Federal regulations require that any institution that engages in research involving human subjects have an IRB, and it is important that KSU have a functioning and effective IRB. Although much of the research that takes place at KSU is exempt from IRB regulations, there are a few research projects every year that are not exempt and, therefore, require review and guidance from an IRB. Furthermore, the Department of Health and Human Services strongly encourages researchers who are engaged in exempt research to seek independent confirmation from an IRB or other individuals informed about relevant federal regulations that that their research is exempt. In recent years, however, KSU has not had a functioning and effective IRB, and this is due in part to lack of clarity and guidance in the current IRB policies and procedures.

In the 2022-2023 academic year, Dr. Sharp reconvened the IRB drawing on a list of faculty names provided to him by the previous provost. It is our understanding that prior to this reconvening, there was a period of at least two years in which there was effectively no IRB (OSP has virtually no records related to the IRB from 2019 through 2022.) While nearly all of the faculty involved in the reconvening of the IRB had good intentions and were helpful, after three meetings, it became clear that the members had different understandings of the role of the IRB and basic concepts for an IRB, such as what qualifies as exempt research and what are the federal regulations regarding informed consent. This is due in part to the fact that the current IRB policies and procedures do not state clearly what the training requirements are for IRB members. Furthermore, none of the members agreed to serve as Chair, and Dr. Sharp was left in the role of Acting Chair. While it is standard practice for the OSP to be centrally involved in the orientation of IRB members and the administration of the IRB, an OSP staff member should not also serve as IRB Chair,