Frequency and nature of informed consent in clinical trials.
Journal Title: Ciencia e Investigación Médica Estudiantil Latinoamericana - Year 2007, Vol 12, Issue 2
Abstract
[b]Objectives:[/b] To determine the frequency and characteristics of informed consent in randomized controlled trials.[b] Design: [/b]descriptive and transverse study. [b]Setting:[/b] Medicine Faculty’s Periodical Library of National University of Trujillo. [b]Participants: [/b]all randomized controlled trials (thesis to get the Degree in Medicine, thesis to get the Major and Professor research) registered from 1994 to 2006. [b]Interventions:[/b] Record files made for the authors to obtaining data. [b]Main outcome measures: [/b]Analysis in absolute and relative frequencies of explicit informed consent, simple mention of informed consent and no reference of informed consent. [b]Results:[/b] We found that 42.3% of the 314 studies evaluated had explicit informed consent: 43% of Degree thesis, 61.4 % of Major thesis and 13.7% of Professor research (p<0.0001). In relation to criteria observed: 80% referred the research's title (p=0.003) and 97% referred the voluntary participation, the rests criteria appeared in less of 40%. [b]Conclusions: [/b]The informed consent in randomized controlled trials have a moderate frequency of appearing, it has a scarce reference in Professor Research; while the majority of criteria observed in the explicit informed consent are infrequent.
Authors and Affiliations
Dora Corrales-Portales, Luis Cruzado-Dávila, Juan Huamán-Saavedra
Keywords
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