Methodological quality and reporting of ethical requirements in clinical trials

Miguel Ruiz-Canela, Jokin de Irala-Estevez, Miguel Ángel Martínez-González, Enrique Gómez-Gracia and Joaquín Fernández-Crehuet

University of Navarre and University of Malaga, Spain

Objectives—To assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods.

Design—Systematic review using a standardised checklist.

Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included.

Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups

Conclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.

Key Words: Clinical trials • informed consent • research ethics committees • research design

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

• Barke, R. (2009). Balancing Uncertain Risks and Benefits in Human Subjects Research. Science Technology Human Values 34: 337-364 [Abstract]  
• Jacobsen, K H (2009). Reporting of ethics-related methods in epidemiological research. J. Med. Ethics 35: 262-267 [Abstract] [Full Text]  
• Marziali, E., Serafini, J. M. D., McCleary, L. (2005). A Systematic Review of Practice Standards and Research Ethics in Technology-Based Home Health Care Intervention Programs for Older Adults. J Aging Health 17: 679-696 [Abstract]  
• Harrison, J. E. (2005). Orthodontic Clinical Trials III: Reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998. J. Orthod. 32: 115-121 [Abstract] [Full Text]  
• Weingarten, M. A, Paul, M., Leibovici, L. (2004). Assessing ethics of trials in systematic reviews. BMJ 328: 1013-1014 [Full Text]  
• Yank, V., Rennie, D. (2002). Reporting of Informed Consent and Ethics Committee Approval in Clinical Trials. JAMA 287: 2835-2838 [Abstract] [Full Text]