Protection of Human Subjects; Informed Consent Verification

The Food and Drug Administration (FDA) is amending its current informed consent regulations to require that the consent form signed by the subject or the subject's legally authorized representative, be dated by the subject or the subject's legally authorized representative at the time consent is given. FDA is also amending its regulation on case histories to clarify what adequate case histories include and to clarify that the case histories must document that informed consent was obtained prior to participation in a study. FDA is taking this action in response to problems the agency has had on occasion verifying that informed consent was obtained from a research subject prior to participation in a study because the consent document was not dated and other verification was not contained in the individual's case history documentation. The agency believes that by explicitly requiring that the consent form be dated at the time it is signed and requiring the case history to document that consent was obtained prior to participation in a study, the agency will be able to help ensure that informed consent was, in fact, obtained prior to entry into the study as required by FDA regulations.