AEP amend

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					                                                                                         PROTOCOL NUMBER:

            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
                                                  AMENDMENT FORM

  Principal Investigator

  Harvard Appointment Title



  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

 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.
Harvard Medical Area                                  Page 2 of 10                             Protocol #
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     MANDATORY RISK DISCLOSURE: Hazardous substance disclosure sheet


 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)

                    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
                    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.

              Contact the HCCM Coordinator of Special Projects via phone at:
                       617-432-4658 or

                    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
         if relevant.):

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)

NAL Animal Use Alternatives Thesaurus

Animal Welfare Institute


          Database(s) Searched:

          Date searched:

          Keywords Used:

          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
         under study

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
Harvard Medical Area                               Page 7 of 10                          Protocol #
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           of discussions):

      e. Literature searches (names of literature searches completed, key
         words, dates covered by search and date of search)**

      f.   Other

**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-
pharmaceutical-grade compound.

      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
non-pharmaceutical-grade compound/chemicals.

•          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

11.      FLOWCHART
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.
Harvard Medical Area                                   Page 9 of 10                         Protocol #
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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
     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
          Microbiological agents
          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)
          Electric shock
          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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          Non-survival surgery
          Physical trauma
          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.
          Death-as-an-endpoint** studies
          Lethal dose studies**
          Noxious stimuli from which there is no escape
          Pain study
          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

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