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Rules for ALL Studies Involving Vertebrate Animals Additional Rules for Projects Conducted in a Non-regulated Site Additional Rules for Projects Conducted in a Regulated Research Institution Sources of InformationAnimal Care and Use Resources Alternative Research and Animal Welfare Resources
The following rules were developed to help pre-college student researchers adhere to the federal regulations governing professional scientists and to protect the welfare of both animal subjects and the student researcher. When students conduct research with animal subjects, health and well-being is of high priority. SSP strongly endorses the use of non-animal research methods and encourages students to use alternatives to animal research. If the use of vertebrate animals is necessary, students must consider additional alternatives to reduce and refine the use of animals. All projects involving vertebrate animals must adhere to the rules below AND to either Section A or Section B rules, depending on the nature of the study and the research site. A project is considered a tissue study and not a vertebrate animal study if tissue is obtained from an animal that was euthanized for a purpose other than the student’s project. (Documentation is required of the IACUC approval for the original animal study from which tissues are obtained.) In tissue studies, a student may observe the vertebrate study, but may not manipulate or have any direct involvement in the vertebrate animal experimental procedures.
1) The use of vertebrate animals in science projects is allowable under the conditions and rules in the following sections. Vertebrate animals, as covered by these rules, are defined as:
Exception: Because of their delayed cognitive neural development, zebrafish embryos are not considered vertebrate animals until 7 days (168 hours) post- fertilization.2) Alternatives to the use of vertebrate animals for research must be explored and discussed in the research plan. Alternatives include the following “Four R’s”:
3) All vertebrate animal studies must be reviewed and approved before experimentation begins. An Institutional Animal Care and Use Committee, known as an IACUC, is the institutional animal oversight review and approval body for all animal studies at a Regulated Research Institution. The affiliated fair SRC serves in this capacity for vertebrate animals studies performed in a school, home or field. Any affiliated fair SRC serving in this capacity must include a veterinarian or an animal care provider with training and/or experience in the species being studied. 4) All vertebrate animal studies must have a research plan that includes:
5) Studies involving behavioral observations of animals are exempt from advance SRC review if ALL of the following apply:
6) Students performing vertebrate animal research must satisfy local, state, country laws and regulations of the jurisdiction in which research is performed as well as U.S. federal law. 7) Research projects which cause more than momentary or slight pain or distress are prohibited. If there is illness or unexpected weight loss this must be investigated and a veterinarian must be consulted to oversee any indicated medical care. This investigation must be documented by the Qualified Scientist, Designated Supervisor who is qualified to determine the illness or a veterinarian. If the illness or distress is caused by the study, the experiment must be terminated immediately. 8) No vertebrate animal deaths due to the experimental procedures are permitted in any group or subgroup. Such a project will fail to qualify for competition.
9) All animals must be monitored for signs of distress. Because significant weight loss is one sign of stress, the maximum permissible weight loss or growth retardation (compared to controls) of any experimental or control animal is 15%.10) Students are prohibited from designing or participating in an experiment associated with the following types of studies on vertebrate animals:
11) Justification is required for an experimental design that involves food or fluid restriction and must be appropriate to the species. If the restriction exceeds 18 hours, the project must be reviewed and approved by an IACUC and conducted at a regulated research institution. 12) Animals may not be captured from or released into the wild without approval of 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, local and national fishing laws and regulations. Students are prohibited from performing electrofishing.13) A Qualified Scientist or Designated Supervisor must directly supervise all research involving vertebrate animals, except for observational studies. 14) After initial SRC approval, a student with any proposed changes in the Research Plan of the project must repeat the approval process before laboratory experimentation/data collection resumes. Sources of Information are available as a separate section at the end of the document.
Vertebrate animal studies may be conducted at a home, school, farm, ranch, in the field, etc. This includes:
These projects must be reviewed and approved by an SRC in which one member is either a veterinarian and/or an animal care provider/expert with training and/or experience in the species being studied.1) These projects must adhere to BOTH of the following guidelines:
All studies meeting the general guidelines but not meeting the above criteria specifically for home, school or field must be conducted at a Regulated Research Institution. See Section B.2) Animals must be treated kindly and cared for properly. Animals must be housed in a clean, ventilated, comfortable environment appropriate for the species. They must be given a continuous, clean (uncontaminated) water and food supply. Cages, pens and fish tanks must be cleaned frequently. Proper care must be provided at all times, including weekends, holidays, and vacation periods. Animals must be observed daily to assess their health and well-being. A Designated Supervisor is required to oversee the daily husbandry of the animals. Any of the following U.S. documents provide further guidance for animal husbandry:
3) The affiliated fair Scientific Review Committee must determine if a veterinarian's certification of the research plan and animal husbandry plans is required. This certification is required before experimentation and SRC approval and is documented on Vertebrate Animal Form 5A. A veterinarian must certify experiments that involve supplemental nutrition, administration of prescription drugs and/or activities that would not be ordinarily encountered in the animal's daily life. 4) If an illness or emergency occurs, the affected animal(s) must receive proper medical or nursing care that is directed by a veterinarian. A student researcher must stop experimentation if there is unexpected weight loss or death in the experimental subjects. The experiment can only be resumed if the cause of illness or death is not related to the experimental procedures and if appropriate steps are taken to eliminate the causal factors. If death is the result of the experimental procedure, the study must be terminated, and the study will not qualify for competition. 5) The final disposition of the animals must be described on Vertebrate Animal Form 5A. Euthanasia for tissue removal and/or pathological analysis is not permitted for a project conducted in a school/home/field site.6) The following forms are required:
All studies not meeting the criteria in Section A. but are otherwise permissible under Intel ISEF rules must be conducted in a Regulated Research Institution (RRI). A Regulated Research Institution within the U.S. is defined as a professional research/teaching institution that is regularly inspected by the USDA and is licensed to use animals covered by the Animal Welfare Act and may also be subject to U.S. Public Health Service Policy. Also included are all federal laboratories such as National Institutes of Health, Veteran’s Affairs Medical Centers and the Centers for Disease Control. In addition, pharmaceutical and biotechnology companies and research institutions that utilize research animals that are not covered by the Animal Welfare Act but have an operational Institutional Animal Care and Use Committee and are in compliance with U.S. federal laws are included in this definition. For project conducted outside of the United States, a Regulated Research Institution would be a comparable research institution that adheres to country laws governing the care and use of vertebrate animals.Some protocols permitted in a Registered Research Institution are not permitted for participation in the Intel ISEF; adherence to RRI rules is necessary but may not be sufficient.1) The Institutional Animal Care and Use Committee (IACUC) or the comparable animal oversight committee must approve all student research projects before experimentation begins. Such research projects must be conducted under the responsibility of a principal investigator. The local and regional SRC must also review the project to certify that the research project complies with Intel ISEF Rules. This local and regional SRC review should occur before experimentation begins, if possible.2) Student researchers are prohibited from performing euthanasia. Euthanasia at the end of experimentation for tissue removal and/or pathological analysis is permitted. All methods of euthanasia must adhere to current American Veterinarian Medical Association (AVMA) Guidelines. 3) Research projects that cause more than momentary or slight pain or distress to vertebrate animals are prohibited unless approved anesthetics, analgesics and/or tranquilizers are used. 4) Research in nutritional deficiency or research involving substances or drugs of unknown effect is permitted to the point that any clinical sign of distress is noted. In the case that distress is observed, the project must be suspended and measures must be taken to correct the deficiency or drug effect. A project can only be resumed if appropriate steps are taken to correct the causal factors.5) The following forms are required:
1) Laboratory Animals, Institute of Laboratory Animal Research (ILAR), Commission on Life Sciences, National Research http://dels.nas.edu/ilar2) Guide for the Care and Use of Laboratory Animals (2010)http://dels.nas.edu/global/ilar/links-care3) Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (2003), Institute for Laboratory Animal Research (ILAR). dels.nas.edu/report/guidelines-carey/10732To order these ILAR publications contact:National Academies Press500 Fifth Street, NWWashington, DC 20055phone: 888-624-8373 or 202-334-3313fax: 202-334-2451; www.nap.edu4) Federal Animal Welfare Act (AWA)7 U.S.C. 2131-2157Subchapter A - Animal Welfare (Parts I, II, III) www.nal.usda.gov/awic/legislat/awicregs.htmAbove document is available from:USDA/APHIS/AC4700 River Road, Unit 84Riverdale, MD 20737-1234email: email@example.comTel: 301-734-7833Fax: 301-734-4978’http://awic.nal.usda.gov5) Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (Agri-Guide)Federation of Animal Science Societies (FASS)1800 S. Oak Street, Suite 100Champaign, IL 61820-6974phone: 217-356-3182email: firstname.lastname@example.org; www.fass.org 6) Guidelines for the Use of Fish in Research (2004), American Fisheries Society.www.fisheries.orghttp://fisheries.org/docs/policy_useoffishes.pdf7) Euthanasia Guidelines AVMA Guidelines on Euthanasia (June 2007)American Veterinary Medical Association.www.avma.org/issues/animal_welfare/euthanasia.pdf
1) The National Library of Medicine provides computer searches through MEDLINE: Reference & Customer ServicesNational Library of Medicine 8600 Rockville Pike Bethesda, MD 20894888-FIND-NLM or 888-346-3656 301-594-5983; email: email@example.com/sites/entrez2) National Agriculture Library (NAL) provides reference service for materials that document a) Alternative Procedures to Animal Use and b) Animal Welfare.Animal Welfare Information CenterNational Agriculture Library10301 Baltimore Avenue, Room 410Beltsville, MD 20705-2351phone: 301-504-6212, fax: 301-504-7125email: firstname.lastname@example.org/awic3) Institute of Laboratory Animal Resources (ILAR) provides a variety of information on animal sources, housing and handling standards, and alternatives to animal use through annotated bibliographies published quarterly in ILAR Journal.ILARThe Keck Center of the National Academies500 Fifth Street, NW, Keck 687Washington, DC 20001phone: 202-334-2590, fax: 202-334-1687 email: ILAR@nas.eduhttp://dels.nas.edu/ilar4) Quarterly bibliographies of Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing may be obtained from:Specialized Information Services NLM/NIH2 Democracy Plaza, Suite 5106707 Democracy Blvd., MSC 5467 Bethesda, MD 20892-5467phone: 301-496-1131; Fax: 301-480-3537Toll Free: 888-FIND NLM or 888-346-3656email: email@example.com; http://toxnet.nlm.nih.gov/altbib.html5) John’s Hopkins Center for Alternatives to Animal Testing (CAAT) has worked with scientists since 1981 to find new methods to replace the use of laboratory animals in experiments, reduce the number of animals tested, and refine necessary tests to eliminate pain and distress.email: firstname.lastname@example.org://caat.jhsph.edu/
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