This section of the consent form includes all of the procedures that are in place to keep the subjects’ participation and information confidential. The investigator should think about all the types of data to be collected, how each type will be stored (e.g., electronic data, paper copies, audiotapes, videotapes, etc.), and when they will be destroyed. In addition, the names of those agencies that have a right to inspect data must be communicated to the subject. The FDA has the right to inspect study data for any study or trial involving medications or devices that are FDA-approved or for which an investigational new drug (IND) or investigational device exemption (IDE) is in place from the FDA. Other agencies, such as the study sponsor, funding agency, or other regulatory agencies and the IRB, may need access to study data for monitoring or auditing purposes. Any such agencies must be listed on the consent form. For example, for those studies involving the General Clinical Research Centers, the research subject advocate as well as the General Advisory Committee for the General Clinical Research Centers must have access to the data for monitoring purposes. The subject should also be told that all individuals with access to their data are required to maintain confidentiality. Situations in which confidentiality cannot be maintained also must be communicated, e.g., reporting requirements for abuse to self or others and neglect, as well as communicable diseases that are reportable to the state Department of Health.