Office of Research Compliance and Regulatory Affairs

Biosafety Program

The Biosafety Program is responsible for the regulatory and compliance oversight of all research conducted in Cincinnati Children’s facilities that involve biological agents, toxins of biological origin, and recombinant DNA materials, collectively biohazardous materials. The primary goal of this program is to prevent, reduce and control the potential for exposures to these biohazardous materials.  

Biosafety program personnel fulfill this goal primarily by providing guidance to researchers in determining appropriate laboratory practices, personnel protective equipment, facilities for biocontainment and proper biohazardous waste disposal methods based on the agents used in their laboratory research. Additionally, biosafety program personnel are actively engaged in delivering educational and awareness initiatives throughout the Cincinnati Children’s research community in support of biosafety “best practices”.

In addition to providing direct support to the Cincinnati Children’s research community, the program supports the Cincinnati Children’s Animal Care and Use Committee (IACUC) and the Institutional Review Board (IRB), by providing regulatory expertise to IRB and IACUC members on matters related to biological safety. Program personnel also frequent collaborate with various other units within Cincinnati Children’s, including Cincinnati Children’s Office of Occupational Safety and Employee Health and the Infection Control Program.    

Lastly, biosafety program personnel conduct preliminary regulatory reviews of all materials submitted for review by the Cincinnati Children’s Institutional Biosafety Committee (IBC) and provide administrative support and policy and regulatory guidance to the IBC. The Cincinnati Children’s IBC reviews research in accordance with applicable National Institutes of Health and Centers for Disease Control standards regarding recombinant DNA, infectious agents, and toxins of biological origin as well as applicable OSHA blood borne pathogen standards.

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. Learn more about educational resources.