By: Sabrina Gonzalez Russi, EHS Regulatory Specialist
The Institutional Biosafety Committee (IBC) frequently receives inquiries regarding its role and questions about what needs to be reviewed. In this brief overview, we aim to address some of the most frequently asked questions and encourage you to visit the WCM Research website for more information. Please reach out with any additional questions.
What is the role of the Institutional Biosafety Committee (IBC) at WCM?
The Institutional Biosafety Committee (IBC) at WCM, composed of faculty and experts in biosafety, operates under NIH guidelines. This committee plays a crucial role in clinical and laboratory safety by evaluating the risks associated with recombinant nucleic acids and biological agents used in research. The IBC’s role is to establish the necessary containment conditions to prevent or reduce the risk of exposure to individuals, the community, and our environment from disease- causing agents.
What Type of Research Requires IBC Registration and Approval?
At WCM, all Principal Investigators must register their research with the IBC, and IBC approval is required before conducting research with any of the following:
Recombinant or synthetic nucleic acid molecules
Biological agents classified by NIH guidelines as Risk Group 2, 3, and 4
Select agents listed by the USDA/CDC
Clinical trials involving human gene transfer and cellular therapies in human subjects
What Changes to Research Protocols Require an Amendment to Previously Approved IBC Laboratory or Clinical Safety Registrations?
- Laboratory Protocols:
- Addition of new agents to the laboratory
- Addition of animal studies with agents previously approved by the IBC
- Clinical Safety Protocols:
- Changes impacting the initial biosafety risk assessment require an amendment
- Changes in the amount or route of study product administration
- Changes in the risk associated with the study product
- Changes in infection control or containment requirements
If you are unsure whether IBC approval is needed or how to initiate an amendment request, please contact the IBC at ibc@med.cornell.edu. Upon receiving your request, the need for an amendment will be evaluated, and if necessary, an amendment will be created and made available in WRG for updates. If an amendment is necessary, your designated EHS Safety Advisor will assist the lab in making necessary updates to the research in the Weill Research Gateway (WRG). If you are unsure who your Safety Advisor is, please email safetyadvisor@med.cornell.edu.
For more information about the IBC, please visit our website at https://research.weill.cornell.edu/compliance/human-subjects-research/institutional-biosafety-committee-ibc