Comprehension Testing in Informed Consent

Abstract

Background: Incorporating comprehension testing into the informed consent process has been suggested as a method to verify that subjects understand the risks and requirements of research protocols. We analyzed our informed consent process and examined the utility of comprehension testing in a complex clinical study using subjective and objective measures. Methods: Healthy subjects taking part in a study of cholesterol absorption and metabolism were recruited for this sub-study and completed the informed consent process, which included a 20-item comprehension test evaluating study-specific risks and procedures. After completing the clinical study, they were reevaluated by a separate 47-item knowledge test that included general informed consent items, the identical 20-item comprehension test, and a self-assessment. Results: Twenty-five of 28 eligible subjects completed the study. All subjects scored well on the comprehension test (mean: 95.1%), and again when the same test was administered a year later (mean: 91.4%). Subjects scored lower on the separate knowledge test (75%), which indicated deficiencies in understanding certain risks of the study, compensation in the event of injury, the experimental nature of research, and certain study-specific concepts. Subjects rated face-to-face explanation of the study as most useful in helping them understand the study (96%), followed by reading the informed consent form (86%). Most subjects (24/25) thought comprehension testing was useful. Conclusions: Comprehension testing, when incorporated into the informed consent process, is a promising tool for verifying subject knowledge, particularly when complex clinical studies are involved. Further work to evaluate the process of administering informed consent and to improve participant knowledge of risk, compensation, and experimental nature of clinical research is warranted.

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