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 which informed consent is being obtained. The IRB may consider any new information indicating that the investigator may not be obtaining informed consent under circumstances that provide subjects with sufficient opportunity to consider whether or not to participate or that minimize the possibility of coercion or undue influence.

Continuing review also provides the IRB with an opportunity to determine whether there is any new information or any significant new finding that should be communicated to subjects who have already enrolled in the research. This could include, for example, important new toxicity information or new adverse event information related to the research interventions that are identified during analysis of the research data.

When appropriate, the reviewing IRB should consider issues regarding the investigator and the institution(s) where the research is being conducted during its continuing review, such as the following: changes in the investigator's situation or qualifications; evaluation, investigation, and resolution of any complaints related to the investigator's conduct of the research; changes in the acceptability of the proposed research in terms of