Accommodating quality and service improvement research within existing ethical principles

Trials

Jamie C. Brehaut¹  Monica Taljaard¹  Dean A. Fergusson¹  Jeremy M. Grimshaw¹  Marion Campbell²  Karla Hemming³  Austin R. Horn⁴  Cory E. Goldstein⁴  Charles Weijer⁴ 

[1] Clinical Epidemiology Program, Ottawa Hospital Research Institute;Health Services Research Unit, University of Aberdeen;Institute of Applied Health Research, University of Birmingham;Rotman Institute of Philosophy, Western University;

关键词: Quality and service improvement research;    Ethics;    Informed consent;    Regulation;    Research ethics committees;   

DOI  :  10.1186/s13063-018-2724-2

来源: DOAJ

【 摘 要 】

Abstract Background 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. 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 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. 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.

【 授权许可】

Unknown