Long Form Consent Checklist
Long Form Consent Checklist: All of the following conditions must be met:
(1) The consent document embodies the basic and appropriate additional Elements of disclosure. (See Elements of Informed Consent Disclosure)
(2) The participant or the participant's legally authorized representative will sign the consent document.
(3) For FDA-regulated research, the participant or the participant's legally authorized representative will sign and date the consent documents.
(4) A copy of the consent document will be given to the person signing the consent document
(5)The investigator will give either the participant or the representative adequate opportunity to read the consent document before it is signed.