Animal Experimentation Protocol

Harvard Medical Area Page 7 of 35 Protocol #
Revised 11/3/15

ANIMAL EXPERIMENTATION PROTOCOL

Principal Investigator
Harvard Appointment Title
Department
Address
HMA phone
FAX phone
Home phone
E-Mail Address
Contact Person
Contact Phone & Email
BIDMC PI Check here: ☐ / BIDMC investigators must send an approved copy of this protocol to BIDMC, East Campus, RN150D
Protocol Title
Funding Source
Grant Number & Title
Please attach the Vertebrate Animal Section for any new grants.

Check one:

New Protocol / Three Year Review of Existing Protocol
This proposal has been reviewed and approved by the HMA Standing Committee on Animals
HMA Standing Committee on Animals Date:

Table of Contents

Sections listed in BOLD must be completed for every protocol.

Sections F through N are to be completed only as they apply to your protocol.

HCCM’S MANDATORY RISK DISCLOSURE (MRD)

A. ANIMAL USAGE

B. PROCEDURES

C. PERSONNEL

D. HOUSING/PROCEDURE LOCATION

E. DISPOSITION OF ANIMALS

F. IMMUNIZATION

G. ASCITES PRODUCTION

H. TRANSGENIC/KNOCKOUT ANIMALS

I. ADMINISTERED SUBSTANCES

J. SURGERY

K. MULTIPLE SURVIVAL SURGERY

L. PAINFUL PROCEDURES

M. BEHAVIORAL CONTROLS, RESTRAINT, OR ANALYSIS OF BEHAVIOR

N. DIET AND OTHER ENVIRONMENTAL CHANGES

O. DRUG AND SURGICAL SUPPLY MANAGEMENT PLAN

P. ALTERNATIVES TO PAIN AND DISTRESS

Q. MINIMIZATION OF DISCOMFORT, PAIN AND DISTRESS

R. DUPLICATION OF RESULTS

S. PROTOCOL PERSONNEL SIGNATURE PAGE

MRD: MANDATORY RISK DISCLOSURE - Hazardous substance disclosure sheet

STOP

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):
☐ / Chemical carcinogen(s)
☐ / Toxic substance(s)
☐ / Radioisotope
license #:______
☐ / Microbiological Agent(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 tissue(s)
☐ / 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:

PI must print and sign below (mandatory; a proxy will not be accepted):

P.I. Name ______P.I. Signature ______Date __/__/__

Introduction

The Harvard Medical School Standing Committee on Animals was established in 1907 almost 60 years prior to the Animal Welfare Act. This Committee charter states: A Committee of at least five, which has the power to inspect the animal rooms at any time, to issue orders and regulations they may deem fit for the proper care and feeding of animals, to discharge any employee of the school who in any way treats animals with cruelty, to dispose of any animal which is in any way objectionable and to determine the sources from which animals are to be obtained. This Committee shall also have general power to stop any experimental work on animals that they may consider improper or unnecessary. This charter is still in effect today and the Committee, appointed by the Dean for Academic and Clinical Programs, continues to have the authority as described.

The Committee members today include scientists, veterinarians, and lay representatives. This Committee is committed to the continued use of animals in research within the constraints of humane treatment as viewed by society. To justify approval of procedures, the Committee must have adequate written information regarding the steps taken to assure humane treatment of animals. Present your material clearly and concisely. Lay members of the Committee must be able to understand this protocol.

The Animal Experimentation Protocol (AEP) MUST include a FLOW CHART AND a written description of the procedures outlined in Section B.2. Failure to comply will result in delay of approval for an additional month.

·  PIs are encouraged to send any new protocols and amendments as soon as the PI completes a reasonable draft.

·  Three-year renewals are due to the IACUC no later than 60 days prior to their expiration date in case the protocol needs to be re-reviewed at a subsequent full committee meeting. Otherwise there is risk of research interruption if any required modifications are not satisfactorily addressed prior to the protocol expiration date. Early submission helps ensure that there is no lapse in approval and that research continues uninterrupted.

·  Submission address

Submissions and scanned signature pages should be sent electronically to: (MS Word format only).

·  Accessing protocol forms

Current forms and supplemental information can be found at:
http://hms.harvard.edu/departments/hma-standing-committee-animals

A. ANIMAL USAGE

1. Checklist – animal usage PER YEAR

·  Place an “X” next to the procedures you will be performing.

·  Enter the total number of animals in each category as well as the total number in multiple categories.

·  Complete a separate ‘Checklist’ for each species.

·  Complete a search for alternatives for each 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
☐ / Breeding colony
☐ / 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
☐ / Forced exercise
☐ / Gavage
☐ / Irradiation
☐ / Microbiological agents
☐ / Non-surgical collection of body fluids (blood, urine, etc.)
☐ / Radioisotopes
☐ / Simple injections (IP, IV, etc.)
☐ / Tail biopsy for genotyping (for mice 21 days of age or younger)
☐ / 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: polyclonal (non-ascites, no footpad)
☐ / Burns
☐ / Controlled drugs or substances (as test material, e.g. cocaine)
☐ / Electric shock
☐ / Food or water deprivation other than pre-surgical fasting
☐ / Introduction of illness (including the administration of toxins, microbiological agents, clinical transgenic phenotypes) WITH pain relief
☐ / Lavage
☐ / Multiple MAJOR survival surgery
☐ / Multiple MINOR survival surgery
☐ / Non-survival surgery
☐ / Physical trauma
☐ / Survival surgery: MAJOR
☐ / Survival surgery: MINOR
☐ / Tail biopsy for genotyping (for mice over 21 days of age)
☐ / Toxic substances (e.g. streptozotocin, MPTP, cisplatin, doxycycline)
☐ / Transgenic mouse production (embryo manipulations to produce novel strains, etc.)
☐ / Tumor induction or implantation
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.
☐ / Antibody production: Ascites
☐ / Death-as-an-endpoint or lethal dose studies*
☐ / Footpad injections (antibody production or microorganism)
☐ / Induction of illness (including the administration of toxins, microbiological agents, clinical transgenic phenotypes) without pain relief
☐ / Noxious stimuli from which there is no escape
☐ / Pain study
☐ / Paralysis
☐ / Total body irradiation (without reconstitution)
☐ / Unusual or prolonged restraint (e.g. pie chamber, chair)
☐ / Withholding of post-operative analgesia for any surgical procedure
Total number of animals to be used in Category E

*You must follow the IACUC Guidelines for ‘Death as an Endpoint’ or ‘Lethal Dose’ studies.

EXCEPTIONS to STANDARDS – Select any policy deviations that will be required in this protocol. Scientific justification must be included in the indicated section of the protocol.
☐ / Single housing of animals / Section D.5
☐ / Withholding of enrichment from singly housed animals / Section D.5.c
☐ / Euthanasia methods that are not consistent with the AVMA Guidelines / Section E
☐ / Ascites collection / Section G
☐ / Non-pharmaceutical grade drugs and other compound suspensions when USP-grade drug or alternative is available. / Section I.7.c
☐ / Withholding postoperative analgesia / Section J.2.k
☐ / Food/water withholding or scheduling (not ad-lib) / Section N
☐ / Smaller caging than the recommended space allotment (e.g.: CLAMS) / Section D.4
☐ / Deviations from housing density standards / Section D.6
☐ / Toe-clipping for identification purposes / Section D.3.b.iii
☐ / Deviations from the 12/12 hour light/dark cycle / Section N
☐ / Any other exceptions to the standards of the PHS Policy, the Guide, or the AWA. - Please specify: / Consult with Research Officer

2. JUSTIFICATION FOR THE USE OF ANIMALS

Federal Assurances: You are required by federal law to provide the following justifications.

a. Why are animals needed for this study? (i.e.: Could the same information be obtained by experiments using tissue culture or computer models? If you are generating antibodies, could you use in vitro methods?)
b. Justify choice of each species:
c. Justify the number of 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 if relevant.)
d. Discuss your strategy to reduce the number of animals and to minimize pain and distress to your animals: (examples include: earlier euthanasia, decreasing the number of time points, changing the methods to those that are less invasive):
e. Breeding Colony users only: The estimated numbers of animals in breeding colonies must be provided and justified. These numbers must be also be tracked on a log sheet in the animal housing room.
i.  Estimated number of breeding adults:
ii.  Estimated number of offspring produced:
iii.  Estimated total number of offspring euthanized without research use:
All offspring euthanized without research use should be accounted for under Category B of the checklist.
iv.  Criteria for offspring euthanized without research use:
f. NHP users only: Are the requested animals naïve in terms of experimental procedures? Yes ☐ No ☐
If NO, submit the approval for reuse summary from the Animal Allocation and Reuse Committee.

B. PROCEDURES

·  Briefly describe the procedures to be conducted on animals. State the aims and significance of your experiments. Do not include in vitro work done on tissue taken from the animal, nor post-mortem procedures or analysis.

·  For 3-year reviews, incorporate all procedures listed in approved amendments in the past three years, if applicable. All amendments expire at the protocol 3-year renewal date.

·  Use language that can be readily understood by investigators and lay persons not familiar with your specific field of research and by non-scientists. Avoid or explain all acronyms.

·  Note: AEP submissions receive veterinary review prior to final submission to, and consideration by the IACUC. Veterinary pre-review and addressing veterinary comments do not guarantee Committee approval.

1. Aims and Significance: Provide a brief lay summary, no more than one page, describing your research. Do not include an excerpt from your grant proposal.
2. Procedures and manipulations: In lay terms, provide a short description of each animal procedure and manipulation (including changes in light cycle, alteration of feeding, etc. DO NOT include details of in vitro work). For SURGERY, state ONLY the name of the procedure in this section. Describe the surgery in detail (including anesthesia and site prep) only in Section J
3. FOR 3-YEAR REVIEWS:
a.  For USDA-covered species (not mice, rats, or birds), describe any unexpected animal deaths in the course of your experiments:
b.  Changes (briefly summarize any changes in the protocol in the past three years, i.e. species, numbers, procedures, etc.):
c.  Progress Report (optional): Briefly describe your results from the past 3 years and explain how the present application continues this work:
d.  List publications and meetings in the past three years (optional):

FOR ALL (NEW and 3-YEAR Review) protocols

4. FLOWCHART - you must diagram your procedures in a flowchart

·  Present an overview of 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.

·  For guidelines on creating your flowchart click here.

·  Excessively long flowcharts may be rejected.

Present your flowchart here:

C. PERSONNEL

1. Will the principal investigator perform the procedure(s)? Yes ☐ No ☐

2. Personnel List:

·  Provide the name(s), title(s) and qualifications for each person who will work with the animals. The Principal Investigator must also be included.

·  Include the number of years and experience working with the species listed in Section A (Checklist) above.

·  If the person needs to be trained, indicate who will do the training.

·  If this is a three year renewal protocol: The list below WILL replace all current lab personnel. Any additional personnel must be added via a personnel form, after renewal.

·  Members of the veterinary staff do not need to be listed.

Name / Title/Job Classification / Qualification/ Experience / Phone / Email Address
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

3. Personnel Training:

All personnel handling animals must be trained in their humane care and use. Records of personnel training must be maintained by the lab.