IRB Additional Verification Procedures

Procedure

The IRB shall have authority to determine which studies need verification from sources other than the investigators that no material changes have occurred since the previous IRB review, particularly

• complex projects involving unusual levels or types of risk to subjects;
• projects conducted by investigators who have previously failed to comply with the requirements of the HHS regulations or the requirements or determinations of the IRB; and
• projects where concern about possible material changes occurring without IRB approval have been raised based upon information provided in continuing review reports or from other sources.

Primary Investigators shall be informed at the time of protocol approval (both initial and continuing) that changes in approved research may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.

Primary Investigators shall be informed at the time of protocol approval (both initial and continuing) that any serious or ongoing problems are to be reported promptly to the IRB.

Serious or continuing noncompliance by an investigator, or any suspension or termination of activities, is to be reported promptly to the Director of Institutional Research, so that appropriate remedial action can be taken, including, but not limited to, appropriate reporting to the granting agency.