ORC Use Only:
Protocol #:
Approval:
Animal Care / Use Application
Appendix D
Use of Hazardous Agents
Form completion instructions: To populate a box, click once on the box to show the “X.” To uncheck box, click on it once more to remove “X.”
For narrative responses, click on the prompt text (“Click here to enter text”) and begin typing.
Protocol Title: Click here to enter text.
Principal Investigator: Name: Click here to enter text.
Department: Click here to enter text.
1. I have received IBC approval and my biosafety protocol specifically details the use of animals as indicated
above as well as in this animal care/use application.
☐ Yes*
☐ No
☐ Pending
*If “YES”, provide the IBC approval # (e.g., 12-014): ___ ___ - ___ ___ ___ OR
If approved by the IBC as BSL-1 and/or exempt rDNA check this box:
☐
If “No” see question #2.
NOTE: THE IACUC WILL WITHHOLD APPROVAL OF THIS APPLICATION UNTIL IBC APPROVAL IS GRANTED.
2. Answer the following questions to determine the need for Institutional Biosafety Committee (IBC)
approval.
Does this animal protocol involve:
a. Introduction of rDNA by any means into animals including, but not limited to, transfer of genetically
engineered cells (transfected by any means), cells that come from a transgenic animal, or using viral
vectors?
a. ☐ Yes ☐ No
Recombinant DNA (rDNA) is defined as the joining of naturally occurring or synthetic DNA sequences (insert)
to host DNA such that the resulting joined sequences are capable of replicating in a host cell (vector).
b. Use or cross-breeding of transgenic or knockout animals except for breeding one line of transgenic or
knockout rodents for colony maintenance?
b. ☐ Yes ☐ No
c. Use of organisms or viruses known to be pathogenic to humans (e.g., parasites, viruses, bacteria, fungi,
prions, rickettsia) or biological materials that may contain these microorganisms?
c. ☐ Yes ☐ No
d. Use of CDC/USDA regulated Select Agents or Toxins (human, animal, or plant)? Refer to the Select
Agents website.
d. ☐ Yes ☐ No
Appendix D: Hazardous Agents
Page 1 of 3
e. Use of human or other primate tissues, blood or body fluids or materials derived from them, including
established cell lines (e.g. HeLa, HEK 293, etc.)?
e. ☐ Yes ☐ No
f.
Use of disease carrying vectors (such as arthropods) or other biologically active agents (e.g., toxins,
venoms) that may cause disease in humans or cause significant impact if released to the environment
f. ☐ Yes ☐ No
IF “YES” to ANY question above, IBC Approval is needed.
If “No” to ALL questions, IBC approval is not needed.
If unsure about ANY question above, contact the Biosafety Compliance Office at (704) 687-1872 to discuss.
For guidance on IBC forms and requirements, refer to the IBC website.
NOTE: THE IACUC WILL WITHHOLD APPROVAL OF THIS APPLICATION UNTIL IBC APPROVAL IS GRANTED.
3. Does this animal protocol involve use of radioisotopes/radiation producing devices? ☐ Yes ☐ No
*If “Yes”, then the protocol must be reviewed and approved by EH&S. The use of radioisotopes/ionizing
radiation producing devices also must follow the requirements outlined in the University’s Radiation Safety
Handbook.
Have you obtained this approval from EH&S? ☐ Yes ☐ No ☐ Pending
NOTE: THE IACUC WILL WITHHOLD APPROVAL OF THIS APPLICATION UNTIL EH&S APPROVAL IS GRANTED.
4. Does this animal protocol involve use of hazardous chemicals?
☐ Yes ☐ No
IF “YES”, Safety Data Sheets (SDS) for the chemical compounds must be provided to EH&S. The use of
chemical compounds must follow the requirements outlined in the University’s Hygiene Plan.
5. Use of agents in animals: If you noted the use of any type of hazardous agents in the screening questions
above please complete the table below.
Agent Name /
Description
Click here to enter
text.
Type of Agent
☐ Biological
Hazard
Dose /
Concentration
Route
Frequency of
Administration
Anticipated
Duration of
Effect
Method of
Waste
Disposal
Click here to
enter text.
Click
here to
enter
text.
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
Click
here to
Click here to
enter text.
Click here to
enter text.
Click here to
enter text.
☐ Chemical
Hazard
☐ Radiation
Hazard
☐ Other
Specify:
Click here
to enter
text.
Click here to enter
text.
☐ Biological
Hazard
Appendix D: Hazardous Agents
Page 2 of 3
Agent Name /
Description
Type of Agent
☐ Chemical
Hazard
Dose /
Concentration
Route
Frequency of
Administration
Anticipated
Duration of
Effect
Method of
Waste
Disposal
enter
text.
☐ Radiation
Hazard
☐ Other
Specify:
Click here
to enter
text.
Appendix D: Hazardous Agents
Page 3 of 3