• T J Mader and S J Playe.
• Department of Emergency Medicine, Tufts University School of Medicine, Boston, MA, USA.
• Ann Emerg Med. 1997 Apr 1;29(4):534-9.

Study ObjectiveTo determine the level of education necessary to understand informed consent documents used to enroll subjects in emergency medicine research.MethodsThe directors of 96 accredited emergency medicine residency programs were asked to provide copies of research consent forms approved for patient enrollment at their facilities. A computer program was used to evaluate the readability of the documents submitted. The consent forms were stratified by degree of risk to the subject and compared with the use of ANOVA and the Kruskal-Wallis test.ResultsNinety-four informed consent documents were received from 45 program directors. After exclusion of 6 forms, 88 were analyzed using the software program RightWriter 5.0. The mean readability index (years of education needed to understand the content) was 10. The length and complexity of the consent forms increased as risk to the subject increased (P = .03).ConclusionInformed consent documents used in emergency medicine research may be too complex for the average patient to understand. A positive correlation exists between protocol risk and consent from complexity.

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