Readability of informed consent documents and its impact on consent refusal rate

• DOI: 10.4103/picr.picr_322_23
• Publication Date: 2024-09-04T20:16:14Z
• Authors: Yash V. Kamath; Yashashri C. Shetty; Ishita C. Lanjewar; Ankita Kulkarni
• Keywords: Medicine (General); R5-920; informed consent; ethics - research; R; Medicine; Original Article; ethics committees

Informed consent documents (ICDs) are integral to a research project and must provide all required information the participant. We undertook 6-year retrospective cross-sectional analysis of ICDs assess same. accessed 300 from studies submitted institutional ethics committee. Studies were selected using random proportional-to-size sampling across years study types (thesis, pharma, government, investigator initiated [OA] studies). used Flesch-Kincaid Reading Ease Score (FRES), estimated reading time (ERT) scored out 13 points on basis Indian Council Medical Research (ICMR)-mandated headings (ICD Quality [IQS]). Information pertaining refusal rate (CRR) each was correlated with FRES, ERT, other parameters. P <0.05 considered statistically significant. Two hundred ninety-three had complete information. Median FRES 48.3 (interquartile range [IQR] = 7), median ERT 4.5 min (IQR 1.3), expected duration participation 35 40); compensation provided by 23 projects Rs. 2500 4750). Mean IQS improved 11.95 12.60 in 6 (Kruskal-Wallis test, < 0.001). weakly negatively CRR (r -0.120, 0.039), while positively 0.144, 0.014). Pharma performed better have their readability ICMR guidelines compliance.