Development of tool for the assessment of comprehension of informed consent form in healthy volunteers participating in first-in-human studies

Informed consent is a process that involves providing all pertinent study information to the potential study participant. The information imparted in the form gives all such information as would enable a potential participant to come to a decision regarding his/her participation in the study. Various study related aspects are outlined in the participant information leaflet including the background of the study, the benefits and risks, treatment alternatives; the methodology of the study, follow up schedules, confidentiality of the data, compensations and remunerations and right to not participate or withdraw from the study. We have continued a similar exercise for a phase I, first-in-human study, conducted by our center. Here, the volunteers were asked certain questions pertaining to the trial background, design, patients' rights and miscellaneous categories. They were then assessed and the scores compared to come up with certain conclusions. The median (range) for the entire comprehension score was calculated and statistically analyzed on various aspects. Readability of the ease of reading of the consent form was also analyzed on a Flesch-Kinkaid reading scale. A total of 69 volunteers were screened out of which 50 were enrolled in the study. The median (range) score was 27 (19 to 33) and the mean (S.D.) score was 28.9 (3.1). The maximum correct responses were observed for the questions falling under the volunteers' rights category. The Flesch reading ease score was 54 and the Flesch-Kincaid Grade level score was 9.8. Investigators may be encouraged to incorporate such tools in their informed consent process. (C) 2011 Elsevier Inc. All rights reserved.