An evaluation of reporting of consent declines in three high impact factor journals

Clinical Ethics 13 (4):189-193 (2018)
Abstract
BackgroundInformed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines to assess the extent of exertion of autonomy by research participants.MethodsCONSORT flow charts in RCTs published in New England Journal of Medicine, The Lancet and Journal of the American Medical Association between 2012 and 2015 were evaluated. The total and per journal proportion of RCTs reporting consent declines was calculated. Percentage of consent declines was also compared based on number of centers and type of setting. Between-groups analysis was done using Chi Square, Chi Squ...
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DOI 10.1177/1477750918802428
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