Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research

Abstract

This cross-sectional survey with 432 patients and 158 nurses investigated the exposure to and understanding of technical terms used in informed consent forms (ICFs) for biomedical research in the Republic of Korea. The percentage of positive responses, when asked if ever exposed to the study-related terms, ranged from 4.9% to 80.8% for patients and 22.8% to 99.4% for nurses. The term phase III was least recognized by both patients and nurses. The percentage of positive responses to “understanding the study-related terms well” ranged from 0.9% to 56.2% for patients and 5.1% to 70.9% for nurses. The average number of positive respondents, when asked if they understood each term well, statistically differed by age group, education, and exposure to clinical research for patients and by education and exposure to biomedical research for nurses. The low level of understanding of technical terms in ICFs should be improved by ensuring that sufficient explanations are provided to patients while obtaining informed consent and by replacing terms with more common and easily understandable words.