Office of Research Compliance and Regulatory Affairs

  • Human Research Program

    The Human Research Program is responsible for regulatory and ethical oversight of all human subjects research conducted by Cincinnati Children’s faculty, staff and employees.  The primary function of this program is to collaborate with researchers in a manner that incorporates compliance with applicable policies and regulations as well as high-quality protection of human subjects standards into the design and conduct of research projects at Cincinnati Children’s.

    In addition to providing this guidance and support to the Cincinnati Children’s research community, this program supports the Cincinnati Children’s Institutional Review Board (IRB), by providing regulatory expertise to IRB members and by conducting preliminary regulatory reviews of all materials submitted to the IRB. The Cincinnati Children’s IRB reviews research in accordance with applicable federal and state regulations as well as AAHRPP accreditation standards. 

    Cincinnati Children’s utilizes an electronic web-based system (ePAS-Electronic Proposal Administration System) to automate the process of submission, review, approval and ongoing oversight of all research activities.  All IRB protocol-related submissions, correspondence and approval notifications are sent through this system.   

    The ePAS application can be accessed by our federated partner institutions via the below link: 
    ePAS Federated Log-in

    In general, researchers who are not employees of Cincinnati Children’s and wish to conduct research here must first identify a Cincinnati Children’s collaborator and then obtain access to the needed Cincinnati Children’s system (including ePAS).  Contact the ORCRA with questions or for additional information, including available ePAS training materials. 

    Cincinnati Children’s maintains a current Federalwide Assurance (FWA) with the US Department of Health and Human Services. It is FWA00002988.
    Visit the U.S. Department of Health and Human Services for additional information regarding this assurance, including the most recent renewal date. 

    Cincinnati Children’s maintains one Institutional Review Board (IRB) that meets weekly and is registered with OHRP in compliance with both HHS and FDA regulations regarding registration of IRBs. It is IRB00000231.
    Visit the U.S. Department of Health and Human Services for additional information regarding this assurance, including the most recent renewal date. 

    For additional information regarding the IRB meeting schedule, a roster of members or if you are interested in joining the Cincinnati Children’s IRB, contact the ORCRA and ask to speak with the HRP manager.

 
  • Educational Resources

    The Office of Research Compliance and Regulatory Affairs provides training programs, seminars and events that improve compliance with federal regulations and institutional policies governing research, while promoting research integrity and best practices for research professionals.

    Read More About Education Opportunities