have not been updated since there were substantive revisions of 45 CFR 46 (the main body of federal regulations governing IRBs) in 2018. Furthermore, over the past several years, many institutions have moved toward a Human Research Protection Program (HRPP) model away from a focus on the authority of the IRB. In this model, the IRB is seen as one part of a larger system protecting human subjects, and there is a greater focus on shared responsibility and ongoing education involving the IRB, administrative staff, and researchers. In view of this move toward HRPPs, the current IRB policies and procedures are out of date. Current policies and procedures also do not clearly reference the criteria to be employed in the IRB review process and options regarding informed consent, creating more opportunities for confusion. Current policies and procedures also do not state that the IRB should include at least one member unaffiliated with the institution, which is an explicit requirement provided in 45 CFR 46.107 (c). Finally, the organization of the current policies and procedures is not very good and makes them difficult to read, and because they are difficult to read, they raise additional challenges with educating IRB members and the broader university community about regulations and policies regarding human subjects.

• 7) The proposed new policies and procedures thoroughly incorporate text from and references to the revised 45 CFR 46. They also follow the HRPP model as much as possible and are presented as HRPP policies and procedures, rather than IRB policies and procedures. They establish clearly what the criteria for IRB review is, present the different options that the IRB can consider regarding informed consent procedures, and require that the IRB include at least one member unaffiliated with KSU. While the new policies and procedures incorporate a considerable amount of text from the current policies and procedures, the text has been carefully edited and reorganized, and the new policies and procedures have a more obvious and streamlined organization, making them easier to read and reference. The new policies and procedures also have functioning hyperlinks to relevant federal regulations and guidance. Finally, in areas where significant revisions were needed, the revisions were made to align with the University of Kentucky's policies and procedures for human subjects, as well as the revised 45 CFR 46.

In sum, we believe that the proposed replacement of the current IRB policies and procedures with the HRPP policies and procedures will put the IRB on a much stronger foundation, by giving the OSP a central but clearly defined role in the IRB, and ensuring that IRB are supported and can be effective in their roles. Furthermore, it will help to create an environment in which faculty and staff can work together to keep KSU in compliance with federal regulations regarding human subjects, which include the requirements that KSU have an IRB comprised of diverse members, that the IRB meets regularly, and that IRB records, including applications for IRB review and approval and meeting minutes, are retained.