOES AN NHS RESEARCH PASSPORT ACTUALLY LOOK LIKE?
It doesn't look like a passport. The Research Passport is a package of documents that the lead NHS Trust has approved (i.e. it includes the completed Research Passport Application form).