IRB: Ethics & Human Research
Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form
The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached 139 volunteers to participate, and 138 completed the questionnaire (response rate 99.3%). The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study.
Key words/concepts: human subjects research, informed consent, informed consent forms, length of forms, comprehension, motivations to participate, payment for participation
Leanne Stunkel, Meredith Benson, Louise McLellan, Ninet Sinaii, Gabriella Bedarida, Ezekiel Emanuel, and Christine Grady, “Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form,” IRB: Ethics & Human Research 32, no. 4 (2010): 1-9.