IACUC Application

Core Experimental Protocol Form

Instructions: Please complete all sections of this core protocol application and all applicable appendices and submit with Principal Investigator signature to the Office of Research Compliance (ORC). All new and continuing applications will undergo Attending Veterinarian consultation and review by ORC prior to IACUC review. Please allow 4-6 weeks from time of submission for IACUC review.

Form completion instructions: To populate a box simply click once on the box to show the “X.” To uncheck box, click on it once more to remove “X.” For narrative responses, click on the prompt text (“Click here to enter text”) and begin typing.

GENERAL INFORMATION: Is this a new or continuation application?☐ New application ☐ Continuation application

Previous protocol #: Click here to enter text. (e.g., 10-001)

Protocol Title: Click here to enter text.

Principal Investigator:Name: Click here to enter text.800 #: Click here to enter text.

Department: Click here to enter text.Campus Address (Building and room #): Click here to enter text.

Email: Click here to enter text.Campus Phone: 7 - Click here to enter text. Emergency phone:Click here to enter text.

Co-Investigator:Name: Click here to enter text.800 #: Click here to enter text.

Department: Click here to enter text.Campus Address (Building and room #): Click here to enter text.

Email: Click here to enter text.Campus Phone: 7 - Click here to enter text. Emergency phone: Click here to enter text.

☐ FUNDED? For all funding sources listed below, submit a copy of the Research and Design Methods and Vertebrate Animal Section(s) of your proposal, scope of work, or contractual agreement with this application for grant/protocol congruency review.
NOTE: If using internal funds (i.e., University or departmental), complete only the “Source” and “Status” areas below. / ☐ N/A
Not Funded

Sponsor #1:

Name:Click here to enter text.

Status of funding: ☐Proposal submitted ☐ Just-in-Time notification ☐ Funds awarded/existing funding ☐ Pending ☐Other Specify Click here to enter text.

Source of funding: ☐Federal ☐State ☐University ☐Private/Foundation ☐Contract ☐ Other Specify Click here to enter text.

Funding Period: Click here to enter text. to Click here to enter text. NORM proposal #: Click here to enter text. (e.g., 14-0500)

Sponsor #2:

Name:Click here to enter text.

Status of funding: ☐Proposal submitted ☐ Just-in-Time notification ☐ Funds awarded/existing funding ☐ Pending ☐Other Specify Click here to enter text.

Source of funding: ☐Federal ☐State ☐University ☐Private/Foundation ☐Contract ☐ Other Specify Click here to enter text.

Funding Period: Click here to enter text. to Click here to enter text. NORM proposal #: Click here to enter text.(e.g., 14-0500)

Should animals be found sick or dead, please provide an emergency contact name, phone number and email address:

Emergency Contact: Click here to enter text.Phone number: Click here to enter text.

Email address: Click here to enter text.

Section I: Personnel

1.Provide the following information for all personnel who will be conducting animal activities on this project.

To add a row, in the “Layout” menu in Word, select “Insert Below” and copy and paste contents of previous row into new one. TIP: Do not use first row to copy.

Personnel / Techniques
Select all that apply for this project/protocol. / FOR IACUC OFFICE ONLY / FOR IACUC OFFICE ONLY / FOR IACUC OFFICE ONLY
CITI Training Completed? / Vivarium Orientation Completed? / Enrolled in Occ Health Program?
Name:#: Click here to enter text.
(Last Name, First Name, Middle Initial)
800 #:______
Proposed Role(s) on Project
(Select all that apply)
☐Principal Investigator
☐Co-Investigator
☐ Animal Handler
☐ Animal Orderer
☐ Official Contact
☐ Emergency Contact
☐ Surgeon
☐ Temporary Personnel
☐ Other Specify:
Click here to enter text. / ☐PI NOT DOING ANIMAL WORK
☐Consulting Only – no animal handling
☐ Handling & restraint
☐Administration of injectable anesthetics & analgesics
☐ Administration of inhaled anesthetics & analgesics
☐ Breeding husbandry
☐Ear notch/ear tag
☐Weighing / measuring
☐ Cardiac puncture
☐ Cervical dislocation w/ anesthesia
☐CO2 euthanasia
☐Decapitation w/ anesthesia
☐Exsanguination / ☐ Aseptic technique
☐ Incision site prep
☐ Instrument prep
☐Suture placement /removal
☐Intradermal injection
☐Intramuscular injection
☐Intraperitoneal injection
☐Intravenous injection
☐Oral gavage
☐Retro-orbital bleed
☐Retro-orbital injection
☐Saphenous bleed
☐Tall clip bleed
☐Other Specify:
Click here to enter text. / ☐ YES
Date:______
☐ NO / ☐ YES
Date:______
☐ NO / ☐ YES
Date:______
☐ NO
Name:#: Click here to enter text.
(Last Name, First Name, Middle Initial)
800 #:______
Proposed Role(s) on Project
(Select all that apply)
☐Principal Investigator
☐Co-Investigator
☐ Animal Handler
☐ Animal Orderer
☐ Official Contact
☐ Emergency Contact
☐ Surgeon
☐ Temporary Personnel
☐ Other Specify:
Click here to enter text. / ☐PI NOT DOING ANIMAL WORK
☐Consulting Only – no animal handling
☐ Handling & restraint
☐Administration of injectable anesthetics & analgesics
☐ Administration of inhaled anesthetics & analgesics
☐ Breeding husbandry
☐Ear notch/ear tag
☐Weighing / measuring
☐ Cardiac puncture
☐ Cervical dislocation w/ anesthesia
☐CO2 euthanasia
☐Decapitation w/ anesthesia
☐Exsanguination / ☐ Aseptic technique
☐ Incision site prep
☐ Instrument prep
☐Suture placement /removal
☐Intradermal injection
☐Intramuscular injection
☐Intraperitoneal injection
☐Intravenous injection
☐Oral gavage
☐Retro-orbital bleed
☐Retro-orbital injection
☐Saphenous bleed
☐Tall clip bleed
☐Other Specify:
Click here to enter text. / ☐ YES
Date:______
☐ NO / ☐ YES
Date:______
☐ NO / ☐ YES
Date:______
☐ NO

SECTION II: Overview of this study

1.Purpose: Briefly describe the overall purpose of this animal use study. This should typically be less than 75 words and be easily understood by nonscientists (e.g., ‘We propose to test the effectiveness of a new class of anti-inflammatory drugs against arthritis in mice.’).

Click here to enter text.

  1. Importance Of and/or Scientific Benefit: Describe in non-scientific terms the importance of and/or the potential scientific benefit of the proposed study with respect to human or animal health, the advancement of knowledge, or the good of society. Please do not copy/paste from your Vertebrate Animal Section of your NIH grant or any other funding application.(250 words or less).

Click here to enter text.

  1. Justification/Rationale for Using Vertebrate Animals: Provide a brief justification for using live vertebrate animals rather than alternative means of achieving the research goal(s) (e.g., cannot be substituted or modeled in simpler systems or nonliving models; supported in literature/preliminary data; anatomy or physiology is uniquely suited to the study; lowest species on the phylogenetic scale that is suitable for the proposed study, etc.).

Click here to enter text.

Section III: identification for Species Use

Provide the following information (to add rows, place cursor in the last column and press ‘enter’): . To add a row, in the “Layout” menu in Word, select “Insert Below” and copy and paste contents of previous row into new one.

Species / Strain / Sex / Age and/or
Weight Range / Source (e.g., vendor name, another institution, etc.) / Quantity
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text.

Section IV: Experimental Design and Procedures

Provide a detailed narrative description of the experimental procedures and manipulations to be used in this project. Additionally, include a flow chart or bulleted list that depicts the sequence of all animal procedures or manipulations (i.e., step-by-step) to be performed on this protocol and that shows the experimental course for an animal from its entry into the experiment to the endpoint of the study.

Click here to enter text.

Section V: Animal NumberS Justification

The number of animals requested for this protocol is based on the following:

(Check all that apply. For guidance, refer to the Sample Size and Statistical Analysis webpage.)

☐A statistical estimate of the number required to achieve statistical significance.

Provide the criteria and detailed results of a power analysis to determine the total number of animals you will require:

Click here to enter text.

☐The estimated minimum number necessary to achieve the goals of the study in the absence of a statistical estimate.

Is this a pilot study? If so, provide justification

Click here to enter text.

Provide justification based on previously published or preliminary data (include reference(s)).

Click here to enter text.

☐The number necessary to obtain sufficient tissue or other material for testing or analysis.

Provide explanation with details for procedures

Click here to enter text.

☐The number required to provide sufficient technical training or practice for the number of trainees expected.

Provide explanation with details for procedures

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☐The expected or established mortality associated with this procedure

Provide previously published or preliminary data or provide explanation

Click here to enter text.

☐Other Explain (details required):

Click here to enter text.

Section VI: Animal Number Calculations

(Considerations: Pain/Distress Category; Alternatives to Pain/Distress Literature Search; and Justification for Category E Studies)

  1. Animal Number Calculations by Pain /Distress Level:

Provide the estimated total number of animals requested for a three(3)-year approval period. Include numbers of animals to be listed in each appropriate USDA pain/distress category using the HIGHEST pain/distress category for proposed use. Refer to the Pain, Discomfort, or Distress Classifications webpage for details regarding the classification of procedures by category.

NOTE:For continuation protocols, if there are animals remaining on the expiring protocol, please include the number of animals (on the expiring protocol) to be transferred to this application in the number of animals requested for this new application. Animals will be transferred to the new application upon IACUC approval.

Pain / Distress Category / Year 1 / Year 2 / Year 3 / Total 3 years
Category B
Category C (only momentary or slight pain & distress)
Category D (use of analgesics/anesthetics
to minimize pain & distress)
Category E (unrelieved pain & distress)
Total
  1. For Protocols Involving Pain/Distress Categories C, D or E: Search for Alternatives to Pain/Distress: Per federal regulations, investigators must provide a written narrative description of the methods and sources they consulted to determine the availability of alternatives (reduction, refinement, replacement) to potentially painful and distressful procedures. This can be satisfied through a literature search.

NOTE:Resources: There are many resources available to guide investigators in completing an alternatives literature search. Please refer to the Tips and Linkswebsite for links to a variety of university and national resources. You may also contact Dr. Melanie Sorrell, Health Sciences Librarian at Atkins Library for assistance in conducting a literature search for your study. She can be reached at (704) 687-8410 or via email at . Please allow a few business weeks ahead of your expected need for Dr. Sorrell to complete your request.

a.Which databases were searched? Please search at least 2 databases. Select all that apply:

☐PubMed

☐AGRICOLA

☐AWIC

☐BIOSYS

☐Embase

☐Paschal

☐INSPEC

☐Other List: Click here to enter text.

  1. Inclusive years searched (i.e. 1970 – 2012): Click here to enter text.
  2. Keywords used in searches: Click here to enter text.

d.Description of search strategy and results:Please list or show how keywords were entered (i.e. show search strings) and briefly describe the results (i.e. how many “hits” for each keyword search string). Also provide a brief explanation as to why any resultant publications ARE / are not pertinent to your experimental design or objectives).

Click here to enter text.

  1. Does the proposed activity duplicate any previous work? ☐ YES☐ NO

If YES, please justify:

Click here to enter text.

  1. Justification: Category E☐ N/A

If you have indicated above in Section VI, Question #1 “Animal Numbers Calculations” that you are proposing procedures involving Category E (i.e., unrelieved animal pain/distress), provide scientific justification for the need to withhold pain relieving agents:

Click here to enter text.

Section VII: Location of Research

Animals will be housed and used (select one):

☐In the Vivarium only

☐Animals will be primarily housed in the Vivarium but will be temporarily removed to:

Building: Click here to enter text.

Room number(s): Click here to enter text.

Length of time: Click here to enter text. hours

(NOTE:When animalsare kept outside the Vivarium for 12 hours or more—whether for research purposes (lab, surgical suite or testing area) or for medical reasons (veterinary or surgical treatment), PHS Policy requires these“satellite” facilities to have all of the required housing parameters for the species involved as stipulated in the Guide. If proposing the use of a location as satellite housing, please contact the Office of Research Compliance at or at (704) 687-1872 for the appropriate form to complete).

☐Animals will not be housed or used on campus for this study (select for field studies, collaborative research where animals will not be housed or undergo procedures at UNC Charlotte, etc.)

☐Other Specify:Click here to enter text.

Section VIII: Animal Identification, Husbandry and Monitoring

  1. Will any markings be used to identify animals? ☐YES☐ NO

If YES, please indicate method of animal identification:

☐ Ear tagging

☐ Ear notching / ear punch

☐ Tattooing

☐ Non-toxic marker or pen
☐ Microchip

☐ Identification via tank/cage cards

☐ Other Specify: Click here to enter text.

  1. Will species-specific standard enclosures (cages; tanks for aquatic animals) be used? ☐YES☐ NO

If NO, please indicate special housing conditions:

☐ Ventilated rack system

☐ Sterile housing for immunocompromised animals

☐ Metabolic cages

☐ Single housing of animals (NOTE: Single housing of social animals is considered a deviation from the Guide and should be noted in Appendix A:Requests for Exceptions/Deviations from the Guide or IACUC policy.)

☐ Quarantined in separate room due to introduction of hazardous agents (i.e. pathogens or radioisotopes) into animals (NOTE: Please complete Appendix D– Use of Hazardous Agents to detail hazardous agent use in animals.)

☐Other Specify: Click here to enter text.

  1. Who will be primarily responsible for animal monitoring (including overnights, weekends and holidays)?

(NOTE: Arrangements should be made with the Attending Veterinarian for care of animals and development of a monitoring plan PRIOR to acquisition of animals.)

☐ Research personnel only

☐ Vivarium staff and research personnel

  1. Please specify how animals will be monitored both post-procedurally and throughout the study.

What complications could arise and how will monitoring address these complications?

Click here to enter text.

  1. Will special handling of sick or dead animals be required? ☐YES☐ NO

If YES,please specify and provide justification:

Click here to enter text.

  1. Are special diets, additives to food/water and/or antibiotics administered?

☐YES☐NO

If YES, provide a brief description here:

Click here to enter text.

NOTE: Food/water restriction or reduction is considered a deviation from standard husbandry guidelines in the Guide. Please provide a brief description below and complete/submit the following Appendix with this application:

  • Appendix A:Requests for Exceptions/Deviations from the Guide or IACUC policy.

SectionIX: Use of Analgesics / Anesthetics

  1. In the table below, provide drug, dose, route, frequency of administration and anticipated duration of therapeutic effect. Also, include ALL medications such as pre- and post-anesthetics, antibiotics, paralytics, etc. (If applicable, describe surgery in Appendix C: Survival and/or Non-Survival Surgery.) Please consult with the Attending Veterinarian when planning use of these agents.

Note on drop down lists: Choose only one item per row. To unselect an option simply click on “Choose an item.” Complete other cell entry in the table by typing in information.

To add a row, in the “Layout” menu in Word, select “Insert Below” and copy and paste contents of previous row into new one.

Drug Name / Dose / Route / Frequency of Administration (indicate pre- or post-procedure if applicable) / Anticipated Duration of Effect (in minutes, hours or days)
Choose an item. / Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. /
  1. Describe monitoring procedures to ensure adequacy and safety of anesthesia or tranquilization:

Click here to enter text.

  1. Describe monitoring procedures for recovery from anesthesia or tranquilization:

Click here to enter text.

Section X: Use of Experimental Drugs or Compounds☐ N/A

The Guide and the USDA Animal Welfare Act Regulations require the use of pharmaceutical-grade substances as part of experimental and/or clinical treatment of animals. However, they also note that as a part of research, it may be necessary to include the use of non-pharmaceutical grade substances as long as such use is based on scientific necessity.

Please refer to the IACUC Policy Use of Non-Pharmaceutical Grade Compounds and Expired Materials in Animals for IACUC-reviewed-and-approved guidance.

1.In the table below, list ALLsubstances to be used in animalsincluding substance name, route, volume, dose, frequency of administration, grade of substance (pharmaceutical or non-pharmaceutical), and whether substance is in-date or expired.

NOTE: For every substance listed, provide the product information sheet or Safety Data Sheet (i.e., “SDS” formerly known as “MSDS”) along with your application for IACUC review. .

To add a row, in the “Layout” menu in Word, select “Insert Below” and copy and paste contents of previous row into new one.

Substance / Route / Volume / Dose (provide unit/kg) / Frequency of Administration / Grade of Substance (select from drop-down list) / In date or Expired? (select from drop-down list)
Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / Click here to enter text. / Choose an item. / Choose an item. /
  1. Please provide scientific justification for the use of non-pharmaceutical grade/expired compounds in animals:

Click here to enter text.

3.Are there any known adverse effects from use of the listed substances at the route/dosage/frequency proposed?

☐ YES☐ NO