What is the MOST appropriate action for an IRB upon receiving self-reported investigator non-compliance regarding inclusion criteria?

Stopping enrollment in all of the Principal Investigator's clinical trials until they are audited is the most appropriate action for an Institutional Review Board (IRB) in response to self-reported investigator non-compliance, particularly regarding inclusion criteria. This action is crucial for safeguarding the integrity of the ongoing research projects and protecting the rights and welfare of study participants.

When an investigator reports non-compliance, especially related to the criteria for including participants in clinical trials, it raises concerns about the validity of the data being collected and the ethical treatment of participants. By halting enrollment, the IRB ensures that no additional participants are potentially being subjected to inappropriate protocols while an investigation is underway. This step helps to maintain the ethical standards of research and allows the IRB to review the situation in detail without further complicating the issue by adding new subjects.

This approach also provides the opportunity for the IRB to evaluate the extent of the non-compliance and determine the necessary corrective actions, whether that be further training for the investigator, corrective plans, or modifications to the study protocols. It protects the integrity of the research as it allows for a thorough investigation of any potential biases or ethical violations before new participants are admitted to the trials.