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

Readability of informed consent documents and its impact on consent refusal rate
Original Article
Yash V. Kamath, Yashashri C. Shetty, Ishita C. Lanjewar, Ankita Kulkarni
Perspectives in Clinical Research, 30 August 2024
Abstract
Introduction
Informed consent documents (ICDs) are integral to a research project and must provide all required information to the participant. We undertook a 6-year retrospective cross-sectional analysis of ICDs to assess the same.
Methods
We accessed 300 ICDs from studies submitted to institutional ethics committee. Studies were selected using random proportional-to-size sampling across years and study types (thesis, pharma, government, investigator initiated [OA] studies). We used the Flesch–Kincaid Reading Ease Score (FRES), estimated reading time (ERT) and scored ICDs out of 13 points on the basis of the Indian Council of Medical Research (ICMR)-mandated headings (ICD Quality Score [IQS]). Information pertaining to the consent refusal rate (CRR) of each study was correlated with FRES, ERT, and other parameters. P <0.05 was considered statistically significant.
Results
Two hundred and ninety-three ICDs had complete information. Median FRES was 48.3 (interquartile range [IQR] = 7), median ERT was 4.5 min (IQR = 1.3), the median expected duration of participation was 35 min (IQR = 40); compensation was provided by 23 projects and median compensation was Rs. 2500 (IQR = Rs. 4750). Mean IQS improved from 11.95 to 12.60 in 6 years (Kruskal–Wallis test, P < 0.001). FRES was weakly negatively correlated to the CRR (r = −0.120, P = 0.039), while the expected duration of participation was weakly positively correlated (r = 0.144, P = 0.014).
Conclusion
Pharma studies performed better and ICDs have improved in their readability and ICMR guidelines compliance.