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

Area of Science:

• Medical Research Ethics
• Clinical Trial Documentation

Background:

• Informed consent documents (ICDs) are crucial for participant understanding in research.
• Assessing the quality and readability of ICDs is essential for ethical research practices.

Purpose of the Study:

• To analyze the quality and readability of Informed Consent Documents (ICDs) over a six-year period.
• To evaluate compliance with Indian Council of Medical Research (ICMR) guidelines and correlate document quality with consent refusal rates.

Main Methods:

• A retrospective cross-sectional analysis of 300 ICDs from institutional ethics committee submissions.
• Utilized Flesch-Kincaid Reading Ease Score (FRES), estimated reading time (ERT), and an ICD Quality Score (IQS) based on ICMR guidelines.
• Correlated document parameters with consent refusal rates (CRR).

Main Results:

• Mean IQS improved significantly from 11.95 to 12.60 over six years (P < 0.001).
• Median FRES was 48.3 and median ERT was 4.5 minutes.
• Lower FRES and longer participation duration showed weak negative and positive correlations with CRR, respectively.

Conclusions:

• ICDs have demonstrated improvement in readability and compliance with ICMR guidelines.
• Pharmaceutical studies generally exhibited better performance in ICD quality.
• Continued efforts are needed to enhance participant comprehension in research consent processes.