The EH&S Biological Use Authorization (BUA) application has undergone major revisions with the goal to clarify and improve the questions necessary for the biosafety risk assessment for biohazardous research approval by the Institutional Biosafety Committee (IBC) and EH&S Biological Safety. These revisions will reduce the review time and follow-up communication on application gaps. The application format, submission, and approval process remain the same.
The main changes include:
- A new section requesting information about the creation or use of induced pluripotent stem cells (iPSCs).
- New tables separating wildtype only and recombinant only microorganisms with new questions about resistance to frontline therapeutics.
- New layout for the Recombinant and Synthetic DNA and RNA (rDNA) section to assist researchers in selecting specific experiments and the appropriate sections of the NIH Guidelines.
- New and updated questions requesting details about replication status of viral vectors.
- A new question to gather plasmid information for third generation lentiviral vectors.
- A new supplemental form for influenza viruses to capture specific information on strains needed to determine the required biosafety level.
- A new question about gene drive modified organisms (GDMOs) based on the April 2024 revisions to the NIH Guidelines.
Additional changes include updated links to resources, instructions, and more inclusive language. We also updated the BUA FAQs and added additional resources including a second database to search for oncogene and tumor suppressor information for your reference.
The BUA Change Application has also been revised to be consistent with the BUA application updates.
The 2024 version of the BUA and BUA Change applications are available on the EH&S Biological Research Approval webpage. Previous versions of the application will not be accepted after August 31, 2024.
We welcome your feedback to improve future versions of the applications. For questions, please feel free to contact EH&S Biological Safety.