Background and Rationale:Ensuring research participants’ autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the informed consent process. This audit examined consent refusals among Indian participants in clinical studies done at our center.Materials and Methods:The number of consent refusals and their reasons in 10 studies done at our center over a 5-year period were assessed. The studies were classified by the authors according to the type of participant (healthy vs patients), type of sponsor (investigator-initiated vs pharmaceutical industry), type of study (observational vs interventional), level of risk [based on the Indian Council of Medical Research (ICMR) “Ethical Guidelines for Biomedical Research on Human Participants”], available knowledge of the intervention being studied, and each patient's disease condition.Results:The overall consent refusal rate was 21%. This rate was higher among patient participants [23.8% vs. healthy people (14.9%); P = 0.002], in interventional studies [33.6% vs observational studies (7.5%); P < 0.0001], in pharmaceutical industry-sponsored studies [34.7% vs investigator-initiated studies (7.2%); P < 0.0001], and in studies with greater risk (P < 0.0001). The most common reasons for consent refusals were multiple blood collections (28%), inability to comply with the study protocol (20%), and the risks involved (20%).Conclusion:Our audit suggests the adequacy and reasonable quality of the informed consent process using consent refusals as a metric.

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 (four-year period) to assess the extent of exertion of autonomy by research participants. Methods: CONSORT flow charts in RCTs published in New England Journal of Medicine (NEJM), The Lancet and Journal of the American Medical Association (JAMA) 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 (single centric vs. multicentric) and type of setting (developed vs. developing). Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] (cOR) were calculated. Results: Only 3.7% (1103/29,825) of the published articles were RCTs. Of the 1103 RCTs, only 532 (48.2%) reported consent declines. JAMA had the highest RCTs reporting consent declines (171/267.64%), 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(95% C. I): 2.27(2.23,2.32), p < 0.000001] and in single centric versus multicentric studies [cOR (95% C.I): 3.63 (3.56,3.71), p < 0.0000001]. Conclusion: Both authors and journal editors need to ensure better reporting of consent declines.