Lynn J. White|J. Stephen Jones|Christopher W. Felton|Linda C. Pool
Informed Consent for Medical Research: Common Discrepancies and Readability
Corewell Health Butterworth Hospital|Corewell Health Butterworth Hospital|Corewell Health Butterworth Hospital|Corewell Health Butterworth Hospital
identify common discrepancies average reading grade levels informed consent forms icfs submitted institutional review boards irbs medical researchersa retrospective evaluation icfs submitted irbs 3 universityaffiliated hospitals 1year period icf content evaluated using checklist 23 requirements specified federal regulations governing human research documents computeranalyzed determine readability scores using 2 common indexes comprehension discrepancy defined instance icf address applicable requirement code federal regulationseightytwo icfs representing 16 medical specialties evaluated 8 10 emergency medicine eighteen icfs 22 conspicuously incomplete lacking 9 federal requirements mean number discrepancies 47 95 ci 3955 common omissions included statement research number subjects study circumstances subjects participation may terminated disclosure alternative procedures notice subjects regarding new findings mean flesch grade level required read icfs 138 95 ci 135142 implying majority us adult population would unable comprehend formsdesigning consent form meet federal requirements maintaining level reading comprehension suitable general population difficult task investigators