Differentiating between research, audit and quality improvement: governance implications

Abstract

Purpose -In the context of changes in the priority given to ensuring that health care is evidence-based, and that service quality should be maximised, there is a new emphasis on quality improvement programmes in the UK National Health Service (NHS). It is not clear how far these programmes can be categorised using the paradigms of research and audit. Making a distinction between what constitutes audit, quality improvement and research is important in the context of enhanced clinical and research governance requirements and in an environment of both sensitivity in relation to the ethics of research and concern about the efficacy of ethics committees. This study aims to address this issue. Design/methodology/approach -This article reviews the literature on how quality improvement differs from audit and research. It considers different ways of considering ethics in research and questions how far one can rely on professional judgement as an alternative to formal ethics committee procedures. The factors that characterise different sorts of activity are reworked to enable a template to be devised. The template, presented in the form of a flow-chart, enables health care workers to better categorise a variety of activities and highlights the necessary procedural requirements that follow. Findings -Key factors are identified in the existing literature that help differentiate between quality improvement, audit and research. These factors range from intent in undertaking the activity, through sample/site selection, choice of methodology, analysis, patterns and speed of dissemination. Originality/value -If quality improvement is to continue to be a central theme in the NHS agenda, it is important that both the Central Office for Ethical Review and NHS organisations review the categorisation system to include quality improvement in their clinical effectiveness structures.

A decision tool to guide the ethics review of a challenging breed of emerging genomic projects

“…51 Indeed, several sources describe generalizability as the consensus criterion. 32,38,42 A similar formulation asks who benefits directly from the activity: the institution or system, the participants, or society in general. 6,19,23,25,37,52,53 However, generalizability on its own fails to consider important factors like risks, methodologies or the types and sources of the data collected.…”

“…19,20,22,37,45,56 NOVELTY Although several authors suggest considering whether an activity departs from standard practice, 52,54,55 a similar criterion asks whether it builds on previous research, such as by comparing performance to best practices, or whether it investigates a new question or area, such as by testing a new technology. 22,23,28,32,37,39,43,44,54 QA is often described as occurring in response to a problem, whereas research is more forward thinking. 32,34,37,43,45 Knowledge gained through research is used to confirm standards and best practices, whereas QA measures practices against those standards once they are established.…”

“…22,23,28,32,37,39,43,44,54 QA is often described as occurring in response to a problem, whereas research is more forward thinking. 32,34,37,43,45 Knowledge gained through research is used to confirm standards and best practices, whereas QA measures practices against those standards once they are established. [22][23][24]28,33,37,44,47,54,57,58 SPEED OF IMPLEMENTATION Another common criterion asks whether the project's results are applied immediately, in the case of QA, or after a delay, in the case of research.…”

“…6,26,45 RISKS AND BENEFITS Many authors classify projects based on their levels of or increases in risks, burdens, and chances of failure, with research being more risky than QA. 6,20,23,31,32,35,37,44,45,47,[53][54][55] A related distinction asks whether risks are limited to privacy or confidentiality breaches or extend to broader emotional, psychological, social, financial, or physical harms. 19,20,22,37,45,56 NOVELTY Although several authors suggest considering whether an activity departs from standard practice, 52,54,55 a similar criterion asks whether it builds on previous research, such as by comparing performance to best practices, or whether it investigates a new question or area, such as by testing a new technology.…”

“…19,22,23,25,28,31,32,34,[37][38][39][40][41][42][43][44][45][46][47][48][49][50] According to the Council for International Organizations of Medical Sciences, 'the defining attribute of research is that it is designed to produce new generalizable knowledge as distinct from knowledge pertaining to a particular individual or program'. 51 Indeed, several sources describe generalizability as the consensus criterion.…”