PREP Course #26: Navigating the IBC Approval Process for Clinical Trials Involving Biological Agents

  • Background: NIH Guidelines, Human Gene Transfer, Northwell Health Biosafety Program
  • Potential bottle necks when managing biological agents
  • Components of the risk assessment
  • Elements of a SOP for clinical trials involving biological agent


  • Submit clinical trials involving biological agents for IBC review and approval
  • Conduct a risk assessment
  • Draft a standard operating procedure (SOP) for the management of biological agents


David E. Smith, director of Environmental Health and Safety
Michelle Aparicio, BS, CPIA, director of the IACUC & IBC



The Public Research Education Program (PREP) is a series of courses developed by various research support offices in conjunction with other health system offices. The courses offer CME credits and are designed to increase quality of research throughout the health system and streamline the process of conducting research.

PREP courses also aim to enhance and expand investigator capacity to conduct research. PREP courses are free and open to all Northwell Health employees, students, and volunteers. In addition, interested research collaborators and community partners are welcome to attend.

Light refreshments will be served at the courses held at the Goldman B Conference Room.

Don’t forget to check out select videos of PREP courses online.

For additional information, please visit:
David E. Smith, director of Environmental Health and Safety