any information about the project that is the subject of the allegation.

When the ad hoc committee determines that its investigation is done, it will prepare, with the assistance of the HRPP specialist, a summary report for the full IRB. The report may consist of a summary of the allegation, interview summaries, and copies of pertinent information or correspondence. The report may or may not include recommendations for IRB action.

The IRB will review the materials presented by the ad hoc committee at a convened meeting at which a quorum is present. The materials provided will include the summary report of the alleged noncompliance and any other relevant materials. The convened IRB determines whether to request additional information or whether to interview additional witnesses. The IRB may give the principal investigator of the project under review the opportunity to meet with the convened IRB before it takes final action.

The convened IRB will make the determination whether the allegation is substantiated, and if so, whether the noncompliance is serious or continuing based on the materials compiled by the ad hoc committee and any additional information that it may request. The IRB may also find that the allegation is unjustified or that noncompliance is a minor issue. If the issue is minor, then it may be resolved through communication involving the IRB Chair, the HRPP specialist, the principal investigator, and the complainant.

Once the IRB has made a determination about the allegation, the convened IRB may vote to approve a variety of actions, including but not limited to the following: approve continuation of research without changes; request formal educational intervention; request minor or major changes in the research procedures and/or consent documents; modify the continuing review schedule; require monitoring of research; require monitoring of the consent process; suspend or terminate IRB approval; require inspections of other active protocols of the investigator; disqualify the investigator from conducting research involving human subjects at KSU; determine that the investigator may not use the data collected for publication; require that the investigator contact subjects previously enrolled in the study and provide them with additional information and/or obtain consent from them again; request that the investigator inform publishers and editors if they have submitted or published manuscripts emanating from the research.

Once the IRB has reached a decision on the allegation and approved a course of action, the OSP will provide a letter to the following individuals notifying them of the allegation, the review process, the findings of the review: the principal investigator, the investigator's immediate supervisor, chair, or dean, and the complainant.

If the principal investigator is directed to take corrective action, the investigator must provide written documentation of the completion or implementation of any required actions to the IRB within 30 days. Once the IRB has evidence and agrees that the appropriate corrective actions have been completed or implemented, the matter will be