General Project Information
I am a postdoctoral fellow/lab manager. Can I serve as Principal Investigator (PI) for submission of the BUA application?
No, it is the PI who is solely responsible for the accuracy of the BUA application and compliance with the applicable regulations. The lab contact section of the application is meant only for contact purposes, to request additional information, and to schedule laboratory inspections. See the FAQ for the Statement of Responsibility.
Once I submit my BUA application, can I start my work right away?
Even though the National Institutes of Health (NIH) categorize certain types of experiments that can be initiated simultaneously with submission of the BUA application, institutional policy requires that you wait for approval from the IBC and/or EH&S.
- For reviews covered under NIH Guidelines, Sections III-A through III-C, contact EH&S for specific instructions.
- For reviews covered under NIH Guidelines, Section III-D, an IBC member and an EH&S biosafety officer will be assigned to your project as primary reviewers and will work with you to obtain approval. All IBC members will also have the opportunity to review your BUA application. You can proceed with your Section III-D research project once you have received your BUA letter.
- For reviews covered under NIH Guidelines, Section III-E, an EH&S biosafety officer will review the application and provide a preliminary approval on behalf of the IBC. The application is then reviewed at the next convened IBC meeting for final approval. You can proceed with your Section III-E research project once you have received your BUA letter.
- Reviews falling under NIH Guidelines, Section III-F are exempt from the NIH Guidelines (e.g., work with E. coli K12 and its derivatives). However, to ensure compliance, the IBC recommends registering the research by submitting a BUA application to EH&S.
- Research with biohazardous agents that are not recombinant (e.g., human cell lines) must be reviewed by EH&S by submitting a BUA application.
The IBC review process includes a biosafety laboratory inspection that is conducted by an EH&S biosafety officer to evaluate lab space, containment practices, training, work procedures, and personal protective equipment (PPE). Once your research has been approved, you will receive a BUA letter from the IBC. If your research is not approved, an EH&S biosafety officer will work with you to address outstanding issues; approval is issued upon resolution.
When should I provide an IACUC (Institutional Animal Care and Use Committee) protocol number?
Provide an IACUC protocol number only when applicable to the research proposed in the BUA application; otherwise, leave the field blank. Specifically, if your research involves any work with transgenic animals or administration of biohazardous agents including recDNA, you must provide the IACUC protocol number. Please note that only one IACUC protocol may be associated with a single BUA application.
When should I provide a Human Subjects Division number?
Provide a Human Subjects Division number only when applicable to the research proposed in the BUA application; otherwise, leave the field blank. Specifically, if your research involves use of human source materials that require Institutional Review Board (IRB) approval or administration of biohazardous materials to human subjects (e.g., recombinant DNA vaccine), you must provide your Human Subjects Division number.
My project involves work with animals. Do I need approval for all my in vitro and in vivo work or just the work tied to my animal protocol?
You need approval for all your in vitro and in vivo work on a BUA. Each animal protocol involving biohazardous agents must have a separate BUA. If you have work with biohazardous agents unrelated to your animal protocol(s), then you may either:
- Submit a separate BUA application for the in vitro work; or
- Include in vitro work on the BUA application associated with one of your animal protocols.
I have not yet submitted my animal protocol to the Office of Animal Welfare (OAW). Can I still include the animal work on this BUA application?
Yes, you may include the animal work on the BUA application, but the risk assessment and IBC review cannot be completed until the IACUC protocol is submitted and reviewed by EH&S. It is best to submit the BUA application at the same time you submit your animal protocol to OAW. If you are not planning to start the animal work right away, you may want to submit your initial BUA application for in vitro work only. Later, you can submit a Change to BUA application to add the in vivo work when you submit the animal protocol. IBC approval always precedes IACUC approval.