Title of Human and Biological Form by HC120808074638



Updated November 2010

 Additional Part B. Identify the species this Part B addresses:
Note: If this protocol involves the use of more than one species complete a Part B for each species. Do not
report multiple species within the same Part B. Additional Part Bs for this form can be downloaded at
http://www.iacuc.umn.edu/download . Separate Part Bs are not needed for different strains of the same species
(e.g. mice) or for wildlife species classified in the same phylogenetic order (e.g. amphibians, fish, birds) if the
work being done (group numbers, procedures, monitoring, etc.) with each species is substantively identical.

4. Scientific Justification for Animal Species and Number Requested

4A. Check all of the statements below that apply:

        This model has previously been used.
        Provide citations, specify and explain why the citation is applicable to your study:

        The results will be directly applicable to the health, care, or study of the species used. Describe how they
        will benefit in item 3A.
        This is agricultural research related to a particular farm animal.
        This is a new model. Describe the features of the species (e.g., anatomic, physiologic, genetic, etc) that make
        it desirable for this model. Contrast with other available models, if any. (RAR veterinarians are available
        for consultation on new model development)

4B. How did you determine how many animals were needed for the activities described in this
    protocol? A statistical analysis should be used to justify animal numbers whenever possible.
    Statements such as “The study requires 50 animals or 50 experiments.” is not sufficient.

    Check all that apply and provide specific answers to the associated questions:

        Pilot study or preliminary project, group variances unknown at present. Describe the information used to
        estimate how many animals are needed.

        Group sizes determined statistically. Describe the statistical analysis used to estimate the number (N) of
        animals needed. A common approach is to estimate N from a simple power analysis for the most important
        measurement in the study. This is usually based on the expected size of the treatment effect, the standard
        error associated with the measurement, and the desired statistical power. Data analysis methods should not
        be submitted unless directly applicable to the estimate of N.
        Several free calculators are available including http://www.math.uiowa.edu/~rlenth/Power/

       Group sizes based on quantity of harvested cells or amount of tissue required. Explain how much tissue is
        needed based on the number of experiments you will conduct and how much tissue you expect to obtain
        from each animal. Example: Need 10 g tissue. Can get 2 g tissue per animal = Need 5 animals.

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       Product Testing. If the number of animals needed is based on FDA guidelines, provide the citation from the
       regulations, the IND tracking number, or relevant FDA correspondence:

       Other - Elaborate, indicating method used to determine group size:

5. Monitoring Animal Health and Welfare
5A. List the anticipated specific study-induced or related adverse health conditions that the
animals might experience (i.e. pain, distress, complications, etc) or any health problems that will
or might result from the genotype or phenotype of the animal. Note that momentary pain or
distress does not need to be described (eg venipuncture or injections).

5B. How will pain and/or distress be monitored? Provide the specific clinical signs which will be
monitored as well as the frequency of monitoring by personnel on this protocol and indicate if this
monitoring will include weekends and holidays.

5C. Explain what steps will be taken to alleviate any pain, distress or discomfort the animals may
experience. Provide the dose (in mg/kg), route of administration, frequency, and type of analgesic or
tranquilizers to be administered. Consider warming pads, fluids, soft bedding, etc. You may provide a
range of doses, frequencies, and drug classes for committee consideration.

5D.        For animals housed in RAR, species specific environmental enrichment is routinely provided.
Do these provisions interfere with your study?

   No     Yes If yes, indicate which provisions interfere and justify the withholding of these provisions
to animals in this protocol.

5E.         Do you intend to inoculate rodents with any cells, tissues or body fluids?

  No      Yes If yes, you must submit Appendix I

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6. Euthanasia/Disposition of Animals                       Regulations            RAR       AVMA Panel

6A. Identify and explain the rationale for the specific endpoint(s) for each animal or group of
    animals used in this protocol. The endpoint is when an animal or a group of animals will no longer
    be used in the protocol. This could be associated with time after administration of a compound,
    collection of a final blood sample, when animals are sacrificed for tissue collection, how long they are
    maintained after surgery, etc. Make sure the endpoints match those identified in your response to
    question 3B. You may provide a range of endpoints for committee consideration.

6B. Do the IACUC Tumor Induction Endpoint Criteria                       interfere with your experimental

      Not Applicable.

      No. The endpoints will comply with the IACUC Tumor Induction Endpoint Criteria.

      Yes. Indicate which criteria interfere with the study and justify an alternate endpoint.

6C. Will the animals be euthanized at the end of the study?

   1) I will use one or more of the Standard Methods                approved by the IACUC for the
   following species used on this protocol.

  Species               Euthanasia Method(s)        (cut and paste from standard methods guidance)

   2) If the standard euthanasia methods referenced above will not be used, specify the method,
   agent, dosage (in mg/kg) and route of administration to be used for euthanasia of each group of
   animals used in this protocol. You may provide a range of options for committee consideration.

       NO. Describe what will happen to the animals that are not euthanized upon completion of the
       activities (eg. experiment, clinical study, teaching demo, etc.) in this protocol.

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6D.        Animals that are experiencing unrelieved pain or distress prior to the defined
      experimental endpoint must be humanely euthanized, unless doing so would interfere with,
      or compromise the scientific goals of the experiment.
      Do the IACUC Criteria for Euthanasia                interfere with your experimental objectives?

         No. All of the personnel on this study have read and will comply with the IACUC Guidelines for
      early euthanasia.

        Yes. Provide the criteria to be used by the PI to determine that euthanasia would be required
      prior to the approved endpoint AND provide scientific justification for why earlier IACUC guideline-
      based euthanasia criteria cannot be used:

6E. Will death or moribund condition be used as the experimental endpoint?

         NO. IACUC Criteria for Euthanasia guidelines (see Goldy Gopher link in 6D. above) will be followed.

          YES.         Death or     Moribundity will be used as the experimental endpoint. These animals are
      classified as pain Class C.

      Provide explanation and justification. Note: It is recommended that earlier, relevant study-specific
      indicators be used as the endpoint. Moribundity should be an option selected mindfully, based in science,
      and justified on the basis of a need to collect essential data which cannot be obtained earlier.

Reminder: If conducting separate experiments with multiple species fill out Part B for each species.
Download another copy of Part B to fill out on the web at http://www.iacuc.umn.edu/download/

You have reached the end of this form. Please make sure that you have responded to
every question on this application (even if your response is “not applicable”) and that you
have completed and attached all of the applicable appendices.

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