Volume : 13, Issue : 09, September – 2026
Title:
ROLE OF E-CONSENT IN IMPROVING REGULATORY COMPLIANCE FOR CLINICAL TRIALS IN INDIA.
Authors :
Jupaka Navya*, P. Srikanth
Abstract :
Informed consent is a foundational ethical and regulatory requirement for clinical trials, ensuring respect for participant autonomy, safety, and rights. In India, persistent challenges such as low literacy levels, linguistic diversity, inconsistent documentation, and inadequate oversight have historically affected the quality and reliability of the informed consent process. The introduction of electronic informed consent (e-consent) has emerged as a transformative digital innovation with the potential to significantly strengthen regulatory compliance in Indian clinical trials. E-consent integrates multimedia tools, interactive content, electronic signatures, and secure audit trails to enhance participant comprehension, standardize documentation, and improve traceability across trial sites. Within the Indian regulatory framework—particularly under the New Drugs and Clinical Trials (NDCT) Rules, 2019, and guidance issued by the Central Drugs Standard Control Organization (CDSCO)—e-consent aligns with requirements for transparency, data integrity, and participant protection. By enabling real-time monitoring, version control of consent documents, and remote oversight by Ethics Committees and regulators, e-consent reduces procedural deviations and strengthens inspection readiness. Moreover, e-consent facilitates decentralized and hybrid trial models, which gained prominence during public health emergencies such as the COVID-19 pandemic. Despite challenges related to digital literacy, data privacy, and infrastructure disparities, e-consent represents a critical tool for enhancing compliance culture, ethical conduct, and participant-centricity in Indian clinical research. This abstract highlights the regulatory relevance, compliance benefits, and implementation considerations of e-consent within India’s evolving clinical trial ecosystem.
Keywords:
Electronic informed consent; e-consent; regulatory compliance; clinical trials; NDCT Rules 2019; CDSCO; ethics committees; India
Cite This Article:
Please cite this article in press Jupaka Navya et al., Role Of E-Consent In Improving Regulatory Compliance For Clinical Trials In India..,. Indo Am. J. P. Sci, 2026; 13(09).
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