Investigator Non-Compliance with IRB Approved Human Subjects Research

June 2003

The JHM IRBs are responsible for reviewing applications for human subject research and approving those studies that both meet the criteria set forth in the federal regulations and satisfy institutional standards.  The approval is limited to the specific protocol procedures, materials, forms, and processes  set forth in the application.  IRB approval notices detail any special conditions that accompany approval and provide a time limit for conduct of the study before the next IRB review.  The IRB expects each principal investigator and the study team to comply with all ethical standards, institutional policies, governmental regulations and IRB conditions placed on the conduct of the trial.

Non-compliance that occurs in the context of IRB approved research requires corrective action.  The IRB will determine the actions required and will take into consideration the nature, severity, and frequency of the non-compliance and the risk that non-compliance poses to human subjects. The JHM IRBs and Institutional officials may consider a range of options to address documented cases of  non-compliance.

When the IRBs determine, or an IRB determines, that protocol specific corrective actions must be implemented, the investigator will be informed in writing and Institutional officials will be informed.

The investigator will be instructed to acknowledge and implement the  corrective action.  The research may or may not be allowed to continue, depending on the specific circumstances of the non-compliance.  Research that the IRB determines may continue will do so only under the terms of the corrective action plan.

Severe and/or continuing significant non-compliance will be reported promptly to Institutional officials.  The IRB may terminate or suspend approved studies in cases of severe non-compliance that affects the rights and welfare of human participants.

Institutional officials will determine whether and when to notify the funding source(s), OHRP, and FDA.  Institutional officials also will determine whether the report rises to the level of professional misconduct.  The Office of Policy Coordination will review any cases forwarded by Institutional officials for inquiry into allegations of professional misconduct.