Informed consent documents in India fall short of ethical and regulatory disclosure requirements

Informed consent documents used in Indian clinical trials and biomedical research frequently fail to meet the disclosure requirements set out in the country’s two main regulatory frameworks, according to a retrospective document review published in BMC Medical Ethics. The study, led by Yogendra Keche and colleagues, assessed how well consent documents complied with the Indian Council of Medical Research (ICMR) National Ethical Guidelines 2017 and the New Drugs and Clinical Trials (NDCT) Rules 2019.

The researchers reviewed 104 clinical trial informed consent documents against a 23-item NDCT 2019 checklist and 397 biomedical research informed consent documents against a 20-item ICMR 2017 checklist. For each checklist item, compliance was calculated as the proportion of applicable documents satisfying the requirement, with Wilson 95% confidence intervals. A per-document compliance score was also computed as the percentage of applicable items met, and a fixed-denominator scoring method was used as a sensitivity analysis.

Mean compliance scores were 56.9% (SD 23.4) for NDCT-assessed trials and 67.5% (SD 14.3) for ICMR-assessed documents, indicating that neither document type consistently met the required disclosures. The study was retrospective and cross-sectional, based on document review rather than observation of the consent process itself, so the findings describe the written content of the documents rather than what participants actually understood or were told verbally.

The most striking contrast emerged between clinical trials of different sponsorship categories. Regulatory or sponsored clinical trials achieved a mean compliance score of 81.2%, compared with 40.5% for academic clinical trials, a difference the authors report as statistically significant with P < 0.0001. Comparisons between sponsorship categories used Fisher’s exact test with Bonferroni correction and absolute risk differences, and statistically significant differences were found for 17 of the 23 NDCT checklist items after correction.

Within the NDCT requirements, the least frequently met items were disclosure of possible investigational-product failure and disclosure of placebo use. For documents assessed against the ICMR 2017 guidelines, the least frequently met requirements were disclosure of alternative treatment options and insurance coverage. These gaps point to specific, recurring omissions in the written information given to prospective participants before they agree to take part in research.

Overall compliance scores were compared using the Mann-Whitney U test with rank-biserial correlation, providing a statistical basis for the sponsorship-related differences. The authors note that the findings identify particular areas, especially 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.

Informed consent documents serve as 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 ICMR National Ethical Guidelines 2017 for biomedical and health research and by the NDCT Rules 2019 for clinical trials, which is why the study evaluated documents against both frameworks separately.

The study’s conclusion is that compliance with informed consent disclosure requirements was incomplete and varied across document types, with academic trials showing substantially lower compliance than regulatory or sponsored trials. Because the analysis was confined to documents from India and to the written requirements of these two frameworks, the results describe the state of consent documentation within that regulatory context rather than consent practices elsewhere. The authors suggest that the identified gaps, particularly around risk disclosure, alternative treatments, and injury-related medical management and compensation, represent concrete targets for improving how research participants are informed before enrolment.

Subject of Research: Compliance of informed consent documents in India with ICMR 2017 and NDCT 2019 disclosure requirements

Article Title: 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

Article References: Keche, Y., Khasbage, S. U., Patel, S., & Keche, A. (2026). 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. BMC Medical Ethics. https://doi.org/10.1186/s12910-026-01648-4

Image Credits: AI Generated

DOI: 10.1186/s12910-026-01648-4

Keywords: informed consent, clinical trials, India, ICMR 2017 guidelines, NDCT Rules 2019, research ethics, biomedical research, sponsorship, academic trials, regulatory compliance, BMC Medical Ethics, participant disclosure