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Salisbury University Animal Care and Use Committee
***For ACUC Use Only***
PROTOCOL FORM
 Original
Release Date: 9/08
 Revision
PROTOCOL #:
DATE REC’D:
New Protocol?
Yes
No
(if no, see below)
EXPIRATION DATE:
3rd Year Replacement of Protocol#:
 Logged
Do you currently have animals housed on this protocol?
Yes
 Database
BSL: 2 3 4
No
ABSL: 1
2 2E
PROTOCOL TITLE:
1. PRINCIPAL INVESTIGATOR (PI): Faculty member responsible for design and implementation of the research.
LAST NAME:
FIRST:
M. INITIAL:
Title:
School:
Dep’t/Div:
DEGREE (S):
Campus Mail Address:
Building:
Phone:
Room Number:
Fax:
E-mail:
2. PRIMARY CO-INVESTIGATOR, if applicable: Person who is delegated authority when the PI is unavailable.
LAST NAME:
FIRST:
M. INITIAL:
Title:
School:
Dep’t/Div:
DEGREE (S):
Campus Mail Address:
Building:
Phone:
Room Number:
Fax:
E-mail:
3. ADMINISTRATIVE CONTACT, if applicable.
Name:
Phone:
Fax:
E-mail:
4. STUDENT, if applicable.
LAST NAME:
FIRST:
M. INITIAL:
School:
Dept:
Class:
YEAR:
Campus Mail Address:
Phone:
ID:
E-mail:
5a. ANIMAL REQUIREMENTS: List rodent strains separately. A separate protocol form is required for each species.
See questions 14 and 18a for giving numbers of animals that will be needed.
Genus/Species
or Common Name
Strain and/or
Stock
Sex
Source (e.g., commercial,
another, investigator)
Indicate Age
and/or Weight
required
The ACUC website, www.jhu.edu/animalcare, contains a wealth of information that will aid you in completing this form and ACUC-approved guidelines
for many procedures. These may be cited as the method to be used instead of listing the information in the form, if it is the same method to be used.
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5b. Breeding at SU: List projected number of offspring that survive beyond weaning per year.
Genus/Species
or Common Name
Strain and/or
Stock
Number of Animals per
year projected
1
2
3
Total
5c. Number of pups to be used in research prior to weaning. ______________
5d. Number of rats or mice that might be used from the euthanasia racks per year: _____________
These are cages of animals that have been marked for euthanasia by their PI or lab personnel. Your name
will be added to a list of approved users and you will be sent instructions.
6. ANIMAL RESOURCES HOUSING: What is the range (lowest # to highest #) of the number of animals you predict to
be housed in and cared for in central facilities at any given time?
7. SATELLITE HOUSING: Will any animals be housed outside an Animal Resources Facility for more than 12 hours if the
species is covered by the USDA or for more than 24 hours if not?
Yes
No
If yes, complete the Satellite Housing Form and submit with protocol as an attachment.
8. PROCEDURE CHECKLIST: Please read each carefully and check all of the following that apply. Provide requested
details in the answer to question 15.
Antibody production – Method to be used (i.e., poly- or mono-clonal). Will ascites be used?
Behavioral studies – Methods & apparatus to be used, as appropriate to understanding what the animals may experience.
Blood collection in survival procedures – Site & methods of collection; quantity & frequency of collection.
Caging – Special caging requirements (e.g., wire bottom, metabolic). Give reasons.
Environmental conditions – That are non-standard (e.g., lack of light cycle, temperature &/or humidity outside of normal range)
Experimentally produced stress (e.g., cold exposure, restraint, forced exercise, uncontrollable aversive stimuli – explain rationale
& why this particular method is being used).
Euthanize and harvest tissue ONLY, i.e., no other procedure on living animals in this protocol.
Food or fluid restriction – Give expected durations
Infectious disease? See question 20a
Irradiation, imaging, or lasers – Type & facility to be used. Describe expected effects on animals after procedure & duration.
Describe precautions to protect personnel and animals.
Human embryonic stem cells?
Survival surgery? See question 16.
Non-survival surgery? See question 15.
Paralyzing agents – must be used in conjunction with anesthesia. See question 15.
Restraint other than by hand or briefly –Method, rationale, procedures for habituation, durations, & monitoring.
Recombinant DNA and/or biohazardous. See question 20.
Teaching – Type of class(es) or students
Tissue collection in survival procedures – Site & methods of collection; quantity & frequency of collection
Toxicology or chronic drug administration studies – Classes or specific substances to be used; give route(s), sites, volume(s)
delivered & frequencies of administration. Give expected effects & their duration if known.
Tumors experimentally induced or transplanted – Expected maximum size & plan for monitoring. If xenografts, identify source.
9. LOCATIONS OF PROCEDURES TO BE PERFORMED ON LIVE ANIMALS: If procedures will be performed in an
Animal Resources facility and you do not know the specific room number, indicate “AR” in place of the room number.
Procedures performed on live animals:
Survival surgery (major & minor)
Non-survival surgery or Euthanize & harvest
Behavioral testing
Imaging
Other
Building(s)
Room Number(s)
Campus
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In answering the questions below, please use terminology that will be understood by a nonspecialist; or define a technical term on first use. Spell out abbreviations on first use.
10. STUDY OBJECTIVE(S): Briefly explain purpose of the project.
11. IMPORTANCE OF RESEARCH: What is the relevance of this work for human or animal health, the advancement of
knowledge, or the good of society?
12. RATIONALE FOR ANIMAL USE: Why are live animals necessary for this study? Include the reason a non-animal
approach such as mathematical models, computer simulations, assigned readings, videos, or other instructional
materials could not be used.
13. SPECIES SELECTION: Explain why you selected this species as opposed to another.
14. NUMBERS OF ANIMALS AND RATIONALE: Explain how many animals (or range of animals) are needed for each
experimental condition. Describe how you determined that this number is appropriate and why fewer animals would not
suffice. The answer should be in relation to the experimental design and statistically if applicable. Append a table
showing experimental and control groups if it aids communication. If the total does not match up with the total for
question 18a, please explain.
15a. DESCRIBE THE PROPOSED PROCEDURES: Provide a complete description of procedures and their sequence for
each animal or group. Refer to prompts in question 8 for details of specific procedures to include. Where multiple
procedures are described, indicate whether an individual animal will serve in more than one. If so, indicate which
combination(s) could occur. Save details of survival surgery and post-operative care for question 16. Save details
of endpoints and euthanasia for question 17. Save details of pain and/or distress for question 18. Describe nonsurvival surgery here.
Guidance: a) In all descriptions that involve chronic drug or toxicant administration, include names or classes, route(s), dose range(s)
or rationale for ultimate selection of a dose range, frequency and duration. b) For blood sampling, include possible sites, quantities,
and frequencies of collection. c) Give ranges of durations of particular conditions unless they are not likely to change or fluctuate. d)
Think ahead to minimize the need to submit amendments later if the possibility of other procedures is likely.
15b. Will drugs used for sedation, anesthesia, or analgesia be pharmaceutical grade? Yes___ No___ (if no, see
below)
If a nonpharmaceutical grade compound will be used, how will sterility and quality will be assured (e.g., use of Millipore
filtration)?
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If the species is a warm-blooded animal other than rat, mouse or bird bred for research, provide the scientific justification
for the use of a non-pharmaceutical grade compound or indicate that is unavailable (cf., policy on jhu.edu/animalcare)
15c. Use of Paralytics: State name, dose, route and frequency of administration of paralytic agent(s). State the name,
dose and route of anesthetic agent to be used during the period of paralysis. How long will the animals be paralyzed?
(note – drugs for anesthesia only are not considered paralytics)
See “Use of Neuromuscular Blocking Agents” guidelines at http://www.jhu.edu/animalcare/committee_blocking_agents.html
15d. Breeding Colony:
What is the age range at which animals will be bred?
What breeding scheme(s) will be used (e.g. monogamous, polygamous, or both)?
For mammals, at what age will offspring be weaned? (Litters from females that have subsequent pregnancies due to postpartum estrus must be weaned at 21 days)
At what age will animals be typed for gene of interest? (Mice over 28 days old from which tail tissue will be collected must
be anesthetized)
What tissue will be used in the typing (e.g. blood, saliva, oral swab, hair, ear or tail)?
If collecting tail tissue, how many mm will be collected?
Describe any special husbandry requirements required for these animals, (e.g. food on the floor, alternate water sources).
What obvious changes in appearance have been reported or can be anticipated from genetic manipulation of these
animals?
16a. SURVIVAL SURGERY: (If more than one type will be performed, fill out a separate question 16 for each one.)
Name of surgical procedure:
16b. Will drugs used for sedation, anesthesia, or analgesia be pharmaceutical grade? Yes___ No___ (if no, see below)
If a non-pharmaceutical grade compound will be used, how will sterility and quality will be assured (e.g., use of Millipore
filtration)?
If species is a warm-blooded animal other than rat, mouse or bird bred for research, provide the scientific justification for
the use of a non-pharmaceutical grade compound or indicate that is unavailable (cf.,ACUC policy on jhu.edu/animalcare).
16c. Name, dose, route and frequency of administration of pre-anesthetic agents.
16d. Name, dose, route and timing of pre-emptive analgesia, if any (i.e., analgesia given before the end of surgery).
16e. Name, dose, and route of surgical anesthesia.
16f. Describe intra-operative procedures including: monitoring, surgical procedure, method of wound closure, etc. M ust be
aseptic technique including assurance regarding the use of gown, gloves, mask, and sterilized instruments.
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16g. Describe immediate post-operative care (first 24 hours). Include analgesia [drug name(s), dose ranges, route(s), and
frequency], monitoring, and record keeping; if omitting post-operative analgesia, give reason.
16h. Describe longer-term post-operative care procedures, including plan for monitoring, suture removal, further analgesia
(name, dose, route, frequency, and duration), special feeding, etc:
16i. “MAJOR SURVIVAL SURGERY:”
Will this surgery penetrate or expose a major body cavity or cause substantial impairment of physical or
physiologic function?
Yes
No
If “yes,” will any animal need to undergo more than one such surgery?
Yes
No
If “yes,” state interval between procedures on same animal.
If “yes,” give the scientific or other justification: (Note: cost savings alone is not considered adequate.)
17. ENDPOINT/EUTHANASIA:
a. If euthanasia is a necessary condition of the study, explain why, and state the planned endpoint.
b. If euthanasia is not required by the study, indicate the disposition of the animals after the study. Where possible,
animals should be adopted-out to individuals who have signed an SU animal adoption form.
c. Give the health conditions and/or criteria under which early euthanasia (withdrawal of an animal from the study) would
be considered.
d. What method(s) of euthanasia will be used?
e. Who will carry out the euthanasia if and when it occurs? Check one or more below.
______ Animal Resources
______ Laboratory personnel
f. If laboratory personnel carry out euthanasia, how will death be verified before disposal? Please state two criteria.
See JHU's Euthanasia Guideline at www.jhu.edu/animalcare for suggested methods.
18a. PAIN/DISTRESS: In addressing pain and distress, please consider all aspects of the study (e.g., surgery, phenotype
of the animal, induced disease or tumor burden, behavioral procedures).
Indicate in the table below, the approximate numbers of animals that will fall in each Pain and/or Distress category. For
protocols that involve more than one procedure, place animals in the category that pertains to the greatest degree of pain,
distress and/or discomfort to which the animal will be exposed. Do not count an animal more than once. The total
number of animals entered must agree with the total animals in question 14. The total should not include the number in
answer to question 5d.
Categories
Examples
B—Breeding
e.g., breeding pairs
C—Procedures cause momentary,
slight, or no pain/distress in absence of
analgesia or anesthesia
e.g., injections, euthanasia, blood
taking, brief restraint, imaging
Total Number of animals for 3 years
(Entered into RAR ordering database at
time of protocol approval.)
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D—Procedures potentially are painful
but anesthetics and/or analgesics are
given
E—Procedures involve pain/distress that
will not be alleviated by drugs.
e.g., surgery, blood taking by
invasive routes
e.g., toxicity studies, pain or stress
studies, some disease models
*** Answer 18b,c,d and e below only if any animals fall into Category D or E.***
18b. What procedure(s) in this protocol met the criterion for inclusion of animals as Category D or E in the chart above?
18c. How often will you be visually monitoring these animals at a minimum during and/or after the procedure(s) named in
18b?
What signs that may be indicative of pain and distress would you expect to see in relation to the procedure(s) named in
18b? If this information has already been provided for surgical procedures in question 16 above, then merely state this
below.
18d. What are your plans for minimizing anticipated discomfort, distress, and/or pain that might occur after the
procedure(s) named in 18b? If Category E, explain why drugs could not be used to alleviate pain and/or distress.
If drugs cannot be used, then consider palliative measures such as special feeding, bedding, early termination of the
study, etc.). If this information has already been provided for surgical procedures in question 16 above, then merely state
this below.
18e. CONSIDERATION OF ALTERNATIVES TO PROCEDURES NAMED IN 18b: Consider whether there is an
alternative method that would produce less or no pain or distress and achieve the same experimental purpose? If there
is no alternative, explain why and also state the basis for your conclusion. The explanation needs to include the
methods and sources you use to determine that a suitable alternative is not available. Acceptable methods and
sources include information obtained from other experts, conferences, and review of the literature. A database search is
also acceptable, but if you use this method, you must give the name(s) of the database(s), keywords (which must be in
relation to the procedures in 18b), the years covered by the search, the number of references, and the alternatives found.
Regardless of the method for searching for alternatives, if an alternative exists, you must explain why you are not using it.
19a. Will you be providing environmental enrichment beyond that provided by central facilities for your animals?
Yes
No If yes, state how?
20a. RECOMBINANT, INFECTIOUS AND/OR BIOHAZARDOUS AGENTS USED IN ANIMAL: Use of certain agents
requires approval from Health, Safety & Environment’s (HSE’s) Institutional Biosafety Office/Committee (955-5918).
Attach documentation of approval for the use of recombinant DNA; virus or viral vectors; bacteria, parasites, or other
pathogens; or human tissue or cell lines. The animal biosafety level will be assigned during the review of the protocol.
Type of Hazardous Agent
Recombinant, plasmid or “naked”
DNA
Virus or viral vectors
Bacteria, parasites or other
pathogens
Human tissues or cell lines
Yes
No
Name of Agent
Biosafety
Approval
Date
Biosafety Regis. #
7
Radioactive compounds
Potentially hazardous chemicals or
toxins
20b. Once an animal is exposed to an agent that has the potential to be hazardous to people, the PI must apply the
appropriate hazardous agent sticker to the animal ID information (i.e., cage or cage card) at the time of initial exposure
and for duration of hazardous effects of agent. Will your animals fall into this category?
Yes
No
If yes, indicate where they will be housed:
Animal Resources:
Yes
No
Room
Outside Housing:
Yes
No
Room
AR
Building
AR
Building
If biological material will be used in rodents, it must be tested for adventitious agents that may infect other laboratory
animals. Note: If the original materials are passed (passaged) from rodent to rodent, the second-generation (and
subsequent) materials must be tested (and found to be free of adventitious agents) before passing material.
If tested, attach copy of results to protocol. If not, contact Comparative Medicine (410-955-3273) for further information.
20c. PROCEDURES TO ENSURE SAFETY OF THOSE WORKING WITH THE AGENT (S) AND OF THOSE WHO
CARE FOR THE ANIMALS. Include spill and personnel exposure precautions, methods of disposal of contaminated
material, and cleaning/decontamination of equipment where applicable.
21. TRAINING & QUALIFICATIONS: Provide specific information on training and/or experience that qualifies each person
to perform the procedures involving animals in this protocol. Make additional copies of these pages as necessary.
If individuals listed below are new to the University, they must complete the online Animal Care and Use training
course, (found at https://secure.lwservers.net/default.cfm) and enroll in the Animal Exposure Surveillance
Program (contact Occupational Health at 955-6211) before the protocol can be approved.
*This form must be accompanied by copies of AESP certificates of enrollment for each individual new to SU.*
Role:
Principal Investigator
Last Name:
First Name:
M. Initial:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
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ACUC office use:
Role:
AESP __
OLT __
Primary Co-investigator (person delegated authority when PI is unavailable)
Last Name:
First Name:
M. Initial:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
ACUC office use:
Role:
AESP __
OLT __
 Co-Investigator  Fellow  Student  Faculty  Staff  Outside Collaborator (Check all that apply.)
Last Name:
First Name:
Department:
Phone Number:
SU Address:
Bldg & Room:
M. Initial:
Email Address:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
ACUC office use:
Role:
AESP __
OLT __
 Co-Investigator  Fellow  Student  Faculty  Staff  Outside Collaborator (Check all that apply.)
Last Name:
First Name:
Department:
Phone Number:
SU Address:
Bldg & Room:
M. Initial:
Email Address:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
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ACUC office use:
Role:
AESP __
OLT __
 Co-Investigator  Fellow  Student  Faculty  Staff  Outside Collaborator (Check all that apply.)
Last Name:
First Name:
Department:
Phone Number:
SU Address:
Bldg & Room:
M. Initial:
Email Address:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
ACUC office use:
Role:
AESP __
OLT __
 Co-Investigator  Fellow  Student  Faculty  Staff  Outside Collaborator (Check all that apply.)
Last Name:
First Name:
Department:
Phone Number:
SU Address:
Bldg & Room:
M. Initial:
Email Address:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
ACUC office use:
Role:
AESP __
OLT __
 Co-Investigator  Fellow  Student  Faculty  Staff  Outside Collaborator (Check all that apply.)
Last Name:
First Name:
Department:
Phone Number:
SU Address:
Bldg & Room:
M. Initial:
Email Address:
1 - Degree(s):
2 Tell procedures each person may be performing or state “all”
3 How much experience with animals does the person have in the type of procedures performed? If training and/or
supervision is needed, who will be providing it?
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ACUC office use:
AESP __
OLT __
22. ASSURANCES:
a) I assume responsibility for compliance with Salisbury University, United States Department of
Agriculture and/or Public Health Service requirements, as applicable, for work carried out under this
protocol.
b) I assume responsibility for providing each member of the laboratory who will perform procedures under
this protocol with a copy of the final version of the approved protocol, and require that they follow the
procedures described.
c) I understand that amendments for significant changes, as defined in the SU ACUC Guideline, must be
submitted to the SU ACUC for approval prior to their implementation, unless otherwise requested by a
Research Animal Resources (RAR) veterinarian for clinical reasons.
d) I certify that I have determined that the research to be conducted under this protocol is not
unnecessarily duplicative of previously reported research.
e) I understand that no work can begin unless I have received approval from the Animal Care and Use
Committee.
Principal Investigator’s
Signature:
Date:
22. APPROVAL:
IACUC Chair's Signature:
Date:
Please submit to the ACUC office – Reed Hall B122 or fax to 443-287-3747 (73747)
Please do not staple.
If you fax the protocol and then also send the original, please put a cover sheet
on the original indicating that the protocol previously was faxed . Thank you .