The Transformative Effect of Training on Informed Consent: A Comparative Study Among Medical Postgraduate Researchers

Inadequate 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.

This 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).

The 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).

A 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.