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117.1 Organization Policy on Signing the Consent/Assent Document

May 2005

The Organization requires that, unless the exceptions meeting federal regulations are documented and approved by the reviewing committee, participants must sign and date a research consent form before study intervention or procedures begin.  The person obtaining informed consent must sign and date the form at the time and on the date that the participant signs it. The Organization does not require a witness signature line, but may allow use of consent forms that have a witness signature line.

For research involving pediatric participants, a determination must be made as to whether an assent form or statement is required.  If the IRB determines that a child is old enough and mature enough to sign the consent form as documentation of assent, an assent signature line must be provided on the signature page.  For research approved under 45 CFR 46.406, 21 CFR 50.53, 45 CFR 46.407, and 21 CFR 50.54, both parents (when applicable according to the regulations) must sign and date the consent form, and the consent form must have signature lines for each parent.  For research approved under 45 CFR 46.404, 21 CFR 50.51, 45 CFR 46.405 or 21 CFR 50.53, the IRB will determine whether the signature of both parents is required or whether the signature of one parent is sufficient.  The proper number of signature lines must be provided in accordance with IRB review and approval.

For research involving adults lacking capacity to consent for themselves, the consent form must provide a signature line for the legally authorized representative who will sign and date the consent form on behalf of the adult subject.