• On the Student Research Plan Form, the student identifies a particular problem and plans what experimental approach he/she will use to solve the problem. The completed form is submitted to the teacher who reviews it for compliance with local, state, and federal regulations and the NJAS guidelines.

• The other form(s) must be signed by the student and the student’s parent or guardian, and then by the teacher after he/she has reviewed it to make sure necessary signatures have been obtained by the adults involved in approving or supervising any part of the experiment.

• Student experimentation begins after forms are on file with the teacher.

• Additional forms and/or signatures are required only if the project requires special supervision by qualified adults because the research poses potential risk to the student and/or to the research organisms. These projects include almost all that involve the use of nonhuman vertebrate animals, human subjects, potentially pathogenic agents (all micro-organisms isolated and/or cultured from any environment are considered pathogenic, including bacteria and fungi but excluding protists), recombinant DNA, controlled substances, human/vertebrate animal tissue, and hazardous substances or devices.

• The rules and regulations for conducting experimentation with each of these "special supervision" subjects are outlined in Chapters 2-7 of Section 1 and Chapters 2-8 in Section 2 of the handbook. It is important that the teacher reads these rules and regulations before allowing students to do experimentation.

• Special supervision must be provided by a Qualified Scientist and/or a Designated Supervisor.

• Roles and Responsibilities of a Qualified Scientist: Must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research. The Qualified Scientist and the teacher may be the same person, if that person is qualified. A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor (see below) who has been trained in the techniques the student will use.

• Roles and Responsibilities of Designated Supervisor: The Designated Supervisor is an adult who supervises a student’s experiment. The Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research. The teacher may act as the Designated Supervisor.

• The teacher must evaluate projects requiring special supervision and make sure criteria for the Qualified Scientist and the Designated Supervisor adhere to those set forth in the NJAS Guidelines.

• The teacher needs to either select the Qualified Scientist and/or the Designated Supervisor for the student or provide substantial input if the student is doing the selecting.

• It is important to be aware that the guidelines are not the same for the two different age groups when the research requires special supervision due to the potential risk to students and/or the research organisms.

Chapter includes general information on flow charts. The following flow charts are on the website to view and/or download.

• Non-Human Vertebrate Animal Projects

• Pathogenic Agents Projects

• Controlled Substances Projects

• Recombinant DNA Projects

• Human and Non-Human Vertebrate Animal Tissue Projects

• Projects Involving Hazardous Substances or Devices

Chapter includes general information on forms. The following flow charts are on the website to view and/or download. Forms may be duplicated as needed for use in NJAS Science Fairs.

• Checklist for Adult Sponsor/Safety Assessment Form (Form 2)

• Approval Form (Form 3

• Qualified Scientist Form (Form 4)

• Designated Supervisor Form (Form 5)

• Human Subjects Form (Form 6)

• Informed Consent Form (Form 7)

• Nonhuman Vertebrate Animals Form (Form 8)

• Human and Non-Human Vertebrate Animal Tissue Form (Form 9)

• Registered Research Institutional/Industrial Setting Form (Form 10)

• Adult Sponsor is ultimately responsible not only for the health and safety of the student conducting the research, but also for the humans or animals used as subjects.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to a specific student project. These may include chemical and equipment usage, experimental techniques, research involving human or nonhuman animals, cell cultures, microorganisms, or animal tissues. The issues must be discussed with the student when completing the Student Research Plan (Form 1).

• Adult Sponsor is responsible for establishing the Institutional Review Board at the local school level to review and approve all high school projects involving the use of human subjects.

• Some experiments involve procedures or materials that are regulated by state and federal laws. If not thoroughly familiar with the regulations, the Adult Sponsor needs to enlist the aid of a Qualified Scientist and/or a Designated Supervisor.

• Adult Sponsor is responsible for ensuring the student’s research is eligible for entry in the Nebraska Junior Academy Science Fairs held in regions across the state.

Part B: General Rules for ALL Senior High School Research Projects

• All projects must adhere to the Ethics Statement below.

• The use of photographs of persons requires the Informed Consent Form (Form 7) and must conform to school policy.

• Exhibits must adhere to NJAS safety and size requirements (see Chapter 11).

Part C: Field Research Projects

• Field research involves making careful observations in a given locale, and sometimes, comparing this survey to known data from other locales. It may involve the making of a detailed inventory of the living and non-living objects, or their characteristics, in a given geographic location, or the interaction among the objects.

• It always involves looking for the patterns in a well-defined area and the keeping of detailed field notes.

• The "controls" in this type of study are in the observational techniques that are used.

• Refer to Section 3: "NJAS Guidelines for Field Research Projects" for facilitating students doing this type of research.

• The rules and regulations for conducting experimentation with each of these "special supervision" subjects are outlined in Chapters 2-8. It is important that the Adult Sponsor read these rules and regulations BEFORE allowing students to do experimentation that requires special supervision.

• Special supervision must be provided by a Qualified Scientist and/or Designated Supervisor.

• Roles and Responsibilities of the Qualified Scientist

• The second form is the Checklist for Adult Sponsor/Safety Assessment Form (Form 2). The sections of the form are filled out by the Adult Sponsor (usually the teacher) in several stages prior to experimentation. Section 1 is completed after the Student Research Plan (Form 1) has been reviewed. Section 2 needs only to be completed if the project requires any SPECIAL forms (as outlined in Section 1 of the form). This section is done after the SPECIAL forms have been completed and submitted to the Adult Sponsor. Section 3 is done after the Approval Form (Form 3) has been completed and submitted to the Adult Sponsor. When all sections have been completed the form should be signed and dated by the Adult Sponsor and kept on file for liability purposes.

• The third form is the Approval Form (Form 3). For ALL projects this form must be signed by the Adult Sponsor, the student, and the student’s parent or guardian. If the project required the completion of any SPECIAL forms, this form will need to be submitted to and approved by the NJAS Regional Director (see Part F "Completing Special Forms Required for Certain NJAS Projects" below). The Approval Form (Form 3) with appropriate signatures should be kept on file with the Adult Sponsor for liability purposes.

• Certain projects require additional SPECIAL forms. These projects include any involving human subjects, nonhuman vertebrate animals, pathogenic agents (all micro-organisms isolated and/or cultured from any environment are considered potentially pathogenic, including bacteria and fungi but excluding protists ), recombinant DNA, controlled substances, human/animal tissue, and hazardous substances or devices.

• If the project does not require completion of any SPECIAL forms, then the student may begin the experimentation. Information on projects requiring SPECIAL forms is included in Part F.

• SPECIAL forms need to be completed if any of the boxes were checked on question two of the Checklist for Adult Sponsor/Safety Assessment Form (Form 2). Special guidelines for these projects are included in Chapters 2-8.

• Adult Sponsor is ultimately responsible not only for the health and safety of the student conducting the research, but also for the humans used as subjects.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving humans. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving human subjects.

• Adult Sponsor needs to read and be familiar with the information provided in this chapter before allowing any students to design/conduct experimental research involving human subjects.

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable. Qualified Scientists include: medical doctors, psychologists or psychiatrists.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

• A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor who has been trained in the techniques the student will use.

3) Designated Supervisor:

• Designated Supervisor is an adult who supervises a student’s experiment.

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• Adult Sponsor may act as the Designated Supervisor.

• All projects involving human subjects require completion of the Human Subjects Form (Form 6. Section 1 of this form is filled out by the student with the Adult Sponsor’s guidance. (Refer to Part F for information on "Assessing Risk and Choosing a Study Group".) A sample Informed Consent Form (Form 7) must also be filled out by the student and attached to the Student Research Plan (Form 1).

• If the research uses tests (standardized or student-prepared), surveys, questionnaires, etc. then samples of these must be attached to the Student Research Plan (Form 1).

• The Adult Sponsor submits a packet containing the Human Subjects Form (Form 6) and the three forms required for ALL projects--Forms 1(with attachments), 2, and 3-- for review and approval by the local IRB prior to experimentation.

• The IRB reviews the forms to determine the level of risk to the human subjects ("minimal", "more than minimal", or "unacceptable risks involved") and completes Section 2 of the Human Subjects Form (Form 6). The Human Subjects Form (Form 6) is returned along with the sample Informed Consent Form (Form 7) and the three required forms to the Adult Sponsor.

• If the local IRB returns a determination of "unacceptable risks involved", then the student must redesign the Student Research Plan (Form 1) and revise the other forms (as determined by the IRB) with the guidance of the Adult Sponsor. All forms must then be resubmitted to the IRB for approval before experimentation may begin.

• If the IRB determines that "more than minimal risk is involved" then the Qualified Scientist Form (Form 4) and the Informed Consent Form (Form 7) are REQUIRED for all subjects and the Designated Supervisor Form (Form 5) MAY be required. The student must enlist (with Adult Sponsor guidance) a Qualified Scientist (role and responsibilities defined in Part B ) to oversee the project and complete the Qualified Scientist Form (Form 4). If the Qualified Scientist cannot be present during the experimentation, a Designated Supervisor (role and responsibilities defined in Part B ) must supervise and complete the Designated Supervisor Form (Form 5). The student must obtain the Informed Consent Form (Form 7) for each test subject.

• The Adult Sponsor sends a packet containing copies of the three required forms (Forms 1 with attachments, 2, and 3) and copies of all SPECIAL forms to the NJAS Regional Director for final approval. Unless the research was done at a registered research institution, this approval must be obtained before experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS or ISEF review and approval, then the Registered Research Institutional /Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. Copies of all completed forms must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• If the local IRB determines only minimal risk--no additional special forms are required.

• If the local IRB determines more than minimal risk --the Qualified Scientist Form (Form 4) and the Informed Consent Form (Form 7) are required and the Designated Supervisor Form (Form 5) is required if the Qualified Scientist cannot be present during the experimentation.

Rule 1: Student researchers must assess the risks to their human subjects when developing the Student Research Plan (Form 1). Any possible risks must be described in the Human Subjects Form (Form 6) and copies of the Human Subjects Form (Form 6) and the Informed Consent Form (Form 7) must be submitted for review and approval by an Institutional Review Board (IRB) at the local level before experimentation begins. Upon assessment of risks by the IRB, changes in the Student Research Plan may be required. If the IRB requires changes in the project, the student must incorporate those changes into the forms before the IRB signs for approval.

Rule 2: Any proposed changes in the Student Research Plan (Form 1) by the student after initial IRB approval must have subsequent IRB approval before such changes are made and before experimentation begins/resumes.

Rule 3: Observational studies and related data collection are exempt from use of the Informed Consent Form (Form 7), but the Human Subjects Form (Form 6), the IRB review and review by the NJAS Regional Director is still required.

Rule 4: Research on students under the age of 18 does not need the Qualified Scientist Form (Form 4) or the Informed Consent Form (Form 7) for the following:

a) Research conducted in established settings:

b) Research involving observation of legal public behavior.

c) Research involving collection or study of existing publicly available data.

Rule 5: Copies of standardized tests and student-prepared tests, surveys, etc. must be attached to the Student Research Plan (Form 1) for both reviews (IRB and the NJAS Regional Director).

Rule 6: Completion of the Qualified Scientist Form (Form 4) by a Qualified Scientist is required if the IRB determines that there is "more than minimal risk". If the Qualified Scientist is unable to supervise the experiment, a trained Designated Supervisor is required (and requires signature on the Designated Supervisor Form (Form 5).

Rule 7: All research forms approved by the IRB must then be reviewed and approved by the NJAS Regional Director before experimentation begins.

Rule 8: Any proposed changes in the Student Research Plan (Form 1) by the student after initial approval by the NJAS Regional Director must have subsequent approval before experimentation begins/resumes.

Rule 9: Research conducted by a precollege student at federally registered research institutions (e.g., university labs, medical centers, NIH, etc.) prior to NJAS or ISEF approval requires completion of the Registered Research Institutional/Industrial Setting Form (Form 10). A letter from the mentor attesting to this approval is not sufficient to replace Form 10. Note: this research must still obtain NJAS approval prior to NJAS Regional Science Fair competition (see Form 3).

Rule 10: A student may observe and collect data for analysis of new procedures and medications only under the direct supervision of a licensed professional. Students are prohibited from administering medications to human subjects. The local IRB must ascertain that the student is not violating the medical practice act of that particular state.

Rule 11: It is illegal to publish or display information in a report that identifies the human subjects directly or through identifiers linked to the subjects, including photographs without written informed consent. (Public Health Service Act, 42 U.S.C., 241(d). Use the Informed Consent Form (Form 7).

Rule 12: All completed forms must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• Once a population is chosen, the NJAS Rules require students to assess any potential risks when developing the Student Research Plan (Form 1). Any possible risks must be explained on the Human Subjects Form (Form 6) and a sample Informed Consent Form (Form 7). The student must submit the Human Subjects Form (Form 6) and a sample Informed Consent Form (Form 7) with the three forms required for all projects--Forms 1(with attachments), 2, and 3--to a local Institutional Review Board (IRB) for review and approval before the beginning of experimentation.

• Parents have the right to deny participation in any study, including those involving tests (standardized or student-prepared), surveys, or questionnaires. The local IRB may judge certain tests, surveys, or questionnaires to involve "more than minimal risks" and the Informed Consent Form (Form 7) will be required for all subjects. Such tests, surveys, or questionnaires must be provided to parents with the Informed Consent Form (Form 7).

• The Informed Consent Form (Form 7) is a) required for subjects under 18 years of age (except for Observational research studies and related data collection), b) required for all subjects when "more than minimal risk" is determined by the IRB, and c) is strongly recommended for all projects involving human subjects. A sample of the Informed Consent Form (Form 7) must be submitted to the IRB before experimentation begins.

In evaluating risk, the following federal definition of minimal risk should be used as a guide: No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered in DAILY LIFE or during performance of routine physical or psychological examinations or tests.

The following are examples of activities or groups that contain more than minimal risks:

• Possible Risk Activities:

This position statement has been substantially borrowed from the Science Service and the Intel ISEF position statement on the use of animals, and has been modified to conform with the NJAS Rules and Regulations.

• Studies involving animals in their natural environment as well as animals in zoological parks with no interaction between the experimenter and the subject animal(s) do not require the Qualified Scientist Form (Form 4) or the Non-Human Vertebrate Animal Form (Form 8). These projects do not require completion of any SPECIAL forms.

1) Adult Sponsor:

• Adult Sponsor is ultimately responsible not only for the health and safety of the student conducting the research, but also for the nonhuman vertebrates used as subjects.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving nonhuman vertebrates. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving nonhuman vertebrate subjects.

• Adult Sponsor needs to read and be familiar with the information provided in this chapter before allowing any students to design/conduct experimental research involving nonhuman vertebrate subjects

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/ professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable. Qualified Scientists include veterinarians.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

• A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor who has been trained in the techniques the student will use.

3) Designated Supervisor:

• Designated Supervisor is an adult who supervises a student’s experiment.

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• Adult Sponsor may act as the Designated Supervisor.

4) Animal Care Supervisor:

• Animal Care Supervisor must be familiar with the proper care and handling of research animals used in the project.

• Qualified Scientist or Designated Supervisor usually serves as the Animal Care Supervisor.

• Adult Sponsor if familiar with proper care and handling can serve as the Animal Care Supervisor.

Rule 1: Alternatives

• Alternatives to the use of nonhuman vertebrate animals for research MUST BE explored and discussed in the Student Research Plan (Form 1). Alternatives may include replacement, reduction or refinement.

• The three Rs of animal experimentation:

• Examples of possible alternatives are listed below:

a) Cells and tissue cultures

b) Plants, yeast and fungi

c) Mathematical or computer models

e) Primary tissue or cell explants from humanely euthanized animals

Rule 2: The NJAS Rules and the International Rules define an animal as any live, nonhuman vertebrate, mammalian embryo or fetus, bird eggs within three days (72 hours) of hatching, and all other vertebrates at hatching or birth.

Rule 3: Students performing animal research must follow local, state, and federal regulations. Research conducted at registered research institutions (e.g., university lab, medical center, NIH, etc.) must be reviewed and approved by that institution's Animal Care and Use Committee. Invasive studies which duplicate previous research by others should be avoided.

• Animals should be healthy and free of diseases that can be transmitted to humans or other animals.

• Animals may not be captured from or released into the wild without approval of authorized wildlife and public health officials.

• All animals are classified as laboratory animals on the first day of study. Proper forms, including the Student Research Plan (Form 1), must be completed and submitted for review and approval by a NJAS Regional Director before experimentation begins.

Rule 5: Housing

• Animals must be housed in clean, ventilated, comfortable environments compatible with the standards and requirements appropriate for the species used. Animals must have adequate lighting, humidity and controlled temperature (with as little variation as possible), and have sanitized cages of adequate sizes for the typical activities and social interactions of the species (unless individual housing is dictated by experimental protocol).

• The conditions above are especially critical with experiments involving small, common laboratory animals (e.g., mice, rats, hamsters, guinea pigs, gerbils, rabbits). The health and well-being of the animals should always be the highest consideration. Because the school setting is not always suitable, the student's home environment setting needs to be compared to the school setting by the student AND Adult Sponsor when deciding where to house the animals and conduct the experiment. Which setting is the best for maintaining the environment, housing and husbandry standards?

Rule 6: Husbandry

• 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.

• Cages, pens, and fish tanks must be cleaned frequently. A highly absorbent bedding should be used in cages and pens. Hardwood chips are recommended (do not use cedar) and can be obtained from local pet or feed stores. Do not use newspaper or paper towels because inks may be carcinogens and adversely affect liver enzyme function.

• If an unexpected illness or emergency occurs, animals must have proper veterinary medical and nursing care under the direction of a veterinarian.

Rule 7: Experimental Conditions

• Experimental procedures that cause unnecessary pain or unnecessary discomfort or unnecessary death to any vertebrate animals, including operant conditioning with aversive stimuli and predator/prey experiments, are prohibited (e.g., mammals, birds, reptiles, amphibians, fish).

• Research on animals involving anesthetics, drugs, thermal procedures, physical stress, organisms pathogenic for humans or other vertebrates, ionizing radiation, carcinogens, mutagens, tumors, or surgical procedures must be directly supervised by a Qualified Scientist or Designated Supervisor within a hospital, school, or clinical/research institution.

• The use of alcohol, acid rain, insecticide, herbicide and heavy metal in toxicity or behavioral studies on live vertebrates is prohibited.

• Research in nutritional deficiency, ingestion, inoculation or exposure to hazardous or reputedly toxic materials or drugs is permitted to proceed only to the point where signs or lesions of the deficiency or toxicity first appear. Appropriate measures must then be taken to correct the deficiency, toxicity or drug effect, if such action is feasible. If not, the animal(s) must be euthanized.

• Food or water deprivation should be appropriate to the species, but may not exceed 24 hours.

• Weight loss is one significant sign of stress or toxicity. Maximum permissible weight loss or growth retardation (compared to controls) of any experimental or control animal(s) is 15 percent.

• LD50: LD means lethal dose or death rate. A death rate of 50 percent or greater in any group or subgroup, by design or as an unexpected result of experimental procedure is not permitted and the project will fail to qualify for competition.

Rule 8: Euthanasia

• Methods of Euthanasia

Rule 9: Any proposed changes in the Student Research Plan (Form 1) and/or the SPECIAL forms by the student after initial approval by the NJAS Regional Director must have subsequent approval before such changes are made and before experimentation begins/resumes.

Rule 10: All signed forms must be available for review by a NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• Alternatives to the use of vertebrate animals for research must be explored.

• All studies involving nonhuman vertebrate animals must have a Qualified Scientist.

• Proper animal care must be provided daily including weekends, holidays and vacations.

• Experiments designed to kill vertebrate animals are not permitted.

• Experimental procedures that cause unnecessary pain or unnecessary discomfort or death of any vertebrate animals, including operant conditioning with aversive stimuli and predator/prey experiments, are prohibited (e.g., mammals, birds, reptiles, amphibians, fish.)

• LD(50) or higher in any group or subgroup is not permitted.

• Students may not perform euthanasia, except in emergency situations.

• Use of alcohol, acid rain, insecticide, herbicide, and heavy metal in toxicity or behavioral studies on live vertebrates is prohibited.

• Proposed research must be reviewed and approved by the NJAS Regional Director before experimentation begins.

• If work was conducted in an institutional or industrial setting prior to NJAS approval, the Registered Research Institutional/Industrial Setting Form (Form 10) must be completed by the scientist who supervised the student research.

• Copies of all signed forms must be available for review at a NJAS Science Fair competition.

• To conduct research with vertebrate animals the student and Adult Sponsor MUST enlist the help of a qualified Animal Care Supervisor and a Qualified Scientist.

• The Qualified Scientist must sign the Qualified Scientist Form (Form 4). If the Qualified Scientist cannot be present during the experimentation a Designated Supervisor must agree to supervise the experimentation and sign the Designated Supervisor Form (Form 5).

• The student (with a lot of guidance/support from the Adult Sponsor) completes Section 1 of the Non-Human Vertebrate Animal Form (Form 8). (Note that in this section the student must provide the name of the veterinarian who will provide veterinary medical and nursing care in case of illness or emergency.) Section 2 of the form is completed by the Animal Care Supervisor.

• After completion, the SPECIAL forms--Non-Human Vertebrate Animal Form (Form 8), Qualified Scientist Form (Form 4), and, if needed, the Designated Supervisor Form (Form 5)--are submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1,2, and 3) and all special forms to a NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS review and approval, then the Registered Research Institutional/Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. Copies of all signed forms must be available for review by a NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• Projects using micro-organisms purchased through a biological supply company and known to be non-pathogenic are exempt and do NOT require completion of any SPECIAL forms as outlined in this chapter.

1) Adult Sponsor:

• Adult Sponsor is ultimately responsible for the health and safety of the student conducting the research.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving pathogenic agents. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving pathogenic agents.

• Adult Sponsor needs to read and be familiar with the information provided in this chapter before allowing any students to design/conduct experimental research involving human subjects.

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/ professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable. Qualified Scientists include: medical doctors and medical technologists.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

• A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor who has been trained in the techniques the student will use.

3) Designated Supervisor:

• Designated Supervisor is an adult who supervises a student’s experiment.

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• Adult Sponsor may act as the Designated Supervisor.

Rule 1: Students are allowed to experiment with pathogenic agents as long as the students adhere to federal regulations and guidelines, which are designed to protect the safety of researchers. Carelessness and improper techniques in working with pathogenic and non-pathogenic agents can lead to laboratory- and/or field-contracted infections.

Rule 2: Research involving pathogenic agents must be approved by a Qualified Scientist before experimentation begins.

Rule 3: Pathogenic agents are disease-causing agents such as bacteria, viruses, viroids, prions, rickettsia, fungi, or parasites. For purposes of these rules, the term "Pathogenic Agent" applies to ALL pathogenic agents whether they infect humans, vertebrates, invertebrates or plants.

Rule 4: When using pathogenic agents, student researchers and their Adult Sponsors are required to follow standard microbiological practices, as defined in Biosafety in Microbiological and Biomedical Laboratories (see reference listing in Part E "Sources

of Information").

Rule 5: All organisms collected, isolated, and/or cultured from any environment during student research projects should be considered pathogenic with the exception of protists. Raw or partially-processed human or animal waste is considered to contain pathogenic agents.

Rule 6: Student research with pathogenic agents may be performed only under the direct supervision of an experienced Qualified Scientist or Designated Supervisor in an institutional laboratory, including a school if facilities are adequate and appropriate.

Rule 9: Studies on microorganisms with multiple antibiotic resistance must be conducted at a Registered Research Institution.

Rule 10: Any proposed changes in the Student Research Plan (Form 1) by the student after initial approval by the NJAS Regional Director must have subsequent approval before such changes are made and before experimentation begins/resumes.

• The Qualified Scientist must sign the Qualified Scientist Form (Form 4). If the Qualified Scientist cannot be present during the experimentation a Designated Supervisor (see Part B for role and responsibilities) must agree to supervise the experimentation and sign the Designated Supervisor Form (Form 5).

• The completed SPECIAL form(s)--Qualified Scientist Form (Form 4), and, if needed, the Designated Supervisor Form (Form 5)--are submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1,2, and 3) and a copy of the SPECIAL form(s) to the NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS review and approval, then the Registered Research Institutional/Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. Copies of all signed forms must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• Adult Sponsor is ultimately responsible for the health and safety of the student conducting the research.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving controlled substances. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving controlled substances.

• Adult Sponsor needs to read and be familiar with the information provided in this chapter before allowing any students to design/conduct experimental research involving controlled substances.

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/ professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable. Qualified Scientists include medical doctors.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

• A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor who has been trained in the techniques the student will use.

3) Designated Supervisor:

• Designated Supervisor is an adult who supervises a student’s experiment.

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• Adult Sponsor may act as the Designated Supervisor.

Rule 1: Research involving controlled substances must be approved by the NJAS Regional Director before experimentation begins.

Rule 2: Student researchers must adhere to all federal regulations governing controlled substances. For further information, contact the regulatory agencies listed in Part E "Sources of Information".

Rule 3: Production of alcohol is federally regulated and students must contact the Bureau of Alcohol, Tobacco and Firearms for regulations (see Part E "Sources of Information" for contact information).

Rule 4: Only under the direct supervision of a Qualified Scientist or Designated Supervisor may a student use any federally-controlled or experimental substances for therapy or experimentation.

Rule 5: Any proposed changes in the Student Research Plan (Form 1) by the student after approval by the NJAS Regional Director must have subsequent approval before such changes are made and before experimentation begins/resumes.

Rule 6: Copies of all signed forms must be available for review by the NJAS Regional Director (or his/her representative) and/or the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• The Qualified Scientist must sign the Qualified Scientist Form (Form 4). If the Qualified Scientist cannot be present during the experimentation a Designated Supervisor (see Part B for role and responsibilities) must agree to supervise the experimentation and sign the Designated Supervisor Form (Form 5).

• The completed SPECIAL form(s)--Qualified Scientist Form (Form 4), and, if needed, the Designated Supervisor Form (Form 5)--are submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1,2, and 3) and the special form(s) to the NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS or ISEF review and approval, then the Registered Research Institutional /Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. All signed forms must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

1) Adult Sponsor:

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

Part C: Rules and Regulations Involving Recombinant DNA

• Copies of all signed forms must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder.

• To conduct research with R-DNA the student and Adult Sponsor must enlist the expertise of a Qualified Scientist (see Part B for role and responsibilities) with thorough knowledge of the student’s area of research to oversee the project a federally registered research institution.

• The Qualified Scientist must sign the Qualified Scientist Form (Form 4).

• The completed SPECIAL form is submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1,2, and 3) and a copy of the special form (Form 4) to the NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS review and approval, then the Registered Research Institutional/Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep the returned forms on file for liability purposes. Copies of all signed forms, certifications, and permits must be available for review by a NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder on the display table.

1) Adult Sponsor:

• Adult Sponsor is ultimately responsible for the health and safety of the student conducting the research.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving human and nonhuman vertebrate animal tissue. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving human and nonhuman vertebrate animal tissue.

• Adult Sponsor needs to read and be familiar with the information provided in this chapter before allowing any students to design/conduct experimental research involving human and nonhuman vertebrate animal tissue.

2) Qualified Scientist:

• Qualified Scientist should possess an earned doctoral/ professional degree in the biomedical sciences. However, a master’s degree with equivalent experience and/or expertise in the student’s area of research is acceptable. Depending on the type of tissue being used in the project, qualified individuals might include: medical doctors, veterinarians, biologists, or biochemists.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

Rule 1: Research involving human or nonhuman vertebrate animal tissue must be approved by the NJAS Regional Director before experimentation begins.

Rule 2: Using viable fresh tissue, organs, human or animal parts, including blood, blood products, teeth, primary cell cultures, and body fluids require the completion of the Human and Non-Human Vertebrate Tissue Form (Form 9) except when using the "exempted" tissues listed in Part A: "Background Information".

Rule 3: A Qualified Scientist is required to supervise the experimentation (except when using the "exempted" tissues) and complete the Qualified Scientist Form (Form 4).

Rule 4: Students must conduct research on human blood, blood products or other body fluids under either one of the following conditions: a) tissue fluids are documented free of HIV and hepatitis B and C before the student receives them; b) tissues are handled in accordance with standards and guidelines set forth in Occupational Safety and Health Act, 29CFR, Subpart Z, 1910.1030 – Blood Borne Pathogens.

Rule 5: Students who use teeth in a research project must use those which are not capable of causing disease, regardless of the source (human, primate, shark, etc.) i.e. they must be sterilized. The method of decontamination should be determined by the mentor, but autoclaving is recommended (121 degrees Celsius for 30 minutes.)

Rule 6: Any proposed changes in the Student Research Plan (Form 1) by the student after initial approval by the NJAS Regional Director must have subsequent approval before such changes are made and before experimentation begins/resumes.

Rule 7: Copies of all signed forms, certifications, and permits must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder on the display table.

• The student and Adult Sponsor must enlist the expertise of a Qualified Scientist (see Part B for role and responsibilities) who has thorough knowledge of the student’s area of research. The Qualified Scientist must complete the Qualified Scientist Form (Form 4).

• The completed SPECIAL form(s)--Human and Non-Human Vertebrate Animal Tissue Form (Form 9) and the Qualified Scientist Form (Form 4)--are submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1,2, and 3) and copies of the special forms (Forms 9 and 4) to the NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS or ISEF review and approval, then the Registered Research Institutional /Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. Copies of all signed forms and certifications must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder on the display table.

1) Adult Sponsor:

• Adult Sponsor is ultimately responsible for the health and safety of the student conducting the research.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to research involving hazardous substances and devices. The issues must be discussed with the student when completing the required forms for ALL projects and the special forms required for research involving hazardous substances and devices.

2) Designated Supervisor:

• Designated Supervisor is an adult who supervises a student’s experiment. Appropriate individuals might include: chemistry teachers (for research involving flammable or explosive compounds), physic teachers (for research involving lasers or radiation), or police (for research involving firearms).

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• The Adult Sponsor may act as the Designated Supervisor.

Rule 1: Research involving hazardous substances or devices must be approved by the NJAS Regional Director before experimentation begins.

Rule 2: The use of hazardous chemicals and equipment, firearms, radioactive substances and radiation require proper supervision by a Designated Supervisor. The Designated Supervisor must be directly responsible for overseeing the student experimentation.

Rule 3: Student researchers working with hazardous substances or devices must follow proper safety procedures for each chemical or device used in the research. Flammable, explosive or highly toxic chemicals are of particular concern. Also included are mutagens and carcinogens as well as chemical mixtures found in pesticides.

Rule 4: For all research requiring a Federal and/or State Permit, the student/designated supervisor will be expected to have the permit prior to the onset of experimentation.

Rule 5: Use of radiation and radioactive substances are tightly regulated. Students should strictly adhere to safety standards of the authorized institution where such substances/devices are used in the research.

Rule 6: Students under 21 are prohibited by federal and most state laws from purchasing and/or handling smokeless powder or black powder for science projects. (For further regulations, contact the Firearms & Explosives Division of the Bureau of Alcohol, Tobacco, and Firearms listed in Part E "Sources of Information".)

Rule 7: Differentiation between hazardous and non-hazardous chemicals can best be determined by utilizing the Materials Safety Data Sheets (MSDS).

Rule 8: If work was conducted in an institutional or industrial setting, Registered Research Institutional/Industrial Setting Form (Form 10 ) must be completed by the scientist who supervised the student research.

Rule 9: Copies of all signed forms, certifications, and permits must be available for review by the NJAS Regional Director (or his/her representative) at the Regional Science Fair competition. It is recommend these be kept in a notebook or folder on display table.

• The completed Designated Supervisor Form (Form 5) is submitted to the Adult Sponsor.

• The Adult Sponsor sends a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) and a copy of the Designated Supervisor Form (Form 5) to the NJAS Regional Director for review. This individual MUST give final approval before any experimentation begins.

• If the research work was conducted in an institutional or industrial setting prior to NJAS review and approval, then the Registered Research Institutional/Industrial Setting Form (Form 10) must be completed following the end of experimentation by the scientist who supervised the student research. The Adult Sponsor needs to send a packet containing copies of the three forms required for ALL projects (Forms 1, 2, and 3) along with a copy of the Registered Research Institutional/Industrial Setting Form (Form 10) to the NJAS Regional Director. Research done at an institution must still be reviewed and approved before competing at the NJAS Regional Science Fair.

• The Adult Sponsor should keep all the returned forms on file for liability purposes. Copies of all signed forms, certifications, and permits must be available for review by the NJAS Regional Director (or his/her representative) and the judges at the Regional Science Fair competition. It is recommended these be kept in a notebook or folder on the display table.

• Adult Sponsor is ultimately responsible not only for the health and safety of the student conducting the research, but also for the humans or animals used as subjects.

• Adult Sponsor must review the student’s Student Research Plan Form (Form 1) to make sure that: a) experimentation is done within local, state, and federal laws and the NJAS Rules; b) that forms are completed by other adults involved in approving or supervising any part of the experiment; and c) that criteria for the qualified scientist adhere to those set forth in the NJAS Guidelines.

• Adult Sponsor must be familiar with the regulations that govern potentially dangerous research as they apply to a specific student project. These may include chemical and equipment usage, experimental techniques, research involving human or nonhuman animals, and cell cultures, microorganisms, or animal tissues. The issues must be discussed with the student when completing the Student Research Plan Form (Form 1). Some experiments involve procedures or materials that are regulated by state and federal laws. If not thoroughly familiar with the regulations, the Adult Sponsor should help the student enlist the aid of a Qualified Scientist and/or Designated Supervisor.

• Adult Sponsor is responsible for ensuring the student’s research is eligible for entry in the Nebraska Junior Academy Science Fair.

• Qualified Scientist must be thoroughly familiar with the local, state, and federal regulations that govern the student’s area of research.

• Qualified Scientist and the Adult Sponsor may be the same person, if that person is qualified as outlined above.

• A student may work with a Qualified Scientist in another city or state. In this case, the student must work locally with a Designated Supervisor (see below) who has been trained in the techniques the student will use.

• In the case of hazardous substances or devices, a Designated Supervisor is directly responsible for overseeing student experimentation. A Qualified Scientist may or may not be necessary.

• Designated Supervisor need not have an advanced degree, but should be thoroughly familiar with the student’s project, and must be trained in the student’s area of research.

• Adult Sponsor may act as the Designated Supervisor.

• If a student is experimenting with live vertebrates and the animals are in a situation where their behavior or habitat is influenced by humans, the Designated Supervisor must be knowledgeable about the humane care and handling of the animals. If the Designated Supervisor is not knowledgeable, the Adult Sponsor must ensure that the student enlists the help of an Animal Care Supervisor.

• If a student is using hazardous substances or devices, the Designated Supervisor must be thoroughly knowledgeable about the project and must be directly responsible for overseeing the student experimentation.

• Qualified Scientist or Designated Supervisor or animal care professional usually serves as the Animal Care Supervisor.

• Adult Sponsor may serve as the Animal Care Supervisor if familiar with the proper care and handling of the research animals used in the project.

• IRB at the school must consist of a minimum of three members. Additional members are recommended to avoid conflict of interest. The IRB should include:

• Any scientific apparatus or invention may be displayed, but not operated. Apparatus must conform to the other display safety rules, such as no water or flames.

• All electrical work must conform to the National Electrical Code or exhibit hall regulations. The guidelines presented here are general ones, and other rules may apply to specific configurations. The on-site electrician may be requested to review electrical work.

• All electrical connectors, wiring, switches, extension cords, fuses, etc. must be UL-listed and must be appropriate for the load and equipment. Connections must be soldered or made with UL-listed connectors. Wiring, switches, and metal parts must have adequate insulation and overcurrent safety devices (such as fuses) and must be inaccessible to anyone but the student with the display. Exposed electrical equipment or metal that is liable to be energized must be grounded or shielded with a nonconducting material or with a grounded metal box or cage to prevent accidental contact.

• There must be an accessible, clearly visible on/off switch or other means of disconnect from the 120 or 220 Volt power source.

• Wiring which is not part of a commercially available UL-listed appliance or piece of equipment must have a fuse or circuit breaker on the supply side of the power source and prior to any project equipment.

• Set of flow charts is located on the website where they can be viewed or downloaded.

• Students participating in NJAS Regional Science Fairs need to adhere to the rules for completing ALL of the form requirements as outlined in specific detail in chapters 2-8.

• Chapter 12 includes all forms that are or may be required for NJAS projects. These forms are on the website where they can be viewed and/or downloaded. All forms may be duplicated as needed.

• Flow charts are for: