Informed consent for medical research: common discrepancies and readability

Abstract

Objective: To identify common discrepancies and average reading grade levels for informed consent forms (ICFs) as 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 1-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 > or = 9 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.