1. Middle Tennessee Science & Engineering Fair 2014 Training & Information Workshop Sponsored by

2. MTSEF and ISEF u Middle TN Science & Engineering Fair (MTSEF)- an ISEF affiliated fair Thursday, March 20 - Saturday, March 22, 2014 http://www.apsu.edu/mtsef http://www.apsu.edu/mtsef u International Science & Engineering Fair (ISEF) LA Convention Center, Los Angeles, CA May 11-16, 2014 http://www.sciserv.org/isefhttp://www.sciserv.org/isef u MTSEF follows rules and guidelines established by the ISEF. –Questions : schillers@apsu.edu (SRC); woodsn@apsu.edu (IRB); mtsef@apsu.edu (MTSEF)schillers@apsu.eduwoodsn@apsu.edu mtsef@apsu.edu –Questions : SRC@sciserv.org -- ISEF SRC@sciserv.org

3. Scientific Review Committee (SRC) u SRC examines projects for the following: –evidence of literature search –evidence of proper supervision –use of accepted research techniques –completed forms, signatures & dates –evidence of search for alternatives to animal use –humane treatment of animals –compliance with rules & laws governing human & animal research –appropriate use of recombinant DNA, pathogenic organisms, controlled substances, tissues & hazardous substances & devices –appropriate documents & substantial expansion for continuation projects.

4. SRC Process u Before Experimentation: –SRC reviews projects involving: v Vertebrate Animals v Potentially hazardous biological agents –Microorganisms –recombinant DNA –Tissues – SRC also reviews & forwards to IRB projects involving humans.

5. SRC Process u After Experimentation: SRC reviews and approves previously approved & all other projects to ensure Research Plan & Rules were followed.

6. The Paper Trail u All SRC & IRB forms are submitted to SRC through Dr. Steve Hamilton (APSU, PO Box 4718, Clarksville TN 37044; hamiltonsw@apsu.edu) u SRC reviews forms, forwards projects involving Human subjects to IRB. u Researcher notified of SRC & IRB decisions. –Communication by email & by U.S. mail u Revisions submitted by researcher. u Researcher notified of SRC & IRB decisions.

7. Required SRC Forms: All Projects u For All Projects –Checklist for Adult Sponsor (1) –Research Plan –Student Checklist (1A) –Approval Form (1B) –Regulated Research Institutional/Industrial Setting Form (1C) - if applicable –Continuation Form (7) – if applicable

8. Required SRC Forms u Some Projects Require Additional Forms Human Subjects Vertebrate Animals Potentially Hazardous Biological Agents Hazardous Chemicals, Activities & Devices

9. Required Forms: Human Subjects u For Projects Involving Human Subjects, add: –Human Subjects Form (4) –Qualified Scientist Form (2) if applicable u Must have IRB approval prior to experimentation

10. Required Forms: Vertebrate Animals Non-Regulated Site u Vertebrate Animal Form (5A) u 5A is for Research in a Non-Regulated Site (Eg. Home, school, farm, ranch, in the field) if the following applies: research involves behavioral, observational or supplemental nutritional studies on animals & Non-invasive/ non-intrusive methods that do not negatively affect an animal’s health or well- being. u Must have SRC approval prior to experimentation

11. Required Forms: Vertebrate Animals Regulated Research Institution u Vertebrate Animal Form (5B), u Qualified Scientist Form (2) u Must have IACUC approval prior to experimentation

12. Required Forms: Potentially Hazardous Biological Agents u Potentially Hazardous Biological Agents Risk Assessment Form (6A) u Human & Vertebrate Animal Tissue form (6B) u Qualified Scientist Form (2) if applicable u Risk Assessment Form (3) u Must have SRC approval prior to experimentation.

13. Required Forms: Hazardous Chemicals, Activities and Devices u Risk Assessment Form (3) u Qualified Scientist Form (2)

14. DEFINITIONS & FORMS More Detail Adults Involved Forms for All Human Subjects Vertebrate Animals Potentially Hazardous Biological Agents Hazardous Chemicals Devices Activities

15. Adult sponsor u Oversees project to make sure that student –is informed of ISEF Rules and Guidelines –is aware of risks associated with project –is aware of forms required for project –will receive proper supervision during experimentation –if required, submits project to IRB or SRC u Teacher usually serves as Adult Sponsor

16. u Required for some projects u Doctoral/professional degree related to student research or Masters degree with SRC approval u Completes Form 2 – QS Form Qualified Scientist

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

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

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

21. Forms required for all projects

24. A Research Plan is required for all projects. It must incorporate all of the relevant topics listed in the Research Plan Instructions.

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

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

31. HUMAN PARTICIPANTS

32. What are human participants studies? Human participants studies involve living individuals where there is u Intervention or interaction with participants and/or u Collection of identifiable private information

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

34. Additional exempt studies u Behavioral observations in unrestricted public settings –No interaction –No manipulation of environment –No recording of any personal identifiers u Studies using certified de-identified/ anonymous data

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

36. Human participants research, cont’d u The IRB evaluates the project and determines –Risk level –Requirement for Qualified Scientist –Requirement for written informed consent/assent/parental permission

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

38. Types of Risk u Physical risks –Exercise –Ingestion, tasting, smelling, application of substances –Exposure to potentially hazardous material u Psychological risks u Invasion of privacy u Participant is a member of an at-risk group

39. IRB decisions are documented on Form 4

41. If IRB determines that written informed consent/assent or parental permission is required, documentation is obtained on an “informed consent” document

43. VERTEBRATE ANIMALS

44. What is a vertebrate animal? u Live, nonhuman vertebrate mammalian embryos or fetuses u Bird and reptile eggs within 3 days of hatching u All other nonhuman vertebrates (including fish) at hatching or birth u Zebrafish embryos 7 days (168 hours) post fertilization

45. Prohibited studies u Induced toxicity studies involving known toxic substances that could impair health or destroy life u Behavioral experiments with –Conditioning using aversive stimuli –Mother/infant separation –Induced/learned helplessness u Studies of pain u Predator/vertebrate prey experiments

46. No vertebrate animal deaths due to the experimental procedures are permitted u Studies designed or anticipated to cause vertebrate animal death are prohibited. u Any deaths must be investigated by a qualified individual u If death was the result of experimental procedure the study must be terminated and the study will not qualify for competition.

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

48. Research sites u School/Home/Field u Regulated Research Institution ( must have an IACUC review and approval process) –Universities –Government research agencies –Private research laboratories

49. Requirements for studies at school/home/field u Agricultural, behavioral, observational or supplemental nutritional studies and u Non-invasive and non-intrusive with no negative effect on animal’s health or well-being and u Require SRC pre-review and approval

50. Additional requirements for studies at school/home/field u SRC determines level of supervision appropriate for the study: –Designated supervisor –Veterinarian –Qualified scientist u Form 5A required

52. Requirements for studies at regulated research institutions u Must be approved by IACUC (Institutional Animal Care and Use Committee) u Local SRC should review project before experimentation u Experimentation must follow ISEF guidelines u QS completes Form 5B which includes documentation of IACUC approval

54. POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS

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

56. All studies involving potentially hazardous biological agents u Studies must have prior approval by SRC/IACUC/IBC u Most studies are prohibited in a home environment u Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited u Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated Research Institution under documented IBC review and approval

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

58. Risk assessment, cont’d u BSL 1 studies can usually be conducted in a high school or college teaching laboratory. u BSL 2 studies are usually conducted in a regulated research institution u BSL 3 and BSL 4 studies are prohibited for ISEF projects u 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

60. Studies exempt from prior SRC review and no additional PHBA forms required u Studies using baker’s and brewer’s yeast (except rDNA studies) u Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, and algae-eating bacteria in natural environment. Not exempt if cultured in a petri dish environment u Studies of mold growth on food items if experiment terminated at first sign of mold

61. Studies exempt from prior SRC review that require Form 3 u Studies involving protists, archae and similar microorganisms u Research using manure for composting, fuel production, or other non-culturing experiments u Studies using commercially available color change coliform water test kits u Studies involving decomposition of vertebrate organisms (forensic studies )

62. Studies involving unknown microorganisms u BSL 1 if –Organisms cultured in plastic petri dish –Culture dish remains sealed throughout experiment –Culture dish disposed of in appropriate manner u BSL 2 if petri dish is opened

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

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

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

66. –Plant tissues –Plant and non-primate established cell and tissue cultures –Fresh or frozen meat, meat by-products, pasteurized milk, eggs – from grocery stores, restaurants, packing houses –Hair –Sterilized teeth –Fossilized tissue/archeological specimens –Prepared fixed tissue slides Exempt as PHBA tissues

67. Form 6B u Required for all projects using –Fresh/frozen tissue –Primary cell cultures –Human and other primate established cell lines and tissue cultures –Blood and blood products –Body fluids

69. HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICES

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

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

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

73. –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 –Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials Alcohol and Tobacco

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

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

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