Amendment Appendix 2 (rev 9-08)
Use of Substances Potentially Hazardous to Humans- Protection of Humans
Materials considered hazardous include, but are not limited to, any of the following categories:
I.

Biological materials
 Bacteria, viruses, parasites, prions, oncogenic material or other potentially infectious
materials
 Human blood, human body fluids, human tissues, normal or tumor cells lines derived
from humans. Note. PI is responsible for ensuring employees working with above have
been offered the Hepatitis B vaccine and obtain annual (BBP) Bloodborne Pathogen
training.
 Recombinant DNA constructs

Chemicals (including pharmaceuticals) that are carcinogenic, mutagenic, teratogenic or
extremely toxic (a compound is considered highly toxic if it has an LD50 as a single oral
dose for rats of < 1 mg/kg.)
 Investigational compounds whose toxicity has not been characterized.
 Non-standard anesthetics (i.e., urethane)

Radiation
 radioisotopes
 irradiation
 X-ray

Lasers
This protocol involves the administration or treatment of biological materials to live animals.
YES , NO
If yes, answer questions below and complete Section II. A.
A. List the bacteria, viruses, parasites, prions, oncogenic material or other potentially infectious
materials:
Name:
Name:
Name:
Name:
B.
Will human blood, tissue, cells, body fluids or established cell lines be administered in
live animals?
YES , NO , If yes, please describe:
C.
Will any tumor cell lines be administered to live animals? YES , NO
If yes, list name(s), designation(s), species,
etc., of cell line(s):
D.
Do animal handlers require vaccination prior to experimentation?
YES , NO , If yes, explain:
E. Recombinant DNA
Do you use or generate recombinant DNA? Yes
, NO . Note: If the recombinant DNA is
generated by the University of Pennsylvania Medical Genetics Vector Core Laboratory, the Vector Core
Laboratory will register the recombinant DNA with the Institutional Biosafety Committee prior to
generation and distribution. Registration by the Principal Investigator is not required.
Amendment Appendix 2 (rev 9-08)
Please contact Dr. Abigail Smith, Associate Director for Diagnostic Services prior to final
approval at abigail4@pobox.upenn.edu or call (215) 898- 4008.
Complete the following table for all rDNA constructs used in this protocol:
Construct
Name
Generated in
your lab
(give IBC #)
Generated by
PENN’s Medical
Genetics Vector
Core Lab (give
IBC #)
Gifted
(give collaborator’s
name/institution)
Purchased
(give company
name)
Recombinant DNA guidelines, the University’s recombinant DNA registration document, and the
form to request exemption from the NIH Guidelines are available at the EHRS website
(http://www.ehrs.upenn.edu/protocols/rDNA.html).
It is your responsibility to renew your recombinant DNA IBC registration every three years.
II.
This protocol involves the administration or treatment of hazardous chemicals, toxins, anesthetics
and/or drugs to live animals. The potential risk to persons (not animals) must be evaluated. If
there is a risk posed through contact with the animals, their excreta or their bedding, describe the
risk(s) in question IIB and include an explanation on how the risk will be controlled.
YES , NO
If yes, complete the chart and answer questions below.
A.
Complete the chart below for all chemicals (including toxins),,anesthetics or other drugs
used in this protocol. This includes use of chemicals used in perfusions, such as
paraformaldehyde.
Substance
Dose
Route of
Administration
Poses a hazard through direct or
indirect contact with the animal,
its excreta or its bedding.
(answer yes or no; do not leave blank)
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
B. Describe how the hazard(s) listed above will be controlled whose use poses a hazard to
humans.
C.
Anesthetic gases will be scavenged using one of the following methods:
Active scavenging with a vacuum system
Filtering with charcoal canister
Used in a fume hood or a Class II type B biosafety cabinet
Other (describe):
Amendment Appendix 2 (rev 9-08)
D.
III.
Animal will be perfused in the following location:
This protocol involves the administration or treatment of live animals with radioisotopes,
irradiation, or X-rays? YES , NO . If yes, answer the appropriate questions below.
A.
Radioisotopes: YES , NO
If radioisotopes are used, a radiation Protocol Summary Form must also be submitted to
EHRS (may be submitted electronically). Please see:
http://www.ehrs.upenn.edu/programs/radiation/licensing.html.
Isotope(s):
Licensee Name:
Activity administered per animal:
Where will radioisotope administration occur? Bldg:
Rm.#:
Will animal(s) be returned to the ULAR facility after isotope administration?
YES , NO .
IV.
B.
Irradiator Use: YES , NO
Irradiator Licensee:
Location of Irradiator:
Name of User(s):
C.
X-Ray: YES , NO
If yes, location:
Will you be using a laser (other than a confocal microscope) in this protocol?
YES
NO , If yes please answer questions below.
A.
B.
C.
D.
E.
Manufacturer:
Model:
Wavelength:
Maximum power output:
Fiber delivery system? Yes
, No