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Accommodating quality and service improvement research within existing ethical principles

Overview of attention for article published in Trials, June 2018
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Title
Accommodating quality and service improvement research within existing ethical principles
Published in
Trials, June 2018
DOI 10.1186/s13063-018-2724-2
Pubmed ID
Authors

Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn, Monica Taljaard

Abstract

Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare 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 healthcare 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. 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 healthcare 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 healthcare system and, as such, is subject to a different set of ethical principles entirely. In this paper, we critically assess each of these views. 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.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 37 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 37 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 7 19%
Researcher 6 16%
Student > Ph. D. Student 6 16%
Student > Doctoral Student 4 11%
Student > Bachelor 4 11%
Other 4 11%
Unknown 6 16%
Readers by discipline Count As %
Medicine and Dentistry 12 32%
Nursing and Health Professions 9 24%
Philosophy 3 8%
Pharmacology, Toxicology and Pharmaceutical Science 1 3%
Business, Management and Accounting 1 3%
Other 2 5%
Unknown 9 24%