An information sheet that is required by law to be provided to potential research participants to enable an informed decision regarding study participation.  The information sheet is also accompanied by a form used to document study participants’ understanding of the study and consent to participate.  Major elements that information sheets should contain include a description of the study purpose, information on the study intervention(s), study procedures, potential side effects, risks and benefits, compensation, and participants’ rights.

Also called ICF.

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