Maine Medical Center s4

Rev 7-2010

MAINE MEDICAL CENTER

Institutional Animal Care & Use Committee

Application of Intent to Use Vertebrate Animals in Research or Instruction

Please Read

Appropriate Animal Facility Training is Required Prior to Starting Any Project.

Please refer to the Animal Facility’s SOPs located on the share drive:

Click on My computer on the desk top → (H :) → Root Share→ Operations→ SOP

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IACUC policy requires PI’s and Lab Assistants to renew
CITI online training every three years.

Online CITI training: http://www.citiprogram.org

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NOTE: ANY ANIMALS ARRIVING FROM NON-APPROVED VENDORS ARE REDERIVED

Refer to SOP: 99-001C Animal Procurement and SOP: 99-005C Quarantine.

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The Maine Medical Center Institutional Animal Care & Use Committee (IACUC) is required by law as stated in the Animal Welfare Act and the 1989 amendments to this Act to review and approve all activities or proposed activities involving the use of vertebrate animals.

Maine Medical Center provides assurance to all PHS agencies that the use of vertebrate animals in research or instruction has been approved by the Institutional Animal Care & Use Committee and that all requirements of the governing agencies have been met. Unapproved or disapproved procedures may not be carried out under any circumstance. Failure to observe this rule could result in removal of all access to animals by the investigator's laboratory. Maine Medical Center's Public Health Service Assurance No. is: A3862-01.

Questions? Call: MMCRI Research Compliance Office: 207-396-8195

Rev 7-2010

MAINE MEDICAL CENTER Institutional Animal Care & Use Committee

Application of Intent to Use Vertebrate Animals in Research or Instruction

Submit an Electronic Copy with Digital Signature, or

If No Digital Signature, Submit both Paper & Electronic Copies

Please fill in all boxes below that apply.

IACUC #: / Current Approval Date: / Expiration Date:
Place “X” next to “YES” or “NO” below:
Type of Submission / Place “X” Next to Submission Type ê / I have completed the online CITI
training for animal research. è / YES / *NO
New Protocol
Complete Entire Form / Mandatory for Triennials Only:
Published papers attached with my triennial. / Yes / No
Triennial Protocol
Complete Entire Form / Replacing Protocol: / #
Amendment è / Additional: / “X” Below ê / Add Brief Note Below
If more space needed, use Notes Box* below.
· Animals & Strain/line: / How many more animals added to the protocol because of this amendment? / #
List Each Strain:
· Personnel:
· Remove Personnel:
· Add Procedure:
· Other:

*NOTES BOX: (Cell will expand)

Rev 7-2010

SECTION: I MANDATORY INFORMATION: Fill all boxes in this section.

Check “X” Here

By checking box to right, PI confirms grant matches PHS funded protocol.
(applies to new grant submissions and continuing reviews)
Title of Protocol:
Title of Grant:
Principal Investigator: / Today’s Date:
Work Address:
Department:
Phone #: / Fax #: / E-mail:
Type of Program: (Place “X” next to selection below.)
Research : / Teaching/training: / Student Project or Fellowship:
*Funding Agency: / Grant or Contract #:
**Cost Center # for this Application:
*Please attach grant page that contains grant # info, and grant page that explains animal experiments.*

Rev 7-2010

SECTION: II INVESTIGATOR ASSURANCE

The undersigned, being the Principal Investigator for the research project described on the preceding pages of this document, hereby gives assurance that he/she will comply fully with Federal Law as set forth in the Animal Welfare Act; further that, if the research protocol described herein is approved by the Maine Medical Center Institutional Animal Care and Use Committee the investigator will:

A. Adhere strictly to the protocol as described herein;

B. Seek the consent of the IACUC for any significant change(s) in the protocol before they are implemented, and notify the IACUC of any change(s) in the location(s) where the animal component of this research is carried out;

C. Ensure that all personnel listed herein are qualified and competent to carry out the procedures described and that they understand and accept the necessity for strict compliance with all laws pertaining to the type of animal experimentation involved in this study;

D. Assure that the activities involving vertebrate animals as described in this application do not unnecessarily duplicate previous experiments; (the IACUC may request evidence that appropriate literature searches have been conducted);

E. Agree to emergency veterinary care by the appointed Maine Medical Center veterinarian if there is evidence of pain or illness.

F. Utilizes the alternative to animal use information to prevent unnecessary animal use.

o Ensure that all animal program SOPs are being followed

o Ensure that protocols involving hazardous material or infectious agents are managed by trained staffed and appropriate safeguards are in use.

o Appropriate measures are being taken to ensure minimum pain and distress, and humane treatment of the animals is being given.

o Inform Animal Care Staff when you will not be available, (vacation, and conference). Therefore appropriate animal care can be given.

o Check on animals at least once per week.

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Signature of Principal Investigator Date

This Assurance must be signed at time of submission.

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Signature of Department Chief Date

Rev 7-2010

SECTION: III NON-TECHNICAL (Lay) SUMMARY OF PROJECT

PURPOSE/GOALS:

MANDATORY: Include any publications with your triennial submission.

The lay summary should be written in clear, simple language which describes the purpose and potential benefits of the project, as well as the animal species to be used and their importance in the project. The summary should be an overview of the goals of the project, and should be in terms that non-scientists can understand. Please limit the length of this summary to one page.

Begin typing in box. (Cell will expand)

(Cell will expand)

Do activities unnecessarily duplicate previous experiments or activities? / Yes: / No:
If yes, describe and justify need for duplication here:

Continue …

Rev 7-2010

SECTION: IV ANIMAL INFORMATION

Please fill in #1 thru #5 below for each species. If you are using more than one species, you will have to copy and paste Section IV for each successive species used. Begin your next species after #5 of this section.

Name of Species:

1. JUSTIFICATION FOR THE SPECIES:

Alternatives to the use of vertebrate animals must be considered.
Have you considered alternatives? / YES / NO

Please provide a copy of your literature search and the keywords that were used, per species. (Refer to SOP: 99-011A Alternatives to Animal Use Policy)

** Attach your search results to this document**

Date search was conducted:
Years Covered:
Databases searched:
Keywords used:

2. NUMBER OF ANIMALS NEEDED

Breeding Colony:

1. / Strain: / # of Breeders:
2. / Strain: / # of Breeders:
3. / Strain: / # of Breeders:
4. / Strain: / # of Breeders:
5. / Strain: / # of Breeders:

Experiment Colony:

1. / Strain: / Experiment 1:
2. / Strain: / Experiment 2:
3. / Strain: / Experiment 3:
4. / Strain: / Experiment 4:
5. / Strain: / Experiment 5:

Continue …

Rev 7-2010

3. JUSTIFICATION FOR THE NUMBER OF ANIMALS:

To ensure all animals within MMCRI Animal Facility are covered under
an approved protocol for proper care and use:

® All animal species and strains to be used must be listed on the protocol

® Anyone producing animals with this intention in mind must first add these strains to their protocols, as an amendment, and gain IACUC approval prior to any production of transgenic mice for this purpose.

® Exemptions will be given in the case if the external user/company directly requests transgenic mouse production service to the Mouse Transgenic Core Facility.

® PI’s who wish to transfer a strain to another MMCRI investigator, refer to SOP: 99-004C, The Transferring of Unused Animals to a Different Protocol.

® Each protocol utilizing animals has an IACUC approved animal allotment and justified amount.

® Upon reaching 80% usage of the allotted approved amount of animals, the PI will be notified by the Animal Facility. The PI has the option to submit an amendment for IACUC approval to add additional animals to the protocol. If the PI has chosen not to amend the protocol, the existing breeders will be separated and no further breeding and animal orders will be allowed. (Pups are added to the census at the time of weaning.)

® Reportable OLAW Incident: If the PI exceeds the number allotted without amending the protocol, and it is funded by an NIH grant, this is considered a reportable OLAW incident.

*Verify the Number of animals needed per procedure and number of animals for maintenance of colony.
(Include USDA Procedure Category B, C, D, E)
Please retain the statistical tests, strategy, or method for evaluating data for your study.
*Verification: (Cell will expand)

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

4. EXPERIMENT DESIGN:

Experiment Design # 1:
Strain: / n =
DAY / PROCEDURE / CATEGORY

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 2:
Strain: / n =
DAY / PROCEDURE / CATEGORY

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 3:
Strain: / n =
DAY / PROCEDURE / CATEGORY

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 4:
Strain: / n =
DAY / PROCEDURE / CATEGORY

Rev 7-2010

5. STRAIN/LINES:

Species:
Strain/line:
Phenotype/special care:
Supplier:
If to be created @ MMCRI, IBC #:
Name of construct:
Function of the gene product:

Rev 7-2010

SECTION: V USDA STUDY PAIN CATEGORIES

Signs of pain may vary from animal to animal, the operational definition of pain described in the U.S. Government Principles for the Utilization of and Care of Vertebrate Animals Used in Testing, Research and Training states, "Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain and distress in other animals." In defining animal stress, we must properly distinguish between "stress" and "distress." The National Research Council (1992) appropriately defines distress as "an aversive state in which an animal is unable to adapt completely to stressors and the resulting stress and shows maladaptive behaviors."

Category C: STUDIES ON LIVE, VERTEBRATE ANIMALS CAUSING NO MORE THAN MINIMAL PAIN, DISTRESS, OR DISCOMFORT.

Involving No Pain or Use of Pain Relieving Drugs

Examples include: routine examinations; blood sampling; MRI, injection of non-toxic materials; approved methods of euthanasia that induce rapid unconsciousness; short periods (up to 24 hours) of withholding food and water. Acceptable levels of "minimal pain, distress, or discomfort" in this category would be those procedures that are normally done on animals given routine physical examinations at veterinary clinics. (How would a human undergoing a similar procedure be treated? Would a sedative or analgesic be provided?) Animals that are euthanized and then have tissues/organs removed would be included in this category.

Category D: STUDIES ON LIVE ANIMALS INVOLVING PAIN, STRESS, OR DISTRESS WHICH IS ALLEVIATED OR CONTROLLED BY ANESTHESIA OR ANALGESIA.

Examples include studies on anesthetized animals (that may or may not regain consciousness), such as survival surgical procedures that may result in even minor post surgical discomfort. Also included are studies using noxious stimuli from which escape is possible; some tumor or device implants; the use of Freund's complete adjuvant. Other examples include major surgery under general anesthesia that results in significant post-operative discomfort, prolonged periods (several hours or more) of uncooperative physical restraint; deprivation of the animals' environmental necessities, such as maternal deprivation; aggression; and predator-prey interactions. Also included are studies in which diseases or toxicities are induced and the animals are expected to become sick or abnormal. Animals in Type 2 studies may experience pain, but the necessary treatments to alleviate the symptoms are available and provided, or the animals are euthanized. Involvement of trained technicians, scientists, and veterinarians is critical if this pain is to be minimized or avoided. Adherence to acceptable veterinary practices is mandatory and will vary depending on the project, i.e. post-op analgesia, fluid therapy or intensive nursing care. The standard at UF is to provide analgesics in all instances in which a human in a similar situation would receive them.

Category E: PROJECTS INVOLVING SIGNIFICANT PAIN OR DISTRESS WITHOUT THE BENEFIT OF PAIN-RELIEVING DRUGS. Also, death as an end point. Examples include: application of noxious stimuli from which escape is impossible; the use of muscle relaxants in surgery without concurrent use of anesthetics, induction of aggressive behavior leading to self-mutilation or fighting where death is the end-point. Also included are studies in which death is the end-point, i.e. diseases are induced and infected animals are permitted to succumb rather than be treated.

Comment: Animals are expected to show clinical symptoms of pain or distress as a result of the research objectives, but these symptoms cannot be treated or otherwise alleviated with the use of drugs or intensive care because doing so would interfere with the research objectives. Type 3 studies place an explicit responsibility on investigators to explore alternative designs to ensure that these methods have to be used. Scientific justification for using these procedures and withholding analgesia or treatment must be explained in a statement by the Principle Investigator. This statement is required by federal law. The IACUC submits these statements in the annual reports to the government.

Rev 7-2010

Procedures and Staffing

· Procedures that may cause more than momentary or slight pain must, in their planning, involve consultation with a veterinarian.

· Mouse tail and toe biopsy are standard procedures and procedure request are not require as long as SOP 00-021C Mouse Procedures is being follow