Nancy E. Kass|Lelia H. Chaisson|Holly A. Taylor|Jennifer Lohse
Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials
Johns Hopkins Berman Institute of Bioethics|Ashland (United States)|Johns Hopkins Berman Institute of Bioethics|Ashland (United States)|Johns Hopkins Berman Institute of Bioethics|Ashland (United States)|Johns Hopkins Berman Institute of Bioethics|Ashland (United States)
informed consent required clinical research humans federal regulations state consent information understandable participants concerns raised consent forms overly long complex consent forms 2006 hiv network trials sponsored national institutes health nih division aids daids analyzed complexity length comparisons made us international sites template site forms adult pediatric trials trial type randomization placebos explained examined frequently misunderstood one hundred twentyfour consent forms 21 template 103 site forms reviewed median readability 92 grade level although confidentiality sections 1235 median grade level international sites forms lower readability us forms p 0025 template forms lower readability site forms p 0046 adult forms less complex pediatric parent forms p 00001 median length forms 224 pages 85 forms adult studies median length 274 pages sections describing randomization median length 53 words consent forms extremely long exceeding recommendations much information readily processed networks consider providing shorter consent templates consistent federal recommendations given sites forms based models research examine whether forms emphasizing key information rather providing details aspects research improve understanding research