The written informed consent form (WICF): factors that interfere with acceptance

Area of Science:

• Medical Ethics
• Health Literacy
• Clinical Research

Background:

• Written informed consent forms (WICFs) are crucial for ethical research, detailing voluntary participation, risks, benefits, and procedures.
• A significant concern exists regarding research subjects' comprehension of WICFs and their rights, even after signing.

Purpose of the Study:

• To assess the readability of WICFs.
• To examine the relationship between WICF acceptance and demographic factors, social elements, risk-benefit assessments, and educational attainment.

Main Methods:

• The study analyzed 793 patients from public and private hospitals undergoing informed consent.
• Demographic and social data were extracted from patient medical charts.
• The Flesch Reading Ease and Flesch-Kincaid Readability Indices were employed to evaluate WICF text readability.

Main Results:

• WICF acceptance was exceptionally high (99.7%) in public healthcare settings and for low-risk protocols (99.73%).
• Education level did not correlate with acceptance, with 58.26% of patients having eight or fewer years of schooling.
• Readability scores indicated significant reading difficulty, with Flesch-Kincaid scores from 9.9 to 12 and Flesch Reading Ease scores from 33.1 to 51.3.

Conclusions:

• Written informed consent forms present substantial reading challenges.
• While patient acceptance is not tied to demographics or social factors, it is significantly influenced by the perceived risk-benefit ratio.