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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.
Resources to Assist with Consent
Information on concise summaries, basic and additional elements of consent.
Consent, signature page, and stand-alone HIPAA authorization templates.
Template language for explanations of common study procedures and their associated risks.
Guidance on the process of obtaining written consent/parental permission.
Information on concise summaries, basic and additional elements of consent as required by the regulations.
When a subject signature is not required (e.g. to obtain verbal consent).
Guidance on when consent is not required or elements of consent can be waived.
May be permitted when it is not a reasonable requirement to protect subjects.
When does HIPAA apply and what needs to be in a HIPAA authorization.
Use of short form consent process, when few limited English proficiency speakers are expected.
Guidance on assessing capacity and who can serve as a legally authorized representative.
Who is a child (state law) and when may minors consent for their research participation.