Ethics and clinical audit and quality improvement
Review of ethics issues related to clinical audit and quality improvement - a literature review
Traditionally, the distinction between research and clinical audit has been used as the basis for deciding if an activity that involves data collection about patient care needs ethical oversight. Ethical issues related to clinical audit and quality improvement activities have often not been recognized or acted on properly. This extensive review and analysis of the literature on ethics and clinical audit and quality improvement demonstrates the range of ethics issues related to quality improvement activities carried out in healthcare organisations. The review concludes that it is no longer appropriate to use the distinction between research and clinical audit as the basis for deciding if ethics review is needed for a proposed activity.
Questions to be used to screen proposals, findings, and the effectiveness of actions taken for clinical audits and quality improvement projects for ethical oversight purposes are set out in the review. Structures and mechanisms used in healthcare organisations to provide ethical oversight of clinical audit and quality improvement programmes are also summarised in the review.
Ethics and clinical audit and quality improvement - a guide for NHS organisations
The guide explains the importance of ethical oversight of clinical audit and quality improvement programmes in NHS organisations and gives practical guidance on the subject. It includes:
- a list of possible ethics issues that apply to a clinical audit or quality improvement programme and how they relate to ethical principles in health care
- stages at which a clinical audit or quality improvement project should be reviewed to identify and act on any ethics issues
- questions to use to screen clinical audit and quality improvement project proposals for ethics issues
- options for managing the screening of projects for ethics issues
- an example of a screening process from Guy's and St Thomas' NHS Foundation Trust
- possible arrangements for providing for ethical oversight of clinical audit and quality improvement programmes in NHS organisations
- possible contents of a policy on ethics and clinical audit and quality improvement for an NHS organisation.
Template Ethics and Clinical Audit and Quality Improvement Policy
The template is the suggested text for a policy on the subject of clinical audit and ethics with guidance on how to use the document in an NHS organisation. The template includes the following subjects:
- purposes and intended outcomes of the policy
- definitions of key terms
- a suggested process for ethical oversight of clinical audit, service evaluation and quality improvement programmes
- a suggested process for ethical oversight of individual clinical audit, service evaluation or quality improvement projects
- suggested responsibilities and accountabilities for ethical oversight of these programmes and activities
- references.
Please note that, in order to protect the environment, HQIP resources have been designed to be printed in duplex, ie double-sided. If you choose to print single-sided, blank pages will appear within the document. Furthermore, HQIP tools and templates are designed using Microsoft Office packages and may lose formatting should they be opened in other formats.
