Roles and Responsibilities

Definition

Research
Research is defined as any systematic activity that generates new knowledge that helps to understand health and illness, including the diagnosis and treatment of diseases and designing better ways of delivering healthcare.

Clinical Audit
Clinical Audit is the monitoring of clinical activity against established good practice guidelines, or developing guidelines from accepted research evidence. The activity of audit and research may be the same - it is the purpose to generate new knowledge of use in other places that marks the distinction between research and audit. For example, guidelines development where there is little existing research evidence should be considered as innovation and research rather than audit.

Unlike research, audit does not usually require ethical committee approval and many of the guidelines in the manual do not apply. However it is the view of the consortium that both research and audit should be of high quality and result in learning. Leaders of audit may therefore find many of these agreements also of relevance to them.

The research methods
These might involve:

• Quantitative methods such as experiments and questionnaires
• Qualitative methods such as interviews and focus groups
• Case studies, interventions and multiple methods approaches
• Historical research
• Participatory action research

Ethical consideration
might be needed about things such as:

• Taking or using samples (tissues, fluids, whole organs…)
• Undertaking additional diagnostic tests
• Physical or psychological tests where full consent may be difficult
• Data from patient records and Trust databases

The multifaceted nature of primary care makes it particularly appropriate for research to include multiple perspectives (e.g. multidisciplinary), multi-paradigm approaches (e.g. multiple methods) and local participation (e.g. within a learning community).

Innovation
Introducing new techniques that have been developed elsewhere, or development and initial small-scale piloting of new techniques prior to formal assessment.

Routine data collection including patient satisfaction surveys
Routine data collection is audit when it is used to monitor clinical performance (e.g. data from general practice computers and patient surveys). The same activity undertaken to answer a research question is research (e.g. morbidity surveillance).

Service Development Assessment
All NHS service development projects should have in-built evaluation that is considered to be audit unless it aims to generate new knowledge.