Abstract

Background Informed 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. Methods CONSORT 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 Square for trend and a Crude odds ratio [95% C.I] were calculated. Results Only 3.7% of the published articles were RCTs. Of the 1103 RCTs, only 532 reported consent declines. JAMA had the highest RCTs reporting consent declines, the Lancet [129,150/781,924, 16.5%] had the most participants declining consent. Difference was significant using Chi square for linear trend [ p < 0.00001]. Consent decline rate was higher in developed countries relative to developing countries [cOR: 2.27, p < 0.000001] and in single centric versus multicentric studies [cOR : 3.63, p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines.