DHHS regulations (45 CFR 46.115) require that an IRB keep approved sample consent forms for at least three years after the completion of the research. The investigator has the responsibility to retain the signed consent forms and to keep these forms confidential. However, the regulations are not clear on the required length of time the investigator must retain signed consent forms. With this in mind, the investigator may wish to contact his or her granting or sponsoring agency in order to verify the length of time required for record retention. According to FDA “Good Clinical Practice,” essential documents for the conduct of a clinical trial (which includes informed-consent documents) must be kept at least two years after the last approval of a marketing application or at least two years after formal discontinuation of clinical development of the investigational product or longer, as required by contract. Since the consent form retention requirements for most other granting or sponsoring agencies are not specified, the investigator might consider the legal purpose of the consent form when deciding on the time period for retention. If this purpose involves defending the investigator and/or the institution from criminal or civil liability, the form should be retained long enough for that purpose. Ordinarily, this means retaining the form for a period longer than the statute of limitations, as per state law, for physicians who are concerned about malpractice litigation. The DHHS regulations also state that the subject should be given a copy of the signed form. In most cases (e.g., when the subject has a medical record with the institution or physician-investigator), a copy of the consent form must be placed in the medical record. Exceptions will be defined in particular cases by the IRB.