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Informed consent is a process and not simply a document. The ICF informs prospective participants of the purpose, procedures and risks and benefits of participation, it serves as a guide during discussions with the investigator and as a reference source during participation.
This section provides links to various topics focused on consent and HIPAA authorization. It includes guidance on the regulatory requirements for consent forms, writing a readable consent form, standard language for consent forms, and consent form templates. It provides information about written and verbal consent, e-consent, parental permission, assent, HIPAA authorization, waivers (consent, assent, and HIPAA authorization), and also addresses obtaining consent for research participation of subjects with limited English proficiency, adults with diminished capacity, and minors who can consent for themselves.