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 considered resolved, and the OSP staff in consultation with the IRB Chair will provide a letter to the principal investigator indicating that the matter is resolved.
The HRPP specialist will provide advice to the IRB regarding the applicable regulations during the review process, assist the IRB in documenting the review, answer questions about the review process, maintain records as required by state and federal laws or regulations, and serve as a liaison with the funding agency or agencies. In cases where the IRB determines that there is serious or continuing noncompliance, OSP will also provide a letter notifying KSU's Institutional Official of the noncompliance. If applicable, OSP will also notify the funding agency and OHRP of the noncompliance.
Research misconduct includes but is not limited to fabrication, falsification and plagiarism. Research misconduct in human subjects research may occur in the proposal, conduct or reviewing of research, or reporting of research results. Examples of misconduct in human subjects research may include: substituting one subject's record for another's; altering