Who must sign the consent form?
21 CFR 50.27 requires that the written consent form approved by the IRB be signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form. It is the IRB’s expectation that the person obtaining consent (sometimes the PI, sometimes a trained delegate), will also sign and date the form, attesting to the informed consent conversation. The PI should sign the form only if he or she was present for the consent interview.
Related Questions
- Designated Premises Supervisor Q: When an applicant for a premises licence also wishes to be the Designated Premises Supervisor, do they need to complete the form of consent in Schedule 2 of the application?
- Last week, my study participant took a consent form home to read it and he signed it at home. He came in today - should I keep the date that he first signed the consent form?
- Does the physician need to sign a consent form before a patient places an order?
