Maine Medical Center

Rev 6-2013

MaineHealth

Institutional Animal Care & Use Committee

Application of Intent to Use Vertebrate Animals in Research

ü Animal Facility Training Required Prior to Starting Any Project

(Refer to the Animal Facility's SOPs located on the share drive)

ü Any Animals Arriving From Non-Approved Vendors Are Rederived

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

ü Questions: MMCRI - Research Compliance Office: 207-396-8195

ü 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.

ü 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.

ü 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.

REVISED FORM – 6/2013

ü NMR Added to Equipment Page

Maine Medical Center Institutional Animal Care & Use Committee

IACUC New Submission/Triennial/Amendment Form

IACUC #: / Old # if Triennial: / Today's Date: / Species:
Principal Investigator: / Email: / Phone:
Work Address if not MMCRI:
Title of Protocol:
Research: / Teaching/Educational: / Student Project or Fellowship:
Grant & Funding Section:
#1 Title of Grant:
Funding Agency: / Grant or Contract #: / Cost Center #:
#2 Title of Grant:
Funding Agency: / Grant or Contract #: / Cost Center #:
#3 Title of Grant:
Funding Agency: / Grant or Contract #: / Cost Center #:
By checking box to right, PI confirms grant matches PHS funded protocol.
(Applies to new grant submissions and continuing reviews) / Initials Here:
Attach the grant page that contains grant number information and
the grant page that explains animal experiments. (NIH Requirement)
Protocol Submission Section: Complete entire form if you are submitting either a New Submission or Triennial
Type of Submission: / New : / Triennial: / Amendment:
Working with Radiation? / YES? / NO? / If so, have you been trained? / Date of training:
Confirm date you spoke with Dr. Breggia: / Date:
Amendment Section:
Adding Additional Strains? List Each Strain Below / Additional Animals/Staff:
Are you working with genetically modified animals? / YES / NO / How many more animals are added to the protocol because of this amendment? / #
Add Procedure(s) Below: / Name(s) of Personnel being Added:
Name(s) of Personnel to Remove:
Notes:

SECTION: II INVESTIGATOR ASSURANCE

The undersigned Principal Investigator for the research project described on the preceding pages document, hereby gives assurance that he/she will comply fully with Federal Law as set forth in the Animal Welfare Act.

Further, if the protocol described is approved by the MMC IACUC, the investigator will:

A. Adhere strictly to the protocol as described herein;

B. Seek consent of the IACUC for any change(s) in the protocol before being implemented, and notify the

IACUC of any change(s) in the location(s) where the animal s research is carried out;

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

D. Assure activities involving vertebrate animals in this application do not necessarily duplicate previous experiments;

E. Agree to emergency veterinary care by the appointed MMC veterinarian, if there is evidence of pain or illness;

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

ü Ensure that all animal program SOPs are followed

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

ü Ensure appropriate measures are in place and are being given for minimum pain and distress,
and humane treatment of animals.

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

ü Check on animals at least once per week.

There have been no changes made to this protocol since my last approval.

Initials Here:

______

Signature of Principal Investigator Date

This Assurance must be signed at time of submission.

SECTION: III NON-TECHNICAL LAY SUMMARY OF PROJECT

1. PURPOSE/GOALS:

MANDATORY: Include publications with your triennial submission.

The lay summary MUST 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 must be in terms that non-scientists can understand. Please limit the length of this summary to one page.

** MUST BE IN CLEAR, SIMPLE LANGUAGE**

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

Please Note: SOP 10-031AProtocol Submission and Renewal Process, Sec. 3.4.4 allows the PIthree weeksto respond to an IACUC request for changes. If no response is received, the submission will be closed.

SECTION: IV IBC/IRB/ESCRO REVIEW - (NEW)

If your protocol requires review from the Institutional Biosafety Committee (IBC), the Institutional Review Board (IRB), or the Embryonic Stem Cell Research Oversight Committee (ESCRO), the IACUC will not issue approval until other committees have done so first. However, the other review(s) may take place concurrently.

In order to determine if you need IBC, IRB, or ESCRO approval, please read below what each committee has authority over and whether or not this protocol should receive review by any of them.

IBC:

o This standing committee has oversight of recombinant DNA (rDNA) research, and the use of biohazardous materials for research. All activities proposed to involve the use of recombinant DNA and/or biohazardous materials must first seek approval from the Institutional Biosafety Committee.

IRB:

o This standing committee is responsible for protecting the rights and welfare of people who are subjects in research activities. All research projects involving human tissue or blood draws are required to be reviewed and approved by the MMC IRB prior to implementation.

ESCRO:

o The Embryonic Stem Cell Oversight committee ensures all federal and state regulations governing the conduct of human embryonic stem cell research are met and that all Human Embryonic Stem cell research is conducted in accordance with the general principles expressed in the NAS Guidelines for Human Embryonic Stem Cell Research (Guidelines), with the Policies and Procedures adopted by the Maine Medical Center hESCRO Committee, with other relevant Maine Medical Center research policies.

Please make a selection in the table below:

Select One From Below ê / ⊠ / This protocol is currently in review
with the following committee: ê / ⊠
I do not require approval from any of the committees listed to the right: / IBC
IRB
*I have already received approval from one of the committees listed to the right: / ESCRO
*If you have already received approval from one of the committees,
please attach a copy of the approval letter to this protocol.

SECTION: V 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 V for each successive species used. Begin your next species after #5 of this section.

1. JUSTIFICATION FOR THE SPECIES:

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

Please provide an electronic 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.

Send in MS Word Format or NotePad Formats Only (Website links are not accepted.)

Date search was conducted:
Years Covered:
(Ex. 1999-2010)
Databases Used:
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:

Tri Breeding (Harem Breeding): The Guide has new regulations regarding tri breeding. Please explain why you will need to tri-breed:

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)

4. NEW! Transporting Animals from MMCRI

Your Response is Required / "X" / "X"
Do you intend to transport animals from MMCRI? / YES: / NO:
Do you plan to transport animals via private vehicle? / YES: / NO:
If "YES" to either question above, you must follow SOP 99-003C Transporting Animals from MMCRI

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

To View an Experimental Design Samples, Click Here

5. EXPERIMENT DESIGN:

Experiment Design # 1:
Strain & Age / n =
DAY / PROCEDURE / CATEGORY
1
Day #/End Point / Euthanize

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 2:
Strain & Age / n =
DAY / PROCEDURE / CATEGORY
1
Day #/End Point / Euthanize

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 3:
Strain & Age / n =
DAY / PROCEDURE / CATEGORY
1
Day #/End Point / Euthanize

FLOW CHARTS ARE MANDATORY FOR ALL EXPERIMENT DESIGNS

Experiment Design # 4:
Strain & Age / n =
DAY / PROCEDURE / CATEGORY
1
Day #/End Point / Euthanize

6. STRAIN/LINES:

#1 Fill in all information

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

SECTION: VI USDA STUDY PAIN CATEGORIES

The definition of pain 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." Distress is defined 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:

Rev 6-2013

o Routine examinations

o Blood sampling

o MRI

o Short periods (up to 24 hours) of withholding food and water

o Injection of non-toxic materials

○ Approved methods of euthanasia
that induce rapid unconsciousness

Rev 6-2013

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:

· Anaesthetized 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; and the use of Freund's complete adjuvant.

· Other examples include major surgery under general anesthesia that results in: