Delete the following if all subjects will assent. For children unable to assent: I certify that __________________ was not capable of understanding the procedures involved in the sufficiently to assent to study participation. Person Responsible for Obtaining Assent Signature of Person Responsible Date COMMENTS 1) Delete assent lines if none of the children will be old enough to assent (e.g., neonates) or if the study only involves subjects capable of consenting for themselves. 2) If some may be old enough and some not, include both statements so that the investigator can document on the Assent page, why a particular subject was unable to assent.
Delete the following if all subjects will assent. For children unable to assent: I certify that __________________ was not capable of understanding the procedures involved in the sufficiently to assent to study participation. Person Responsible for Obtaining Assent Signature of Person Responsible Date COMMENTS 1) Delete assent lines if none of the children will be old enough to assent (e.g., neonates) or if the study only involves subjects capable of consenting for themselves. 2) If some may be old enough and some not, include both statements so that the investigator can document on the Assent page, why a particular subject was unable to assent.
consent_form_with_hipaa_and_directions_02-23-2016.docx