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Informed Consent for Medical Research: Common Discrepancies and Readability
Author(s) -
White Lynn J.,
Jones Jeffrey S.,
Felton Christopher W,
Pool Linda C.
Publication year - 1996
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/j.1553-2712.1996.tb03509.x
Subject(s) - readability , notice , checklist , medicine , comprehension , informed consent , population , task (project management) , family medicine , reading (process) , medical education , computer science , alternative medicine , psychology , law , pathology , environmental health , management , political science , economics , cognitive psychology , programming language
Objective: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) us submitted to institutional review boards (IRBs) by medical researchers. Methods: A retrospective evaluation of ICFs as submitted to IRBs of 3 university‐affiliated hospitals during a I‐year period. ICF content was evaluated using a checklist of 23 requirements specified in the federal regulations governing human research. Documents then were computer‐analyzed to determine the readability scores using 2 common indexes of comprehension. A discrepancy was defined as any instance in which an ICF did not address an applicable requirement in the Code of Federal Regulations. Results: Eighty‐two ICFs representing 16 medical specialties were evaluated; 8 (10%) were from emergency medicine. Eighteen ICFs (22%) were conspicuously incomplete, lacking 29 federal requirements. The mean number of discrepancies was 4.7 (95% CI, 3.9–5.5) Common omissions included: a statement about who is doing the research, number of subjects in the study, circumstances when a subject's participation may be terminated, disclosure of alternative procedures, and notice to subjects regarding new findings. The mean Flesch grade level required to read all ICFs was 13.8 (95% CI, 13.5–14.2), implying that the majority of the U.S. adult population would be unable to comprehend these forms. Conclusion: Designing a consent form to meet all of the federal requirements while maintaining a level of reading comprehension suitable for the general population is a difficult task for investigators.