Zdrowie i gospodarka · 22.12.1995

Protection of Human Subjects; Informed Consent

The Food and Drug Administration (FDA) is proposing to amend its current informed consent regulations to require that the written 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 proposing this requirement because the agency has had problems 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. The agency believes that by explicitly requiring that the consent form be dated at the time it is signed, 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. FDA is also proposing to amend its regulation on case histories to clarify what adequate case histories include. DATES: Written comments by March 21, 1996.