Abstract

IBELLI, Fabiana B. et al. Degree of satisfaction with the informed consent process and participation in clinical trials. A 3400 patients’ study. Medicina (B. Aires) [online]. 2022, vol.82, n.4, pp.534-543. ISSN 0025-7680.

The level of comprehension on the information provided in the process of the informed consent can provide a free and voluntary decision. The comprehension and satisfaction of the participants affect their adherence to clinical trials. The objective of the study was to analyze the level of satisfaction of the subjects with the informed consent process as well as with their participation in clinical trials. A total of 3115 out of 3404 surveys received were included, from 362 protocols (with a similar number of investigators), conducted in different Argentinian provinces. Overall, 91% of the people classified the received information as rather good or excellent, and 95% replied that all of their doubts were cleared up. In the sur veys, 97% expressed their willingness to participate in future studies, and 98% would recommend participating in clinical trials to others. The satisfaction score with participation in the study was associated, independently of age and socioeconomic level, with the desire to participate in a clinical trial again (OR 13.6: 95% CI: 4.7- 39.1, p < 0.001) and with the recommendation to participate given to others (OR 16.7: 95% CI: 4.4-63.4, p < 0.001). In this sample from Argentina, there was a high degree of satisfaction both with the process of obtaining informed consent and with participation in clinical trials, regardless of age and socioeconomic status.

Keywords : Satisfaction; Informed consent; Clinical trial; Research.

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