Patient safety

Ethical issues in patient safety research

Interpreting existing guidance

World Health Organization

Publication details

Number of pages: 41
Publication date: 2013
Languages: English
ISBN: ISBN 978 92 4 150547 5


What is this document?

This document reflects on the specific ethical questions that can arise in the conduct of patient safety research and improvement activities, and aims to provide clear guidance on how to interpret internationally accepted ethical principles in such contexts. It also includes patient safety and quality improvement activities, not always considered research, but which sometimes contain some ethical risks to patients or providers.

Who is the audience for the guide?

Research ethics committees, patient safety researchers, quality improvement professionals and other interested individuals can use this guide understand how to interpret existing research ethics guidelines in the context of patient safety research and other quality improvement activities.

Rationale of this guide

While patient safety research and related improvement activities share features with many other types of research, questions are frequently raised about the type and extent of ethical oversight that may be warranted, in a context where members of research ethical committees are not always comfortable issuing advice, or where researchers and quality or safety practitioners are not always fully aware of how to minimize the risks associated with their activity, to best protect their recipients. This publication is a first attempt to provide some clear guidance in this area.

What does the guide contain?

It provides thirteen specific guidance points about the specific nature of ethical risks associated with patient safety activities and ways to minimize these. It also looks at the criteria for identifying minimal risks, breaches of confidentiality and offers suggestions for protecting it, together with privacy and anonymity. It also identifies other ethical situations where patients or providers may be affected by research and patient safety activities, providing guidance on the obligations that researchers have towards patients and research participants in such scenarios.