Health and Social Care Research

UWE's policy on research ethics

Researchers (both staff and students) involved in health and social care research need to comply with the requirements of The Research Governance Framework of the Department of Health. This gives guidance on good practice in the collaboration of research between researchers, health and social care teams, employers and research funders. The framework includes any person involved in health and social care research: participants, principal investigators and researchers, host organisations, funders, and managers. It includes research undertaken by industry, charities, research councils, universities, and NHS staff.

Recognising that implementation of the Framework in social care requires separate consideration, the DoH has also published an Implementation Plan for Social Care.

back to top

The DoH Research Governance Framework: Does it apply to your research?

All types of research are included, and research is defined as 'the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods'.

In relation to the NHS, Research Governance covers research involving patients, service users, care professionals or volunteers, or their organs, tissue, data or other body material of patients deceased or alive. This is very wide ranging and means that its coverage includes:

• all research involving NHS staff or patients, service users, care professionals or volunteers of the NHS
• all methodologies including focus groups, observational studies and action research where this involves those mentioned above or their organs, tissue, data or other body material of patients deceased or alive.
• student research (undergraduate and postgraduate research dissertations as well as doctoral students) as well as research by staff
• all research using NHS premises or resources
• research based in a social care environment
• any human participant research in an NHS context by any Faculty of UWE and not just relevant research in Life Sciences and Health and Social Care

back to top

How does this affect staff and students at the University of the West of England, Bristol?

All students and staff at UWE who undertake any relevant research must comply with the Department of Health Framework. For those students and staff undertaking research within the NHS or using NHS resources or affecting staff or patients of the NHS, there are clear requirements from both the health services and UWE. For those undertaking social care research, the boundaries have not yet been fully defined, therefore researchers need to consider governance issues when undertaking any research which encompasses social care until the picture is clearer. UWE believes the DoH Framework to be a good standard and you should consider working towards these standards for relevant research within the NHS. Further guidance for researchers

back to top

NHS requirements

It is important that PIs conducting research in the NHS appreciate that both UWE and NHS Ethics clearance will be needed and are separate. However, in order to assist PIs in this as far as possible, you are recommended to apply for NRES ethics approval first (using the IRAS form) and submit the letter of approval to your FREC or to UREC (as applicable). This approach has been designed to retain the right of ultimate ‘sign off’ by the University without having to go through a separate protracted University process. However, achievement of the one does not guarantee success with the other.

You are also advised to consult Differentiating between research, service evaluation and audit to determine whether or not your ‘research’ requires NRES ethical scrutiny.  This can be particularly complex for those carrying out social care rather than health care research, those carrying out what the NHS might deem to be an audit or a service evaluation and when research involves respondents who lack mental capacity.

In addition, you must comply with UWE procedures, for example bid and contract approval for all externally funded research.

The NRES website contains a wealth of information about applying for ethical approval for research. The processes have undergone significant changes in recent months – with the introduction of the new IRAS form, to replace the old COREC form, and the Research Passport.

If you are intending to apply for NRES approval you should consult their guidance for the most up-to-date information.  

back to top

Integrated Research Application System (IRAS)

IRAS is a web-based integrated research application system that captures the information a researcher needs to submit for the relevant permissions and approvals to enable the conduct of health and social care research. It streamlines the application process by allowing study information to be entered in one place without duplication in separate application forms for each review body.

IRAS is currently available for use, and becomes mandatory from summer 2008. This replaces the previous NRES (formerly COREC) form.

See the Integrated Research Application System (IRAS)

back to top

Clinical trials and investigative studies

UWE's insurance definition of a research trial (clinical trial) is:

"an investigation or series of investigations conducted on any person for a Medicinal Purpose"

where Medicinal Purpose means:
a) treating or preventing disease or diagnosing disease or
b) ascertaining the existence degree of or extent of a physiological condition or
c) assisting with or altering in any way the process of conception or
d) investigating or participating in methods of contraception or
e) inducing anaesthesia or
f) otherwise preventing or interfering with the normal operation of a physiological function

For staff to be covered by UWE clinical trials insurance, a questionnaire must be completed for insurance purposes, for all research which is included in the insurance definition of Clinical trials.

UWE insurance questionnaire for research involving human participants

Additionally, the Medicines and Healthcare Product Regulatory Authority definition of a Clinical Trial is an investigation "involving administration of a medicinal product to a patient to assess the product's safety and efficacy." For anyone within UWE wishing to carry out this type of a Clinical Trial, an application for a clinical trial certificate would have to be made to the Licensing Authority and strict regulations would have to be adhered to. Authorisation to proceed with this type of a Clinical Trial would have to come through your Executive Dean.

back to top

Auditing and monitoring

All research projects that are covered by the Framework must have a named person who is responsible for monitoring the project, commensurate with the scale of the research. This might be the Supervisor, Director of Studies, Project Manager or Line Manager, for example.

Annual audits of research projects should be carried out within each Faculty and across UWE as a whole.

back to top

The Mental Capacity Act 2005

The Mental Capacity Act 2005 came into effect on 1 October 2007 and requires all intrusive research on or in relation to people who do not have capacity to consent to be subject to ethical scrutiny by a Research Ethics Committee established under the Governance Arrangements for NHS Research Ethics Committees (GAfREC, DH July 2001).

Intrusive research (defined in section 30(2) of the MCA as: “[research] of a kind that would be unlawful if it was carried out on or in relation to a person who had capacity to consent to it, but without his consent”)  is not limited to medical and biomedical research, health-related research or research taking place within the NHS.

UWE legal advice on the requirement for NRES approval is as follows:

The legal advice will vary according to each individual case, and depends on a carer’s perception of the individual’s ability to give consent in the particular case. There should not be an assumption that an individual is unable to give consent just because he or she happens to have some sort of mental impairment.

The requirement for NRES approval is confined to acts involving what would otherwise be (1) an assault or battery or some other offence against the person, or unlawful restraint or imprisonment, or (2) unlawful entry on to someone else's property. So if the research were to involve physical touching of, or medical treatment of, an individual, or the confining of an individual while the research is being carried out, NRES approval would be needed; similarly if the research involved administering a questionnaire or observing the behaviour of an individual in their own home (because not to have consent to enter would be a trespass, which is unlawful without the occupier's consent and it has to be assumed that consent has not been given); but if the research were only to involve say, administering a questionnaire to an individual in an institution to which the researcher has obtained the owner's permission to enter and do the research, or observing what the individual does voluntarily and of their own accord out in the street or some other public place, then no approval would be needed. 

The location of the research is particularly significant in dictating whether or not NRES approval needs to be applied for. Problems would be likely to arise when conducting questionnaires in participants’ own homes – if the research were to take place in a care home, for example, the consent of the person in charge of the care home must be sought (or the researcher may be deemed to be trespassing, and hence acting unlawfully). Written evidence of consent may be helpful should there later be a dispute about whether a consent was given, or what it covered. The wording of the Act is unambiguous, but no doubt case law will develop as and when legal challenges are made. Subject to that, it is clear that not all research involving people subject to mental incapacity must go through the NRES process. William Evans, either directly or via Katie Owen-Jones, Clerk to the Governors may be contacted for advice on individual cases. It should be stressed that this advice may change over time as case law and good practice guidance emerges.

See Research involving adults unable to consent for themselves and The Mental Capacity Act code of practice, and Mental Capacity Act - Fact Sheet for Social Scientists

back to top

Differentiating between research, service evaluation and audit

Ethical approval from a University research ethics committee is required for all research and service evaluation which involves human participant and/or tissues. Audit does not require ethics scrutiny. However, the NRES Ethics Consultation E-Group has decided that Audit and Service Evaluation were recognised to have no, or minimal risk, and there was broad agreement that such work need not come before a full committee meeting of an NHS REC, unless specifically requested. Further information

back to top