702. When and Where to Report Noncompliance to the IRB
Anyone who becomes aware of a situation or occurrence that is inconsistent with an approved protocol should immediately contact the RIO for direction as to the preferable course of action.
Investigators, research personnel, or individuals not affiliated with a research study who believe that an incident of noncompliance has occurred must report the incident to the RIO or the IRB within five working days of their becoming aware of the incident.
When results of audits or inspections conducted by sponsors, external entities such as the FDA, or internal oversight committees indicate noncompliance occurred, PIs must notify the IRB within five working days of being notified of the determination.
Where to Report Noncompliance
Individuals who are uncertain if an incident or occurrence constitutes noncompliance should contact the RIO by phone at 775.327.2368 to discuss their concerns and preferable next steps.
Situations, incidents, or events that may indicate noncompliance has occurred must be reported to the RIO (775.327.2368) within five working days.
Reports of noncompliance involving the conduct of a University IRB, IRB Chair or members, or the RIO Director or staff may be reported to the Vice President for Research by phone 775.327.2363 or email firstname.lastname@example.org.
Reporting Noncompliance for Multi-Site Research
When a University or affiliate investigator is involved the conduct of a multi-center study, reporting requirements vary as follows:
- The investigator must inform the University IRB of possible noncompliance occurring at the local site.
- If the University or affiliate investigator is the lead PI or managing investigator for a multi-center study, she/he must inform the University IRB of noncompliance that occurred at external sites.
- If the University or affiliate investigator is not the lead PI or managing investigator she/he is not required to inform the University IRB of noncompliance that occurred at external sites.
Reporting Noncompliance for Research Reviewed by an External IRB
For research in which the University accepts an external IRB as the Reviewing IRB, University and affiliate PIs must report potential noncompliance to the Reviewing IRB as required by that institution, and according to all applicable regulations and laws.
- If the Reviewing IRB determines serious or continuing noncompliance has occurred, the PI must immediately provide a copy of the determination notification to the University IRB.
- All IAAs require the Reviewing IRB to notify the University IRB of determinations of serious or continuing noncompliance.