Animal Research
New Protocol
Modification*
3-Year Renewal / / Protocol #: AR-
ORSP Ref #:

Institutional Animal Care and Use Committee

ProtocolReview Form

Directions:Submit this completed Protocol Review Form with original signature(s) along with any additional information, including appendices, attachments, etc. to the Office or Research Compliance.If electronic signature is used, submissions can be sent to . The project cannot begin until the Principal Investigator(PI) has received documentation of IACUC approval.

*If this is a Modification to a previously approved protocol, you must insert all changes in bold, italics or highlights in order to distinguish between previously approved information and current requested changes.

Submit to:Office of Research Compliance, 560 N. 16th Street, Room 102

Phone: 414-288-6271 Fax: 414-288-6281 E-mail:

Principal Investigator:
Department:
Telephone
E-mail:

Project Title:

(If funded, provide the title of the corresponding grant)

PI Certification

This signature certifies that the Principal Investigator has read and understands the requirements of the PHS Policy on Humane Care and Use of Laboratory Animals, applicable USDA regulations, the Guide for the Care and Use of Laboratory Animals, and the Marquette University policies governing the use of vertebrate animals for research, testing, teaching or demonstration purposes. This signature certifies that the PI will maintain the project in full compliance with the aforementioned requirements and that the PI assumes responsibility for all aspects of this project, including assurance that all research staff involved in handling animals are qualified and appropriately trained. If grant funded, the PI further certifies that the information stated in this protocol is consistent with the animal care and use information provided on the grant application. In signing this description of the research project, I agree to accept primary responsibility for its scientific and ethical conduct as approved by the IACUC.

______

Signature of Principal Investigator Printed Name Date

For Office Use Only

Institutional Animal Care and Use Committee

Date of Approval ____/____/____ Animals Approved (type & number/year): ______
Disposition: Designated Review Full Review Approved through ____/____/____
______/____/____
Signature of IACUC Representative Printed Name Date
______/____/____
Signature of IACUC Representative Printed Name Date
IACUC Comments:

1

Marquette University, IACUC Protocol Review Form

Revised: 03/27/2014

***Please note that in order to choose any of the check boxes on this form, you must double click the box and select "Checked" as the Default Value. To activate hyperlinks within this document hold down the Ctrl button at click on link. ***

Section A: RESEARCH PROJECT CHARACTERISTICS

Collaborative Research Statement:

There may be a need for the IACUC to review studies that require transportation of animals to other institutions. These collaborations raise several complexities, including compliance agreements between the institutions, management of risk to animal health at both institutions, and regulatory compliance in the transport of the animals.

For more information on Marquette University’s IACUC Guidelines on Collaboration with other institutions, please click on the link.

NOTE: Collaborations with multiple institutions will require that protocol documentation be shared with all institutions involved, including but not limited to all protocol reviews and approvals.

  1. This protocol is for:

Research Proposal

Breeding Colony (you must complete Appendix A)

Teaching (you must complete Appendix B)

Other (specify):

Note: In the remaining sections of the protocol the term “procedures” corresponds to any and all of the above.

  1. Grant or Contract Funded (may select “Yes”and“Pending”): Yes Funding is Pending No

Have you registered your project with Research and Sponsored Programs (ORSP)? Yes No

If Yes, Please list your ORSP Reference #: ______

If your project is grant funded or funding is pending, submit a copy of the funding/grant proposal and list the grant number and funding source here:

GRANT NUMBER:______

FUNDING SOURCE:______

If the funding agency requires an official IACUC approval letter, list the program area, contact person, title and complete mailing address:

  1. Inclusive dates of Project (Project may not start prior to approval)

Anticipated start date: ____/____/____Anticipated end date: ____/____/____

  1. Animal Housing Location:

Schroeder Facility

Wehr Life Science Facility

Other (specify): ______

  1. Identify the person(s) or unit responsible for daily animal husbandry care:

PI and/or PI research staff

Animal Care Staff

  1. Classification of Animal Research Use (check highest category applicable):

USDA Category /

Procedure

B / Breeding or Holding ColonyProtocols
C / No more than momentary orslight pain or distress and nouse of pain-relieving drugs, or
no pain or distress. Forexample: euthanized fortissues; just observed undernormal conditions; positivereward projects; routineprocedures; injections; andblood sampling; manual restraint that is no longer than would be required for a simple exam.
D / Pain or distress appropriatelyrelieved with anesthetics,analgesics and/or tranquilizerdrugs or other methods forrelieving pain or distress.
E / Pain or distress or potential pain or distress that is not relieved with anesthetics, analgesics and/or tranquilizer drugs or other methods for relieving pain or distress.
*Note: If Category E is checked, the IACUC is required to perform a harm/benefit analysis
  1. List the names, rolein the lab, and contact phone and e-mailaddresses of all individuals who will come into contact with the animals used for this protocol. For each individual, please indicate whether they have completed animal care and use training or if it is pending. Training must be completed prior to personnel working with animals. Note that all individuals who handle animals must participate in the Marquette University Occupational Health and Safety Program. Information on this program will be discussed during the animal care and use training provided by the Animal Resource Center. Also, any collaborative work with another institution will require the submission of that institution's IACUC approval letter.

Name / Role in Lab (student, employee, grad student, post doc, etc. / Contact Phone # / Contact e-mail Address / Animal Care and Use Training(completed or pending) / Enrolled in Occupational Health and Safety Program
Completed
Pending / Completed
Pending
Completed
Pending / Completed
Pending
Completed
Pending / Completed
Pending
Completed
Pending / Completed
Pending
Completed
Pending / Completed
Pending

(Add more tables if needed)

Personnel unknown at this time.

The Animal Resource Center will be notified prior to animal use and personnel will complete Animal Care and Use Training.

If added personnel will be conductingsurgery (survival and/or terminal), anesthesia, and/or euthanasia using a physical method, I will complete and submit Appendix G (found on the ORC website).

By checking the following box I certify that personnel will not perform any animal procedures until they have been trained by the Animal Resource Center and will ensure that all personnel are enrolled in the Occupational Health and Safety Program prior to their contact with animals.

PI certification with the above statement

Please Print Name (PI):

Section B: ANIMAL INFORMATION

  1. Animal Species and where obtained:

Species (please check) / Strain and gender (please write in) / Vendor (please check) / Other (specify if from a vendor not listedand answer Question 18)
RAT / Harlan Labs
Charles River Labs
MU PI with an approved IACUC protocol AR-______
Other
MOUSE / Harlan Labs
Charles River Labs
Jackson Labs
MU PI with an approved IACUC protocol AR-______
Other
RABBIT / Harlan Labs
Kuiper Rabbit Ranch
Other
FROG / Niles Biological
Other
FISH / Acme Lamprey
DLM Aquatics
Hammond Bay Biological Station
Other
TURTLE / Niles Biological
Other
OTHER
  1. Total Number of Animals Per Year for each species selected from the above table (Note: The total number per year includes all animals purchased,obtained from other protocols or investigators, and animals requested for training purposes).

If you will be breeding please indicate the total number of offspring (the number born), the number of animals weaned from offspring (the number weaned), and number off weaned that will be used in experiments (the number used):

  1. Will any animals listed in Question 9 be used for training purposes?Note: This also includes animals used for surgical training

Yes No If Yes, please specify how many animals will be used. Note: animals used for training should be accounted for in the Animal Project Summary:

  1. In an effort to accommodate space requests from all investigators, please provide the anticipated average number of cages in the facility at any given time and the expected maximum(add more tables if needed):

Species 1

Average # of cages per day
Maximum # of cages anticipated

Species 2

Average # of cages per day
Maximum # of cages anticipated
  1. Is the species endangered or protected? If the species is endangered or protected, indicate appropriate federal/state license number:

Yes (License number______) No

  1. Any special care necessary for your animals beyond routine animal husbandry?

Examples of special care include: special diets, frequency of cage changes (beyond the once a week mandatory for single housed or twice a week for group housed animals), PI or PI staff responsible for administering food and/or water,and PI or PI staff responsible for cage changes.

Yes No If Yes, please specify thespecial care required, and who will be responsible for this care:

If the animals require a special diet (commercial or non-commercial prepared diet that has ingredient(s) altered compared to maintenance diets) answer the following questions. If not, check N/A

For commercially prepared diets:

Provide the name/source of the diet:
Describe how the diet is altered:
How long will the animals be on the proposed diet?:
Provide a scientific justification for the use of the diet:
N/A
  1. Will this study utilize food or fluid restriction? Yes No

If Yes, please complete Appendix C.

  1. Animal Housing:

IACUC Guidelines and Policy for Housing andthe Use of Enrichment for Laboratory Animals:Group housing of social animals is the standard set by the “Guide for the Care and Use of Laboratory Animals”and used by Marquette University. Any deviation from this standard must be scientifically justified.

How will your animals be housed in the Animal Resource Center?(Please check all that apply)

NOTE: If your animals will be grouped housed upon arrival but, later singly housed check both group and single and state your justification in the box provided.

Species / Single/Group / Cage Type / Scientific justification is needed if “single” is checked and if “other” cage type is selected (please describe cage type). If using wire-bottom caging please answer the following; Justify the need for wire-bottom caging, how long will rodents be housed on wire-bottom caging, what is the anticipated weight range of the rodents during the housing period, what measures will be taken to monitor animals for foot lesions and what will be the action taken if foot lesions develop.
Rat / Single
Group / Shoebox(standard)
XL shoebox(for running wheels)
Wire bottom cages
Other
Mouse / Single
Group / Shoebox(standard)
Super-mouse – quarantine cages
Large Shoebox (for trio breeding)
Other
Rabbit / Single
Group / Standard rabbit caging
Other
Frog / Single
Group / Shoebox
Aquarium
Other
Turtle / Group / Aquarium
Other
Fish / Single
Group / Aquarium
Other
Other / Single
Group
  1. Will animals be housed outside of the ARC facilities (e.g. labs) for more than 24 hours?

Yes No

If Yes, describe where animals will be housed, duration of housing outside the ARC, the environmental conditions of the housing (e.g. temperature, lighting), and who will be responsible for animal care and monitoring:

  1. Please list what enrichment items may be provided to your animals by checking the appropriate boxes below. If “none” is selected, provide a scientific justification. Also, if only one type of enrichment is preferred please select only one enrichment type.(Please coordinate special requests/needs with the Animal Resource Center). For reference please see the IACUC Guidelines and Policy for Housing and the Use of Environmental Enrichment for Laboratory Animals on the ORC website.

Enrichment type / Scientific justification needed when “none” is selected
Nestlets (nesting)
Paper tubes
PVC tubing
Shepard Shacks
Refuge Huts
Enviro-Dri (nesting)
Alpha-dri (nesting)
Wood Blocks
Wood Clothespins
Plastic balls
Plastic dumbbells
None (Justify at right)
All/Any
  1. Quarantine Procedures: If you have selected “other” from the list of vendors in Question 8, this indicates that you will be using vertebrate animals that were acquired from an outside source (other University, vendor, or research laboratory) and must be placed into quarantine for a minimum of six weeks.

18A: Will you be working with the animals while they are in quarantine?

Yes (see question 18B) No (continue to question 19)

18B: Please describe how your quarantine procedures are designed to reduce the possibility of disease transmission to vertebrate animals within the ARC facility (see ARC facility management staff on training for quarantine procedures and read the quarantine policy and standard operating procedures).

  1. Animal Transportation:

Will animals be transported to/from Marquette facilities or between Marquette and other institutions or facilities? Please note that this does not apply to animals received or transported by commercial vendors.

YesCheck appropriate box (19A) below and complete the following questions

NoProceed to question 20

  1. Where will the animals be transported to and from:

  1. Describe the care of the animals during transport:

19A. I am familiar with the Marquette University Animal Transportation and Shipping Guidelines and will file the Marquette University Transportation Check-Off sheet for Rats, Mice, Fish, and Rabbits with the Animal Resource Center at the time of transport if I am personally transporting the animals.

Section C: ANIMAL PROJECT SUMMARY

  1. Below, please provide an outline addressing the following areas (use attachments as appropriate):
  1. The specific goal(s) and significance of this project in language understandable to a lay person;
  2. Discussion of why you have chosen the species; and
  3. The basis for your estimate of the number of animals required.
  1. Will this protocol incorporate a pilot study?

Yes (see question 30 on unexpected outcomes) No

  1. Does your protocol include the use of any surgical procedures?

Yes No If Yes, you must complete AppendixD and attach to this protocol submittal.

  1. Will animals be restrained for greater than 1 hour?

Yes No If Yes, you must complete Appendix E and attach to this protocol submittal.

  1. Will antibody production methods be used or body fluids collected?

Yes No If Yes, you must complete Appendix F and attach to this protocol submittal.

  1. Describe your experimental procedures (outside of routine husbandry) to be performed on the animals and reference Appendices C-F where appropriate. For example, identify all drugs given, including dosage range, routes and frequency of administration; social or environmental manipulation; biological samples taken. Describe methods of physical restraint and length of time animal(s) are restrained and describe acclimation procedures. Be sure to account for all animals and their inclusion in any and all procedures from the beginning to the end of their involvement in this protocol. Specify the expected sequence, frequency, and duration of these procedures. For IACUC recommended best practices, go to

Marquette University IACUC policy requires consideration of the use of alternatives (such as in vitro studies, computer models or less sentient animals) to procedures that may cause more than momentary or slight pain or distress to animals. The IACUC is required to document that you have made such a consideration.

  1. May procedures cause more than momentary or slight pain or distress? Note that this includes survival and terminal surgery (the IACUC considers cardiac perfusion as a terminal/non-survival surgery),in which case you must address appropriate anesthesia in Appendix H.

Yes (complete Appendix H) No (answer question #27)

  1. Describe the method and frequency used to monitor your animals to ensure they are not experiencing pain or discomfort from your procedure(s) or from unanticipated illness or injury (Signs of Pain and Distress in Rodents). Also define who is responsible for training those tasked with monitoring animals:
  1. Do you anticipate any adverse outcomes as a result of the listed procedure(s)? Examples include infection, mortalities or morbidities due to injections, equipment used, experimental drugs, new procedures, etc. Note: a separate question for reporting adverse outcomes as a result of surgical procedures is asked in Appendix D.
  1. Does this project utilize non-pharmaceutical grade compounds for administration to animals?

(Please refer to the Office of Research Compliance website for FAQ’s on non-pharmaceutical grade compounds).

Yes (complete Appendix I) No

IMPORTANT: It’s expected that all chemical compounds administered to any animal species be pharmaceutical grade, if that agent is available in pharmaceutical grade, even in acute procedures. It’s expected that all PI’s that propose to use chemical compounds to be administered to animals conduct a search in any recognized pharmacopeia to find a pharmaceutical grade equivalent to be used.Please see Appendix I to propose justification for the use of non-pharmaceutical grade agents.

  1. Reporting unexpected outcomes not listed in Question 28 or Appendix D:

“By checking the following box I certify that I, as the PI, will report any adverse events (unanticipated outcomes) involving animals promptly to the IACUC. Please read a copy of the “Guidance on Prompt Reporting of Adverse Events and Unexpected Outcomes” that can be found on the Office Of Research Compliance website.”

PI certification of the above statement