1. Science Fair Independent Dependent Variable Rules and Regulations Abstract SRC Biological Hazards IRB Sponsor District Regional State Safety PHBA Risk Assessment Human Subjects BSL1 BSL2 BSL3 Forms Research Plan

2. INTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines

3. SRC Scientific Review Committee Reviews some projects before experimentation Reviews some projects before experimentation Reviews all projects just prior to competition Reviews all projects just prior to competition Membership must include: Membership must include: a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) an educator an educator one other member one other member

4. IRB Institutional Review Board Reviews human subject studies Reviews human subject studies Membership must include: Membership must include: an educator an educator a school administrator a school administrator someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor

5. Forms REQUIRED for ALL projects

6. Forms Required for All Projects 1 Checklist for Adult Sponsor 1AStudent Checklist 1A Research Plan 7Abstract 1BApproval Form

7. To be completed by Adult Sponsor in collaboration with the student researcher.

8. This form is required of ALL projects; to be completed by student researcher.

9. Part of Form 1A A guideline explaining components of Research Plan which must be attached to 1A

10. Abstract to be completed after experimentation; one page, 250 words.

11. To be completed by student and parent. If necessary, SRC and IRB are completed here.

12. Adult Roles and R esponsibilities Adult Sponsor Adult Sponsor Qualified Scientist Qualified Scientist Designated Supervisor Designated Supervisor Institutional Review Board (IRB) Institutional Review Board (IRB) Scientific Review Committee (SRC) Scientific Review Committee (SRC)

13. Adult Sponsor Oversees project Oversees project Completes Form 1 – Checklist for Adult Sponsor Completes Form 1 – Checklist for Adult Sponsor Parents DO NOT sign this form Parents DO NOT sign this form

14. Required for some projects Required for some projects QS must have a Doctoral professional degree related to student research QS must have a Doctoral professional degree related to student research Master’s degree with SRC approval Master’s degree with SRC approval Completes Form 2 – QS Form Completes Form 2 – QS Form Qualified Scientist

16. Designated Supervisor Animal Care Supervisor for vertebrate animal projects Animal Care Supervisor for vertebrate animal projects Supervises projects involving hazardous chemicals, activities or devices Supervises projects involving hazardous chemicals, activities or devices Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student

17. When applicable, the DS signs the Risk Assessment Form 3

18. Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C

20. Project based on prior research in the same field of study Project based on prior research in the same field of study Longitudinal studies are permitted Longitudinal studies are permitted Multi-year study Multi-year study Studies time-based change Studies time-based change Require form 7 Require form 7 Continuation Projects

22. HUMAN SUBJECTS

23. What are human subjects studies? Human Subjects studies involve living individuals where there is: Human Subjects studies involve living individuals where there is: Intervention or interaction with subjects Intervention or interaction with subjectsand/or Collection of identifiable private information Collection of identifiable private information

24. Exempt Studies do not require IRB review nor human subjects forms Product testing of a student invention, program, concept, etc. Product testing of a student invention, program, concept, etc. No health hazards No health hazards No personal data collected No personal data collected Feedback directly related to product Feedback directly related to product Studies using pre-existing, publicly available human data Studies using pre-existing, publicly available human data

25. Additional Exempt Studies Behavioral observations in unrestricted public settings Behavioral observations in unrestricted public settings No interaction No interaction No manipulation of environment No manipulation of environment No recording of any personal identifiers No recording of any personal identifiers Studies using certified de-identified/ anonymous data Studies using certified de-identified/ anonymous data

26. Human Subjects Research The IRB must review and approve the research plan before experimentation begins The IRB must review and approve the research plan before experimentation begins Research subjects 18 years of age or older must give informed consent Research subjects 18 years of age or older must give informed consent Research subjects under 18 must give assent and their parents may be required to give permission Research subjects under 18 must give assent and their parents may be required to give permission

27. Human Subjects Research The IRB evaluates the project and determines The IRB evaluates the project and determines Risk level Risk level Requirement for Qualified Scientist Requirement for Qualified Scientist Requirement for written informed consent/assent/parental permission Requirement for written informed consent/assent/parental permission

28. Risk Evaluation No more than minimal risk No more than minimal risk Anticipated harm and discomfort not greater than encountered in daily life More than minimal risk More than minimal risk Anticipated harm or discomfort is greater than encountered in daily life More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB

29. Types of Risk Physical risks Physical risks Exercise Exercise Ingestion, tasting, smelling, application of substances Ingestion, tasting, smelling, application of substances Exposure to potentially hazardous material Exposure to potentially hazardous material Psychological risks Psychological risks Invasion of privacy Invasion of privacy Subject member of an at-risk group Subject member of an at-risk group

30. IRB can waive requirement of written informed consent if study is of minimal risk study is of minimal riskand data collection is anonymous data collection is anonymousand one of the following one of the following Study of normal educational practices Study of normal educational practices Behavioral study with no manipulation Behavioral study with no manipulation Surveys of perception, cognition, game theory Surveys of perception, cognition, game theory Physical activity with no more than minimal risk (routine physical activities, tasting of commonly available food or drink, etc.) Physical activity with no more than minimal risk (routine physical activities, tasting of commonly available food or drink, etc.)

31. IRB decisions are documented on Human Subjects Form 4 Must be completed prior to experimentation.

33. Written informed consent is obtained from the research subject on a form like the sample provided

34. Each research subject is required to sign the Informed Consent Form All Forms must be present at all fairs.

35. VERTEBRATE ANIMALS

36. What is a vertebrate animal? Live, nonhuman vertebrate mammalian embryos or fetuses Live, nonhuman vertebrate mammalian embryos or fetuses Bird and reptile eggs within 3 days of hatching Bird and reptile eggs within 3 days of hatching All other nonhuman vertebrates (including fish) at hatching or birth All other nonhuman vertebrates (including fish) at hatching or birth

37. Prohibited studies Induced toxicity studies involving a poison or toxin that could impair health or destroy life Induced toxicity studies involving a poison or toxin that could impair health or destroy life Behavioral experiments with Behavioral experiments with Operant conditioning with aversive stimuli Operant conditioning with aversive stimuli Mother/infant separation Mother/infant separation Induced/learned helplessness Induced/learned helplessness Studies of pain Studies of pain Predator/vertebrate prey experiments Predator/vertebrate prey experiments

38. Additional restrictions A weight loss or growth retardation greater than 15% is not permitted A weight loss or growth retardation greater than 15% is not permitted A death rate of 30% or greater in any group or subgroup is not permitted A death rate of 30% or greater in any group or subgroup is not permitted

39. Behavioral observations of animals are exempt from SRC review if There is no interaction with the animals There is no interaction with the animalsand There is no manipulation of the environment There is no manipulation of the environmentand All federal or state fish, game and wildlife regulations are followed All federal or state fish, game and wildlife regulations are followed

40. Research Sites Examples of non- regulated sites Examples of non- regulated sites Home Home School School Farm, ranch Farm, ranch Zoological parks Zoological parks Field Field Examples of regulated sites ( must have an IACUC review and approval process) Examples of regulated sites ( must have an IACUC review and approval process) Universities Government research agencies Private research laboratories

41. Requirements for studies at non-regulated sites Agricultural, behavioral, observational or supplemental nutritional studies Agricultural, behavioral, observational or supplemental nutritional studiesand Non-invasive and non-intrusive with no negative effect on animal’s health or well-being Non-invasive and non-intrusive with no negative effect on animal’s health or well-beingand Require SRC pre-review and approval Require SRC pre-review and approval

42. Additional requirements for non- regulated sites SRC determines level of supervision appropriate for the study: SRC determines level of supervision appropriate for the study: Designated supervisor Designated supervisor Veterinarian Veterinarian Qualified scientist Qualified scientist Form 5A required Form 5A required

44. Requirements for studies at regulated sites Must be approved by IACUC (Institutional Animal Care and Use Committee) Must be approved by IACUC (Institutional Animal Care and Use Committee) Local SRC should review project before experimentation Local SRC should review project before experimentation Experimentation must follow ISEF guidelines and adhere to restrictions regarding pain Experimentation must follow ISEF guidelines and adhere to restrictions regarding pain QS completes Form 5B which includes documentation of IACUC approval QS completes Form 5B which includes documentation of IACUC approval

46. POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS

47. Potentially hazardous biological agents include Microorganisms (including bacteria, viruses, fungi, etc.) Microorganisms (including bacteria, viruses, fungi, etc.) Recombinant DNA Recombinant DNA Human or animal fresh/frozen tissues, blood or body fluids Human or animal fresh/frozen tissues, blood or body fluids

48. All studies involving potentially hazardous biological agents Must have prior approval by SRC/IACUC Must have prior approval by SRC/IACUC Most studies are prohibited in a home environment Most studies are prohibited in a home environment Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited

49. Risk assessment Required of all PHBA projects Required of all PHBA projects Defines potential level of harm, injury or disease to plants, animals or humans Defines potential level of harm, injury or disease to plants, animals or humans Involves Involves Assignment of biological agent to risk group Assignment of biological agent to risk group Determination of level of biological containment Determination of level of biological containment Assessment of expertise of adult(s) Assessment of expertise of adult(s) Assignment of final biosafety level Assignment of final biosafety level

50. Risk assessment, cont’d BSL 1 studies can usually be conducted in a high school or college teaching laboratory. BSL 1 studies can usually be conducted in a high school or college teaching laboratory. BSL 2 studies are usually conducted in a regulated research institution BSL 2 studies are usually conducted in a regulated research institution BSL 3 and BSL 4 studies are prohibited for ISEF projects BSL 3 and BSL 4 studies are prohibited for ISEF projects Form 6A (Potentially Hazardous Biological Agents form) required for most projects involving microorganisms, and for all projects involving rDNA and fresh human and vertebrate animal tissues Form 6A (Potentially Hazardous Biological Agents form) required for most projects involving microorganisms, and for all projects involving rDNA and fresh human and vertebrate animal tissues

52. Studies exempt from prior SRC review and no additional PHBA forms required Studies using baker’s and brewer’s yeast (except rDNA studies) Studies using baker’s and brewer’s yeast (except rDNA studies) Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and algae-eating bacteria in natural environment. No exempt if cultured in a petri dish environment. Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and algae-eating bacteria in natural environment. No exempt if cultured in a petri dish environment.

53. Studies exempt from prior SRC review that require Form 3 Studies involving protists, archae and similar microorganisms Studies involving protists, archae and similar microorganisms Research using manure for composting, fuel production, or other non-culturing experiments Research using manure for composting, fuel production, or other non-culturing experiments Studies using commercially available color change coliform water test kits Studies using commercially available color change coliform water test kits

54. Studies Involving Unknown Microorganisms BSL 1 if BSL 1 if Organisms cultured in plastic petri dish Organisms cultured in plastic petri dish Culture dish remains sealed throughout experiment Culture dish remains sealed throughout experiment Culture dish disposed of in appropriate manner Culture dish disposed of in appropriate manner BSL 2 if petri dish is opened BSL 2 if petri dish is opened

55. rDNA technologies Experiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DS Experiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DS Experiments with BSL 2 organisms must be done in a regulated research institution with a QS Experiments with BSL 2 organisms must be done in a regulated research institution with a QS

56. Tissues If animal is euthanized solely for student project – vertebrate animal study which requires IACUC approval If animal is euthanized solely for student project – vertebrate animal study which requires IACUC approval If animal is euthanized for a purpose other than student project – tissue study If animal is euthanized for a purpose other than student project – tissue study

57. Classification as BSL 1 or 2 based on source of tissue and possibility of containing infectious agents Classification as BSL 1 or 2 based on source of tissue and possibility of containing infectious agents All studies with human or wild animal blood are BSL 2. Studies with domestic animal blood are BSL 1. All studies with human or wild animal blood are BSL 2. Studies with domestic animal blood are BSL 1. Studies with human body fluids which can be associated with a person must have IRB approval Studies with human body fluids which can be associated with a person must have IRB approval Tissues

58. Plant tissues Plant tissues Established cell and tissue cultures Established cell and tissue cultures Meat and meat by-products – grocery stores, restaurants, packing houses Meat and meat by-products – grocery stores, restaurants, packing houses Hair Hair Sterilized teeth Sterilized teeth Fossilized tissue/archeological specimens Fossilized tissue/archeological specimens Prepared fixed tissue slides Prepared fixed tissue slides Exempt as PHBA tissues Potentially Hazardous Biological Agents

59. Form 6B Required for all projects using Required for all projects using Fresh/frozen tissue Fresh/frozen tissue Primary cell cultures Primary cell cultures Blood and blood products Blood and blood products Body fluids Body fluids

61. HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICES

62. Hazardous chemicals, activities or devices include Chemicals Chemicals Equipment Equipment DEA-Controlled Substances DEA-Controlled Substances Prescription Drugs Prescription Drugs Alcohol and Tobacco Alcohol and Tobacco Firearms and Explosives Firearms and Explosives Radiation Radiation

63. General Rules Studies do not require prior SRC review and approval Studies do not require prior SRC review and approval All studies require a Risk Assessment documented on Form 3 All studies require a Risk Assessment documented on Form 3 DEA - controlled substances require a Qualified Scientist DEA - controlled substances require a Qualified Scientist All other studies require a Designated Supervisor All other studies require a Designated Supervisor

64. DEA-Controlled Substances Consult DEA list of controlled substances Consult DEA list of controlled substances All studies require Qualified Scientist All studies require Qualified Scientist Controlled substances on Schedule 1 require DEA protocol review Controlled substances on Schedule 1 require DEA protocol review Firearms and Explosives Must adhere to local training and certification requirements Must adhere to local training and certification requirements

65. Must follow local laws for purchase, possession and consumption Must follow local laws for purchase, possession and consumption Home production of ethyl alcohol (wine or beer) must follow U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations Home production of ethyl alcohol (wine or beer) must follow U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials Alcohol and Tobacco

66. Prescription Drugs Cannot be administered to human subjects Cannot be administered to human subjects Animal administration must follow ISEF vertebrate animal guidelines Animal administration must follow ISEF vertebrate animal guidelines Hazardous Chemicals Refer to MSDS Sheets for safety and handling guidelines Refer to MSDS Sheets for safety and handling guidelines

67. Hazardous Devices Involve level of risk beyond that encountered in student’s everyday life Involve level of risk beyond that encountered in student’s everyday lifeRadiation Non-ionizing Non-ionizing Ionizing Ionizing

68. Form 3 Required for all projects involving Required for all projects involving DEA-Controlled Substances DEA-Controlled Substances Prescription Drugs Prescription Drugs Alcohol and Tobacco Alcohol and Tobacco Hazardous Chemicals Hazardous Chemicals Hazardous Devices Hazardous Devices Hazardous Activities Hazardous Activities Radiation Radiation