Harvard Medical Area (HMA) Standing Committee on Animals – “Established in 1907”
180 Longwood Avenue, Suite 113 Boston, MA 02115 Tel: 617-432-3192 Fax: 617-432-3169
ANIMAL EXPERIMENTATION PROTOCOL
Harvard Appointment Title
Contact Phone & Email
BIDMC PI Check here: BIDMC investigators must send an approved copy of this protocol to BIDMC, East Campus, RN150D
Grant Number & Title
The undersigned individuals accept responsibility for compliance with all federal and non-federal regulations and laws pertaining
to humane care of animals used in research. Additionally, the undersigned verifies that protocol changes have been reported to
the funding agency as so required.
Principal Investigator’s Signature: Date:
This proposal has been reviewed and approved by the HMA Standing Committee on Animals
HMA Standing Committee on Animals Date:
YOU MAY NOT begin any work described in this amendment UNTIL you receive a letter from the
Committee signifying APPROVAL of this amendment.
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MANDATORY RISK DISCLOSURE: Hazardous substance disclosure sheet
YOU MUST RECORD AND CHECK OFF THE FOLLOWING PERTAINING TO YOUR SUBMITTED
PROTOCOL: FAILURE TO DO SO WILL RESULT IN A DELAY IN PROTOCOL APPROVAL
Note- items checked below must correspond with the information provided in your protocol.
**MUST CHECK (X) ALL THAT APPLY**
Check: Procedures: Identify specific agent(s): Route(s):
COMS/PIBC #: ____-___
Provide Biosafety Level next to each agent
Human or NHP cell line(s) or tissue(s)
COMS/PIBC #: ____-___
Non-human animal cell line(s) or
Other (must specify)
NONE OF THE ABOVE
This box must be checked if none of the above agents apply to your work
described in this protocol.
By checking this box & signing below you are emphatically stating that
you are NOT using any of the above in research animals.
Note: YOU MUST NOTIFY THE HCCM WHEN YOU BEGIN WORK WITH THESE AGENTS.
Contact the HCCM Coordinator of Special Projects via phone at:
617-432-4658 or mailto:email@example.com
PI must print and sign below (mandatory; a proxy will not be accepted):
P.I. Name ___________________ P.I. Signature ________________________ Date __/__/__
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1. List the change(s) to the protocol
State each specific proposed change to your protocol and how it improves or enhances the overall stated
goal of your project:
2. Reason for the change
Indicate the reason and provide justification for the change(s):
3. Details of the change(s)
a. Provide details of the proposed changes and/or procedures
b. Complete the corresponding, appropriate sections of the Protocol form that are new or changing as
part of this amendment: (check off and include the appropriate section of the protocol from the list below)
Disposition (SECTION E)
Immunization (SECTION F)
Hybridomas (SECTION G)
Transgenic/Knock-out (SECTION H)
Administered Substances (SECTION I)
Surgery (SECTION J)
Multiple Survival Surgery (SECTION K)
Painful Procedure(s) (SECTION L)
Behavioral Controls, Restraint or Analysis of Behavior on Alert Animals (SECTION M)
Diet or Environmental Changes (SECTION N)
4. Additional Animals
a. Are you requesting additional animals? YES NO
b. If ‘YES’, how many ADDITIONAL animals per year are required as a result of the amendment?
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c. Justify the number of ADDITIONAL animals to be used (You must convince the Committee that the
number of animals is appropriate to the work being proposed. Provide groups and statistical analysis to be used
5. New Species
a. Are you requesting a new species? YES NO
b. If ‘YES’, Justify choice of each new species:
6. Work Location
In the fields below, indicate the area(s) where your new animal procedures, including euthanasia, will be
Species Building Room Procedure Amount of time in this area,
Number if not an HCCM facility:
IMPORTANT: If this amendment involves procedures listed under USDA Pain CATEGORY D or E, or, if
you are conducting the same procedures with a NEW SPECIES, for which you do not have IACUC
approval for, you must answer “YES” to QUESTION #7a and COMPLETE Sections 7 and 8. It is the
responsibility of the investigator to search for ways to reduce, refine or replace animal procedures.
7. Pain & Distress
a. Will any of the new proposed procedures cause more than slight or YES NO
momentary pain or distress to the animal(s)?
If ‘YES,’ complete 7.b. through 7.e. below.
Alternatives do NOT exist. You know this because the following sources were consulted:
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b. Literature search: Complete a search for each potentially painful and/or distressful procedure used in
this amendment in the table below (copy & paste for each additional painful procedure).
NOTE: Key words should specify the painful or distressing procedures, not the model being studied.
You must include Pubmed and at least one of these free alternative resources websites in your search:
ALTWEB (Alternatives to Animal Testing on the Web) http://altweb.jhsph.edu
NAL Animal Use Alternatives Thesaurus http://agclass.nal.usda.gov/altrntvs/index.htm
Animal Welfare Institute http://www.awionline.org/lab_animals/index.htm
Years Covered by the Search:
c. Meetings or conferences (names and dates of meetings attended):
d. Periodicals (names of periodicals or journals read on a regular basis):
e. Consultation with colleagues (names and credentials of colleagues, such as MD, PhD, dates of
consultations and nature of discussions):
Alternatives DO exist or are found, COMPLETE 7.f through 7.i below:
f. Explain why alternative experiments are unsatisfactory:
g. Explain the steps you will take to assure that the animals will not be subject to any more discomfort
than is absolutely necessary:
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h. Confirm that the duration of the discomfort will be as short as possible:
i. Explain your plans to monitor and correct problems (e.g., by euthanasia):
8. Alleviation of Pain & Distress
For each procedure unique to this amendment that will cause pain or distress, you must describe your
plans to minimize discomfort, pain, or distress.
• Your schedule for observing your animal(s)
• Your criteria for determining whether an animal is in pain and/or distress and plans to mitigate this
• Your action(s) taken to relieve pain and distress
• List the names and dosages of analgesics or tranquilizing drugs to be used for each species of animal
Procedure Observation Evaluation Plan to relieve pain and/or distress
(include species) schedule criteria (include name, dosage and route of
Note: If no analgesia is given post-operatively, check ‘Category E’ on the Animal Usage Checklist.
9. Duplication of Results
Do these activities unnecessarily duplicate previous experiments, either YES NO
your own or other investigators’?
If ”NO”, answer the following to indicate how you determined that these activities do not unnecessarily
duplicate previous experiments:
b. Meetings or conferences (names and dates of meetings
c. Periodicals (names of periodicals or journals read on a regular
d. Consultation with colleagues (names and credentials of
colleagues, such as MD, PhD, dates of consultations and nature
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e. Literature searches (names of literature searches completed, key
words, dates covered by search and date of search)**
**If possible, use DIFFERENT key word(s) from those used in 7.b.
10. Pharmaceutical-grade compounds
a. Will you be using agents that are not pharmaceutical-grade? YES No
In keeping with the USDA and OLAW guidance, it is the policy of the IACUC that pharmaceutical-grade
compounds, including diluents and carriers, must be used in experiments instead of non-USP drugs or
reagents, even in acute procedures. Non-pharmaceutical-grade chemical compounds, diluents and carriers
may only be used after specific review and approval by the IACUC. The IACUC may consider scientific
necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product as sufficient
reasons for accepting the use of non-pharmaceutical grade drugs or diluents in animal experiments. Cost
savings alone is not a sufficiently compelling reason to justify use of a potentially ineffective or toxic non-
b. If you are administering ANY non-pharmaceutical grade drugs, diluents or carriers, list each in the table
below and check appropriate box a., b., or c.
Agent X Identify need for non-USP compound
a. Non-commercially available experimental compound
b. Only non-USP grade is commercially available and no other alternatives exist
c. USP grade drug or alternative is available, but a non-USP grade is requested
c. If pharmaceutical-grade compounds are available and you are NOT administering pharmaceutical-
grade compound(s) to your animal(s), (c is checked) you must also complete the detailed scientific
justification column below.
The IACUC expects researchers to justify the use of a non-pharmaceutical grade drug, compound, diluent, or
carrier and to demonstrate consideration (and rejection) of pharmaceutical grade alternatives for experimental
reasons. Reasons related to the cost of USP grade products are generally deemed insufficient on those
grounds alone to justify substitution of non-pharmaceutical grade alternatives for USP drugs and reagents.
Provide sufficient detail and present the respective advantages and disadvantages of the pharmaceutical and
• Describe how rejected alternatives will negatively impact outcomes or measurements.
• Describe how experimental logistics have influenced the choice of the chosen agent.
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• Address any issues of animal or human safety, compound efficacy related to the experimental aim, and
address the possibility of inadvertent introduction of research-complicating variables.
Provides detailed scientific justification
You MUST include a flow chart of the procedures, with the procedures unique to this amendment highlighted in
BOLD. Throughout the flowchart, please list an estimate of the number of animals for each procedure specific
to this amendment:
Present your experiments in a flowchart format (as opposed to a table, grid, or paragraph).
Show the schedule for the animal procedures in your flow chart, including the time points when the animals will be
euthanized, if applicable.
Include animal numbers
For guidelines on creating your flowchart click here.
USDA covered species users note: This flowchart will be included with the medical record of each animal.
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12. Checklist – animal usage PER YEAR
Place an “X” next to the procedures you will be performing that are new to this amendment.
Enter the total number of animals in each category.
Complete a separate ‘Checklist’ for each species.
Complete a search for alternatives for each new or changed procedure in Category D and/or E.
Species # Used per year
CATEGORY B -Teaching, research, or tests that involve breeding or housing of animals only
Housing ONLY (no other procedures)
Total number of animals to be used in Category B only
CATEGORY C -Teaching and/or research experiments that do not involve more than momentary pain
and/or distress or require the use of pain relieving drugs.
Alert animals (behavioral observation or brief restraint)
Anesthetize and release for non-invasive procedures (e.g. imaging, bandage change)
Change in environmental parameters (diet, light cycle, room temperature, etc.)
Chemical carcinogens (e.g. BrdU)
Euthanasia with or without tissue/organ harvest
Non-surgical collection of body fluids (blood, urine, etc.)
Simple injections (IP, IV, etc.)
Use as a parasitic host
Total number of animals to be used in Category C
Note: For all procedures in Categories D & E (below) a search must be completed in Section P
CATEGORY D – Teaching and/or research experiments or tests that will involve pain and/or distress
and for which appropriate anesthetic, analgesic or tranquilizing drugs will be used.
Anesthetize and release for non-surgical painful procedures (e.g. retro-orbital bleeds)
Antibody production: ascites
Antibody production: polyclonal (non-ascites, no footpad)
Controlled drugs or substances (as test material, e.g. cocaine)
Food or water deprivation other than pre-surgical fasting
Footpad injections (antibody production or microorganism)
Introduction of illness (including the administration of toxins, microbiological agents,
clinical transgenic phenotypes)
Multiple MAJOR survival surgery
Multiple MINOR survival surgery
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Survival surgery: MAJOR
Survival surgery: MINOR
Tail biopsy for genotyping
Toxic substances (e.g. streptozotocin, MPTP, cisplatin, doxycycline)
Transgenic mouse production (embryo manipulations to produce novel strains, etc.
Tumor induction or implantation
Unusual or prolonged restraint (anything other than standard, e.g. pie chamber)
Use of paralytic agents
Total number of animals to be used in Category D
CATEGORY E – Teaching and/or research experiments, surgery or tests that involve PAIN and/or
DISTRESS, and for which appropriate anesthetic, analgesics or tranquilizing drugs are NOT used
because they would adversely affect the results or interpretation of data.
Lethal dose studies**
Noxious stimuli from which there is no escape
Withholding of post-operative analgesia for any surgical procedure
Total number of animals to be used in Category E
**You must follow the Guidelines for ‘Death as an Endpoint’ or ‘Lethal Dose’ studies at:
EXCEPTIONS to STANDARDS – If this amendment requests any of the following exceptions to standards, or if
this amendment requests additional animals that will be subject to any of these exceptions, complete this table.
Single housing of animals Section D.4
Withholding of enrichment from singly housed animals Section D.4.c
Euthanasia methods that are not consistent with the AVMA Guidelines Section E & Exemption
Ascites collection Section G & Exemption
Non-pharmaceutical grade drugs and other compound suspensions Section I.7
Withholding postoperative analgesia Section J.2.k & Exemption
NHPs offered water on a schedule (not ad-lib) Section N
Smaller caging than the recommended space allotment (e.g.: CLAMS) Exemption form
Deviations from housing density standards Exemption form
Toe-clipping for identification purposes Exemption form
Deviations from the 12/12 hour light/dark cycle Section N
Any other exceptions to the standards of the PHS Policy, the Guide, or Exemption form
the AWA. - Please specify:
Total number of animals subject to these exemptions