Analysis of informed consent documents for compliance with ICMR guidelines for biomedical and health research

Abstract

Ethical conduct of research depends on the voluntary expression of consent and adequate disclosure of information about the research in informed consent documents (ICDs). The objective of this study was to analyze ICDs of academic studies for compliance with National Ethical Guidelines for Biomedical and Health Research laid down by the Indian Council of Medical Research (ICMR) and to determine the readability of ICDs using the Flesch–Kincaid Grade Level scale and Flesch reading-ease (FRE) score. ICDs of academic research projects submitted during 2020–22 were retrieved from the IEC office and analyzed for compliance with ICMR 2017 guidelines. The readability of the documents was assessed by the Flesch–Kincaid Grade Level Scale and FRE score. Among 177 protocols analyzed, the most common were epidemiological studies (36.72%), followed by diagnostic studies (28.81%). Vernacular translations of ICDs were present in significantly more studies in 2022 (χ 2 = 7.18, P = 0.02) as compared to 2020 and 2021. FREs score was 45.75 ± 10.76, and Flesch–Kincaid Grade Level was 8.67 ± 1.44. Content analysis of participant information sheet (PIS) revealed that significantly more PIS submitted in 2022 mentioned expected duration of participation (χ 2 = 6.95, P < 0.001), benefit to patient/community (χ 2 = 26.63, P < 0.001), disclosure of foreseeable risk or discomfort (χ 2 = 21.72, P < 0.001), payment for participation (χ 2 = 21.72, P < 0.001), and identity of research team and contact details (χ 2 = 18.58, P < 0.001). Compliance score was significantly better in 2022 as compared to 2020 and 2021. Gradually, ICDs became more compliant with ICMR guidelines. Still, there is scope for improvement in ICDs regarding content and readability so that patients can comprehend facts easily to make informed decisions in a real sense.