Supplement I Boston College IACUC Proposal Form
Protocol number:
Use of Hazardous Materials in Animals
This form may be submitted in support of a protocol application or separately, as an addendum.
If this is an addendum, please also provide a cover letter that includes the following: PI
Name/Department; Protocol Number/Title; Contact Person/Contact Email; Objectives and rationale;
and PI Signature (required).
Section 1
General Information
Fill out one form for each hazardous agent (radioactive, chemical, biological) unless agents are closely
related (e.g., similar radioisotopes may be combined) or two agents will be administered together (e.g., a
radiolabeled chemical agent).
Investigators must obtain approval from the Radiation Safety Committee for radioactive hazards or
approval from the Institutional Biosafety Committee for biological hazards before the IACUC can approve
this research. For general information regarding hazardous agents, see
http://www.bc.edu/offices/facilities/ehs/labs.html
Once completed, return this form to the Office for Research Protections, irb@bc.edu, Waul House, 3rd
Floor.
Principal Investigator:
Phone:
Email:
Department:
Address:
Title of IACUC Protocol:
Section 2
Type of Hazard
IACUC Protocol Number:
Contact Person:
Phone:
Email:
BIOLOGICAL HAZARD
Name:
Attach approval letter from the University IBC.
Amount kept in laboratory:
RADIOACTIVE HAZARD
Isotope(s):
Attach approval letter from the University Radiation
Safety Committee.
Total amount of activity (µCi) per experiment and
per animal:
Preparation/chemical form:
CHEMICAL HAZARD*
Name:
Storage location and physical state:
Method of preparation and amount:
Source:
*Attach MSDS for all chemical hazards and relevant scientific literature to clarify occupational health risk.
Attach approval letter from the Chemical Hygiene Committee.
Section 3
Administration of
Multiple Hazards
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If an individual animal will receive other previously approved hazards in addition to those listed above, list
other agents (in Section 5, describe the time interval(s) between dosing with the different hazards):
Supplement I Boston College IACUC Proposal Form
Section 4
Personnel Training
Protocol number:
Training is required prior to the use of biological, radiation, or chemical hazardous materials.
Appropriate courses may be found on the EHS website:
http://www.bc.edu/offices/facilities/ehs/training.html
Documentation of such training must be given to the Animal Facility Manager prior to the use of
such materials.
List all personnel handling hazard
List pertinent EHS training and date received
Section 5
Administering Hazard
Give specific details of:
Do not refer to sections
of the IACUC protocol.
The EHS reviewer
receives this form only
and it must contain all
details of dosing, time
points, etc.
a.
Species (strain if relevant) and numbers of animals. Indicate if immunosuppressed.
b.
Dose per animal (amount per unit body weight AND total volume per dose):
c.
Route of administration:
d.
Frequency of dosing:
e.
Survival time after dosing:
Section 6
Manipulations and
Procedures
Describe all manipulation(s) for preparing the material for dosing and administration to the
animal(s). Indicate any other animal manipulations that are planned after the hazard(s) have been
administered (e.g., surgery, transport out of animal facility, behavioral testing, etc.), including
procedures at necropsy unique to the hazardous material. If additional hazards will be used in the
Do not refer to sections same animal, please describe time intervals between dosing with the different agents:
of the IACUC protocol.
The EHS reviewer
receives this form only
and it must contain all
details of dosing, time
points, etc.
If any procedures will be performed outside of BC animal facilities, list those locations and how animal(s)
are transported:
Section 7
Agent/Metabolite
Excretion/Secretion
or Propagation
Provide amounts (chemical/biological hazards) or activity (radioactive hazards) expected to be
excreted/secreted. Appropriate scientific literature must be consulted to complete this section; any
answer of “unknown” must be substantiated.
Urine:
Feces:
Expired air:
Secretions (be specific):
Duration of excretions/secretions:
Method of detecting agent/metabolite:
List metabolites to be excreted/secreted:
Are any metabolites hazardous? If yes, which ones? Are any metabolites volatile? If yes, which ones?
List reference/source(s) of information on metabolites and excretion/secretion:
For biological hazards, will the agent replicate in the animal? How is this monitored? (Provide
references.):
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Supplement I Boston College IACUC Proposal Form
Section 8
Compliance Statement
Protocol number:
I affirm the accuracy of all the information on this “Use of Hazardous Materials in Animals” form.
I agree that hazard use in animals cannot start until the following has occurred, in listed order:
(1) The IACUC has approved the corresponding protocol application/addendum that describes the
use of hazardous materials in animals.
(2) A specific “Required Protection/Control” form for each particular hazard has been generated by
the Animal Facility Manager and EHS, and the Principal Investigator has signed and returned the
form(s) to the Office for Research Protections, irb@bc.edu, Waul House, 3rd Floor.
(3) Study personnel have been contacted by the Animal Facility Manager or designee for
consultation, space allocation, and orientation in the animal facility on the use of each particular
hazard in animals.
(4) Applicable training needs to occur shortly before the study is initiated; retraining may be
required if the study is delayed. Documentation of the successful completion of EHS training must
be sent to the Animal Facility Manager before the study is initiated.
(4) Study personnel will in every respect abide by the directions of the Animal Facility Manager
including, but not limited to, safety concerns, appropriate protective clothing and proper
procedures.
Contact Person (print name)
Signature
Date
Principal Investigator (print name)
Signature
Date
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