Merck-funded, Non-clinical Protocols involving Laboratory

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					              Guideline for Submitting IISP Non-Clinical Protocols/Proposals
                         - includes the use of Laboratory Animals

1.   Full Study Title
     The title of the protocol should include study design, the dosage, dosage form, and comparative agent(s) if
     applicable and the species studied.

2.   Investigator /Institution /Address /Phone /Fax Number

3.   Objectives:

     List the objectives. The objectives must clearly define and specifically state what the study is intended to
     accomplish.

4.    Hypothesis

     List the hypotheses. The wording of the hypothesis should include a sentence describing the direction of interest
     for the alternative hypothesis. All hypotheses should be in the order of priority

5.   Background, Significance of Selected Topic and Preliminary data

     A brief presentation should be made of the reasons for conducting the study based on
     current knowledge so that the study is put into proper perspective. The data presented in this section should
     reflect the current knowledge of the area or the product studied. Selected literature references critical to the
     study design, dosage selection, or rationale for the study should be cited, as appropriate.

6. Methods & Materials, Include information on all animal procedures:

          -   Species, number, and source of animals to be used
          -   Method, frequency and dose of compounds to be administered
          -   Method, frequency and volumes of blood collections
          -   Anesthetics, analgesics, and tranquilizers used during painful or distressful procedures. Include dose,
              route of administration, frequency and how they will be monitored. If pain-relieving agents will not be
              used during painful procedures, a scientific justification must be provided.
          -   If food or drinking water is to be restricted during the study, please provide information regarding
              schedule, amounts and methods of monitoring
          -   If the study involves a surgical procedure, a description of the proposed surgical procedures and pre-
              surgical and post-surgical care must be provided
          -   If physical restraint greater than one hour is involved with the study, please describe the method,
              device, and preconditioning training.
          -   Describe the specific end points for the study
          -   Methods of euthanasia


7. Study Duration: Estimate the length of time (e.g., number of days, weeks, months) required to complete the
   study.

8. Statistical Analysis: Sample Size Justification and Power

     State who will be responsible for analyzing the data (Investigator, outside contractor, etc.)

     Hypotheses or Estimation

     State the primary and secondary hypotheses. The wording of the hypotheses should be the same as the
     hypotheses stated earlier in the protocol. The recommended wording of the primary hypothesis includes a
     sentence describing the alternative hypothesis and direction of interest. If interval estimation is the primary
     purpose of the study, this should be stated instead of a hypothesis.

     Statistical Methods

     All planned primary and key secondary analyses should be discussed in this section. If other secondary and
     tertiary analyses are planned, then a statement should be included in this section as to what these analyses are.

     Describe in detail the statistical methods that will be used for the primary hypotheses or estimation. State the
     statistical tests, which will be used (e.g., ANOVA, Kaplan-Meier) along with other important considerations (e.g.,
     factors in ANOVA, pre-specification of covariates, strata for Mantel-Haenszel, use of historical controls).
          Final Legally Approved 27-Mar-08                                                                              1
9. Specific Drug Supply Requirements

   The drug supply requirements should be outlined in this section of the study protocol.
   Here is an example:

    Aim 1: Eighty-eight mice will be on Compound X diet for three weeks. Based on the regular dosage of Compound X
    (10 mg/kg/day) and mouse body weight (~25g), we will need about 462 mg. For specific aim 2, half of mice (64 mice)
    will be on Compound X diet for three weeks. We will need about 336 mg of Compound X for this specific aim. Since
    Compound X will be mixed with diet and we usually feed a mouse a little more than daily dietary intake (~5g), thus, a
    total of 1g Compound X will be required.


10. Animal Welfare

    The following information should be provided:

             -    Animal Facility location and contact person (Name. telephone number and e-mail).
             -    State why animal studies are necessary for the project
             -    Provide the justification for the species (animal model) selected for the project
             -    Provide t he justification for number of animals used in the study.
             -    State whether the animals are maintained in a facility, animal husbandry and environmental conditions
                  that are appropriate based all governmental regulations and standards.
             -    State whether the animal care program is in good standing with all governmental regulations
             -    Discuss why the proposed research does not constitute unnecessary duplication
             -    State if the animal facility is accredited by the Association for Accreditation and Assessment of
                  Laboratory Animal Care International (AAALAC International)
             -    Merck is committed to the 3Rs* of laboratory animal research. For any studies that may involve pain
                  and/or distress to the laboratory animals please explain what measures have been taken to assure that
                  scientifically valid alternative test methodologies that include the 3Rs* are unavailable:
                       *REPLACEMENT- Replacement of proposed animal with non-animal methods or replacement of
                       proposed species with a less sentient species. Non- animal methods include, but are not limited to,
                       isolated organ preparations, cell or tissue cultures, mathematical models, and computer
                       simulations.
                       *REFINEMENT- Refinement of a model or technique to lessen or eliminate pain or distress.
                       Examples include, but are limited to, use of less invasive procedure, elimination of restraint or
                       significantly shorter study duration.
                       *REDUCTION- Reducing the number of animals proposed. Examples include, but are not limited
                       to, serial collection of samples and increasing sensitivity of endpoint assays.

11. Itemized Study Budget

    A preliminary study budget must be provided with the initial proposal submitted to give guidance to the IISP
    Committee as to the expected study costs. A refined itemized budget detailing the costs associated with the study
    should be provided with the final protocol or included in the study agreement as Exhibit B.

12. References

    All literature references cited in the protocol should be listed accordingly in the reference section.

13. Publication Plan

    Generally, a publication plan is discussed between the investigator and Merck /MSD during time when the protocol is
    under development. Details of the publication and the obligations to Merck/MSD are outlined in the study agreement.

    The following should be considered for the publication plan:
    What are your publication plans? How many manuscripts do you anticipate?
    What is the projected target date for manuscript submission and the name of the journal?
    Do you anticipate abstracts? How many?
    What scientific meetings would you consider for presentation of the study results?

14. Curriculum vitae

    Investigator should provide curriculum vitae and listing of references to Merck/MSD. Assure that all scientists
    involved with the study are trained in proper animal handling and the described procedures. If they are not fully
    trained, please describe how they will be trained.

             Final Legally Approved 27-Mar-08                                                                           2
15. Protocol Submission for External Studies:

       U.S. protocols should be submitted by US investigators directly or through the Global Research Specialist at
        www.merckiisp.com

       Non-U.S. protocols should be submitted to the local MSD office.




            Final Legally Approved 27-Mar-08                                                                           3
                         MERCK RESEARCH LABORATORIES
                           ANIMAL PROCEDURE STATEMENT
IMPORTANT INFORMATION AND INSTRUCTIONS

Merck/MSD policy and federal laws and regulations require review of all animal research projects to
assure humane treatment and safe use of laboratory animals. This Animal Procedure Statement
(APS) form must be completed and approved by Merck prior to the initiation of the research project.

The purpose of this form is to provide information required to evaluate and ensure:
   1.) Non-animal alternatives have been considered.
   2.) Satisfactory evidence that the research does not constitute unnecessary duplication is
       provided.
   3.) All personnel designated to conduct procedures are appropriately trained and qualified.
   4.) All animals are provided appropriate pre- and post-procedural housing, husbandry and
       veterinary care.
   5.) A qualified veterinarian is available to provide any necessary medical care.
   6.) Appropriate safety precautions are exercised at all times throughout the procedure.
   7.) Minimum numbers of animals and the appropriate species are used.
   8.) Satisfactory measures have been taken to prevent or minimize pain and distress.
   9.) Alternatives to painful procedures have been considered.
  10.) A written description of the methods and sources used to determine that alternatives to
        painful procedures are not available is provided.
  11.) If necessary, the conduct of painful and distressful procedures is supported by justification.
  12.) Appropriate anesthetics, analgesics and tranquilizers are used during painful and distressful
       procedures unless withholding pain relieving agents is scientifically justified and continues
       only for the time period necessary.
  13.) Painful or distressful procedures including those which utilize anesthetics, analgesics and
       tranquilizers to minimize or alleviate pain are developed in consultation with the attending
       veterinarian or his/her designee.
  14.) If required, paralytic agents are used in conjunction with anesthesia.
  15.) Any animal which experiences severe or chronic pain which cannot be alleviated is
       euthanized.
  16.) All survival surgeries on rodents are conducted aseptically.
  17.) Major surgical procedures on non-rodent species are conducted in dedicated facilities.
  18.) The conduct of multiple survival surgeries is supported by satisfactory justification and/or
        scientific evidence.
  19.) Appropriate pre-surgical and post-surgical care is provided.
  20.) Compliance with the facility primate enrichment and canine opportunity to exercise
       programs during the conduct of the research or if exempted, justification and/or scientific
       evidence is provided.
  21.) Appropriate methods of euthanasia are used.

[These are internal instructions and are not appropriate to share with investigators]

All investigators are responsible for maintaining accurate animal usage records. These records must
be made available to Merck upon request.
(VERSION 6APS3-03)                                                            IACUC No.
________


                         MERCK RESEARCH LABORATORIES
                          ANIMAL PROCEDURE STATEMENT


DO NOT INCLUDE PROPRIETARY INFORMATION ON THIS FORM. PLEASE TYPE AND ANSWER
ALL QUESTIONS.
PLEASE RETAIN A COPY OF THIS APS FOR YOUR RECORDS.

SECTION 1:       INVESTIGATOR and PROJECT INFORMATION

Project Leader or
Principal Investigator                                                          Mailcode

ISID

Dept. Name                                                       Dept No.

Office Phone                    Lab Phone                         Emergency Phone

Emergency Backup
Contact                                                333333                  Mailcode

Office Phone                     Lab Phone                       Emergency Phone


Project Title

Study Title

Start Date                                           End Date



SECTION 2:       APS APPLICATION TYPE

CHECK A. or B. If you check B., please enter the most recent IACUC No. assigned to this
protocol and answer the three questions below:

Is this procedure statement:

A.        a new APS ?
B.        an annual renewal ?                      IACUC No.
Note: All Animal Procedure Statements must be resubmitted for IACUC review on an annual
basis if the research will continue beyond the twelve-month IACUC approval period. No animal
research can be conducted under expired APS's. Research animals maintained at the Rahway
facility under expired APS's will be transferred to other current IACUC-approved programs.

1. Approximately how many animals were used during the last year? NOTE: animal usage
   numbers from the previous year’s reporting period can be cited.




2. During the last year, approximately what percentage of the animals used were euthanized
   due to being moribund or being in significant pain/distress?




3. During the last year, what were the actual pain and distress percentages in categories “A”, “B”
and “C” (ranges can be provided; animal usage numbers from the previous year’s reporting
period can be cited)?

        Pain/Distress Categories %

            A

            B

            C


SECTION 3:      STUDY LOCATION

Please indicate where the research will be conducted by checking all that apply:

         Rahway Facility                                        Merck - Operations Outside U.S.

         Branchburg Farm                                        **Contract Facility (name/location below)


                                                                Other (name/location)
         Other U.S. Merck Facility (name below)


     **Evidence of review and approval of the proposed research by the IACUC at the
contract facility        is required before full-approval to conduct the research can be
granted by the Rahway-IACUC.

     A. Rahway Site Animal Procedure Space - The IACUC is required to inspect all animal
facilities and
      animal study areas at least once every six months. To comply with USDA regulations
and AAALAC,
      International guidelines, the IACUC must know if procedures, other than surgical
      procedures (Section 9), are performed outside of the core animal facilities, or if animals
      are to be housed for observation
      outside of the core facilities for any period of time. The core animal facilities are those
managed and
      maintained by the Laboratory Animal Resources Department.

        1. Are live animals associated with this APS removed from the core animal facilities for
any reason?
                                                  YES[ ]        NO[     ]      N/A[       ]

                  If yes, please complete the following:

        2. What is the scientific justification for removing the animals from the core facility?


          3. Where are procedures conducted/animals housed?
                 Building:              Room #


          4. What is the maximum length of time animals are used or housed outside of the core
facilities?


          5. Are the animals returned to the core facilities?        YES[     ]                NO[
    ]


SECTION 4:        EXPERIMENTAL DESIGN

1. State the purpose of the research. What are its objectives?


2. Animal Model

    Species                                        *Study Length (in vivo portion only)
    Strain                                         *Number of Studies per Year
    Sex                                            *Number of Animals per Study
    Weight                                         *Number of Animals per Study
                                                   Group
    Age                                            *Total Number of Animals per Year
                                                  *Ranges can be provided


Accurate animal usage records and pain/distress category distribution records for programs
conducted
at U.S. Merck facilities must be maintained and be made available upon request.

3. Pain/Distress Category Distribution

A painful procedure is "any procedure that would reasonably be expected to cause more than slight or
momentary
pain or distress in a human being to which that procedure was applied, that is, pain in excess of that
caused by
injection or other minor procedures". (USDA Animal Welfare Regulations 9CFR Ch.1 Section 1.1)


     Check all that apply. Note A + B + C = 100%                                                %Animals

A.        Animals will suffer no pain or distress greater than that produced by routine
          injections or venipuncture.

B.        Animals will receive anesthetics, analgesics and/or tranquilizers to minimize
          or alleviate potential pain or distress during:

                             i.         Nonsurgical procedures
                             ii.        Nonsurvival surgery
                             iii.       Survival surgery

          B.1   Describe the methods and literature sources (e.g. Medline, Agricola, etc.) used to determine
                that alternatives to the potentially painful procedure(s) are not available .



C.        Animals may experience pain or distress greater than that produced by
          routine injections or venipuncture but will not receive pain-relieving agents.

"Procedures that may cause more than momentary or slight pain or distress to the animals will be
performed with appropriate sedatives, analgesics or anesthetics, unless withholding such agents
is justified for scientific reasons, in writing, by the principal investigator and will continue for only
the necessary period of time."(USDA Animal Welfare Regulations 9CFR Ch.1 Section 2.31)

          C.1 Provide the scientific justification for withholding pain-relieving agents.


          C.2 Describe the degree and duration of pain/distress.



          C.3 Provide assurance that the painful procedure will continue only for the minimum time period
              necessary.



          C.4 Describe the methods and literature sources (e.g. Medline, Agricola, etc.) used to determine
              that alternatives to the painful procedure(s) are not available .



4. Use of Animals for Training Purposes

     Will any animals on this application be used for training purposes?
                 YES                       NO

    If “YES”, approximately what percentage of the total number of animals will be used for these
purposes?
If, at any time during the conduct of the research, the pain/distress category distribution
changes,
the IACUC coordinator must be notified. If the distribution changes from the A category to
the B and/or C category, or from the B category to the C category, the APS must be
resubmitted for review. All investigators are requested to conduct a post-trial
reassessment of the pain category distribution.
Animal usage records must include accurate account of the numbers of animals assigned
to the A, B, and/or C pain/distress categories.


5. Animal Research Protocol

    Provide a concise description of the animal research plan in sequential order. Note the
    approximate length of time required for each component. Describe materials and
    procedures used. Include the dose, volume, route and frequency of agents
    administered (e.g. test compound, Freund's adjuvant, steroids, antibiotics). Describe the
    route, volume and frequency of tissue, blood or fluid collection. (Non-terminal blood
    collection volumes (ml) should not exceed 1% body weight (grams) over a two to four week
    period; maximum blood collection volumes will be determined on a case-by-case basis.)
    Describe procedures for preparing sites for injection (shaving, betadine scrub, etc.) or
    surgical procedures. Describe surgical procedures. Indicate any potential adverse
    effects on the animal's well-being. Include the time schedule for observing animals during
    the study period and post-procedurally, and the steps which will be taken if any adverse
    reactions to the study procedures occur. (Do not attach research publications or
    extensive detailed procedures such as departmental protocols in lieu of completing
    this question. Do not use MK- or L-numbers.)

    Do not include proprietary information.




6. What experimental requirements necessitate the use of this species?




7. Has this type of research been conducted using other species of              YES                 NO
   animals?

   If YES, please list these animal species and indicate any adverse reactions or toxicity
observed.



     (If this study proposes the use of a threatened species, provide specific toxicity data from
studies
    conducted in lower species of animals including the animal species, route and frequency of
test compound            administration, dose concentration and vehicle description )
8. What experimental requirements necessitate this quantity of animals? Please check all of the
applicable
    boxes below and provide an explanation and justification for the number of animals per study
group, the
    number of groups per study, and the total number of animals projected for use per year.



         •supporting historical data          •published literature               •statistical consultation or
                                                                                  software**

     **If “statistical consultation or software is checked, please identify the consultant or software.
    (NOTE: The Biometrics Research Department http://biometrics.merck.com/ is available for
statistical
    consultation).




    Are the proposed numbers of animals per group dictated by regulatory
    requirements?                                                                   YES                   NO

    (If it is necessary to exceed the total numbers of animals or to increase the numbers of
animals per            study group approved by the IACUC, an addendum justifying the
need to increase animal use must               be submitted for IACUC review and approval
prior to the conduct of the research.)



9. Will study animals be used in more than one study?                              YES                    NO

    If YES, complete the following:

    a.) What is the duration of rest periods between studies?

    b.) How many studies will be conducted on an individual animal?

    c.) Will study animals be active in any other research programs?               YES                    NO

        If YES, EXPLAIN:


10. Can similar data be obtained by mathematical models, computer
    simulation, in vitro biological methods or other non-animal alternatives?      YES                    NO

    EXPLAIN

11. Do literature references or in vitro data support this experimental design
    and species selection (i.e. is this an established animal model)?              YES                    NO

    EXPLAIN and/or PROVIDE LITERATURE REFERENCE:
12. What measures are taken to assure that this work does not unnecessarily duplicate previous
work?




13. Will any of the animals be food or water restricted at any time throughout the duration of the
study?

                                                                          YES                    NO

If yes, please describe the restrictions, provide scientific justification for them and indicate what
criteria will be used to assure animal well being.


14. Please assure that PR&D Guidelines http://prd.merck.com/dosingvehicles/dosingvehicles.docwill
be followed for compound dosing in animals.

   If the Guidelines will not be followed, please justify.



SECTION 5: FACILITY CANINE OPPORTUNITY FOR EXERCISE AND NONHUMAN
PRIMATE
           ENVIRONMENTAL ENRICHMENT PROGRAMS

If the research protocol proposes the use of either dogs or nonhuman primates, please answer
questions 1 or 2, respectively.
                                                                                    NOT APPLICABLE

1. If the research protocol proposes the use of dogs, will restrictions be placed on the
   study animals' participation in the facility's program for the opportunity to exercise?
                                                                                   YES                  NO
   If YES, please complete questions 3 - 4.


2. If the research protocol proposes the use of nonhuman primates, will
restrictions be
    placed on the study animals' participation in the facility's program for
environmental
    enrichment?
                                                                                    YES                 NO
    If YES, please complete questions 3 - 4.

3. Describe the extent and duration of the restrictions. Indicate if restrictions will be in place
during the acclimation period, the study period, and/or the washout or recovery periods.


4. Provide justification for the restrictions and supporting evidence, including literature
references, if
    available.
SECTION 6: ANESTHETICS, ANALGESICS, TRANQUILIZERS

If the research design includes the use of anesthetics, analgesics or tranquilizers, complete the
following:

                                                                                        NOT APPLICABLE


     List the pain relieving agents used (tranquilizers, analgesics, anesthetics) for each procedure.

    Procedure                        Drug                     Dose              Route                   Frequency




SECTION 7:       PARALYTIC AGENTS

If the research design includes the use of paralytic agents, complete the following:

                                                                                        NOT APPLICABLE
1. Complete the following table:


    Procedure                        Agent                    Dose              Route                   Frequency



2    Will the paralytic agents be used without the benefit of anesthesia?        YES                    NO

     If YES, please provide justification:




SECTION 8:       PHYSICAL RESTRAINT

    If animals will be confined longer than one hour to an area which is less than either the USDA
or NIH standards for housing, complete the following: (Note, if animals are restrained in
stanchions, provide the               interior dimensions of the holding pen, if applicable, and
describe the animal's range of movement in the stanchion.)
                                                                                        NOT APPLICABLE
1. Describe the restraint device or caging, including its interior dimensions.




2. State the duration of the restraint including the length and frequency of the restraint periods
and the length        of rest periods between restraint periods.




3. Justify use of restraint.
4. Describe the preconditioning methods used.



5. List the procedures performed during the restraint period.




6. Describe the frequency of observations during the restraint period.




7. List the criteria used to evaluate the animal's well being during the restraint period.



8. Will pain-relieving agents, sedatives or tranquilizers be used while the       YES             NO
   animal is restrained?


SECTION 9:      SURGICAL PROCEDURES

If the research design includes a surgical procedure, please complete the following:
                                                                                        NOT APPLICABLE

CHECK all that apply:

    Study animals will undergo:

         Nonsurvival Surgery: Animals will be euthanized prior to anesthetic recovery.
         If checked, complete section 9A: Nonsurvival Surgery

         Survival Surgery less than or equal to 24 hours: Animals will recover from anesthesia but will be
        Euthanized within twenty-four hours post-initiation of the surgery.
        If checked, complete the Section 9B: Survival Surgery = 24 hours

         Survival Surgery greater than 24 hours: Animals will recover from the anesthesia and will survive
        Greater than twenty-four hours post-initiation of the surgery.
        If checked, complete the Section 9C: Survival Surgery > 24 hours


SECTION 9A: Nonsurvival Surgery

1. Building/Room Location of Surgery:



2. Describe perioperative care. Include the approximate length of the procedure, frequency of
observations
    during anesthesia, supportive care during surgery, criteria used to assess anesthetic depth
    and administration of any pain-relieving agents.


SECTION 9B: Survival Surgery        = 24 hours
1. Will the surgical procedure be minor or major?

         MINOR: (e.g. peripheral vessel cannulation, dermal incision and suturing, etc.)

         MAJOR: "...any surgical intervention that penetrates a body cavity or has the potential for producing a
        Permanent handicap in an animal that is expected to recover" (Guide for the Care and Use of Laboratory
        Animals, NIH Publication No. 86-23). "...any surgical intervention that penetrates and exposes a body cavity or
        any procedure which produces permanent impairment of physical or physiological functions". (USDA Animal
        Welfare Regulations 9CFR Ch.1 Section 1.1))

2   Building/Room Location of Surgery:


3. What will be the time period between anesthetic recovery and euthanasia?




4. Justify anesthetic recovery.




5. Will pain-relieving agents be administered post-operatively?                  YES                  NO

    If NO, please justify:


6. Describe pre- and post-operative care. Include frequency of observations during anesthetic
recovery, frequency of examinations, supportive therapy, criteria used to assess pain,
administration of pain relieving   agents.




SECTION 9C: Survival Surgery > 24 hours

1. Will the surgical procedure be minor or major?

         MINOR: (e.g. peripheral vessel cannulation, dermal incision and suturing, etc.)


         MAJOR: "...any surgical intervention that penetrates a body cavity or has the potential for producing a
        Permanent handicap in an animal that is expected to recover" (Guide for the Care and Use of Laboratory
        Animals,, NIH Publication No. 86-23). "...any surgical intervention that penetrates and exposes a body cavity
        or any procedure which produces permanent impairment of physical or physiological functions". (USDA
        Animal Welfare Regulations 9CFR Ch.1 Part 1 Section 1.1)
2. Will multiple survival surgeries be performed?                                      YES          NO

    If YES, justify:



3. Building/Room Location of Surgery:

Major surgeries on non-rodent species must be conducted in facilities dedicated to surgery and
maintained and operated under aseptic conditions. Minor surgery and all rodent surgery must be
conducted aseptically but do not have to be conducted in a dedicated facility. (USDA Animal
Welfare Regulations 9CFR Ch.1 Part 2 Subpart C Section 2.31)

    Is this a dedicated facility (i.e. used exclusively for aseptic surgeries)?        YES          NO

4. Describe aseptic procedures (e.g. sterile gloves, sterile fields, masks, gowns, sterile
instruments, etc.).



5. Building/Room Location of Post-Surgical Recovery:



6. Describe pre- and post-operative care. Include frequency of observations during anesthetic
   recovery, frequency of examinations, description of monitors, supportive therapy,
   administration of antibiotics, criteria used to assess pain, administration of pain relieving
   agents, care for surgical incisions, and long term care.




7. Where will post-operative care records be maintained?




SECTION 10:      HAZARDOUS AGENTS

1. Will potentially hazardous agents be used?                  YES                NO          UNKNOWN

2. If YES or UNKNOWN, complete the following table where applicable and question 3:

BIOLOGICALS: Living agents potentially hazardous to animals (non-infectious, infectious, or
oncogenic).

                                                          AGENT                          QUANTITY
 Antibody or Antiserum
 Cell or Tumor Lines
 Cell Cultures
 Clinical Specimens
 Organs or Tissues
 Serum, Plasma, Whole Blood
 Vaccines
 Viral Vectors
  Other

If listed, the Laboratory Animal Resources staff should review this protocol to assure absence of
potential rodent pathogens.


BIOHAZARDS: Living agents potentially hazardous to humans or animals (infectious or
oncogenic).

                                                          AGENT                         QUANTITY
  Bacterial Pathogen*
  Viral Pathogen
  Fungal Pathogen
  Protozoal or Multicellular Parasites
  Cell or Tumor Line
  Clinical Specimen
 * includes actinomycetes, chlamydia and rickettsia

If listed, site or corporate Biosafety should review this protocol.


GENETICALLY ENGINEERED MATERIALS
                                                               AGENT                         QUANTITY
Transgenic Animals
Genetically Engineered Pathogen
Genetically Engineered Non-Pathogen
Other Genetically Engineered Materials

If listed, the Institutional Biosafety Committee should review the protocol.


HAZARDOUS CHEMICALS: Check with site or corporate safety for a toxicological classification
and/or risk assessment.
                                                   AGENT                         QUANTITY
 Bacterial Toxins
 Mycotoxins
 Chemical Carcinogen
 Mutagen
 Teratogen
 Other Hazardous Chemicals

If listed, site or corporate safety should perform a job safety analysis, a toxicological classification
and/or risk assessment. If a special agent is being used, the Institutional Toxicology Advisory
Committee should review its use.


RADIOISOTOPES:

                                                             ISOTOPE                  QUANTITY (mCi/study)
Radioisotope


RADIOLOGY:
                                                             TYPE                 FREQUENCY
DEXAScan
x-ray
other

    If the study will be conducted at the Rahway or Branchburg Farm, has   YES                        NO
    Health Physics reviewed and approved the procedure? If YES, attach Health
    Physics approval.


3. List precautions to be used. Be specific (e.g. gloves, masks, hoods, disposal procedures,
posting areas,        etc.). Note, safety glasses, gloves and labcoat are required at all times
when handling animals regardless of the potential hazard. (Appropriate disposal of waste and
safe and legal transportation of material should be arranged.)


SECTION 11:     EUTHANASIA/DISPOSITION

Euthanasia is defined as "the humane destruction of an animal accomplished by a method that
produces rapid unconsciousness and subsequent death without evidence of pain or distress, or
a method that utilizes anesthesia produced by an agent that causes painless loss of
consciousness and subsequent death".
(USDA Animal Welfare Regulations 9CFR Ch.1 Part 1 Section 1.1)

The following section must be completed. Even if the endpoint of the study is not euthanasia, it
is necessary to assure that an appropriate method of euthanasia will be used in the case of an
unrelated and unresolvable deterioration in the health of any study animal.

1. Please complete the following table:

                    AGENT                                        DOSE                          ROUTE




2. Please check one of the boxes below:

        If the end point of the study is euthanasia or if the animals are euthanized at some point during
        the study

        If the end point of the study is not euthanasia or if the animals are not euthanized at some point during
        the study, indicate the disposition of animals at the termination of the study or program (e.g. transfer to anothe
        program, reuse for numerous programs until additional reuse determined inappropriate.)

        EXPLAIN:


3. Please assure by checking the box below that

         all moribund animals and animals which experience severe or chronic pain will be euthanized.
4. If there exists the potential for the moribund condition in rats and mice, will the Guidelines for the
   Recognition and Assessment of the Moribund Condition in Rats and Mice be followed for this study?
    http://iacucry.merck.com/pdf/MORIBUND%20GUIDE%2098.pdf


                                                          YES                  NO                   N.A.


    If not, justify:



    For species other than rats and mice, will the Guidelines for the Prevention of the Moribund Condition in
    Non-Rodent Species be followed in this study?
    http://iacucry.merck.com/pdf/Guidelines%20for%20the%20Prevention%20of%20the%20Moribund.pdf b


                                                          YES                  NO                   N.A.
      If not, justify:


SECTION 12:        VETERINARY CONSULTATION

*Check those aspects of the study, if any, which have been developed in consultation with and/or reviewed by the
attending veterinarian or his/her designees. (A list of appointed designees is available from the IACUC coordinator.)

     Animal Model                                             Research Design

    Exemption to:                                            Exemption to:
    Canine Opportunity to Exercise Facility Program           Nonhuman Primate Enrichment Facility Program

     Anesthesia, Analgesia, Tranquilizers                     Physical Restraint

     Surgical Procedures                                      Euthanasia

*The conduct of painful or distressful procedures, including those which utilize anesthetics,
analgesics and tranquilizers to minimize or alleviate pain/distress (i.e. those protocols which assign
animals to the B and/or C pain/distress categories) must be developed in consultation with the
attending veterinarian or his/her designees (USDA Animal Welfare Regulations 9CFR Ch.1 Part 2
Subpart C Section 2.31)

If checked, provide the name(s) of the veterinarian(s) and the date(s) of the consultation and/or
review.


                 VETERINARIAN'S NAME                            DATE

                 VETERINARIAN'S NAME                            DATE

SECTION 13:        PERSONNEL

List all personnel performing animal procedures including summer interns and temporary employees,
participating LAR personnel and the primary investigators at the contract facilities. If additional
personnel will participate in this program, the IACUC coordinator must be notified and written
assurance that the personnel are qualified and trained to conduct the activities must be provided.
Indicate with an   X assigned responsibilities.

Name                                 Nonsurgical Surgical       Post-Op      Scheduled Euthanasia             Animal
Office Phone/ Lab Phone              Procedures Procedures      Care and    Observations                       Use
Mail Drop                                                       Records                                       Records




    Do all personnel have the experience or training necessary to perform        YES                     NO
    the procedures?


SECTION 14:        ASSURANCE STATEMENT

As the principal investigator or project leader, I acknowledge responsibility for the conduct of these
procedures with animals. I hereby certify that the information provided is correct and reflects the
procedures to be used. I further promise to conduct this work with animals in accordance with the
procedures approved by the IACUC and MRL policy. I will submit a revised animal procedure
statement or an addendum and obtain IACUC approval prior to making significant changes in the
procedures as approved by the IACUC.



 Principal Investigator/Project Leader                   Signature                                 Date



 Preparer's Typed Name                                  Date

				
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