as the effectiveness of the IRB ultimately depends on shared responsibility between OSP and the broader university community. The current IRB policies and procedures do not provide clear guidance on what the role of the OSP should be in relation to the IRB, who the IRB Chair should be, and how the Chair is designated.

  1. At the end of the 2022-2023 academic year, the IRB reached an impasse and did not meet again after it could not reach a broad consensus regarding a proposed change in the application that researchers complete for IRB review and approval. Because of this, a faculty member was not able to submit their application for review, and their research project is on hold. The current IRB policies and procedures do not provide guidance on how changes in applications should be made, nor do they establish an appeals process allowing researchers to file an appeal when they feel they are negatively affected by an IRB’s actions or lack of action. More generally, the current IRB policies and procedures do not emphasize that the IRB should help create a collaborative environment where faculty, staff, and students are working together to increase involvement in and advance research at KSU, while ensuring the safety and wellbeing of human subjects.
  2. The proposed new policies and procedures directly address the problems the IRB encountered over the past year, by establishing clearly what the role of the IRB is, how members and the Chair are appointed, and what the training requirements are for IRB members and OSP staff involved in supporting the IRB. They also clarify some key terms and establish clearly what exempt research is, what qualifies for expedited review, and what the role of OSP is in the IRB and, more generally, the protection of human subjects at KSU. In line with the policies of the University of Kentucky and other institutions, they allow for OSP staff members to be very involved in providing guidance to the IRB and serve as alternate IRB members. They require that one member of the OSP staff serve as KSU's HRPP specialist and IRB administrator, in addition to their other duties (Dr. Sharp will serve in this role for the next academic year.) The new policies and procedures explicitly state that an OSP staff member cannot serve as the Chair of the IRB.
  3. The proposed new policies and procedures also give the OSP staff the responsibility for revising and updating applications and ensuring that they are in line with standard practices at other institutions. This change is important given that many institutions are now adopting online application and review systems for their IRBs; if this is an option for KSU in the future, it will make the transition to an online system easier. The new policies and procedures establish an appeals process allowing faculty to present concerns about IRB procedures and decisions and requiring the IRB to address their concerns. Finally, and most importantly, they stress the importance of shared responsibility, collaboration, and continuous learning and adaptation.
  4. The revocation of the current IRB policies and procedures and their replacement with the proposed new policies and procedures are needed for more than just addressing some immediate issues; they are also needed because the current IRB policies and procedures