Test OLAW form

Date of submission*

A. ADMINISTRATIVE DATA

Principal Investigator*

First Last

Phone*

FAX

Email*

Enter Email Confirm Email

Address*

Street Address Address Line 2 City State ZIP Code

Project title*

Submission Type*

Initial Submission
Triennial
Modification

Funding Source(s)*

Key Personnel & Personnel authorized to conduct procedures on animals*

Personnel Name	UFID	Role in the Study	Phone #	e-mail	Department

List the names of all individuals authorized to conduct procedures involving animals under this proposal and identify key personnel [e.g., co-investigator(s)], providing their department, telephone, and e-mail.

B. ANIMAL REQUIREMENTS

Genus*

Species*

[e.g., musculus]

Strain, subspecies, or breed*

[e.g., C57BL/6]

Common Name*

[e.g., Black6]

Approximate age, weight or size*

Sex*

Males only
Females only
Both males and females

Bacteriological status*

Viral status*

[e.g., simian immunodeficency virus, simian retrovirus]

Source of animals*

[e.g., name of vendor or breeder, or bred in-house]

Primary housing location(s)*

Building	Room	ACS controlled (Y/N)?

If animals will be housed in lab or anywhere else outside central facility for more than 12 hours, provide building and room number.

Procedure Location(s)*

Building	Room

Location(s) where manipulation or procedures will be conducted

Number of Animals Used*

Year 1	Year 2	Year 3	TOTAL

C. TRANSPORTATION

Movement of animals*

Transportation of animals must conform to all institutional guidelines/policies and federal regulations. If animals will be transported on public roads or out of state, describe methods you will use to comply with USDA regulations. If animals will be transported between facilities, describe the methods and containers that will be used. If animals will be transported within a facility, include the route and elevator(s) that will be used.

D. STUDY OBJECTIVES

Aim(s) of the Study*

Briefly explain the aim of the study and why the study is important to human or animal health, the advancement of knowledge, or the good of society in language that a layperson can understand. Please comment on whether the study unnecessarily duplicates other studies.

E. RATIONALE FOR ANIMAL USE

Rationale*

[The rationale should include reasons why it is necessary to use animal models.]

Appropriateness of Species Justification*

Justify the appropriateness of the species selected. [The species selected should be the lowest possible on the phylogenetic scale.]

Animal Number Justification*

Justify the number of animals to be used. [The number of animals should be the minimum number required to obtain statistically valid results. Include justification for group size through a power analysis when possible.]

F. DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES

Explanation of the experimental design and all animal procedures*

Briefly explain the experimental design and specify all animal procedures. All procedures to be employed in the study must be described. This description should allow the IACUC to understand the experimental course of an animal from its entry into the experiment to the endpoint of the study. A flowchart may be an effective presentation of the planned procedure. A best practice is to provide an acceptable range of the specific items described below to allow flexibility in the use of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly restricted parameters. Include the following specific information, if applicable: • Animal identification methods [e.g., ear tags, tattoos, collar, cage card, implant, etc.]. • Methods of restraint [e.g., restraint chairs, collars, vests, harnesses, slings, etc.]. Describe how animals are restrained for routine procedures like blood withdrawals. Prolonged restraint must be justified with appropriate oversight to ensure it is minimally distressing. Describe any sedation, acclimation or training to be used. • Experimental injections or inoculations [substances, e.g., infectious agents, adjuvants, etc.; dose, sites, volume, route, and schedule]. • Blood withdrawals [volume, frequency, withdrawal site, and methodology]. • Radiation [dosage and schedule]. • Food or fluid restriction If food, or fluid, or both food and fluid, will be restricted, describe method for assessing the health and wellbeing of the animals. [Amount earned during testing and amount freely given must be recorded and assessed to assure proper nutrition.] If you are seeking a departure from the recommendations of the Guide, provide a scientific justification. • Pharmaceutical-grade and Non-pharmaceutical-grade Compounds Identify any drugs, biologics, or reagents that will be administered to animals. If these agents are not human or veterinary pharmaceutical-grade substances, provide a scientific justification for their use and describe methods that will be used to ensure appropriate preparation and administration. • Other procedures [e.g., survival studies, tail biopsies]. • Resultant effects, if any, that the animals are expected to experience [e.g., pain or distress, ascites production, etc.]. Animal Study Proposal v12/8/2015 2 • Other potential stressors [e.g., noxious stimuli, environmental stress] and procedures to monitor and minimize distress. If a study is USDA Classification E, describe any non-pharmaceutical methods that will be used to minimize pain and distress. • Experimental endpoint criteria [e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavioral abnormalities, clinical symptomatology, or signs of toxicity] must be specified when the administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals are expected to cause significant symptomatology or are potentially lethal. List the criteria that will be used to determine when euthanasia is to be performed. Death as an endpoint must be scientifically justified. • Veterinary care Indicate the plan of action in case of animal illness [e.g., initiate treatment, call investigator prior to initiating treatment, euthanize]. • Surgical procedures [provide details of survival and non-survival surgical procedures in Section G.].

G. SURGERY

If surgery is proposed, complete the following:

Is surgery, either survival or non-survival proposed in this protocol?*

Yes
No

Surgical procedure description

Identify and describe the surgical procedure(s) to be performed. Include preoperative procedures [e.g., fasting, analgesic loading], and monitoring and supportive care during surgery. Include the aseptic methods to be used.

Personnel conducting procedures*

Name	UFID	Qualifications, Training & Experience

Identify the individual(s) that will perform surgery and their qualifications, training, and/or experience.

Surgery location

Identify the location where surgery will be performed. [building(s) and room(s)]

Survival surgery?*

Yes
No

Survival surgery description

Describe postoperative care that will be provided and frequency of observation. Identify the responsible individual(s) and location(s) where care will be provided. [building(s) and room(s)] Include detection and management of postoperative complications during work hours, after hours, weekends and holidays.

Non-survival surgery

Yes
No

Non-survival surgery description

For non-survival surgery, describe how euthanasia will be provided and how death will be determined.

Are paralytics used?

Yes
No

Paralytics use

Please describe how ventilation will be maintained and how pain will be assessed.

Has major or minor survival surgery been performed on any animal prior to being placed on this study?

Yes
No

[Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation)]

Prior surgery / non-naive animal explanation

[Major survival surgery penetrates and exposes a body cavity or produces substantial impairment of physical or physiologic functions or involves extensive tissue dissection or transection (such as laparotomy, thoracotomy, craniotomy, joint replacement, or limb amputation)]. If yes, please explain.

Will more than 1 survival surgery be performed on any animal?

Yes
No

If yes, please justify

H. PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES

Animal Classification & Use Table

Species (common name)	USDA Classification B, C, D or E	Number of Animals expected to be used YR1	Number of Animals expected to be used YR2	Number of Animals expected to be used YR3	Total Number of Animals

Fill out the USDA Classification Table

Does this protocol have animals USDA classified as "D" or "E"?*

Yes
No

Consideration of Alternatives

If any procedures fall into USDA's Classification D or E, causing more than momentary or slight pain or distress to the animals, describe your consideration of alternatives and your determination that alternatives are not available. Delineate the methods and sources used in the search. Database references must include databases searched, the date of the search, period covered, and the keywords used. Alternatives include methods that: • refine existing tests by minimizing animal distress, • reduce the number of animals necessary for an experiment, or • replace whole-animal use with in vitro or other tests. If you use ascites production to produce antibodies, you must provide the reason for not using an in vitro system. Note that you must certify in Section Q.5. that no valid alternative was identified to any described procedures which may cause more than momentary pain or distress, whether relieved or not.

I. ANESTHESIA, ANALGESIA, TRANQUILIZATION, OTHER AGENTS

Drugs and / or chemicals list*

Name	Pharmaceutical grade (Yes/No)?	Dose Range	Route given	Frequency of administration

For animals indicated in Section H.1. Classification D, specify the anesthetics, analgesics, sedatives or tranquilizers that will be used. [A best practice is to provide an acceptable range of the specific items to allow flexibility in the use of professional judgment and avoid non-compliance due to work conducted off protocol as a result of overly restricted parameters.] Include the name of the agent(s), the dosage range, route(s) and schedule of administration. Description of tracking and security of controlled drugs (Drug Enforcement Agency requirements) will be found in Section K..

J. METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY

Indicate the proposed method of euthanasia*

If a chemical agent is used, specify the dosage range and route of administration. If the method of euthanasia is not consistent with the AVMA Guidelines for the Euthanasia of Animals, provide scientific justification as to why such method must be used. Indicate the method of carcass disposal if not described in Section K. below.

K. HAZARDOUS AGENTS

Use of hazardous agents requires the approval of the institutional Biosafety Office/Committee. Attach documentation of approval for the use of recombinant DNA or potential human pathogens.

Radionuclide Use?*

Yes
No

Hazardous Agents / Radionuclides

Agent Name	Date of Approval	Registration #

Detail the radionuclides used in your animal proposal

Radioactive monitoring and waste removal

Describe the practices and procedures required for the safe handling and disposal of removal of radioactive waste and, if applicable, the monitoring of radioactivity.

Biological Agent Use?*

Yes
No

Hazardous Agents / Biological Agents

Agent Name	Date of approval	EHS registration #

Detail the biological agents used in your animal proposal

Hazardous biological material practices and procedures*

Describe the practices and procedures required for the safe handling and disposal of contaminated animals and material associated with this study.

Hazardous Chemicals or Drugs use?*

Yes
No

Hazardous Agents / Chemicals & Drugs

Agent Name	Pharmaceutical grade?	Purpose	Dose range?	Delivery route?	Freqency of administration

Are any chemicals or drugs DEA regulated?*

Yes
No

DEA license number

DEA license expiry date

Describe tracking and security of controlled drugs (Drug Enforcement Agency requirements).

Are any chemicals or drugs regulated by the State of Florida?*

Yes
No

Are any chemicals or drugs state regulated and require a letter of exemption from the Division of Business & Professional Regulation (DBPR)?

State of Florida DBPR Exemption Number

Please provide the ID number for your DBPR Exemption letter

State of Florida DBPR Exemption Letter expiry date

Study Conducted at Animal Biosafety Level*

ABSL-1
ABSL-2
ABSL-3
ABSL-4

Additional safety considerations

Describe any additional safety considerations

L. BIOLOGICAL MATERIAL / ANIMAL PRODUCTS FOR USE IN ANIMALS

[e.g., cell lines, antiserum, etc.]

Biological materials

Material	Source	Sterile or Attenuated	Pathogen tested (Y/N)

Specify Material, Source, Sterile or Attenuated, whether tested for pathogens

Upload pathogen testing documents

Drop files here or

Please provide pathogen testing data: eg MAP - Mouse Antibody Production; RAP - Rat Antibody Production; HAP - Hamster Antibody Production, PCR test

Certification / Rodent Pathogens

I certify that the tested materials to be used have not been passed through rodent species outside of the animal facility in question and/or the material is derived from the original tested sample. To the best of my knowledge the material remains uncontaminated with rodent pathogens.

Rodent Pathogens Certification, PI Signature*

M. GENETICALLY ENGINEERED ANIMALS

Will you use any Genetically Modified Animals (GMAs)?*

Yes
No

Care and use of GM animals

Describe any anticipated phenotypic consequences of the genetic manipulations to the animals. Describe any special care or monitoring that the animals will require.

N. EXEMPTIONS FROM ENVIRONMENTAL ENRICHMENT FOR NONHUMAN PRIMATES OR EXERCISE FOR DOGS

Will you use non-human primates or dogs in your research*

Yes
No

Seeking primate exemption from enrichment?

Yes
No

Primate enrichment exemption justification

If you are seeking an exemption for scientific reasons from the institution’s plan for environment enrichment, please provide the basis of the request.

Seeking dog exercise exemption?

Yes
No

Dog exercise exemption justification

O. FIELD STUDIES

Will any animals in the wild be used?*

Yes
No

How will they be observed?

Describe any interactions with the animals

Will the animals be disturbed or affected by observations or interactions made by the study staff?

Yes
No

Are permits required for this work?

Yes
No

Indicate if federal, state, and/or local permits are required

What permits are required?

Indicate the particular federal, state, and/or local permits needed

What permits have been obtained?

P. SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY

Will there be any departures from "The Guide"*

Yes
No

Special housing, equipment, animal care, special caging, water, feed, waste disposal, environmental enrichment, etc.

Describe departures from "the Guide" or any special conditions that must be met.

Q. PRINCIPAL INVESTIGATOR CERTIFICATIONS

Certification / PI training*

I certify that I have attended the institutionally required investigator training course.

Certification / PI training Information*

Year of course attendance	Location

Please provide the year of course attendance and location.

Certification / Duplication*

I certify that I have determined that the research proposed herein is not unnecessarily duplicative of previously reported research.

Certification / Personnel Safety*

I certify that all individuals working on this proposal who are at risk are participating in the institution's Occupational Health and Safety Program.

Certification / Personnel Training*

I certify that the individuals listed in Section A. are authorized to conduct procedures involving animals under this proposal, have attended the institutionally required investigator training course, and received training in: the biology, handling, and care of this species; aseptic surgical methods and techniques (if necessary); the concept, availability, and use of research or testing methods that limit the use of animals or minimize distress; the proper use of anesthetics, analgesics, and tranquilizers (if necessary); and procedures for reporting animal welfare concerns.

Certification / Alternatives Review*

For all USDA Classification D and E proposals (see section H.1.): I certify that I have reviewed the pertinent scientific literature and the sources and/or databases as noted in Section H.2. and have found no valid alternative to any procedures described herein which may cause more than momentary pain or distress, whether it is relieved or not.

Certification / Approval for IACUC Changes*

I certify that I will obtain approval from the IACUC before initiating any significant changes in this study.

Certification / Unexpected Results Procedure*

I certify that I will notify the IACUC regarding any unexpected study results that impact the animals. Any unanticipated pain or distress, morbidity or mortality will be reported to the attending veterinarian and the IACUC.

Certification / Regulatory Compliance

I certify that I am familiar with and will comply with all pertinent institutional, state, and federal rules and policies.

Principal Investigator Authentication

PI Name*

Signature

Date*

University of Florida

Cell & Tissue Analysis Core

University of Florida, McKnight Brain Institute