Eastern Michigan University IACUC Application

Eastern Michigan University IACUC Application

This form is Eastern Michigan University's (EMU's) IACUC application. Please fill it out in its entirety. Responses can be edited after the form has been submitted.
If you have any questions, please contact EMU's IACUC at emu_iacuc@emich.edu.
Name

First NameLast Name
Emich E-mail
example@example.com

New ApplicationModificationRenewal

Study Information
Title of Study
Principal Investigator (PI) Information
YesNo
Principal Investigator (PI) Information
Additional Study Personnel
Please list all personnel with who will have live animal contact. Only individuals listed below will be authorized to handle animals when IACUC approval is granted. All individuals listed below are required to complete Animal Care and Use Training on Canvas. Please enroll in the training here.
Please upload grade reports from the Canvas Animal Care and Use training for all Study Team Members and PIs.

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Study Funding
Grant/Sub-awardContract/Sub-contractDepartment or campus fundsOther
YesNoOther
If you answered "other" above, please clarify your response in the box below.

Type of Animal Use
Basic ResearchApplied ResearchField ResearchStudent ResearchClassroom Instruction or TrainingTesting (toxicology, etc)Service (breeding, core facility, surveillance, etc.)Other
If you answered "other" above, please clarify your response in the box below.

Animal Numbers
Please provide your animal number details:

Protocol Narrative
Section 1: Project Overview
Using language understandable to a non-scientist, provide a summary of the proposed project. The summary must explain the long-term or overall scientific goals of the proposed work, describe the specific objectives of the proposed work, and describe the ways the proposed work will benefit human or animal health and welfare, serve the advancement of knowledge, and the good of society.

Section 3: Experimental Design

Provide a concise description below of the experimental design, describing all experiments to be performed.
Provide the rationale behind the experiment or the hypothesis being tested.
Define the groups and number of animals per group needed for the experiment(s), including both experimental and control animals and list the procedures to be performed on each group.
Explain how the number of animals for the experiment was determined to be adequate for the generation of statistically significant data (i.e., power analysis, previous publications).
Describe the sequence and timing of all live animal procedures to be performed, according to the groups defined above. Provide a timeline, diagram or flowchart if appropriate.
Describe any expected adverse consequences to the animals.
Describe any possible severe complications to the animals.
Define the procedural endpoints for each group of animals defined in above (i.e., what determines when the live animal portion of the experiment is complete and animals are euthanized.)

Section 4: Non-Surgical Procedures
Describe in detail all non-surgical procedures to be performed on live animals.

• Procedures described here must be referenced in the previous section.
• Animal monitoring and management (as applicable) must be addressed in the "Adverse Effects & Animal
Monitoring and Management" section .
• Each subsection below should be completed as it applies to the protocol.
• If a subsection does not apply, state “N/A” (Not Applicable).
• If non-surgical procedures WILL NOT be performed on live animals, skip this section.
YesNo
Terminal Procedures

Please explain the following if they apply
Euthanasia followed by tissue harvest:
Cardiac perfusion:
Blood and Tissue Collection in Live Animals

Please explain the following if they apply.
Please explain blood and tissue collection of live animals:
Behavioral Studies

Please explain the following if they apply.
If applicable, please explain the nature of how the behavioral study will involve animals:
Methods for Administering Experimental Agents in Live Animals
Please explain the following if they apply.

• Describe all non-surgical methods that will be used to administer experimental agents in animals (e.g., tail-vein injection,
retro-orbital injection, oral gavage; etc).
• Provide details such as total volume (agent + vehicle) in any one injection; location of repeated injections (e.g. rotating IP
injection sites to minimize soreness); size of gavage needle, etc.

DO NOT list surgical methods (e.g., implantation of cannulae, stereotaxic injections) – this should be described in the "Surgical Procedures" section.
If applicable, please explain the methods for administering experimental agents in your live animals.
Induction of Anesthesia/Sedation for Non-Surgical Procedures in Live Animals

Please explain the following if they apply.
Indicate how anesthesia/sedation is induced for non-surgical procedures:
Describe how the level of anesthesia/sedation is assessed to be adequate to begin the non-surgical procedure:
Describe how animals are monitored throughout the non-surgical procedure (e.g., respiration pattern, response to noxious stimulation (paw pinch, etc.), heart rate/pattern, EKG, blood pressure, temperature, etc.):
Discuss the duration of anesthesia and any supplemental anesthesia dosing that may be required:
If animals will be placed on artificial ventilation, describe the range of respiration rates and tidal volumes.
For survival non-surgical procedures, describe how animals are monitored for recovery from anesthesia/sedation and when animals are returned to their home cages. Estimate how long it will take for the animal to recover from anesthesia/sedation (i.e. ambulatory and feeding, etc.):
Describe any analgesia or supplemental pain relief methods that will be used:
Describe any neuromuscular blocking agents that will be used:
Other Non-Surgical Procedures in Live Animals
If applicable, please list and describe any other non-surgical procedures that you will be using on live animals:
Post-Procedural Care for Non-Surgical Procedures in Live Animals
If applicable, please list and describe any other post-procedural care for non-surgical procedures in live animals:

Section 5: Surgical Procedures
Describe in detail all surgical procedures to be performed.

• Procedures described here must be referenced in the "Experimental Design" section which is in the "Protocol Narrative" document.

• Animal monitoring and management (as applicable) must be addressed in the "Adverse Effects & Animal Monitoring and Management" section.

• Each subsection below should be addressed as it applies to the surgical procedure, for each type of surgical procedure that will be performed.

• If a subsection does not apply, state “N/A” (Not Applicable).
YesNo
Pre-Operative Care

Please explain the following if applicable.
Describe any care given to the animals prior to the surgery (e.g., fasting, sedation, pre-operative physical exam or blood work, etc.):
Provide the names and describe the qualifications and experience of each surgeon:
Induction of Anesthesia for Surgical Procedures in Live Animals

Please explain the following if applicable.
Indicate how anesthesia is induced:
Describe how the level of anesthesia is assessed to be adequate to begin the procedure:
Describe how animals are monitored throughout the procedure (e.g., respiration pattern, response to noxious stimulation such as a paw pinch, heart rate/pattern, EKG, blood pressure, body temperature, etc.). Discuss any supplemental anesthesia dosing that may be required:
If animals will be placed on artificial ventilation, describe the range of respiration rates and tidal volumes:
Aseptic Techniques

Please explain the following if applicable.
Preparation of the surgical space:
Preparation of the surgeon (e.g., surgical scrub of hands, donning surgical attire, sterile gloves, etc.):
Preparation of the animal (e.g., clip fur, clean surgical site with antiseptics, use of sterile drapes, application of eye ointment, etc.):
Sterilization of instruments - Describe how instruments will be sterilized (e.g., autoclave, glass bead sterilizer, chemical sterilant, etc.):
Description of Surgical Procedures

Please explain the following if applicable.
YesNo
Provide details of the surgical procedures that will be performed during the terminal surgery. State the surgical endpoints.
YesNo
Provide details of the surgical procedures that will be performed during the survival surgery. State the surgical endpoints.
Multiple Surgeries
YesNo
Describe the surgery, including all surgical procedures to be performed:
Indicate the minimum interval of time between procedures.
Describe how animals will be monitored for healing between survival surgical procedures. Indicate whether adjustments will be made to accommodate animals who may take longer to heal.
Briefly describe the purpose of the multiple major surgical procedures.
If animals have undergone major surgical procedures prior to use in this project, briefly describe why an animal will be used in a second project involving major surgical procedures from which the animal is allowed to recover.
Methods to Prevent Dehydration & Hypothermia
If applicable, please describe the methods to prevent dehydration and hypothermia:
Post-Operative Care and Analgesic Usage

Please explain the following if applicable.
For survival surgeries, provide details of the post-operative care that will be provided to the animals following surgery. Describe how animals are monitored for recovery from anesthesia and when animals are returned to their home cages. Estimate how long it will take for the animal to recover from anesthesia (i.e., ambulatory and feeding).

Section 6: Adverse Effects & Animal Monitoring and Management
The questions in this section will ask you to describe, if applicable to your study:

1. The clinical signs and symptoms of pain, destress, and other adverse effects

2. The monitoring and management of pain and distress

3. Euthanasia criteria
Clinical Signs & Symptoms of Pain/Distress and other Adverse Effects
Briefly summarize all possible adverse effects or phenotypic abnormalities that may present in the animals as a result of study procedures, agents, disease processes, genetic alterations, etc. (i.e., tumor formation, ascites, neurologic deficits, infection, diabetes, etc.). Describe the clinical signs and symptoms that may appear in the animals, including any associated pain, distress, or discomfort.
Monitoring and Managing Pain & Distress
Describe the monitoring parameters that will be used to assess pain, distress, and discomfort in animals (i.e., signs, symptoms, and species-specific behaviors):
Provide details of the management plan that will be used to assess and treat pain, distress and discomfort in the animals, including any special procedures that will be used (e.g., periodic weighing of animals) and any interventions that will be performed to relieve pain, distress and discomfort in the animals:
Describe the frequency in which laboratory staff will be monitoring that animals, in addtion to the daily general observations made by vivarium staff.
Monitoring of animals (e.g., daily observations, treatments performed by research staff) must be documented. Monitoring records must be made available to IACUC members upon request. Describe how monitoring will be documented:
Euthanasia Criteria
Describe the criteria that will be used to determine that an animal must be removed from the study and euthanized.

Section 7: Table of Drugs and Agents Used in Live Animals

Anesthetic, Analgesic, and Paralytic Agents

Rows	Species	Drug/Agent	Dose Range	Route*	Frequency	Duration
1.
2.
3.

Therapeutic Agents (including antibiotics, fluids, antimicrobials, etc.)

Rows	Species	Drug/Agent	Dose Range	Route*	Frequency	Duration
1.
2.
3.

Experimental Agents (including investigational new drugs, placebos, tumor cells, stem cells, gene markers, tracers, radioisotopes, imaging contrast agents, viruses, etc.)

Rows	Species	Drug/Agent	Dose Range	Route*	Frequency	Duration
1.
2.
3.

Other Agents (anything not listed in a previous section)

Rows	Species	Drug/Agent	Dose Range	Route*	Frequency	Duration
1.
2.
3.

Section 8: Euthanasia Methods
CO2 overdose with secondary physical methodAnesthetic overdosePhysical methodsCardiac PerfusionOther
CO2 Overdose with Secondary Physical Method. NOTE: All rodents euthanized with CO2 need to undergo a secondary physical method of euthanasia to ensure death. Indicate secondary physical method:

Open chest inspection of the heartExsanguination (cutting a major blood vessel)Physical methodOther (describe below)
Please describe "other" method of confirmation of death in animals.

If animals WILL NOT be anesthetized before the physical method of euthanasia, provide strong scientific justification and a reference.
Other Methods. Please describe other methods:
Justification
Provide a scientific justification for all methods of euthanasia below.

*If you plan to use ether, provide a justification below and include the precautions you will follow per recommendations in the Guide for the Care and Use of Laboratory Animals.
Justification:

Rows	Description
Decapitation
Cervical Dislocation
Other Physical Methods

Investigator Assurance and Departmental Approval Form
Investigator Assurance and Departmental Approval Form
Please upload your completed Assurance and Departmental Approval form to this section.*

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Should be Empty:

Rows	Species	Agent	Dose (mg/kg)	Route of Administration
1.
2.
3.

Rows	Species	Agent	Dose (mg/kg)	Route of Administration
1.
2.
3.

Eastern Michigan University IACUC Application

Study Information

Additional Study Personnel

Study Funding

Type of Animal Use

Animal Numbers

Procedures to be Performed on Live Animals

Hazardous Agents

Anesthetic Gases

Chemical and Biohazard Use

Radioactive Agent Use

Other Hazardous Agents

Controlled Substances

Animal Housing and Procedure Locations

Building and Room Information

Protocol Narrative

Section 1: Project Overview

Section 2: Justification for the Use of Animals

Rationale for the Use of Animals

Consideration of Alternatives to Live Animal Use, Painful Procedures, and Unnecessary Duplication

Potential Future Consolation Information

Section 3: Experimental Design

Section 4: Non-Surgical Procedures

Terminal Procedures

Blood and Tissue Collection in Live Animals

Behavioral Studies

Methods for Administering Experimental Agents in Live Animals

Induction of Anesthesia/Sedation for Non-Surgical Procedures in Live Animals

Other Non-Surgical Procedures in Live Animals

Post-Procedural Care for Non-Surgical Procedures in Live Animals

Section 5: Surgical Procedures

Pre-Operative Care

Induction of Anesthesia for Surgical Procedures in Live Animals

Aseptic Techniques

Description of Surgical Procedures

Multiple Surgeries

Methods to Prevent Dehydration & Hypothermia

Post-Operative Care and Analgesic Usage

Section 6: Adverse Effects & Animal Monitoring and Management

Clinical Signs & Symptoms of Pain/Distress and other Adverse Effects

Monitoring and Managing Pain & Distress

Euthanasia Criteria

Section 7: Table of Drugs and Agents Used in Live Animals

Section 8: Euthanasia Methods

Justification

Investigator Assurance and Departmental Approval Form