Documenting Informed Consent
You must document an individual's decision to participate in your research using a written consent form. The consent form may be either of the following:
The full form includes all of the required elements of informed consent as outlined in the checklist above. Even though you may review some or all of the information orally, you must give the potential subject an opportunity to read the form before signing it. Leave a copy of the form with the subject for future reference.
The short form states the required elements of informed consent, as outline in the checklist above, have been presented orally to the subject. A witness must be present if you use the short form. The subject and the witness sign the short form; you and the witness sign a copy of the oral summary. Leave a copy of the short form and the oral summary with the subject for future reference.
*All consent documents must be approved by the Institutional Review Board.