Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

Trials

Monica Taljaard⁷  Merrick Zwarenstein⁵  Jeremy Grimshaw^1,10  Martin Eccles⁸  Allan Donner⁶  Shazia Chaudhry⁷  Jamie Brehaut⁴  Robert Boruch¹  Charles Weijer⁹  Judith Belle Brown²  Carol Bennett³  Andrew D McRae^1,11 

[1] Education and Statistics, Graduate School of Education, University of Pennsylvania, Philadelphia, PA, USA;Centre for Studies in Family Medicine, Department of Family Medicine, The University of Western Ontario, London, Ontario, Canada;Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada;Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa Hospital, Ottawa, Ontario, Canada;Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada;Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Canada;Ottawa Hospital Research Institute, Clinical Epidemiology Program, Ottawa, Ontario, Canada;Clinical Effectiveness, Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK;Department of Philosophy, Philosophy and Medicine, Rotman Institute of Philosophy, University of Western Ontario, London, Ontario, Canada;Ottawa Hospital Research Institute Department of Medicine, University of Ottawa, Ottawa, ON, Canada;Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, Rm C231, 1403 – 29 Street NW, Calgary, Alberta T2N 2T9, Canada

关键词: Implementation research;    Quality improvement;    Knowledge translation;    Bioethics;    Clinical trials;    Informed consent;    Research ethics;    Cluster randomized trials;   

Others  :  1095019
DOI  :  10.1186/1745-6215-14-1

 received in 2012-09-06, accepted in 2012-12-18,  发布年份 2013

【 摘 要 】

Background

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Methods

Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.

Results

Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.

Conclusions

Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

【 授权许可】

   
2013 McRae et al.; licensee BioMed Central Ltd.

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