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Biosafety and Recombinant or Synthetic Nucleic Acids

The Purdue University Institutional Biosafety Committee (IBC) reviews research protocols involving the use of recombinant DNA (rDNA), synthetic nucleic acids, and/or biohazardous agents that present a risk to humans, animals, and plants.

The Purdue IBC operates in accordance with the guidance and requirements of the National Institute of Health (NIH), the Centers for Disease Control (CDC), and Purdue University policies. The Purdue IBC consists of Purdue University faculty, staff, and local community members. The IBC convenes as a group as frequently as needed to fulfill its responsibilities. The functions and structure of the IBC, are outlined in the IBC Charter.

Principal Investigators must be closely familiar with health and safety guidelines applicable to their work and the required methods to uphold these practices. Purdue’s Environmental Health and Safety (EHS), the Office of Research, and the Biosafety Officer collaborate to support the IBC to carry out its responsibilities.

IBC Application Process

Principal Investigators must register with the IBC whenever research with recombinant DNA, synthetic nucleic acids, biohazardous agents, or unfixed human fluids and tissues is planned.

Completing an IBC Application - Renewal required every three years

Personnel training. IBC Form 1A Application. Research Space Inspection. Review and Clarification. IBC Approval. IBC Form 2A for Changes.

Personnel Training – All personnel working with recombinant or synthetic nucleic acids and/or biohazardous agents must complete CITI training (links). Records of CITI training should be verified by the Principal Investigator before submitting an application for review. Please ensure that the completion of Biosafety Modules occurs by all staff. Other lab safety training may also need to occur through Radiological and Environmental Management courses prior to an IBC protocol approval. Please see the EHS Training page to access any additional courses relevant to the research being conducted.

IBC Form 1A - This form will determine the biosafety level and NIH categories applicable to the research protocol. If possible, the use of an application that covers all of the activities of the research space is preferred. Send the completed form, signed by the PI to the Biosafety Officer via e-mail.

Research Space Inspection - Shortly after submission of the application, a laboratory inspection personnel responsible for biosafety within Radiological and Environmental Management, will complete a walk-thru to ensure that all safety procedures are in place. Any corrective actions identified upon inspection will require correction before IBC approval. This process will be repeated annually.

Dialogue and Clarification - Depending on the activities of the laboratory and the biosafety levels, the application will be reviewed by the IBC Chair or Committee. If there are questions about any of the application materials, the Biosafety Officer (or designee) will reach out to the PI for clarification.

IBC Approval - Once the IBC has approved a protocol, all documents should be kept in a central location in the laboratory space. Ensure all signage and emergency materials described in the protocol appear in a central location in the laboratory. Please utilize the EHS website for more information. Approvals from the committee are valid for a period of three years.

Protocol Changes - PIs must report substantial changes in the biosafety protocol to the IBC. Examples of changes are: change in personnel, change to the location or assignment of a research space, use of a new biohazardous agent requiring risk level evaluation (example: checkbox items on the form 1A where an answer changes from the original answer). When in doubt, please contact the Biosafety Officer or utilize the Form 2A to report changes to an approved protocol.

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