Accommodating quality and service improvement research within existing ethical principles

Background: Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of health care delivery. QSI research differs from traditional health care research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts, should it be considered research for regulatory purposes? Is review by a research ethics committee required? Should health care providers be considered research participants? If participation in QSI research entails no more than minimal risk, is consent required? The lack of consensus on answers to these questions highlights the need for ethical guidance.

Main Body: Three distinct approaches to classifying QSI research in accordance with existing ethical principles and regulations can be found in the literature. In the first approach, QSI research is viewed as distinct from other types of health care research and does not require regulation. In the second approach, QSI research falls within regulatory guidelines but is exempt from research ethics committee review. In the third approach, QSI research is deemed to be part of the learning health care system and, as such, is subject to a different set of ethical principles entirely. In this paper we critically assess each of these views.

Conclusion: While none of these approaches is entirely satisfactory, we argue that use of the ethical principles governing research provides the best means of addressing the numerous questions posed by QSI research.