Research, Audit or Service Evaluation?

Differentiating Research, Audit or Service Evaluation

The "Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees" recommended NRES should develop guidelines to aid researchers and committees in deciding what is appropriate or inappropriate for submission to RECs, and NRES (with the Health Departments and with advice from REC members) has prepared the guidelines in the form of the attached table.

RESEARCH	CLINICAL AUDIT	SERVICE EVALUATION
The attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.	Designed and conducted to produce information to inform delivery of best care.	Designed and conducted solely to define or judge current care.
Quantitative research – designed to test a hypothesis. Qualitative research – identifies/explores themes following established methodology.	Designed to answer the question: “Does this service reach a predetermined standard?”	Designed to answer the question: “What standard does this service achieve?”
Addresses clearly defined questions, aims and objectives.	Measures against a standard.	Measures current service without reference to a standard.
Quantitative research -may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced.	Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.)	Involves an intervention in use ONLY. (The choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference.)
Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care.	Usually involves analysis of existing data but may include administration of simple interview or questionnaire.	Usually involves analysis of existing data but may include administration of simple interview or questionnaire.
Quantitative research - study design may involve allocating patients to intervention groups. Qualitative research uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications.	No allocation to intervention groups: the health care professional and patient have chosen intervention before clinical audit.	No allocation to intervention groups: the health care professional and patient have chosen intervention before service evaluation.
May involve randomisation	No randomisation	No randomisation
ALTHOUGH ANY OF THESE THREE MAY RAISE ETHICAL ISSUES, UNDER CURRENT GUIDANCE:-
RESEARCH REQUIRES R.E.C. REVIEW	AUDIT DOES NOT REQUIRE R.E.C. REVIEW	SERVICE EVALUATION DOES NOT REQUIRE R.E.C. REVIEW

When do I need ethical review?

Although Ethical Review is not normally required for Audit or Service Improvement projects ethical issues may arise. Staff surveys have raised ethical concerns for the well-being of staff and patients. These need to be given consideration in the planning of audit and service development.

For any research involving patients and users of the NHS, including all potential research participants recruited by virtue of the patient or user’s past or present treatment by, or use of, the NHS. It includes NHS patients treated under contracts with private sector institutions.

Individuals identified as potential research participants because of their status as relatives or carers of patients and users of the NHS

Access to data, organs or other bodily material of past or present NHS patients

Foetal material and IVF involving NHS patients

The recently dead in NHS premises

Use of, or potential access to NHS premises or facilities (including ‘healthy volunteers’ seen on an NHS site)

NHS staff recruited as participants by virtue of their professional role.

Research, Audit or Service Evaluation?

Latest Headlines

MHRA Inspection Dates Confirmed

full story....