Valid informed consent requires date

A final rule issued by the Federal Drug Administration (FDA) in Washington, DC, makes clear that an informed consent document for participation in drug and device clinical trials must be dated.

Previously, informed consent documents for drug and device clinical trials were not necessarily dated, and that sometimes led to doubts that the consent was obtained before the fact. The new FDA rule clarifies that the date must be noted in order for the consent to be valid, and it also requires that the patient’s case history include a notation that informed consent was obtained prior to participation in the study.

The rule went into effect Dec. 5, 1996.