Federal regulations state that when new findings developed in the course of a study affect the balance of risks and benefits to subjects and, therefore, may also affect a subject’s willingness to continue his or her participation, the investigator has a duty to tell the subject about this new information. This information may be derived from the study in which the subject is participating; from the same study at another site; or from another study with the same agents, medications, devices, or procedures. This new information may be positive, e.g., study results suggesting that no further research is required, or negative, e.g., the reporting of adverse events. When this occurs the principal investigator must inform the IRB, determine if changes to protocol procedures and/or the consent form are required, and, if so, propose how subjects will be informed. The IRB will then determine how the investigator should proceed. The IRB should approve and have on file copies of any communication or information (including amended consent forms) conveyed or given to subjects.