Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

Clinical Trials : Journal of the Society for Clinical Trials
Rami TadrosSepehr Shakib

Abstract

A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer's autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8-6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to ...Continue Reading

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Citations

Sep 29, 2020·The Cochrane Database of Systematic Reviews·Maree A CrepinsekFiona Stewart
May 15, 2021·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·Felizitas A EichnerPeter U Heuschmann

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