Does your project involve the use of any of the following?
- Live nonhuman vertebrate mammalian embryos or fetuses at any age (exception: see age requirement for zebrafish below)
- Birds and reptile eggs within 3 days (72 hours) of hatching
- Zebrafish embryos that are at least 7 days (168 hours) post fertilization
- All other nonhuman vertebrates (including fish) at hatching or birth
If you answered YES, your project must comply with the ISEF rules for VERTEBRATE ANIMALS. Please read the guidelines below for details about each topic, allowable projects, and any additional forms you may need to complete.
ALL projects involving Vertebrate Animals must adhere to the rules rules in Sections I-VI below. In addition, projects must adhere to additional rules based on the nature of the study and the research site:
- Projects conducted at a school, at home, or at a field site (Section VII)
- Projects conducted at a regulated research institution (Section VIII)
I. Requirement for Review and Pre-Approval PRIOR to Beginning Experimentation
The Research Plan of all vertebrate animal studies must be reviewed and approved prior to experimentation. The committee that grants this preapproval depends upon the nature of the study and the research site:
- For vertebrate animal studies performed at school/home/field, the affiliated fair Scientific Review Committee (SRC) serves as the review and approval committee (see Section VII below).
- For projects to be performed at a federally-regulated research institution, the regulated research institution’s Institutional Animal Care and Use Committee (IACUC) serves as the review and approval committee (see Section VIII below).
- After initial SRC and/or IACUC approval, a student with any proposed changes in the Research Plan must repeat the approval process before experimentation/data collection can resume.
- Certain studies involving behavioral observations of animals may be exempt from prior SRC review provided that ALL of the following apply:
- There is no interaction with animals being observed,
- There is no manipulation of the environment in any way, AND
- The study meets all federal or state fish, game, and wildlife laws
Note: Students performing vertebrate animal research must also comply with local, state, county, and U.S. federal laws and regulations in the jurisdiction in which the research is performed.
II. Requirements for the Research Plan for Vertebrate Animal Projects
For projects involving Vertebrate Animals, the Research Plan must contain ALL elements requested in the Vertebrate Animals portion of the Research Plan Instructions, #1, including the following detailed information:
- Justification of animal use, including choice of species and number of animals to be used
- Description of alternatives to animal use considered and why they were unacceptable. Alternatives that should be included are the following “4 R’s”:
- Replace vertebrate animals with lower life form, tissue/cell cultures, or computer simulations
- Reduce number of animals without compromising statistical validity
- Refine experimental design to reduce animal pain or distress
- Respect animals and their contribution to research
- Explanation of potential benefit of study to broad fields of biology or medicine
- Description of how animals will be used (methods and procedures, such as experimental design and data analysis)
- Description of procedures to be used to minimize pain and distress
- Description of species, strain, sex, age, weight, source, and number of animals proposed for use
III. Requirement for Supervision by a Qualified Scientist or Designated Supervisor
All research involving vertebrate animals must be directly supervised by a Qualified Scientist or a Designated Supervisor, except for projects that consist strictly of behavioral observations. The specific type of supervisor required depends upon the nature of the study and the research site (see Sections VII and VIII below).
IV. Areas of Vertebrate Animal Study that are Prohibited
Certain types of projects are inappropriate for pre-college students and are prohibited:
- Projects causing more than momentary pain or suffering are prohibited
- Projects that are designed to cause the death of an animal are prohibited
- Students are prohibited from designing or direct involvement in the following types of studies on vertebrate animals:
- Inducted toxicity studies involving a substance that could impair health or destroy life (including, but not limited to, alcohol, acid rain, insecticides, herbicides, heavy metals)
- Behavioral studies involving conditioning with adverse stimuli, mother/infant separation, or induced helplessness
- Studies of pain
- Predator/vertebrate prey experiment
- A student may perform a tissue study involving the above types of research if the animal was euthanized for a purpose other than the student’s project and if the animal study was conducted by a Qualified Scientist at a regulated research institution with appropriate IACUC review and approval.
- Humane euthanasia (termination of life) is permitted under only certain conditions when the research is conducted at a federally regulated research institution (see Section VIII below).
V. Requirements for Monitoring Vertebrate Animals for Signs of Pain and Distress
- All animals must be monitored for signs of distress:
Signs of distress include: weight loss, diarrhea, progressive dermatitis (skin inflammation), rough hair coat, hunched posture, lethargy, coughing, labored breathing, nasal discharge, jaundice (yellowing of skin and/or eyes), anemia (low red blood cell count), neurological signs, bleeding, self-induced trauma, inability to eat or drink, self-isolation, etc.
- Any illness, unexplained weight loss, or death in either the control or experimental groups must be investigated, and a veterinarian must be consulted to oversee any necessary medical care. This applies both to Projects Conducted at School/Home/Field (Section VII) and at Regulated Research Institutions (Section VIII). This veterinary review must be documented.
- If illness or distress caused by the study, experiment must be stopped immediately.
- Projects that exceed specific humane endpoints are excluded from competition:
- Weight loss or growth retardation >15% in any experimental or control animal
- Death rate ≥ 30% in any group or subgroup
VI. Additional Rules for Specific Types of Research
- Experiments involving food or fluid restriction:
- Food or fluid restriction must be justified in the Research Plan and must be appropriate to the species.
- If food or fluid restriction exceeds 18 hours, the project must be conducted at a regulated research institution under an IACUC-approved protocol.
- Experiments involving animals captured from or released into the wild:
- May only be performed with approval from authorized wildlife or other regulatory officials.
- Fish may be obtained from the wild only if the researcher releases the fish unharmed, has the proper license, and adheres to state and local fishing laws and regulations.
- Electrofishing is prohibited.
VII. Additional Rules for Projects Conducted in a School/Home/Field
Vertebrate animal studies may be conducted at a home, school, farm, ranch, in the field, etc. This category includes studies involving:
- Animals in their natural environment
- Animals in zoos
- Livestock (used in standard agricultural practices)
- Type of Projects Allowed to be Conducted at School/Home/Field
Projects in this category must meet both of the guidelines below:
- The research must involve agricultural, behavioral, observational, and/or supplemental nutritional studies on animals,
- The research must involve only non-invasive and non-intrusive methods that not adversely affect animal’s health or well-being.
Note: Any project not meeting both of the above criteria must be conducted at a Regulated Research Institution (see Section VIII below). Termination of life (euthanasia) for tissue removal and/or pathological analysis is prohibited for a project conducted in a school/home/field.
- The research must involve agricultural, behavioral, observational, and/or supplemental nutritional studies on animals,
- Requirement for Scientific Review Committee Review and Prior Approval
- Prior to experimentation, the Research Plan must be reviewed and approved by the affiliated fair’s Scientific Review Committee (SRC), which must include a veterinarian or an animal care provider with training and/or experience in the species being studied.
- The SRC will determine if a veterinarian is required to certify that the research plan and animal husbandry are appropriate. If so, a Qualified Scientist Form 2 must be completed.
- A veterinarian must be consulted in experiments involving supplemental nutrition, administration of prescription drugs, and/or activities that would be ordinarily be encountered in the animal’s daily life.
- Requirements for Animal Husbandry at School/Home/Field research sites
- Animals must be housed in clean, ventilated housing appropriate for the species.
- Animals must be provided with continuous, clean (uncontaminated) water and food supply.
- Cages, pens, and tanks must be cleaned frequently.
- Care must be provided at all times, including weekends, holidays, and vacations.
- Animals must be observed daily to assess their health and well-being.
- A Designated Supervisor is required to oversee the daily animal husbandry.
- The final disposition of animals must be explained on the Vertebrate Animal Form (5A).
- Required Procedure in the Case of Animal Illness or Emergency
The following procedure must be followed in the case of animal illness or emergency:
- The affected animals must receive proper medical and nursing care that is directed by a veterinarian.
- The student researcher must stop experimentation if there is unexplained weight loss or death in an experimental subject.
- The experiment may only be resumed if the cause of illness or death if not related to the experimental procedure and if appropriate steps are taken to eliminate the causal factors.
VIII. Additional Rules for Projects Conducted in a Regulated Research Institution
All studies not meeting the criteria in Section VII above must be conducted in a Regulated Research Institution. These projects require completion of a Regulated Research Institution Form (1C), a Vertebrate Animal Form (5B), and a Qualified Scientist Form (2).
- What is a Regulated Research Institution?
A regulated research institution is defined as a professional research/teaching institution that is regularly inspected by the USDA and is licensed to use animals in research under U.S. federal law. Also included are federal laboratories [e.g., the National Institutes of Health (NIH), Veteran’s Affairs Medical Centers, the Centers for Disease Control (CDC)]. Additionally, pharmaceutical and biotechnology companies and research institutions that have an operational Institutional Animal Care and Use Committee (IACUC) and a program compliant with U.S. federal laws are also included.
- Requirement for Institutional Animal Care and Use Committee (IACUC) Review and Preapproval
- The IACUC must approve all student research projects BEFORE experimentation begins.
- Research projects at regulated research institutions must be conducted under the responsibility of a Principal Investigator.
- The affiliated fair’s Scientific Review Committee (SRC) must all review the project to certify that the project complies with NCSEF rules; this review should occur before experimentation begins if possible.
- Rules for Specific Types of Projects Conducted at Regulated Research Institutions
Euthanasia (deliberate termination of life) for tissue removal and/or pathological analysis permitted, but must be performed by the Qualified Scientist or an institutional representative under current American Veterinarian Medical Association (AVMA) Guidelines. Students are prohibited from performing euthanasia.
- Research projects that cause more than momentary or slight pain or distress to vertebrate animals:
This type of research is prohibited unless approved anesthetics, analgesics, and/or tranquilizers are used.
- Research in nutritional deficiency or research involving substances or drugs of unknown effects:
This type of research is permitted but must be stopped when first sign of clinical distress is noted. The deficiency or drug effect should then be corrected, if feasible; otherwise, the animal(s) must be euthanized.