further research involving human subjects until approval is renewed.

For continuing review, the IRB must have the same considerations and use the same criteria to approve the continuation of a protocol as in the initial review of research.

At the same time, when conducting continuing review, the IRB needs to determine whether any new information has emerged either from the research itself or from other sources that could affect the IRB's approval of the continuation of research, particularly with respect to risk to subjects. In addition to the considerations outlined in section 7.2, the IRB at the time of continuing review will consider the following:

The IRB's continuing review should consider relevant information received from the investigator, any monitoring entity (such as the research sponsor, a coordinating or statistical center, a data and safety monitoring board, or a data monitoring committee), or any other source since the date of the last IRB approval of the project. Information regarding any unanticipated problems or irregular activities that have occurred since the previous IRB review in most cases will be pertinent to the IRB's determinations at the time of continuing review regarding determinations of risks and benefits.

It also may be appropriate for the IRB at the time of continuing review to confirm that any provisions under the previously approved protocol for monitoring the research data and ensuring safety of subjects have been implemented and are working as intended. This may include requesting that the investigator provide a report from any monitoring entity involved in the project and described in the protocol initially approved by the IRB.

At the time of continuing review, the IRB should review the informed consent documents submitted by the investigator to verify that the investigator is using the most recently approved version and that the document contains the most accurate, up-to-date information. When reviewing an informed consent document, the IRB should also confirm that the currently approved or proposed consent document adequately addresses all the required elements of informed consent.

If the IRB waived the requirement for the investigator to obtain a signed consent form for some or all subjects, the IRB should reassess the accuracy of the content of the information that is being provided to subjects orally and of any written statement regarding the research that is being provided to subjects.

The IRB also may determine if there is any new information presented by the investigator or others (for example, subjects or other individuals who have observed the investigator obtaining subjects' informed consent) that raises concerns about the circumstances under