IBC- Determination Checklist
Office of Regulatory Research Compliance
Institutional Review Board
Does This Protocol Need Institutional Biosafety Committee Review (IBC)?
(Must be completed as Part of IBC, IRB or IACUC application)
To determine whether this protocol needs IBC review, please answer Yes/No to the following
questions. If during review, the ORRC – IBC/IACUC/IRB determines that your study meet certain
criteria, you will be asked to submit the PROTOCOL application to the IBC for review.
Criteria
YES NO
1. This project will require use of vertebrate animal subjects.
2. This project will require use of human body fluids, and you will store, or
analyze the samples in a non-commercial or your laboratory at HU?
3. This project will require t h e use of human and/or primary or established cell
lines (#3 only relevant to IRB application).
4. This project will require t h e use o f non-human primate tissues, and/or
primary or established cell lines (#4 only relevant to IACUC application).
5. This project will use genetically modified organisms including viruses, bacteria,
fungi, animals or plants.
6. This project will require use of recombinant DNA, synthetic nucleic molecules or
genetically modified plants or organisms.
7. This project will require use of biohazards or infectious material.
8. This project will involve receipt of or transfer of biological material (Material
Transfer Agreement required).
9. This project will require use of ionizing or non-ionizing radiation.
10. This project will require the receipt or transmission of classified
information or materials.
If you have responded “NO” to all of the above statements, then your application
qualifies for an exemption.
If you have responded “YES” to items 1 and 2 in the above statements, then your
laboratories may need to be inspected, and certified by the Laboratory Safety Officer on
behalf of the ORRC - IBC/IRB/IACUC (Assess compliance with appropriate standards).
If you have responded “YES” to items 3 to 10 in the above statements, then your
application will need to be reviewed by the IBC on behalf of the ORRC - IRB/IACUC.