Biosafety Registration

Any Baylor investigator planning a research project that involves recombinant or synthetic nucleic acid molecules (r/sDNA) must submit an application for Institutional Biosafety Committee (IBC) review and approval before initiating the work.

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: Submission to the IBC is achieved by completing the F-01 IBC Registration. (Click on “Forms” in the left side menu for more information). All information pertaining to recombinant DNA or synthetic nucleic acid molecules and the personnel involved with the research will be reviewed.
2. Pre-Review: A Research Compliance Administrator (RCA) will review your research information. The RCA may contact EHS to review the risk assessment based upon the information submitted. Any questions/problems/concerns will be directed back to the PI for clarification. Once all aspects of the risk assessment have been satisfied by Research Compliance (RC), your research will be reviewed.
3. Administrative or IBC Review: RC will determine whether the research is eligible for exemption from the NIH Guidelines or if IBC review is required. The IBC will review the research information submitted 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 RC or the IBC has made a review decision, a decision letter will be sent to the PI from the Research Compliance Office. 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, an annual status report is required.
• Any changes (minor or major) to your approved IBC registration must be submitted to Research Compliance for review.
• If you would like help completing or modifying your IBC Registration, please contact Research Compliance at IBC@baylor.edu for assistance.