title: Reading Level and Length of Written Research Consent Forms.
abstract: In 100 Institutional Review Board approved consent forms (CFs), we assessed pages, reading levels, and whether they included essential elements. CF page numbers ranged from 3 to 28 (mean, 10.3) and readability ranged from grades 5.6 to 28.9 (mean, 11.6). The CF mean score for including essential elements was 90.8% (range: 63.5-100%). There were no significant differences by specialty in number of pages (p = 0.053), but surgical specialties had the highest readability (mean, 13.1), and pediatrics the lowest (10.5), p = 0.008. While approved CFs generally included the Office for Human Research Protections recommended essential elements, they were very long, and even pediatric forms, which had the lowest reading levels, were written on average at a tenth grade level. Researchers need guidance to resolve pressure between regulatory mandates and guidelines and "keeping it simple and clear."
authors.affiliation: School of Nursing, Mailman School of Public Health, Columbia University, New York, New York, USA.
authors.forename: Elaine
authors.initials: E
authors.lastname: Larson
authors.affiliation: School of Continuing Studies, Columbia University, New York, New York, USA.
authors.forename: Gabriella
authors.initials: G
authors.lastname: Foe
authors.affiliation: Human Research Protection Office, Columbia University, New York, New York, USA.
authors.forename: Rachel
authors.initials: R
authors.lastname: Lally
mesh_terms: D032882:Comprehension; D032962:Consent Forms; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D014956:Writing
keywords: ethics; evidence-based medicine; patients; prevention; psychosocial; risk management