Protecting the rights and welfare of participants sometimes requires that the IRB verify independently, utilizing sources other than the investigator, that no material changes occur during the IRB designated approval period. Additional sources may include: audit by the Education and Compliance Office for Human Subject Research, investigational pharmacy records, incident reports, radiation safety or source documents, as well as information from staff, research participants, families, sponsors or others.
Criteria for determining if verification is required includes, but is not limited to:
- Complex protocols involving unusual levels or types of risks to subjects;
- Protocols conducted by PIs who previously have failed to comply with Federal regulations or the requirements or determinations of the IRB;
- Protocols where concern about possible material changes occurring without IRB approval have been raised based on information provided in continuing review reports or from other sources.