Status Report

If you need to apply for an extension or renewal of a project that has already received IRB approval once, you don't need to resubmit your entire application. Using the IRB application form, submit just a status report of the project to date. This report must include:

• the number of subjects accrued
• a summary of adverse events and any unanticipated problems involving risks to subjects or others and withdrawal of subjects from the research or complaints about the research since the last review
• a summary of any relevant amendments or modifications to the research since the last review
• any other relevant information, especially information about risks associated with the research
• a copy of the current informed consent document and any newly proposed consent document