What is meant by “Informed Consent”?

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By law, before any study-related assessments and procedures can be conducted, and before you can be permitted to take any study-related medication, you must be advised and understand up front a) that you know and are agreeing to participate in the study, b) what your participation in the study will entail, and c) what your rights as a study participant are. You will be given a written document known as an “Informed Consent Form” for you to review and sign. One copy will be kept on file at the site and one will be given to you for your files.

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