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

Article ID	Journal	Published Year	Pages	File Type
6151459	Contemporary Clinical Trials	2011	4 Pages	PDF

Abstract

âº We generated and validated a tool for assessing comprehension of an informed consent form in healthy volunteers. âº The generated tool was easily understandable by an average student of the 8th grade. âº The questionnaire covered all the areas of the informed consent. âº The scores indicated the extent to which the volunteers comprehended the informed consent.

Keywords

Assessment tool Healthy volunteers Phase I

Related Topics

Health Sciences Medicine and Dentistry Medicine and Dentistry (General)

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

Authors

A. Arora, S. Rajagopalan, N. Shafiq, P. Pandhi, A. Bhalla, D.P. Dhibar, S. Malhotra,