Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research
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Exposure to and Understanding of Technical Terms in Informed Consent Forms for Biomedical Research
Drug Information Journal 46(1) 19-26 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861511427878 http://dij.sagepub.com
Ihn Sook Jeong, RN, PhD1, Dong-Hee Kim, RN, PhD1, Myunghee Kim, RN, PhD1, So Hee Kim, MS2, Dongwook Jeong, MD, PhD3, and Ji Hong Shon, MD, PhD4
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. Keywords comprehension, informed consent, consent forms, biomedical research, terminology
Introduction Informed consent is one of the most important concepts as an ethical and legal standard to protect subjects participating in biomedical research. Since the advent of the Nuremberg Code,1 which enshrined the ethical principles concerning modern biomedical research and highlighted the fundamental right of subjects to informed consent, many ethical principles2–5 have been recommended to sufficiently provide information to subjects and to obtain their consent based on adequate and freely offered explanations. In particular, the Belmont Report considered informed consent a crucial way to protect subjects participating in biomedical research and emphasized that effective informed consent requires sufficient information disclosure, proper comprehension of provided information, and voluntary consent. Section 4.8.6 of the International Conference on Harmonization (ICH) guidelines suggests that the terms used in informed consent should be as nontechnical as practical and understandable to the subject.4 Furthermore, the US National Institutes of Health also has a specific criterion that the readability level, measured by the Flesch-Kincaid method, should be lower than an eighth-grade level.5 Yet, studies of
informed consent documents have revealed language that is more difficult than these standards.6,7 As well, studies have reported that subjects may not fully understand or may even misunderstand aspects of the biomedical
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