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					Protocol Number:                 Approval Date:




                         IACUC Protocol Submission

                             Checklist
To expedite the review of your protocol, please make sure that you take the
following steps before submitting your IACUC protocol application:

          EHS Workbook
           Complete an EHS workbook as per #70 of the application and submit it to
           biosafe@ehs.pitt.edu (not the IACUC office). This is a requirement for all new
           protocols, three-year renewals and major modifications. The IACUC office
           cannot process your application until it receives confirmation from the EHS
           office that your workbook has been submitted.

          Letter of Scientific Merit
           If your project is being funded by departmental funds, industry, or any other
           source that does not conduct a peer-review as a means to determine funding,
           you must submit a letter certifying the scientific merit of the project. This letter
           must be on departmental letterhead, must state the name of the PI and the
           title of the protocol and must be signed by your dean, departmental
           chairperson or division chief. Please either email a PDF of the letter along with
           your application or fax it to 412-383-2020.

          Training
           Direct listed personnel to make sure that all applicable training has been
           completed. See the IACUC Training Modules page for guidance on specific
           required training.

          Completeness
           Make sure that the application is complete, including all yes/no questions,
           contingent questions and all required attachments. Incomplete applications
           cannot be reviewed and will be returned for revision before review by the
           committee.




                                                  1
Protocol Number:                  Approval Date:



                                                2011
                        APPLICATION FOR APPROVAL TO USE
                   VERTEBRATE ANIMALS IN RESEARCH and TEACHING
                                NEW SUBMISSION
                               Institutional Animal Care and Use Committee
                              University of Pittsburgh, Suite 200, Hieber Bldg.

Instructions for Filling out this form
  1. The Institutional Animal Care and Use Committee (IACUC) must approve all use of living
  vertebrate animals for research and teaching at the University of Pittsburgh. In addition, the use of
  animal tissues obtained from vertebrate animals procured and sacrificed solely and specifically for
  research and teaching must also be approved by the IACUC. An Application to Use Vertebrate
  Animals in Research and Teaching (IACUC Application) must be completed and submitted to
  obtain IACUC approval. The IACUC requires that each application be renewed yearly following
  initial evaluation and approval. All IACUC protocols must be re-submitted after three years.

             The IACUC strongly recommends that applicants consult with a
                   DLAR veterinarian prior to application submission
                            DLAR@pitt.edu 412-648-8950.
  2. The National Institutes of Health (NIH) require that any NIH grant application that proposes to
  use vertebrate animals must be associated with approved IACUC protocols before funds will be
  released to the Primary Investigator and the University for that research. The Office of Research is
  charged with certifying that the IACUC has reviewed all proposed animal work included in every
  NIH grant application. Those PIs receiving notice of a fundable score from the NIH must download
  a Grant Application Review Form: (http://www.iacuc.pitt.edu/forms/forms_iacuc.htm), and submit it
  along with a copy of the original NIH grant application to the IACUC office as soon as possible to
  initiate a review.

  3. Go to http://www.iacuc.pitt.edu to obtain an IACUC Application; click on „Forms‟; click on
  „Applying for IACUC Approval‟; and finally „New Application‟. Submit the completed application via
  email to: iacuc@pitt.edu. Hardcopy applications will not be accepted. You will receive confirmation
  via email that the IACUC office has received your application within two days. Your application will
  be assigned to an appropriate subcommittee for review; this can be expected to take
  approximately 45 days. Federal regulations do not allow for expedited reviews. Please contact
  Michael Kessler (IACUC Director of Regulatory Affairs) at kesslermc@upmc.edu (412-383-2018)
  or Dr. Frank Jenkins (IACUC Chair) at fjenkins@pitt.edu (412-623-3233) for more information
  regarding the IACUC application and/or review process.

  4. New IACUC Applications will not be reviewed until the University of Pittsburgh‟s Department of
  Environmental Health and Safety (EH&S) has received a completed Registration Workbook for
  Use of Biological and Chemical Agents form:
  (http://www.ehs.pitt.edu/biological/workbook.html) and submitted by email to
  biosafe@ehs.pitt.edu.

                                                     2
Protocol Number:                  Approval Date:




  5. Any IACUC application for research supported by an internal (Departmental) or corporate
  funding source must be accompanied by a letter from the appropriate Dean, Department Head, or
  Division Chief attesting to the scientific merit of the proposed research.

  6. Postdoctoral fellows, graduate students, and undergraduate students submitting applications as
  principal investigators must also include sponsorship by an appropriate academic advisor. Please
  include the sponsor‟s name and contact information on the certification page of this application
  (Section R and Section S). The sponsor will be copied on all correspondence related to the
  protocol.

  7. Protocols will not be approved unless all individuals handling or manipulating animals for
  experimental purposes have completed the required training programs. This training includes the
  “Research Integrity” module and the “Use of Laboratory Animals in Research” module on the
  Internet-Based Studies in Education and Research Website: http://cme.hs.pitt.edu . Additional
  species-specific training is also required. Most of the species-specific training modules are also
  available online. Please contact the IACUC‟s Training Coordinator (Julie Cursi) at 412-383-1737
  or cursieja@upmc.edu for additional information.

  8. Procedures involving recombinant DNA (rDNA) must be approved by the Institutional Biosafety
  Committee for rDNA. Obtain the Institutional Biosafety (Recombinant DNA) Application at:
  http://www.rcco.pitt.edu/rdna and submit it via email to rdna@pitt.edu for approval to use rDNA.
  Please note that animals cannot be ordered until the rDNA protocol is approved. Any IACUC
  protocol that utilizes rDNA must fill out Attachment 6. For more information, call the rDNA office at
  383-1768.

  9. Protocols proposing the use of any animals in Pain and Distress Classification E require a
  scientific justification to explain why the use of anesthetics, analgesics, sedatives or tranquilizers
  during and/or following painful or distressing procedures is contraindicated. This justification must
  be provided in Attachment 1 of the IACUC Application. See section O for further iniformation.

  10. Work involving ionizing radiation must be approved by the Radiation Safety Office (RSO), as
  described in the “Guidelines for Use of Ionizing Radiations with Animals”
  (http://www.radsafe.pitt.edu/ProgInfo/guideanimal.htm) posted at http://www.radsafe.pitt.edu.
  Approval can be requested by completing Attachment 2 of the IACUC application. This form will
  be forwarded to the RSO by the IACUC. For more information, call 412-624-2728. For information
  regarding work involving non-ionizing radiation (microwave, lasers, etc.), contact EH&S laser
  safety at 624-9505

  11. Investigators who wish to introduce human or animal-derived cells, transplantable tumors, body
  fluids, serum, tissues or antibody preparations into animals in the University Animal Program, and
  subsequently return these animals to approved housing sites, must first receive written permission
  from the University Attending Veterinarian or their designee before any of these materials may be
  injected into animals. This permission is obtained by completing Attachment 3 of the IACUC
  Application and forwarding to dlar@pitt.edu. Certain cell lines and biologically derived products
  may be required to undergo screening for adventitious agents before approval is granted; please
  refer to the “Cell Line Usage and Rodent Biologicals” policy
  (http://www.iacuc.pitt.edu/sop/CellLine.pdf) posted on the IACUC web site (www.iacuc.pitt.edu).
                                                   3
Protocol Number:                  Approval Date:


  Failure to complete any required testing prior to use in animals is considered a noncompliance
  issue and puts the whole program at risk.

  12. The University‟s Human Stem Cell Research Oversight Committee (hSCRO) provides
  additional oversight for the injection of human stem cells into animals. The hSCRO does not
  regulate the use of animal stem cells in experimentation. Research that involves 1) the injection of
  human embryonic stem cells NOT included in NIH‟s Stem Cell Registry (see
  http://stemcells.nih.gov/) into any animal or 2) the injection of human stem cells into the germ line
  or brain of any animal must be approved by the hSCRO before the IACUC approves this protocol.
  The hSCRO application can be downloaded from: http://www.rcco.pitt.edu/hscro/index.htm. The
  injection of human embryonic stem cells that ARE included in NIH‟s Stem Cell Registry (see
  http://stemcells.nih.gov/) or adult human stem cells into any tissue except the brain or germ line
  requires the registration of the activity with the hSCRO before experimentation is initiated. The
  application can be downloaded from: http://www.rcco.pitt.edu/hscro/index.htm .

  13. All investigators requesting use of nonhuman primates must complete Attachment 4 to provide
  all information regarding the enrichment plan and socialization options. For information regarding
  enrichment techniques or any part of the enrichment plan, please contact the Enrichment
  Specialists at enrichment@dlar.pitt.edu or 412-967-6571.

  14. Investigators who plan to breed rodents as part of their study must complete the Breeding and
  Weaning Supplemental Application (Attachment 5). It is important that investigators understand
  that all aspects of breeding and weaning must be followed as outlined in the protocol. Failure to
  comply is regarded as a protocol violation and may result in IACUC sanctions.

  15. All Principal Investigators with approved protocols involving physical, chemical, and/or
  biological hazards may be required to schedule a pre-study implementation safety strategy
  meeting with the Division of Laboratory Animal Resources (DLAR) prior to ordering animals or
  initiating the project. Contact the DLAR at 412-648-8950 to arrange such a meeting.

  16. The public can misconstrue photographs or movies of research animals. For this reason,
  photography of research animals at the University of Pittsburgh is prohibited unless approved by
  the IACUC. If videotaping or photography of research animals is required as a routine part of your
  research program, this activity must be described and justified in the IACUC protocol governing the
  project. As part of the review process, the IACUC will require a description of the procedures to
  safeguard the imaged material. See: http://www.iacuc.pitt.edu/sop/restricted/ImageRecording.htm

  17. Sponsors of studies involving the safety testing of a drug or device that is subject to regulation
  by the FDA typically require compliance with GLP (Good Laboratory Practice) standards. GLP
  standards are defined in the Code of Federal Regulation (Title 21, Part 58), Good Laboratory
  Practice for Nonclinical Laboratory Studies, and are outlined on the following web site:
  http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html. At present, the University of
  Pittsburgh cannot provide the rigorous quality control oversight required for GLP studies, and thus
  the IACUC Application cannot be used to request authorization to perform a study that
  requires GLP standards.

      Responses should be entered in gray shaded areas or space provided.

                                                   4
Protocol Number:                                       Approval Date:



             Questions are provided in blue shaded areas.

                 IACUC approval does not assure that space is available to complete the study
A.        Project Administration - Personnel:

     1.       PI Name (First Name Last Name):                                               Degree(s):
     2.       Co-PI 1 (First Name Last Name):
     3.       Co-PI 2 (First Name Last Name):
     4.       Co-PI 3 (First Name Last Name):
     5.       PI Faculty Title:
     6.       PI Department:
     7.       PI‟s Department Chair:                                                        Title:
              (List Dean or Div. Chief if no Chair)
     8.       PI Mailing Address:
     9.       PI Office Phone:
 10.          PI Lab Phone:
 11.          PI Fax:
 12.          PI E-mail Address:
 13.          Emergency Contact
              (PI - 24 hr phone/pager):
 14.          Secondary Contact
              ( CO-PI or Staff - 24 hr phone/pager):

B. Project Information:

15.            Title:
16.            Source of Funding (If internal, please list Dept. as well as source of funds)
               If project is supported by a funding source that does not conduct peer review
               (e.g., industry, dept. funds), has the letter of Scientific Merit been provided       YES          NO
               by the Dean, Dept Chair or Division Chief and attached to this application?
17.            Dates of Total Project Period:
18.            Grant Title and Number:
19.            Are the Research Funds administered through the University of Pittsburgh?                 YES      NO
If NO, please answer the following questions:
20             What institution is administering the grant?
               Administering Institution‟s Protocol Approval # and
21.
               Expiration Date:
22.            Administering Institution‟s USDA Registration #:
23.            Contact Person at Administering Institution:
               Contact Name:                           Phone:               E-Mail:

              Is this submission a major modification or a renewal of a currently active protocol? (Please
              note that approval of a major modification will result in the termination of the parent protocol.
              Investigators are responsible for ensuring that all animals covered under the original protocol
24.                                                                                                               YES   NO
              (both for major modifications and 3 year renewals) are transferred to the new protocol once it
              is approved. The SOP for animal transfers can be found at
              http://www.iacuc.pitt.edu/sop/Transfers.pdf and the transfer form at

                                                                        5
Protocol Number:                              Approval Date:

        http://www.iacuc.pitt.edu/forms/forms_dlar.htm.
25.     If yes, please list the protocol #:
26.     Please list the protocol‟s title:

        Will any animal housing or experimentation be performed at another institution
27.                                                                                                    YES        NO
        (including custom antibody production)?
If Yes, provide the following: (See http://www.iacuc.pitt.edu/sop/ContractHousing.DOC)
28.     Institution Name:
29.     Institution‟s IACUC Approval # and Expiration Date:
30.     USDA Registration #:
31.     AAALAC Accreditation Status:
32.     Contact Person at Administering Institution (name, phone, e-mail):
License and accreditation info is available from the Office of Research at the contract institution.

              Will custom antibodies be produced at a commercial company (non-
33.                                                                                                     YES         NO
              institution)
If Yes, provide the following: (See USDA policy 10 for further guidance)
34.            Company Name:
35.           Company NIH Assurance Number:
NIH Assurance status and assurance number should be available from the company‟s Office of Research or from the
Office of Laboratory Animal Welfare (http://grants.nih.gov/grants/olaw/olaw.htm )

C. Research Staff (List all individuals handling live/dead animals or animal tissues, including PI).


                                                                                                                   ***Listed
36.                                             POSITION        **PROJECT                                          on Non-
                             *PITT ID #                                             E-MAIL        PHONE #
       NAME                                      TITLE            DUTIES                                           Pitt IACUC
                                                                                                                   Protocols?




* Do not list Social Security Numbers!
**List the duties this person will perform relating to the animal studies.
*** Indicate if the person is listed on an animal protocol at a University or Institution other than the University of Pittsburgh.




                                                                6
Protocol Number:                           Approval Date:

36a. If any of the personnel listed in Question 33 are listed on animal protocols outside the University of Pittsburgh,
please indicate the University or Institute for each person. The purpose of this question is to identify individuals who
travel between different animal facilities and therefore may provide for potential cross- trafficking of infectious organisms.
See (http://www.iacuc.pitt.edu/sop/RodentBiosecurity.pdf)

36b. If any aspect of this protocol will involve individuals attending teaching, training, or demonstration sessions who are
not listed above in Question 33, you must describe in detail what training will be provided prior to any animal
experimentation. Your description must include the topics to be covered, who will perform the training, the expected
length of time for the training session, a description of the individuals attending and how you will document training. If
you need assistance in preparing this please contact the IACUC Training Coordinator at 412-383-1737.




D. Animal Usage:
 Animals must be obtained from DLAR approved sources/vendors only. Quarantine may be required for certain animals
 based on their origin before they enter Institutional Animal Housing Space(s). Contact the DLAR (412-648-8950 or
 dlar@pitt.edu ) for further information. Approximate weight range and age range of experimental subjects at time of
 arrival should be provided. Note that protocol approval does not guarantee that the desired space for housing animals will
 be available. For more information about space availability, contact the DLAR space allocation team: space@dlar.pitt.edu

37       SPECIES                       STRAIN                      AGE          WGT.       SEX       Number projected
                                                                                                       for 3 Years*




*Only the number of individual animals of each species needs to be denoted here, not the number of individual animals of
each strain.

If you are maintaining a breeding colony, your projected animal numbers should include new founder animals, current
breeding stock, weaned offspring, and any other animals that will be required to maintain the colony.

If you need assistance in estimating numbers, please refer to ILAR Guidelines for the Care and Use of Mammals in
Neuroscience and Behavioral Research (2003): http://www.nap.edu/books/0309089034/html.

If nonhuman primates are included in the study. Investigators who plan to use nonhuman primates as part of their study
must complete the Nonhuman Primate Enrichment and Socialization Supplemental Application (Attachment 4).

If rodent breeding is included in the study, Investigators who plan to breed rodents as part of their study must complete
the Breeding and Weaning Supplemental Application (Attachment 5).




                                                               7
Protocol Number:                          Approval Date:


E. Animal Housing, Use Sites, and Identification:

Housing and Identification:
38.                                                                                    If an IDENTIFICATION METHOD
                    HOUSING                HOUSING             MAXIMUM # of
                                                                                         in addition to a Cage Card is
                   LOCATION                DURATION          ANIMALS HOUSED
  SPECIES                                                                                used (Tattoo, Ear Clip, Punch
                 (Animal facility)           (Days)             @ ONE TIME                            +
                                                                                       Method, etc.) Describe Below*




+
 If the identification method requires a surgical manipulation (e.g., implantation of a transponder), then the technique
must be described in detail in the relevant sections below, along with the treatments employed to eliminate pain and
distress.

*Animal caretakers need this information so they can adhere to animal identification paradigms established by
investigators. For advice regarding methods for identifying rodents, see the IACUC web site Policies section
http://www.iacuc.pitt.edu/sop/rodentID.doc



Caging Requirements:

39a. Will special caging be required for holding animals > 12 hours that deviates from the
                                                                                     1
   minimum size specified in the Guide for the Care and Use of Laboratory Animals (pp. 27 –28)?             YES        NO
1
 Available online from: http://www.nap.edu/readingroom/books/labrats.
Will modifications to caging be required such that the caging deviates from the standards
                                                                             1
   specified in either the Guide for the Care and Use of Laboratory Animals or the Animal Welfare
      2
   Act ?                                                                                                    YES        NO
1
 Available online from: http://www.nap.edu/readingroom/books/labrats.
2
 Available online from: http://www.nal.usda.gov/awic/legislat/usdaleg1.htm.
Will any other special husbandry requirements be needed as part of the proposed animal use
   (e.g. Individual housing, more frequent bedding changes, special diets, water or feed                    YES        NO
   restrictions, treatments in feed or water, etc).
If Yes, provide the following: please describe details and scientific justification below:




                                                              8
Protocol Number:                         Approval Date:


39b. Rodent Husbandry Requirements (Complete only for Rodent protocols):
     The standard caging employed in the animal housing site is adequate (microisolator caging is standard in most
     facilities).
     Rodents are of an immunocompromised phenotype or will be research manipulated such that it alters the immune
     system in a manner that renders the animal immunocompromised or severely immunosuppressed. The standard
     Immunocompromised Rodent Husbandry policy (http://www.iacuc.pitt.edu/sop/ImmunocompromisedRodents.pdf)
     will be followed.

     If deviation from the standard Immunocompromised Rodent Husbandry policy is required, describe and
     scientifically justify alternative husbandry plans below.



     Rodents are exposed to biohazards and or chemical hazards requiring containment husbandry conditions to be
     employed. Describe husbandry safety precautions planned below.



     Animals are immunocompromised (any defect in immune status) and/or exposed to biohazards, such that special
     microisolator caging is required.
     Wire bottom caging is required for the scientific purposes of this study, but rats will not exceed 500 grams or be
     maintained for > 9 months. *
     *(See http://www.iacuc.pitt.edu/sop/wire_caging.pdf on the IACUC web site).
     Wire bottom caging is required for the scientific purposes of the study, and animals may be housed in this caging
     > 9 months or may exceed 500 grams in weight. (Provide justification below).*
     *(See http://www.iacuc.pitt.edu/sop/wire_caging.pdf on the IACUC web site).
     Another type of caging is required (describe to the right and
     justify below):



39c. Animal Enrichment.
The animal program at the University of Pittsburgh uses, as part of the routine housing, species-        YES
   specific environmental cage enrichment devices and techniques. (See web site:
   (http://www.dlar.pitt.edu/non-primate_enrichments.doc). For any animal other than a non-              NO
   human primate or dog listed on this protocol, do you require exemption from this enrichment
   program?
If you answered “yes” please describe and scientifically justify below:




F. Use Sites and Transportation Methods:

40. Are animals transported from the holding room to another lab outside of DLAR
operated facilities? See (http://www.iacuc.pitt.edu/sop/restricted/Transport.pdf) and
(http://www.iacuc.pitt.edu/sop/OutsideDLARHousing.doc)
                                                                                                    YES        NO
* If you manipulate animals only within a DLAR procedure room or surgery suite, you should
answer “No” to this question.
If Yes, provide the following: describe details and scientific justification below:
41. If animals are moved from the holding room to another lab outside of DLAR facilities, indicate the building(s) and
room(s) to which they are taken.
(If using hospital areas, see Transport of Animals to Hospital Areas Policy on the IACUC web site.)




                                                             9
Protocol Number:                           Approval Date:


42. Provide rationale for the need to remove animals from dedicated facilities and justify why such work cannot be
performed in dedicated, approved animal facility space.



43. Describe animal transportation route(s):



 44. Describe animal containment & transport mechanism:
(See Policy on Animal Transportation on the IACUC web site).



 45. If you answered “yes” to 40, are live animals returned to the holding room after
 manipulation in a laboratory outside of DLAR animal holding space?
                                                                                                        YES         NO
 * If you manipulate animals only within a DLAR procedure room, you should not answer this
 question, as your response to 40 should have been “no”.
 46. Will vertebrate animals be housed in these alternate locations for greater than 12
 hours? If yes, please note that you must follow the IACUC SOP for investigator-managed
 housing entitled Approved Investigator-Managed Use Sites and Housing Areas found at                    YES         NO
 (http://www.iacuc.pitt.edu/sop/OutsideDLARHousing.doc). In addition, you must contact the
 Compliance Office (412-383-2009) to arrange a site visit prior to starting your study.
47. Indicate laboratory sites (if different than above) where hazardous tissues (e.g., nonhuman primate or animal
tissues from studies involving the use of radiation, residual hazardous chemicals, or BSL-2 or greater containment) are
to be taken.
 Note that if the tissue(s) being transferred will be handled by investigators not listed on this protocol, you are required
 to inform that person(s) of any inherent dangers associated with the tissues. Your electronic signature on the
 certification page (Section Q) verifies you have provided this information.

48. Describe tissue containment & transport mechanism.



G. Study Summary:

49. Briefly summarize (in approximately three sentences) the aim(s) of the study, and why the study is important to
human or animal health, the advancement of knowledge, or the good of society.




H. Animal Welfare Act Required Information:

50. Explain the rationale for animal use, including why non-animal models cannot be used:

51. Justify appropriateness of each species selected and why phylogenetically lower or other species are not used:


52. Provide the number of experimental and control groups, and the number of animals per group. If the experimental
design is complex, it is helpful to summarize this information in a table format. The number of animals justified in
this section must account for the total number of animals requested in 37.




                                                              10
Protocol Number:                          Approval Date:


53. How was sample size determined? (Answer by placing an X in the appropriate box(s) below)
(The number of animals requested should be the minimum required for statistically valid results).*
    *(See “Numbers and Species of Animals” at http://grants.nih.gov/grants/olaw/GuideBook.pdf and “Fundamental
    Issues, Review Criteria” at ftp://ftp.grants.nih.gov/IACUC/GuideBook.pdf)
        No preliminary or prior data are available to determine the number of animals required to complete the
        experiment. The IACUC permits requests to perform pilot studies (typically employing < 10 animals total) to
        collect the preliminary data necessary to determine the number of animals required for a full experiment.
        Previous experience by this PI (if checked, answer question 54).
        Studies cited in the literature (If checked, answer question 54).

54. If previous experience and/or literature review was used to determine sample size, a power analysis should be
     described (if possible) that cites the type of statistical analysis used.
     If the experimental approach is not amenable to a power analysis, a thorough justification of the number of
     animals required must be provided and include appropriate literature citations.
The following link provides advice regarding conducting a power analysis: http://statpages.org/#Power.




I.      Drug Administration

For all drugs used please note:
  Animals must be treated exactly as indicated with regards to the use of the specific drug(s) designated, their dose,
        and the duration of the treatment.
  Variations must be approved either via protocol amendment or through a consultation with the attending veterinarian
        for the animal‟s facility that is documented in the animal‟s medical treatment record. If a veterinary
        recommendation results in a permanent change to the protocol, then a modification form must be
        submitted to obtain IACUC approval.
  If specifying a variable dosing duration (e.g. 3 – 5 days), please define what clinical, laboratory or other parameters
        are used to make such determinations.
  Investigators are required to maintain treatment records on all animals.
For more information, see the “Medical Record Keeping Requirements – Rodents” and “Medical Record Keeping
Requirements – Large Animals” policies on the following IACUC web pages:
http://www.iacuc.pitt.edu/sop/policies_DesignSmAnimalStudy.asp (rodents)
http://www.iacuc.pitt.edu/sop/policies_DesignLgAnimalStudy.asp (large animals)




                                                            11
Protocol Number:                          Approval Date:


55. Anesthesia, Analgesia, Tranquilizing, and Paralytic Drugs (Specify dosage in mg/kg)
    Note: A drug formulary that provides recommended doses for commonly-used drugs is available on the IACUC
    web site in the Policies sections under Design and Implementing an Animal Study (see “: List of Anesthetic,
    Analgesic and Tranquilizer Drugs Frequently Used with the Common Laboratory Species”; *See formulary:
    (http://www.iacuc.pitt.edu/druglist.pdf) on the IACUC web site‟s Policies section).
    SPECIES                  DRUG                DOSE             ROUTE                 ADMIN. FREQUENCY
                                                                                  (“as needed” is not an acceptable
                                                                                             response)




56. For drugs listed above, please supply the duration of treatment and method of monitoring efficacy:
      DRUG                           *Duration of Treatment                       Method of Monitoring Efficacy




*Note: Please provide the exact time period that post-surgical analgesia will be administered to all animals. It is not
acceptable to state that analgesia will be provided as necessary.
(See http://grants.nih.gov/grants/olaw/GuideBook.pdf -Minimization of Pain & Distress)




 57. Are Paralytic Drugs Used?               YES        NO
       If Yes, paralytic drug used:
If yes, provide the following information regarding the use of paralytic agents:
a. Justification for use of the paralytic agent in this study.
b.     Provide information and/or data that demonstrate the proposed anesthetic regiment is adequate for proper
       anesthesia without the paralytic agent. This can be based on a) literature citations specifically using the same
       regime, b) documented experience of the PI with this anesthetic regime without paralytic inclusion or c) the
       previous documented performance of a “sham” procedure utilizing the regime without paralytic agent use.
c.      Provide a plan to titrate the amount of anesthetic to establish a verifiably adequate plane of anesthesia in each
       animal prior to inducing paralysis.
d.      Describe the proposed anesthetic monitoring procedures in paralyzed animals (e.g. electroencephalogram,
       electrocardiogram, blood pressure, etc). Please note if heart rate or blood pressure is monitored, elevations or
       depressions of 15-20% from baseline prior to adding paralytics may be indicative of need for alteration of
       anesthetic levels.




                                                             12
Protocol Number:                           Approval Date:



58. Drugs Administered for Therapeutic Purposes (excluding anesthetics, analgesics, and tranquilizers)
        SPECIES                  AGENTS              DOSE            ROUTE                    EFFECT




Describe any adverse effects associated with the administration of these agents and a detailed plan for monitoring and
alleviating these effects if applicable:




Complete question 59 only if you are using Animal Welfare Act Regulated Animals (“Large Animals”).
59. Are any *non-pharmaceutical agents to be introduced into Animal Welfare Act (AWA)
                                                                                                YES       NO
regulated species (warm-blooded animals excluding rats, mice and birds)?
Please note: As per specific Animal Welfare Act directive, “Non-pharmaceutical-grade chemical compounds should
only be used in regulated animals after specific review and approval by the IACUC for reasons such as scientific
necessity or non-availability of an acceptable veterinary or human pharmaceutical-grade product. Cost savings alone
are not an adequate justification for using non-pharmaceutical-grade compounds in regulated animals.” See
http://www.iacuc.pitt.edu/sop/NonPharmDrug.htm in the Policies section of the IACUC web site, under Designing and
Implementing an Animal Study)
*Non-pharmaceutical agent – An agent that was not specifically prepared for injection into animal or human in its
current form.
If Yes, provide the scientific rationale for their use, source, proposed sterilization technique, sterile packaging,
labeling and expiration information along with proposed methods to determine efficacy.


Complete question 60 if you are using aquatics (e.g., frogs or fish), birds, rats, and mice.
60. Are *non-pharmaceutical agents to be introduced into Animal Welfare Act (AWA) non-
regulated species (rats, mice, birds, or aquatics) for the purpose of veterinary medical
                                                                                                    YES        NO
care or to relieve pain and distress (e.g., anesthetics, analgesics, sedatives, antibiotics, or
paralytics)?
Please note: As per University of Pittsburgh IACUC approved policy, all compounds used in aquatics, rats, mice or
birds for veterinary medical care or to relieve pain and distress (e.g., anesthetics, analgesics, sedatives, antibiotics, or
paralytics) must be pharmaceutical grade (when available) unless scientifically justified. Cost savings alone are not
considered by the IACUC an adequate justification for using non-pharmaceutical grade drugs for veterinary medical
care or to relieve pain and distress in these species.
(See http://www.iacuc.pitt.edu/sop/NonPharmDrug.htm in the Policies section of the IACUC web site, under Designing
and Implementing an Animal Study)
*Non-pharmaceutical agent – An agent that was not specifically prepared for injection into animal or human in it’s
purchased form.
If Yes, provide the scientific rationale for their use, source, proposed sterilization technique, sterile packaging,
labeling and expiration information along with proposed methods to determine efficacy.




                                                              13
Protocol Number:                          Approval Date:


J. Euthanasia

61. Will animals be euthanized?                            YES       NO
If using CO2 asphyxiation, indicate secondary
method of euthanasia and/or how death will be
verified.
62. If NO, what is final disposition of animals?
63. If YES, provide drug and dose or method used.
See http://www.avma.org/resources/euthanasia.pdf for approved euthanasia methods AVMA Guidelines 2007

K. Animal Exposures: These sections will be compared to applicable safety committee(s) and EH&S workbook
reviews and should be consistent between documents.

Radioactive Agents (Prior to any study involving the administration of radioisotopes to animals, the Radiation Safety
Office must review and approve the use).
64. Will radioactive substances be administered in live animals?
                                                                                              YES        NO
If Yes, complete Attachment 2 and the table below:
          SPECIES                            ISOTOPE                                       ACTIVITY




65. Will X-Ray equipment, accelerators, CT scanners, irradiators, or external beam
radiation be used?
                                                                                              YES       NO
If Yes, complete the table below. (It is not necessary to complete Attachment 2 for a
“Yes” response to this question.)
                      +
         EQUIPMENT                         LOCATION OF USE                                    DOSE*




*Dose not applicable to imaging studies
+
  Please note: if any staff members who operate the equipment would need to touch or handle the animals, they
should be listed as research personnel in section 36 and complete all IACUC-mandated training.

Biological Agents
66. Will Biological Agents be used in living and/or dead animals?
                                                                                        YES     NO
If Yes, describe the agents in the table below:
   SPECIES         BIOLOGICALS            DOSE                ROUTE                             EFFECT




Describe any adverse effects associated with the administration of these agents and a detailed plan for
monitoring and alleviating these effects if applicable:




                                                            14
Protocol Number:                           Approval Date:



Introduction of any genetically modified tissues, cells, viruses, or vectors into animals requires approval from the
Institutional Biosafety Committee (IBC). The IBC registration form is available from: http://www.rcco.pitt.edu/rdna.


67. Chemical Agents (Do not include drugs used for therapeutic purposes)
Will chemical agents be introduced to the living and/or dead animals?
                                                                                         YES         NO
If Yes, describe the chemicals in the table below:
   SPECIES          CHEMICALS             DOSE                ROUTE                                  EFFECT




Describe any adverse effects associated with the administration of these chemicals and a detailed plan for monitoring
and alleviating these effects if applicable:



 68. Cells/Tumor Lines/Bodily Fluids (complete Attachment 3) see Policy on Cell Line Usage and Rodent Biologicals
 Will cells, tumor lines, or bodily fluids be introduced to the live and/or dead
 animals?                                                                          YES       NO
 If Yes, describe the cells/tumor lines/bodily fluids in the table below:
    SPECIES             AGENTS               DOSE                   ROUTE                   EFFECT




69. Do you plan to capture any animal images via
photography, video or other recording devices as part         YES        NO
of your research project?
Please justify why you need to capture these images.
Please describe how these images are to be
captured and what procedures you will use to
safeguard the images.


L. Environmental Health and Safety Registration for Use of Biological and Chemical Agents


70. A Registration Workbook for Use of Biological and Chemical Agents must be completed for each IACUC
application. Please visit http://www.ehs.pitt.edu/biological/workbook.html to download this MS Excel document and follow
the associated instructional guide to submit your registration. Upon successful submittal, you will receive an email
notification of receipt from EHS, which is also distributed to the IACUC office.
Please note that hardcopy or incomplete registrations will not be accepted. IACUC protocols
will not be processed for review unless a completed workbook has been submitted to EHS.
For assistance, please call EHS at 624-9505.


                                                              15
Protocol Number:                           Approval Date:




M. Description of Experimental Design and Animal Procedures:
 71 Describe the specific experimental manipulations and treatments of the animals in terms that are intelligible to non-
 specialists. This description should allow the IACUC reviewer to understand exactly what will be done to all the animals
 from entry into the study to the endpoint of the study. It would be helpful to provide a flow chart or table illustrating your
 experimental design and include animal numbers to be used. The experimental endpoint that is being measured must
 be indicated for each procedure. (Please do not insert the Methods Section from the grant application. The IACUC is
 only required to review procedures that are done to animals).



 72. Experimental Endpoints
       (At what timepoint and/or after how many days will experiments be completed on animals?):
       See http://www.iacuc.pitt.edu/sop/PainIndicators.htm for more information regarding establishing experimental
       endpoints.




                                                               16
Protocol Number:                           Approval Date:



For each Non-surgical Procedure for each species: Specifically address the following:
73. Will blood sampling be conducted?                                                                       YES        NO
74. If Yes, provide rationale, method, site, volume, & frequency:

75. Will food scheduling or restriction (other than standard pre-operative fasting) be conducted?           YES        NO
76. Provide rationale, method, frequency, & duration:

77. Will water scheduling or restriction (other than standard pre-operative fasting) be conducted?          YES        NO
78. If Yes, provide rationale, method, frequency, & duration:

79. Will restraint methods be utilized?                                                                     YES        NO
*Note: Restraint in this instance is defined as more than momentary. Brief restraint for the
purposes of blood collection would not qualify as a restraint method.
80. If Yes, provide rationale, method, frequency, & duration*:
*Note: Provide a detailed description of non-human primate handling methods (other than chemical immobilization) and
justify the use of alternative methods and provide assurances of personnel safety.

81. Will stress paradigms be utilized?                                                                      YES        NO
82. If Yes, provide rationale, type, frequency, & duration:
(See “ Methodology” at: http://grants.nih.gov/grants/olaw/GuideBook.pdf)

For Each Surgical Procedure for each species, specifically address the following:
(The surgical SOPs are available on the IACUC web site under the Policies section for Designing & Implementing
Animal Studies; See http://www.iacuc.pitt.edu/policies.asp).
83. Will non-survival surgery be performed?
Please note that the IACUC classifies perfusion of or tissue collection from a live, anesthetized           YES     NO
animal as a non-survival surgery
84. Will survival surgery be performed?                                                                     YES     NO
85. Will multiple survival surgeries be performed on one animal?                                            YES     NO
If so, why can‟t the procedures be completed during the same anesthetic event?
Note: Federal guidelines and regulations require special and substantial scientific justification if major surgical
procedures are performed during separate anesthetic events. If you propose to perform multiple major surgeries, skip
to question 86. If multiple minor procedures are to be performed, please justify below:

(If your protocol involves multiple major surgeries, leave blank and complete 86).
86. Will two or more of these survival surgeries involve major procedures (defined as a surgical
intervention that penetrates and exposes a body cavity or any procedure that produces                  YES       NO
substantial or permanent impairment of physical or physiological functions)?
Federal guidelines specify that no animal is to be used in more than one major survival operative procedure except in
cases of scientific necessity or to provide adequate veterinary care.

If you are requesting to perform multiple major survival surgeries, you must provide substantial scientific justification
below. (See “Policy 14” at: http://www.aphis.usda.gov/ac/polmanpdf.html).


87.   Surgical Site (Building, Room Number):
88.   Name(s) of Surgeon(s):
89.   Has the surgeon(s) performed this procedure on the species requested?                                 YES        NO
90.   If no to question 89, please provide training plan:




                                                              17
Protocol Number:                          Approval Date:


91. Postoperative Plan (Methods to assess/alleviate pain/distress, recovery criteria, monitoring criteria.
See http://grants.nih.gov/grants/olaw/GuideBook.pdf):



N. Anticipated Effects on Experimental Animals

92. Health and Well-Being Complications Resulting from Experimental Procedures:
92a. Describe the likely (expected) consequences of the experimental manipulations performed on the animals, or the
physiological manifestations of the genetic background of the animals, on their health and well-being. Examples of such
consequences might include weight loss, loss of mobility, tumor formation, etc.


92b. Describe any additional potential complications of the experimental manipulations performed on the animals on
their health and well-being. In addition, indicate the expected frequency of these complications. Examples of such
consequences might include infection, wound breakdown (surgical dehiscence), drug toxicity, etc.


92c. How will you deal with the consequences and complications indicated in 92a and 92b?


93a. Describe in detail the species-specific criteria that the investigator will monitor to ascertain the experimental
animals‟ health and well-being, including the presence of pain and distress. IN ADDITION, indicate the frequency at
which animals will be monitored.
*Note that the IACUC holds the PI (and not the animal care or veterinary staff) principally responsible for monitoring the
well-being of animals. The DLAR can assume more of this responsibility if a specific contract is established for this
purpose; for more information about contracting for animal welfare monitoring, contact the DLAR at dlar@pitt.edu or
412-648-8950.


93b. If pain or distress is anticipated as a consequence of* or occurs as a complication from experimental
manipulations, how will it be alleviated? **

*Note: According to PHS policy, painful procedures are defined as “Any procedure that would reasonably be expected
to cause more than slight or momentary pain or distress in a human being to which the procedure was applied . . .”
(http://www.aphis.usda.gov/ac/polmanpdf.html). Also be aware that the preemptive use of analgesics must be
employed for painful procedures as default methodology (versus their employment based on clinically perceived need),
unless specific scientific justification is provided (See IACUC Policy for Pain Management Guidelines in Designing and
Implementing a Small Animal Study section). Unanticipated pain or distress from experimental manipulations that is
detected clinically or pain or distress that is not successfully managed by the analgesic regime employed should be
addressed through immediate consultation with the DLAR Veterinary Services unit.

**If any drugs would potentially be employed for pain relief, these drugs should also be listed above in sections 55-56.




                                                             18
Protocol Number:                         Approval Date:




94. Describe in detail the specific clinical, laboratory, or other diagnostic criteria utilized to determine when an
experimental animal will be euthanized or removed from a study prior to reaching the experimental endpoint(s) listed in
item 68. In addition, indicate the anticipated frequency of premature removal of animals from the study due to these
endpoint criteria. Examples of such criteria are a weight loss > 20%, intractable or uncontrollable pain or distress,
indicators that an animal is failing to thrive, etc.
*See http://www.iacuc.pitt.edu/sop/PainIndicators.htm for more information.



95. Are any animals expected to die due to complications prior to being euthanized? If so, indicate this fraction of
animals (relative to the total number requested) below. If mortality is expected, also discuss the procedures* employed
to minimize its occurrence.
*See http://www.iacuc.pitt.edu/sop/PainIndicators.htm for more information.




O. Pain or Distress Classification

96a.                                                                        USDA CLASSIFICATION*
                      SPECIES                                                 % of Animals Classified
                   (Common Name)                                 B          C          D            E         TOTAL
                                                                     %         %           %            %      100%
                                                                     %         %           %            %      100%
                                                                     %         %           %            %      100%
                                                                   %            %           %          %      100%
96b. If you have animals in more than one pain category, please describe which animals (based on your experimental
design) you have placed in the different categories. This information will allow the IACUC to determine whether the
pain and distress classifications that you specified are correct.




                                                            19
Protocol Number:                          Approval Date:



* USDA Classifications (see “Policy 11” at: http://www.aphis.usda.gov/ac/polmanpdf.html for more information)

Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery,
but not yet used for such purposes.

Classification C: Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, no
distress, or no use of pain-relieving drugs. Euthanasia must precede any invasive procedure (i.e. tissue harvesting) to be
in Classification C.

Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving
accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will
be used. Acute or terminal surgery is considered a painful procedure, which is alleviated by anesthesia.

Classification E: Animals upon which teaching, experiments, research, surgery (survival or non-survival), or tests will be
conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic,
analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research,
experiments, surgery, or tests and/or animals upon which teaching, experiments, research, surgery (survival or non-
survival), or tests will be conducted resulting in either death as an endpoint or permanent physiological impairment that
may lead to chronic pain or distress.

NOTE REGARDING CLASSIFICATION E: An explanation of the procedures producing pain or distress in these animals
and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided on Attachment
1. This information is required to be reported to the USDA, will be available from the USDA under the Freedom of
Information Act, and may be publicly available through the Internet via USDA‟s website.

P. Consideration of Alternatives To Painful/Distressful Procedures
This section is only applicable to warm-blooded species other than birds, mice of the genus Mus, and rats of the genus
Rattus. If this protocol utilizes only rats, mice, birds or aquatics, please skip to section R.

This section applies to all USDA regulated species. A Reference Librarian is available for consultation in performing
literature searches; to reach Melissa Ratajeski, MLIS, RLAT, call 648-1971 or email mar@pitt.edu.

If any procedures fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the
animals, USDA Policy 12 requires that you must address all three of the following issues:
1)       You have refined potential pain-producing methods as much as possible to minimize distress.
2)       You have reduced animal use as much as possible without jeopardizing statistical validity.
3)       You have considered replacing potential pain-producing methods with other techniques (e.g., in vitro techniques,
         computer simulations, lower animal species, etc.).

As part of the response, you must provide written narratives that will convince the IACUC reviewers you have made a
good faith effort to substantively address each of these three issues. You must also provide two sources of information to
show that you have addressed each of the three issues. At least one of these sources of information should be a search
of a scientific database. For each search executed, you must specify the database searched, the date of the search, time
period covered by the database search, and the search strategy used. If you elect to search two databases to satisfy the
consideration of alternatives, please note that OVID Medline, ClusterMed, and PubMed are search engines that all access
the same database, Medline, produced by the National Library of Medicine, and thus employing a combination of these
search engines is considered to be a single database search. Note: the investigator should retain all searches, as they
are reviewable by federal agencies.

An alternate method of consideration for alternatives is consulting with an expert (e.g, DLAR veterinarian, another PI with
extensive experience with the issue in question) or attending conferences or colloqui that provide relevant and up-to-date
information directly related to the issue. When sources other than database searches are included, sufficient
documentation, such as the consultant‟s name and qualifications and the date and content of the consult, should be
provided to the IACUC to demonstrate the expert‟s knowledge on availability of alternatives in the specific field of study.
For more information, see http://www.aphis.usda.gov/animal_welfare/index.shtml -Policy #12.


                                                             20
 Protocol Number:                              Approval Date:


 Instructions:
 For each section below, provide at least 2 database searches, or 1 database search + an expert consultation, then
 provide a written narrative.

97. Refinement Provide evidence that you have refined potential pain or distress-producing procedures as much
                as possible to minimize distress. Any procedure that may cause pain or distress to an animal must be
                addressed.
     Date of Search(s)               Database(s) Searched                         Inclusive Date(s) of Search




 Provide the search strategy (keywords and delimiters) used to search the literature. In addition, indicate the
 number of references obtained from the search. The following is an example of an abbreviated Replacement
 search.

 Ovid MEDLINE(R) Daily Update, Ovid MEDLINE(R)
  #                                   Searches                                      Results
 1      animal testing alternatives/                                            1755
 2      "animal use alternatives"/                                              169
 3      computer simulation/                                                    82535
 4      disease models, animal/                                                 141555
 5      1 or 2 or 3 or 4                                                        225702
 6      "Islets of Langerhans Transplantation"/                                 6084
 7      6 and 5                                                                 168
 8      limit 7 to yr="1998 - 2009"                                             110

 Provide Search Strategy and Results Below:
                Search Strategy / History                                                       Results


     Source of Expert      Qualifications of Expert   Extent, Nature, and Content of Expert          Date of Expert Consultation
       Information                 Source                         Consultation


  Written narrative based exclusively on the information gathered from the literature search or expert consultation. Narratives must
  be clearly based on the information uncovered during the database searches or expert consultation, rather than anecdotal
  information. If a possible refinement was uncovered or is known, but will not be employed, discuss why.



 98. Reduction - Provide evidence that you have reduced animal use as much as possible without jeopardizing
 statistical validity.
      Date of Search(s)           Database(s) Searched                   Inclusive Date(s) of Search




                                                                  21
Protocol Number:                              Approval Date:


Provide Search Strategy Below:
               Search Strategy / History                                                          Results


    Source of
                      Qualifications of Expert     Extent, Nature, and Content of Expert
      Expert                                                                                       Date of Expert Consultation
                              Source                           Consultation
   Information


Written narrative based exclusively on the information gathered from the literature search or expert consultation. Narratives must be
clearly based on the information uncovered during the database searches or expert consultation, rather than anecdotal
information. If a possible reduction strategy was uncovered or is known, but will not be employed, please discuss why.



99. Replacement - Provide evidence that you have considered replacing potential pain or distress-producing
methods with other techniques (e.g., in vitro techniques, computer simulations, etc.).
    Date of Search(s)           Database(s) Searched                       Inclusive Date(s) of Search




Provide Search Strategy Below:
              Search Strategy / History                                                         Results


    Source of
                      Qualifications of Expert     Extent, Nature, and Content of Expert
      Expert                                                                                       Date of Expert Consultation
                              Source                           Consultation
   Information


Written narrative based exclusively on the information gathered from the literature search or expert consultation. Narratives must be
clearly based on the information uncovered during the database searches or expert consultation, rather than anecdotal
information. If a possible replacement model was uncovered or is known, but will not be employed, please discuss why.



Q. Exemption from Environmental Enrichment For Nonhuman Primates or Exercise Program for Dogs

100. For dogs, are you seeking an exemption from the institution‟s plan for exercise (see
       IACUC Policy on Exercise and Socialization Program for Dogs)?                                            YES         NO
     If Yes, justify below:




                                                                  22
Protocol Number:                          Approval Date:


R. Questions on the Use of Human Embryonic Stem Cells in Animals
.    This protocol will involve either:
       1) the injection of human embryonic stem cells that are NOT included in NIH‟s Stem Cell         YES     NO
       Registry (see http://stemcells.nih.gov/) into animals or
       2) the injection of any human stem cells into the germ line or brain of animals
       If yes, has an application been submitted to the Human Stem Cell Research Oversight
       Committee (hSCRO)?
                                                                                                       YES     NO
       Approval for these uses of human stem cells must be secured from the hSCRO before the
       IACUC will approve this protocol. The hSCRO application can be downloaded from:
       http://www.rcco.pitt.edu/hscro/index.htm
       This protocol will involve the injection of human embryonic stem cells that ARE included in
       NIH‟s Stem Cell Registry (see http://stemcells.nih.gov/) or adult human stem cells into
       animals, into any tissue EXCEPT the germ line or brain.
                                                                                                       YES     NO
       These uses of human stem cells require the registration of the activity with the hSCRO,
       before the research involving the stem cells commences. The hSCRO application can be
       downloaded from: http://www.rcco.pitt.edu/hscro/index.htm.


S. Inclusions*: (Please respond by placing an X in the appropriate box):

101. This protocol involves animals in Pain or Distress (Classification E)?                              YES    NO
     If yes, has Attachment 1 been completed?                                                            YES    NO

102.   This protocol involves ionizing radiation usage?                                                  YES    NO
       If yes, is this protocol registered with the Radiation Safety Office (Attachment 2)?              YES    NO

103. This protocol introduces cells/tumor lines or bodily fluids into animals?                           YES    NO
     If yes, has this protocol been registered with the DLAR (Attachment 3)?                             YES    NO

104.   This protocol includes the use of nonhuman primates?                                              YES    NO
       If yes, has the Nonhuman Primate Enrichment and Socialization Supplemental Application
                                                                                                         YES    NO
       (Attachment 4) been completed?

105. This protocol includes the breeding of rodents?                                                     YES    NO
     If yes, has the breeding & weaning supplemental application (Attachment 5) been completed?          YES    NO

106. This protocol involves rDNA?
     Introduction of any genetically modified tissues, cells, viruses, or vectors into animals, the
                                                                                                         YES    NO
     modification of genetic material within living animals, as well as the breeding of genetically
     modified animals requires approval from the Institutional Biosafety Committee (IBC).
     If yes, has a registration been submitted to the IBC?
                                                                                                         YES    NO
     The IBC registration form is available from: http://www.rcco.pitt.edu/rdna
     If yes, has Attachment 6 (rDNA supplemental) been completed?                                        YES    NO
     If the rDNA is registered, has the IBC been notified to add this protocol to your registration?     YES    NO




                                                              23
Protocol Number:                            Approval Date:


107. Will any aspect of this work be performed in the Regional Biocontainment Laboratory
     (RBL)?
     Use of RBL facilities requires approval from the RBL Management. Investigators must submit a                 YES       NO
     Pre-project form to the RBL (http://www.cvr.pitt.edu/Facilities/RBL.asp) to obtain approval
     for any proposed work.
     If yes, has a Pre-grant form been submitted to the RBL?
                                                                                                                  YES       NO
     The RBL pre-grant form is available from: http://www.cvr.pitt.edu/Facilities/RBL.asp
     If yes, has Attachment 7 (RBL supplemental) been completed?                                                  YES       NO


108. Does the funding source/sponsor for the study proposed in this application require
     compliance with GLP (Good Laboratory Practice) standards?
     GLP standards are defined in the Code of Federal Regulation (Title 21, Part 58), Good
     Laboratory Practice For Nonclinical Laboratory Studies, and outlined on the following website:
     http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html.                                               YES       NO

      At present, the University of Pittsburgh cannot provide the rigorous quality control
      oversight required for GLP studies, and thus the IACUC Application cannot be used to
      request authorization to perform a study that requires GLP standards.
      Does the study involve the safety testing of a drug or device that is subject to FDA regulation?            YES       NO

T. Principal Investigator Certifications.
Your electronic signature on this protocol form certifies your agreement to the following terms.

   I certify that I have determined that the research proposed herein is not unnecessarily duplicative.
   I certify that I will notify the IACUC before initiating any changes in this protocol.
   I certify that I will notify the IACUC regarding any unexpected results that impact animals. Any unanticipated pain,
       distress, morbidity or mortality will be reported to the attending veterinarian.
   I understand that if I cannot be contacted in the event that animals in this project show evidence of distress, illness
       or pain, emergency care, including euthanasia if necessary, will be administered at the discretion of the veterinary
       medical staff.
   For all USDA Classification D and E proposals (see Section N): I certify that I have reviewed the pertinent scientific
       literature and the sources and/or databases as noted in Section O and have found no valid alternative to any
       procedures described herein which may cause more than momentary pain or distress, whether it is relieved or
       not.
   For any animal body fluids or tissues, derived from the studies described in this application and transferred to
       persons not listed in Section C, I certify I will notify the recipient of all hazards associated with these materials and
       will instruct them to register with the EHS Department (624-9505)
   I certify that I will share a copy of the approved protocol with all personnel identified in Section C and they will read
       and understand all elements described for the study.
   I certify that all surgeons involved in this project have read the Surgical Guidelines. (The Surgical Guidelines are
       available on the IACUC web site under the Policies section for Designing & Implementing Animal Studies).




                                                               24
Protocol Number:                          Approval Date:




DECLARATION OF CONFLICT OF INTEREST

Does any investigator* involved in this study:

Possess an equity interest in the publicly-traded entity that either sponsors this research
or owns the technology being evaluated that exceeds 5% ownership interest or a current                    Yes      No
value of $10,000?
Possess any equity interest in the non-publicly-traded entity that either sponsors this
                                                                                                          Yes      No
research or owns the technology being evaluated?
Receive salary, consulting fees, honoraria, royalties or other payments from the entity
that either sponsors this research or owns the technology being evaluated that is                         Yes      No
expected to exceed $10,000 in any twelve-month period?
Have rights to the intellectual property (IP) being evaluated, as either the inventor of the
IP for which a patent has been issued, or as the inventor of the IP that has been optioned                Yes      No
or licensed to a company?
Have a financial relationship with a Licensed Start-up Company (which is being
monitored by the COI Committee) that has an option or license to utilize the technology                  Yes      No
being evaluated?
* 'Investigator' means any member of the study team who participates in the design, conduct, or reporting of this research,
as well as his/her spouse, registered domestic partner, dependents, or other members of his/her household.
If yes to any item, please attach detailed information describing the nature of the relationship indicated
above.



Principal Investigator Certification: (First Name Last Name):
Date Submitted:
If Applicable, Post-Doctorate and Graduate Student Sponsor (Name, phone #, e-mail address):
Per IACUC policies, the study sponsor will be copied on all correspondence regarding the protocol.

As a sponsor, I have read this protocol and agree with its contents. In addition, I agree to take
responsibility for all experimental studies performed pertaining to this protocol and agree to assure    YES        NO
compliance with all federal regulations applicable to this research.




                                                             25
Protocol Number:                           Approval Date:


IACUC Attachment 1

Explanation for USDA Classification E
(This report is required to accompany USDA Form 7023 to support any USDA Classification E listings.
Name of investigator (First name Last name)

Animal Study Proposal Title:

Species and number of animals listed in Classification E for each year:
                          NUMBER OF                NUMBER OF                 NUMBER OF              TOTAL NUMBER OF
                            ANIMALS                  ANIMALS                  ANIMALS                   ANIMALS
      SPECIES                YEAR 1                   YEAR 2                   YEAR 3                 (ALL YEARS)




Description of project including reason(s) for species selection:



Provide a scientific justification to explain why the use of anesthetics, analgesics, sedatives or tranquilizers during
and/or following painful or distressing procedures is contraindicated:




Signature of investigator:
Date:




                                                              26
  Protocol Number:                        Approval Date:


  IACUC Attachment 2

                          USE OF RADIOACTIVITY IN ANIMAL STUDIES (FORM RSO-AN1)
                       Approval must be obtained from the IACUC before this study may be performed.

  Prior to any study involving the administration of radioisotopes to animals, the Radiation Safety Office must
  review and approve the use. This form will be forwarded to the Radiation Safety Office by the IACUC.
  AUTHORIZED USER NAME:
  Protocol No(s):
  Species/Strain 1:                                       Weight (in grams):
  Species/Strain 2:                                       Weight (in grams):
  Species/Strain 3:                                       Weight (in grams):
  Number of animals per study:
  Number of experiments per study:
  Project start date:
  Period of time over which experiments will be
  performed:
  Radio-nuclide:                                          Compound:
  Activity to be administered per animal:
  Route of Administration:
  Location where administration will occur:     Room#:             Building:
  Location where radio-labeled animals will                        Animal Facility
                                                Lab:
  be housed:                                                       Room:
  Period of time before animal will be sacrificed:
  Are pathogenic/infectious agents to be administered also?                        YES      NO

  REQUIREMENTS:

  UNLESS AN EXEMPTION IS GRANTED BY THE RSO, THE FOLLOWING REQUIREMENTS ARE MANDATORY:
     1. For animals housed in CAF facilities, all cages must be labeled with a ''Caution Radioactive Material'' label
        stating the isotope and amount per animal, the date of administration, and the authorized users name.
     2. Animal cages must be properly surveyed for contamination before being returned to the CAF cage washer.
     3. Animal carcasses that are disposed of as radioactive waste must be packaged separately. Do not include any
        other materials such as pads, tubing, needles, instruments, etc. with the carcass.
     4. The RSO should be notified each time a study is to be undertaken.

  Submitted by:                                            Date:
  Reviewed by:                                             Date:
  SPECIAL CONDITIONS AND REQUIREMENTS:
Revised 12/05




                                                            27
 Protocol Number:                            Approval Date:


IACUC Attachment 3

   REQUEST TO INTRODUCE CELL LINES, TRANSPLANTABLE TUMORS, BODY FLUIDS, SERUM, TISSUES, AND
                                    ANTIBODIES INTO ANIMALS

 •       Due to the risk of human or animal cell lines, transplantable tumors, body fluids, serum, tissues, and antibodies
 being contaminated with rodent viruses, which can cause disease outbreaks within the rodent colonies or adversely affect
 research, the IACUC requires testing of all such material that is deemed to be at risk.

 •        Required testing is for pathogens to which the colony of recipient species is Specific Pathogen Free (SPF). See
 the “Cell Line Usage and Rodent Biologicals” policy on the IACUC web site for more details. Failure to complete any
 required testing prior to use in animals is considered a noncompliance issue and puts the whole program at risk.

 •       Investigators wishing to introduce any of the above biologicals into animals in the University Animal Programs
 must have an approved protocol that describes the use of these biologicals and receive written permission from the
 University Attending Veterinarian/Clinical Director of the DLAR or their designee before any animals may be ordered.

 •       Written documentation from the testing laboratory of completed tests and results will be required. Accepted tests
 include PCR or murine or rat antibody production tests. Test results or other documentation should be submitted to DLAR
 via e-mail at dlar@pitt.edu or fax (412) 648-8449.

 •       To ensure rodent biosecurity, previously tested materials may be required to be retested depending on how the
 materials have been handled and stored since testing and if the original testing still meets the current policy standards.
 The need to retest previously tested biologicals will be reviewed as part of the standard three year IACUC protocol
 renewal process and upon submission of IACUC protocol modifications.

 •         Introduction of any genetically modified tissues, cell, viruses, or vectors into animals requires approval from the
 Institutional Biosafety Committee (IBC). The IBC registration form is available from: http://http://www.rcco.pitt.edu/rdna.



A. Project Administration – Personnel:

 PI Department:
 PI‟s Department Chair:
 (List Dean or Div. Chief if no Chair)
 PI Mailing Address:
 PI Office Phone:
 PI Lab Phone:
 PI e-mail Address:

 B. Description of Biological. Please complete questions below for each biological listed in Section 65 of the protocol.
 Copy and paste the questions below to accommodate additional biological materials.

 1. List the category of the biological (cell line, transplantable tumor, body fluid, serum,
 tissue, or antibody):
 2. Designation (i.e., ID#, name, description):
 3. Histological type of material introduced:
 4. Species of origin of material introduced:
 5. Recipient species:
 6. Provide the name and contact information of the source (institution and/or the
 individual) providing the biological.




                                                                28
Protocol Number:                          Approval Date:


7. Has this material been passaged through live rodents or exposed to any products        Yes            No
of rodent origin? If “Yes”, please describe.


8. Has this material been PCR, MAP, or RAP tested for viral pathogens? If yes, fax        Yes        No
or e-mail test results to 412-648-8449 or dlar@pitt.edu.
9. Please describe how the biological is stored or propagated in your laboratory. In the case of a cell line please
include the following information in your description:

 a. Is the cell line frozen as a stock and used as needed or is it propagated in vivo or in vitro?
 b. Is culture medium containing rodent serum or rodent-derived feeder cells used during in vitro propagation?
 c. Is the cell line incubated in the same incubator with other rodent or human cell lines?
 d. Is the cell line ever manipulated at the same time in the same biosafety cabinet as other rodent cell lines?




                                                             29
Protocol Number:                       Approval Date:




IACUC Attachment 4

NONHUMAN PRIMATE ENRICHMENT AND SOCIALIZATION SUPPLEMENTAL APPLICATION

For information regarding enrichment techniques or any part of the enrichment plan, please
contact the enrichment specialists at enrichment@dlar.pitt.edu, (412) 967-6571.

 1. Are you seeking an exemption from any part of the institution’s environmental enrichment
 program? (see Plan to Promote the Psychological Well-Being of Nonhuman Primates [Plan],
 available at www.dlar.pitt.edu, in the Animal Enrichment section of the Services tab) This
 includes, but is not limited to:
 I. Social needs of infants (separation of the mother before 6 months of age in the absence of
 illness or rejection)
 II. Social housing (pair or group housing)
 III. Housing structure and substrate (deviation from standard enclosures and cage
 furnishings)
                                                                                                    Yes     No
 IV. Foraging opportunities (cage pans and foraging boards)
 V. Manipulanda (toys, food puzzles, complex food treats and others) and use of all five
 senses (radios, television, mirrors, frozen treats and others).

 If yes, please supply justification for exemption from each element of the Plan requested.
 Exemption requests should be based on documented and/or referenced scientific
 contraindications. Subjective concerns (such as fear of fighting or trauma) although
 potentially valid, will not be sufficient alone to grant exemptions. Providing references would
 be helpful.

 Please supply the number of animals and duration for each exemption.

 2. Single housing, either as an exemption from the Plan or as an acceptable exception (see Plan section IIIA),
 requires special enhanced enrichment measures to compensate for the lack of social contact. It is the
 responsibility of the investigator to provide these enhanced enrichments, either directly or through contracted
 services through the DLAR. This enhanced enrichment must be documented on a daily basis and supplied to
 the Enrichment Specialists monthly. Please supply your enhanced enrichment plan that will be employed for
 any single housed nonhuman primate under this protocol, including what will be provided, specific
 frequencies, who will be responsible for providing this, and an example of the documentation that you intend
 to use (See Plan section IIIA6 for an example/template). As exceptions are usually unanticipated and
 unavoidable, every investigator housing NHPs must supply this plan to be employed as needed. Questions
 regarding the enhanced enrichment or documentation process may be directed to the Enrichment Specialists
 at enrichment@dlar.pitt.edu or (412) 967-6571.

 3. Please indicate in what situations the NHPs on this study may be socially housed. Each grouping is
 unique, and will be discussed with the enrichment specialists prior to initiation.
 NHPs pose no additional risk or variable, and may be housed with any other NHP.
 NHPs pose a significant risk or variable to unrelated studies, and may be housed only with NHPs on a
 similar study.
 Describe and scientifically justify:
 NHPs pose a risk or variable that is unique to this protocol, and may only be housed with any others
 on this protocol.
 Describe and scientifically justify:
 NHPs are unique to specific experimental groups within this protocol, and may only be housed within
 these groups.
 Describe and scientifically justify:
 An exemption has been requested above, and NHPs may not be socially housed.



                                                        30
Protocol Number:                          Approval Date:


IACUC Attachment 5
                                 Rodent Breeding and Weaning Supplement
                             http://www.iacuc.pitt.edu/sop/RodentBreeding.pdf
A. INDIVIDUAL(S) RESPONSIBLE FOR COLONY MAINTENANCE

P.I. NAME:                                                    DEPARTMENT:
WORK PHONE #:                                                 EMERGENCY PHONE
                                                              (after hours) #:
E-Mail:
Other Individuals Involved in Colony Maintenance (Must Also be Listed in Item 33 in Main Application)




Describe training and experience of these individuals as it relates colony maintenance & breeding of animals:


SECTION 1: BREEDING COLONY JUSTIFICATION
What strains will be bred?

Provide a justification for establishing and maintaining a breeding colony of animals at the University of
Pittsburgh. Refer to the Introduction of the University of Pittsburgh IACUC on Breeding Colonies found on the
IACUC web site in the Policies section under Implementing and Designing a Small Animal Study


SECTION 2: HOUSING AND HUSBANDRY ISSUES:
List the location(s) where animals will be housed and bred.
                                         BUILDING AND ROOM NUMBER




Are there any special husbandry requirements needed for the maintenance of the colony?            Yes           No
If you answered yes, please describe the needs (e.g., special diets, special housing, immunocompromized
strains, etc.).


Will you be breeding genetically modified animals?                                                    Yes      No
Breeding of animals with a unique genotype requires the submission of a registration to the Institutional Biosafety
(RDNA) Committee. The RDNA Registration Form can be downloaded from: http://www.rcco.pitt.edu/rdna



SECTION 3: COLONY MANAGEMENT INFORMATION
Please provide the following information below. Refer to the University of Pittsburgh’s IACUC Policy on Breeding
Colonies for additional instruction, found on the IACUC web site in the Policies section under Implementing and
Designing a Small Animal Study




                                                            31
Protocol Number:                          Approval Date:


a. Breeding Scheme
        Harem Mating
        Pair Breeding
        If this method is selected, describe how you will ensure that multiple litters do not occur within one cage?


          Timed (hand) Mating
          Other – Describe and provide a justification:

          Post-Partum Breeding – Within 1-3 days after delivery

b. Weaning Plan – As per IACUC policy, no greater than one litter is to be kept in a cage. The Principal Investigator is
   responsible for weaning unless otherwise contracted.
        Animals will be weaned at 21-28 days
        The breeding requires additional time for weaning (beyond 28 days).
        Please describe and justify below. You must include in your response how you will ensure that the
        density of animals does not exceed the Guidelines for Animal Care and Use.


c. Phenotype Information

Are there any health concerns associated with the development of the phenotypes for the
                                                                                                   Yes      No
strains described?
If yes, please describe the health concern (e.g., immunocompromised, behavioral, anatomical and/or physiological) and
describe how the health of these animals will be managed.




SECTION 4: GENOTYPING AND OTHER COLONY MANAGEMENT PROCEDURES – The goal of this section is to
identify techniques and procedures used to manage your colony.
a. Genetic Identification - Refer to the University of Pittsburgh IACUC Guidelines for Genotyping of Rodents found at
   http://www.iacuc.pitt.edu/sop/policies_DesignSmAnimalStudy.asp.
Indicate how animals in the breeding colony will be identified genetically and the age of the animals for genotyping (if
applicable).


Sample type:
    Tail Clip. If clipping is done on animals over 28 days of age, local or
    general anesthesia is required.
    If this is the case what anesthetic method(s) will be used? (Specify to
    the right)
    Reference: “Drug List (PDF)” found in the Policies section of the IACUC
    website under Designing & Implementing an Animal Study.
    Blood sample--Describe the collection procedure:
    Anesthesia method (if applicable):
    Other, (e.g., ear notch, buccal swab). Specify:

a.      Age of animals for genotyping:
      0-21 days (anesthesia is recommended)
      21-23 days (anesthesia is highly recommended)
      21-28 days (anesthesia is strongly recommended)
      > 28 days and older (adult post-weaning - anesthesia is mandatory)


                                                             32
Protocol Number:                          Approval Date:



b. What method of animal identification will be used?
          Ear notch
          Ear tag
          Tattoo
          Microchip implant
          Cage card identification only
     Euthanasia:
Will animals that cannot be utilized be euthanized in the same manner as
described above (items 61-63) in the main part of the IACUC Protocol                 Yes      No
Application?
If no, please describe the alternate euthanasia method planned:

c. Breeder Manipulations
    Manipulations of breeder animals
Ovulation agents used?                                                              Yes      No
Experimental compounds?                                                             Yes      No
In-utero therapies / therapeutics?                                                  Yes      No
    NOTE: All of these agents should be listed in the tables in Section K of the main protocol application

SECTION 5: ESTIMATED NUMBER OF ANIMALS TO ESTABLISH AND MAINTAIN THE COLONY.
A mechanism for tracking colony management should be employed to allow review during semiannual IACUC
inspections. If you need assistance in estimating numbers, please refer to ILAR Guidelines for the Care and Use of
Mammals in Neuroscience and Behavioral Research (2003): http://www.nap.edu/books/0309089034/html.

    Enter Estimates:
Estimated number of weaned and adult animals to be subject to experimental manipulations.
Estimated number of suckling animals to be subject to experimental manipulations.
Estimated number of breeders held but not subject to experimental manipulations.
Estimated number of suckling animals to be euthanized at or prior to weaning, and not subject to
experimental manipulation.
TOTAL ESTIMATE:




                                                            33
Protocol Number:                           Approval Date:


IACUC Attachment 6

IBC Supplement
Name of investigator (First name Last name)

IACUC Proposal Title:

Has an IBC protocol been approved for this study?                YES   NO

        If YES, list the protocol number and title:


        If NO, has an IBC protocol been submitted?               YES   NO

If an IBC protocol has been submitted, but not approved,
please list the title of the submission and date of
submission (confirmation) to the rDNA Office.
Describe any recombinant molecules, vectors, viruses and/or genetically modified animals, tissues or other organisms
used in the attached IACUC protocol.

Note: If you have questions whether materials used in your research qualify as recombinant DNA, please contact the
rDNA office at 412-383-1768 or by email rdna@pitt.edu.




Signature of investigator:




                                                            34
Protocol Number:                           Approval Date:


IACUC Attachment 7

RBL Supplement
Name of investigator (First name Last name)

IACUC Proposal Title:

Has an RBL Pre-project form been submitted for this                YES   NO
study?
Describe all pathogens to be used in RBL facilities in this
study.


Describe the animal species to be housed in RBL space.



Signature of investigator:




                                                              35

				
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