Biosafety for Human Subject Research

 

Institutional Requirement

 

Per institutional policy, an Institutional Biosafety Committee (IBC) protocol is required for all activities involving the use of human biological material including (but not limited to): blood and its components, body fluids, tissues and tissue fluids. This IBC protocol must receive review and approval by the Institutional Biosafety Committee.

 

It should be noted that the IBC is not part of the IRB. Subsequently, an IBC protocol is considered separate from the IRB protocol and IRB approval process. Therefore, researchers should not assume that obtaining IRB approval satisfies this or other institutional requirements. Recall that researchers are responsible for obtaining the appropriate approvals and clearance from all applicable offices, departments and regulatory agencies (e.g., Institutional Biosafety Committee, Office of Clinical Trials, Grants and Contracts, Research Conflict of Interest, Legal, Sponsor or funding agency and/or Marketing) before initiating a study in order to remain compliant with institutional policy, federal regulation and state law.

 

However, for IRB approval, you will need IBC approval if you are working with human biological material. Please contact the Biosafety Program Office (ibc@unthsc.edu) or Maya Nair, PhD (817-735-5431) for additional information and submission requirements.

 

General Note for Researchers

 

While an IRB protocol focuses on the risk/benefit management of research from a human subject perspective, an IBC protocol focuses on the risk management of biological material from a biosafety perspective.

 

When developing a biosafety plan, researchers should consider the following items:

 

  • Potential safety issues when collecting, managing, transferring and storing (short-term and long-term) of human biological material.

 

  • Precautionary measures for minimizing the potential risks associated with the collection, handling, transferring and storage (short-term and long-term) of human biological material.

 

  • Measures for maintenance, surveillance / monitoring and enforcing the safety protocol.

 

  • Education and training – Researchers involved in the collection, handling and management of human biological material must complete Blood-Borne Pathogens ( BBP) Training. For questions about BBP training contact Janet Jowitt, RN, Chief Nursing Officer at Janet.Jowitt@unthsc.edu

 

  • An emergency response plan in the event exposure to a hazardous agent or pathogen occurs.

 

NOTE: For specific guidance on developing an IBC protocol, contact the Bio Safety Officer, Maya Nair, PhD, by phone at (817)735-5431 or email the Biosafety Program Office (ibc@unthsc.edu).

 

 

This page was last modified on April 20, 2016