Human subject research approved under Expedited and Full Board review is subject to continuing review “at intervals appropriate to the degree of risk, but not less than once per year” (45 CFR 46.109(e)).
Requests for progress reports are e-mailed to investigators three months prior to the protocol’s approval expiration date. It is the principal investigator’s responsibility to complete and return the progress report form before the protocol’s expiration date. If the PI is a student and the IRB is unable to contact him or her, it then becomes the advisor’s responsibility to complete and return the form.
The progress report is a request for the status of the research project, including questions on (a) the number of subjects accrued; (b) withdrawal of subjects from the research; and (c) a summary of any recent literature, findings, or other relevant information, especially information about risks associated with the research. If the research project is not complete at the time of the report, the investigators should ask for a renewal of approval.