Compliance of informed consent documents with Indian ethical and regulatory requirements: a retrospective analysis of ICMR 2017 and NDCT 2019 requirements and clinical-trial sponsorship

Abstract Background Informed consent documents are the primary written record of the information provided to participants before they agree to take part in research. In India, their content is governed by the Indian Council of Medical Research (ICMR) National Ethical Guidelines 2017 for biomedical and health research and the New Drugs and Clinical Trials (NDCT) Rules 2019 for clinical trials. This study assessed the extent to which informed consent documents complied with the disclosure requirements of these two frameworks. Methods This retrospective, cross-sectional document review included 104 clinical trial informed consent documents assessed against the 23-item NDCT 2019 checklist and 397 biomedical research informed consent documents assessed against the 20-item ICMR 2017 checklist. Compliance for each item was calculated as the proportion of applicable documents satisfying the requirement, with Wilson 95% confidence intervals. A per-document compliance score was calculated as the percentage of applicable items met, with a fixed-denominator scoring method used as a sensitivity analysis. Clinical trials were compared by sponsorship category, regulatory/sponsored versus academic, using Fisher’s exact test with Bonferroni correction and absolute risk differences. Overall compliance scores were compared using the Mann-Whitney U test with rank-biserial correlation. Results Mean compliance scores were 56.9% (SD 23.4) for NDCT-assessed trials and 67.5% (SD 14.3) for ICMR-assessed documents. Compliance was substantially higher in regulatory/sponsored clinical trials than in academic clinical trials (mean score, 81.2% versus 40.5%; P < 0.0001), with statistically significant differences for 17 of 23 checklist items after Bonferroni correction. Disclosure of possible investigational-product failure and placebo use were the least frequently met NDCT requirements, whereas disclosure of alternative treatment options and insurance coverage were the least frequently met ICMR requirements. Conclusion Compliance with informed consent disclosure requirements was incomplete and varied across document types. Among clinical trials, academic trials showed substantially lower compliance than regulatory/sponsored trials. The findings identify specific areas, particularly risk disclosure, alternative treatment options, injury-related medical management and compensation, that may benefit from targeted training and institutional support for informed consent document preparation and review.