ArticleCureus2025
The Transformative Effect of Training on Informed Consent: A Comparative Study Among Medical Postgraduate Researchers.
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
3 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundInadequate implementation of the informed consent (IC) process remains a major ethical and regulatory challenge, particularly among postgraduate (PG) students conducting thesis research. This study aimed to assess the impact of a structured training program on the IC documentation and practices of medical postgraduates.
methodsThis prospective cohort, comparative study included 60 PG students from two consecutive batches: an untrained batch (n=30) and a trained batch (n=30). The trained batch underwent a 9-hour, three-session formal training on IC practices aligned with the Indian Council of Medical Research (ICMR) 2017, New Drugs and Clinical Trials (NDCT) 2019, and ICH-Good Clinical Practice (GCP) guidelines. Informed consent forms (ICFs) and the consent process itself were evaluated using a 30-item checklist across five domains: Content Quality, Counseling Process, Comprehension Assessment, Documentation Standards, and Regulatory Compliance. Data was collected via document review and direct observation by independent investigators. Comparative analysis used the Chi-square and independent t-test (p < 0.05).
resultsThe mean overall checklist score was significantly higher in the trained batch (26 ± 2, 86%, Excellent grade) compared to the untrained batch (15 ± 3, 51%, Satisfactory grade) (p<0.05). Domain-specific analysis showed dramatic improvement in the trained group, notably in Comprehension Assessment (92% scoring ≥80% vs. 13% in the untrained group) and ICF/Informed Consent Document (ICD) Content Quality (95% scoring ≥80% vs. 8%). Deficiencies in the untrained group included absent comprehension checks, lack of compensation clauses, and poor regulatory compliance (e.g., 0% for re-consenting after protocol amendments).
conclusionA structured, comprehensive training significantly and immediately improves the quality of IC documentation and practices among medical postgraduates, moving performance from a "Satisfactory" to an "Excellent" standard. Integrating such targeted, hands-on training into the PG curriculum is essential for enhancing ethical standards in clinical research.
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