OFFICE FOR RESPONSIBLE RESEARCH USE ONLY / Review Date: / Committee ID:
Approval Date: / Length of Approval:
Continuing Review Date: / FULL Committee Review Date:
Date OSPA Database: / Date in Compliance Database:
Project Closure Date:
Key Personnel Training: Complete / Date of Completion: Incomplete

ISU RESPONSIBLE RESEARCH REVIEW FORM -

USE OF ANIMALS IN RESEARCH

SECTION I: GENERAL INFORMATION
Principal Investigator (PI): / Phone: / Fax:
Degrees: / Correspondence Address:
Department: / Email Address:
Center/Institute: / College:
PI Level: Faculty Staff Postdoctoral Graduate Student
Alternate Contact Person: / Email Address:
Correspondence Address: / Phone:
Title of Project:
Start Date for involvement of Animals or Biohazards (mm/dd/yy):

KEY PERSONNEL

List all members and relevant experience of the project personnel. This information is intended to inform the committee

of the training and background related to the specific procedures that each person will perform on the project.

NAME / DEGREE / SPECIFIC DUTIES ON PROJECT / TRAINING & EXPERIENCE RELATED TO PROCEDURES PERFORMED, DATE OF TRAINING

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FUNDING INFORMATION

Provide the funding source for the project below. Do not skip this question. If not applicable, please explain under “Other.”

Internally funded, please provide account number:
Externally funded, please provide funding source and account number:
Funding is pending please provide OSPA Record ID on GoldSheet:
Title on GoldSheet if different from above:
Other:

SCIENTIFIC REVIEW

Yes No Has or will this project receive peer review?

If “yes,” please indicate who did or will conduct the review:

If a review was conducted, please indicate the outcome of the review:

COLLECTION OR RECEIPT OF BIOLOGICAL SAMPLES

Will you be: (Please check all that apply.)

YesNoReceiving samples from outside of ISU? See examples below.

YesNoSending samples outside of ISU? See examples below.

Examples include: genetically modified organisms, body fluids, tissue samples, blood samples, and pathogens.

If you will be receiving samples from or sending samples outside of ISU, please identify the name of the outside organization(s) and the identity of the samples you will be sending or receiving outside of ISU:

SECTION II: APPLICATION FOR INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPROVAL

YesNoDoes this project involve live vertebrate animals? If “no” is checked, you don’t need to answer the questions in SECTION II.

SECTION III: APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) APPROVAL

YesNoDoes this project involve any of the following: Recombinant DNA (including transgenic animals); human, plant or animal pathogens; biological toxins; or administration of experimental biological products? If “no” is checked, you don’t need to answer the questions in SECTION III.

SECTION IV: ENVIRONMENTAL HEALTH AND SAFETY INFORMATION (EH&S)

YesNoDoes this project involve laboratory chemicals, human cell lines or tissue culture (primary OR immortalized), or human blood components, body fluid or tissues? If “no” is checked, you don’t need to answer the questions in SECTION IV.

ASSURANCE
  • I certify that the information provided in this application is complete and accurate and consistent with any proposal(s) submitted to external funding agencies.
  • I agree to provide proper surveillance of this project to ensure that the health and welfare of animal subjects are protected. I will report any problems to the appropriate compliance review committee(s).
  • I certify that this project does not unnecessarily duplicate previous experiments involving animals.
  • I agree that modifications to the originally approved project will not take place without prior review and approval by the appropriate committee(s), and that all activities will be performed in accordance with all applicable federal, state, local and Iowa State University policies.
  • I will follow applicable biosafety level requirements, comply with all shipping requirements and required waste management practices.
  • I will ensure that all personnel have appropriate training. including but not limited to: biosafety principles and techniques, accidental spills, shipping regulations, proper handling of biohazardous materials and waste management, animal welfare regulations, and human subject regulations training.

CONFLICT OF INTEREST

YesNoWill you or any member of your research team have an actual or potential conflict of interest?

YesNoIf yes, have the appropriate disclosure forms been completed?

SIGNATURES

Signature of Principal InvestigatorDate

Signature of Department Chair Date

FOR OFFICE FOR RESPONSIBLE RESEARCH /IACUC USE ONLY:

Project approved (date: )

Project not approved (date: )

IACUC Approval SignatureDate

FOR OFFICE FOR RESPONSIBLE RESEARCH /IBC USE ONLY:

Initial action by the IBC :

Project exempt. Date: ______Project referred to the full committee. Date: ______

Project approved. Date: ______Pending further review. Date: ______

Project not approved. Date: ______

Follow-up action by the IBC:

Signature of IBC ChairDate

PLEASE NOTE: Any changes to an approved protocol must be submitted to and approved by the appropriate committee(s) before the changes may be implemented.

SECTION II: APPLICATION FOR INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE APPROVAL

STUDY OBJECTIVES

Provide an overall summary of the project and briefly explain in language understandable to the general public the specific aim(s) of the study.

BENEFIT

Explain in language understandable to the general public how the information gained in this study will benefit human or animal health, the advancement of knowledge, and/or serve the good of society. This information is intended to inform the committee why it is important to conduct this study.

PART A:SPECIES

Table 1:

Genus/Species

or Common

Name

/ Strain, Subspecies or Breed / Total* Number to Be Used in Entire Project / Humane Use Category / Approximate Age, Weight or Size /

Sex

In B / In C / In D / In E

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*You must include the total number of each species that you anticipate will be used during the entire project. This

includes any animals that will be purchased as extra animals or that are started on the study but removed before

completion.

PAIN OR DISTRESS CLASSIFICATION AND CONSIDERATION OF ALTERNATIVES

A) If animals in this project will be in category D, you must provide a written narrative below of the sources consulted to determine whether or not alternatives exist to procedures that may cause pain or distress. At a minimum you must include: the names of the databases searched; the date the search was performed; the period covered by the search; and the key words and/or the search strategy used; potential alternatives and why they were not appropriate.

B) If any animals in this project will be in category E, an explanation of the procedures producing pain or distress in the animal and the justification for not using appropriate anesthetic, analgesic or tranquilizing drugs must be provided below. This information is required to be reported to the USDA, will be available from the USDA under the Freedom of Information Act, and may be publicly available through the Internet via the USDA’s website. At a minimum, you must include: the names of the databases searched; the date the search was performed; the period covered by the search; the key words and/or the search strategy used; and potential alternatives and why they were not appropriate.

USDA PAIN OR DISTRESS CLASSIFICATION AND EXAMPLES

Classification B: Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes.

Examples:

  • Breeding colonies of any animal species (USDA does not require listing of rats, mice, or birds) that are held in legal sized caging and handled in accordance with the Guide for the Care and Use of Laboratory Animals and other applicable regulations.
  • Newly acquired animals that are held in proper caging and handled in accordance with applicable regulations.
  • Animals held under proper captive conditions or wild animals that are being observed.

Classification C: Animals upon which teaching, research experiments, or tests will be conducted involving no pain, distress, or use of pain-relieving drugs.

Examples:

  • Procedures performed correctly by trained personnel such as the administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice (dog cephalic, cat jugular) or catheterization of same, standard radiography, parenteral injections of non-irritating substances.
  • Euthanasia performed in accordance with the recommendation of the most recent AVMA Guidelines on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death.
  • Manual restraint that is not longer than would be required for a simple exam.

Classification D: Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs will be used.

Examples:

  • Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy.
  • Blood collection by more invasive routes such as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs.
  • Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics.

Classification E: Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests.

Examples:

  • Procedures producing pain or distress unrelieved by analgesics such as toxicity studies, microbial virulence testing, radiation sickness, and research on stress, shock, or pain.
  • Surgical and postsurgical sequelae from invasion of body cavities, orthopedic procedures, dentistry or other hard or soft tissue damage that produces unrelieved pain or distress.
  • Negative conditioning via electric shocks that would cause pain in humans.

Table 2:

SOURCES OF SPECIES / NUMBER OF EACH SPECIES
Procured through Laboratory Animal Resources
IowaStateUniversity breeding colony or herd / NUMBER:
IACUC LOG NUMBER:
Privately owned / NUMBER:
Transferred from another study. / NUMBER:
IACUC LOG NUMBER:
Other – List other Source
Captured from the wild / NUMBER:
PERMITS REQUIRED:

1) Preferred housing location(s) and any special housing, caging, or bedding needs. If animals will be housed

outside of an ISU-approved housing facility for more than 12 hours, please provide the alternate housing location,

including the building and room number.

2) Location(s) where procedures will be conducted including where surgery will take place:

3) Please indicate what will happen to the animals at the end of the project. Please designate the number of animals for each category.

Slaughtered. Number:

Sold. Number:

Returned to colony, herd, or owner. Number:

Transferred to another project. Number:

Please provide log number and Principal Investigator:

Other. Number:

Please specify:

Euthanized. Number:

Please specify how the carcass will be disposed of following euthanasia.

Can be rendered

Must be incinerated

Other. Please specify:

Please specify who will dispose of the carcasses.

Disposed of by key personnel.

Disposed of by LAR personnel.

Collected by Environmental Health and Safety

Other. Please specify:

PART B: RATIONALE FOR ANIMAL USE

4) Explain your rationale for using live animalsand why the species proposed is appropriate for this study.

5) What alternatives to use of live animals have been considered, and why were they not appropriate? This question is designed to inform the committee of the alternatives that were considered, why it was determined that they were not useful for this study, why a species lower on the phylogenetic scale could not be used, if methods have been incorporated into the study to reduce animal numbers or refine techniques, and an explanation of those methods.

6) Describe how the number of animals needed for the study was determined. The Guide recommends that the number of animals should be the minimum number required to obtain statistically valid results. A power analysis is strongly encouraged to justify group sizes when appropriate. Note: this question overlaps with other questions but is needed for clarification and documentation purposes.

PART C: DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES

Please do not respond to any questions with the statement “industry practice” as the community and nonscientist members of the committee will not be familiar with industry practice and will not have the information necessary to vote.

7) Briefly explain the experimental design and specify the treatments (including nutritional manipulations) and the number of animals per treatment group. 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.

8) YesNoWill this project involveinjections, inoculations or drugs? (Note: this question overlaps with #9 but is required for clarification.) If “yes,” please provide the information below for all substances that will be administered.

Substance / Dose / Schedule / Route of Administration

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9) Yes No Will this project involveadministration of substances to animals that have not been approved for marketing by the FDA/USDA-APHIS? If so, please describe your plan for conforming with requirements of the FDA and USDA under 21 CFR 511 (New Animal Drugs for Investigational Use) and 9 CFR 309.17 (Livestock Used for Research).

This information is intended to inform the committee if the study is in support of an application for marketing approval for a new drug, if a “slaughter authorization” is required from the FDA (i.e., the animals must be held for a set period specified by the FDA), and if the animals may be rendered or must be incinerated. If the FDA has issued a “slaughter authorization,” attach it and any other applicable communications from the FDA with your application.

10) Yes No Will this project involveblood draws? If “yes,” please describe below including volume,

frequency, withdrawal sites, and methodology. (Note: this information overlaps with Question 9, but a follow-up

is needed for clarification.)

11) Yes No Will this project involveradiation or isotope administration? If “yes,” please explain below and include doses and schedules.

12) Yes NoWill this project involve restraint of the animals for procedures included in the protocol(e.g., metabolism cages/stalls, chutes, stanchions, manual restraint, etc.)? If “yes,” please explain below including the length of time and how animals will be restrained for procedures included in the protocol. Prolonged restraint must be justified with appropriate oversight to ensure that the potential for pain and/or distress is minimized. Also describe any sedation, acclimation, or training to be utilized.

13) Yes No Will this project involveanimal identification methods (e.g., ear tag, tattoo, collar, cage card, implant, etc.)? If the answer is “yes,” please explain the method(s) to be used.

14) Yes No Will this project involveother non-surgical procedures (e.g., husbandry procedures, tail biopsies, etc.)? If “yes,” please specify below.

15) Yes No Will the animals in the study experience any resultant effects from the procedures in this study (e.g., pain or distress, ascites production, etc.)? If “yes,” please explain below, and explain to what extent affected animals will be treated.

16) Yes No Will this study involveother potential stressors (e.g., food or water deprivation, noxious stimuli, environmental stress)? If “yes,” please explain below and include the procedures to monitor and minimize distress. If a study is USDA Humane Use Category E, indicate any non-pharmaceutical methods to minimize pain and distress. Please note that a monitoring log must be kept in each room.

17) Yes No Will this study involve the administration of tumor cells, biologics, infectious agents, radiation or toxic chemicals that have the potential to be lethal or cause significant symptomatology? If “yes,”the experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavior abnormalities, clinical symptomatology, or signs of toxicity) MUST be specified below. Also list the criteria to be used to determine when euthanasia is to be performed. Use of a moribund state or death as an endpoint must always be scientifically justified.

18) Indicate how the animals will be monitored during the project, including criteria used to determine when an

animal should be removed from the project. Please be specific, and do not list categories such as “general

health.”

SPECIES / PARAMETERS TO BE MONITORED / FREQUENCY OF MONITORING / PERSON RESPONSIBLE FOR MONITORING

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NOTE: A copy of the monitoring records must be kept in the animal facility/room.

19) Please specify the experimental endpoint criteria (e.g., tumor size, percentage body weight gain or loss, inability to eat or drink, behavior abnormalities, clinical symptomatology, or signs of toxicity). Also list the criteria to be used to determine when euthanasia is to be performed. Use of a moribund state or death as an endpoint must always be scientifically justified.

20) Veterinary care. Please indicate desired plan of action in case of animal illness (e.g., initiate treatment, call

investigator prior to initiating treatment, euthanize). Please include the veterinarian responsible for providing

care and the names of project personnel authorized to approve medical treatment or euthanasia.

*Please note: if none of the individuals listed below can be contacted in a timely manner, the decision to treat

or euthanize animals will be made by the LAR veterinary staff.

21) Will this study involve euthanasia of animals?

Yes No

If “yes,” please describe the method of euthanasia below. You must justify any methods not fully approved by

the AVMA Guidelines on Euthanasia.

If “no,” please describe the method of euthanasia that will be used, should the need arise for euthanasia to alleviate unrelieved pain and distress (e.g., animal has not or will not recover with treatment). You must justify any methods not fully approved by the AVMA Guidelines on Euthanasia. If euthanasia will need to occur, please indicate the individual(s) that will perform euthanasia and the training/experience the individual(s) has with euthanasia.