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Biosafety Registration

Any Baylor investigator planning a research project that involves recombinant DNA (rDNA) or synthetic nucleic acid (SNA) molecules must submit an application for Institutional Biosafety Committee (IBC) review and approval before initiating the work. Baylor investigators must also register their work with other potentially hazardous biologics.

The IBC review process is conducted in a step-wise fashion, starting with the submission of research information by the PI.

  1. Submit your research to the IBC: Online submission to the IBC is achieved using the BioRAFT online registration system (Click on “BioRAFT” in the left side menu for more information). All information pertaining to biological hazard usage and the personnel involved with the research will be reviewed in this system. This information is maintained in BioRAFT and you can update or revise it any time there is a change in your research program.
  2. EHS Pre-Review: The Biological Safety Officer will review your research information and conduct a risk assessment based upon the information submitted. A biosafety audit of the lab will be conducted as part of the risk assessment. Any questions/problems/concerns will be directed back to the PI for clarification. Once all aspects of the risk assessment have been satisfied by EHS, your research will be reviewed by the IBC committee.
  3. IBC Review: The IBC will review the research information submitted through BioRAFT and discuss the safety and regulatory aspects of the research project. Discussion topics include: the nature of experimentation, location, rDNA aspects, training requirements fulfilled by research staff, past laboratory inspection record, etc. If it is warranted, researchers may be invited to present their research protocols to the IBC committee.
  4. Decision Letter Sent to PI: Once the IBC has made a decision regarding the research project reviewed, a decision letter will be sent to the PI from the Office of Research Compliance. This decision letter should be retained for your records.
  5. Conduct Research: Research may begin once approval is received.

Attention

  • IBC approval is good for 3 years; however, any new research (new funding, new collaborations, etc.) is reviewed ad hoc as a modification.
  • You will need to amend your approved IBC registration if you are adding or changing:
    • genes studied or host/vector systems used in your rDNA work
    • infectious agents or biological toxins
    • work with substances from humans or certain vertebrate animals
    • transgenic animal or plant work
    • administration of biologics to animals
    • administration of biologics to plants
    • anything else that may have an impact on the biosafety level of the work being performed BSL2 laboratory space
  • If you would like help completing your BioRAFT IBC Registration, please contact Wyndi Klement, BSO, for assistance.