The Contractor shall develop and submit a Report of Findings (ROF) related to the current CPHS IRB Policies and Procedures. The CPHS IRB ROF should include at minimum: Identify all applicable Federal and State regulations including but not limited to the OHRP and FDA IRB. Identify any recent or upcoming changes to the regulations described in item A above. Identify any gaps between the Federal or State regulations and the CPHS IRB policies and procedures including but not limited to: IRB informed consent requirements. IRB data security and confidentiality protections. Reliance agreements and cooperative IRB review processes. IRB Roster process. Meeting minutes process and template. IRB centralized research request application process including user experience. Recommendations for implementing enhancements needed to address gaps for compliance to the required Federal and State regulations. Recommendations for improvements to the current CPHS IRB policies, processes, and procedures. Recommendations for clear, standardized supporting documents to facilitate IRB review and compliance. Identify and recommend opportunities for efficiencies in workflow.
