Science Fair Rules & Guidelines

Transcription

1 Science Fair 2014 Rules & Guidelines

2 "Discovery consists of seeing what everybody has seen and thinking what nobody has thought." - Albert Szent-Gyorgyi

3 Forms REQUIRED for ALL Projects Abstract 2 copies Keep ORIGINAL with Project point type on Official Abstract Form (250 words or less) Checklist for Adult Sponsor/Safety Assessment Form (1) Research Plan (1A) for Individual or Team Projects Approval Form (1B)

4 Adult Roles and Responsibilities Adult Sponsor Qualified Scientist (QS) Designated Supervisor (DS) Institutional Review Board (IRB) Scientific Review Committee (SRC)

5 Important Definition ADULT SPONSOR 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 reviews student checklist and research plan to certify that the experimentation is within local, state and federal laws and ISEF rules if required, submits project to IRB or SRC Teacher usually serves as Adult Sponsor

6 Adult Sponsor Oversees project Completes Form 1 Checklist for Adult Sponsor

7 Checklist for Adult Sponsor (1)

8 Important Definition Qualified Scientist (QS) Required for some projects Doctoral/professional degree related to student research or Masters degree with SRC approval or Bachelors degree with industry experience & SRC approval Completes Form 2 QS Form

9 Qualified Scientist Form (2)

10 Important Definition Designated Supervisor (DS) Animal Care Supervisor for vertebrate animal projects Supervises projects involving hazardous chemicals, activities or devices Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student

11 IRB (Institutional Review Board) Reviews human subject studies Membership must include: an educator a school administrator someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychologist, licensed social worker or licensed clinical professional counselor Additional members added for specific expertise. This can be done with correspondence.

12 SRC (Scientific Review Committee) Make up can change specific to project Reviews some projects before experimentation Reviews all projects just prior to competition Membership must include: a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., PharmD., D.O.) an educator one other member additional expertise added as needed based on content of experimentation

13 Combined IRB/SRC a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.) a school administrator an educator someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor

14 Forms REQUIRED for ALL Projects

15 Checklist for Adult Sponsor (1)

16 Student Checklist (1A)

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

18 Research Plan Instructions

19 Approval Form (1B) REQUIRED for EACH Participant

20 Research at Institutions or Industrial Settings Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form (1C)

21 Regulated Research Institutional/Industrial Setting Form (1C)

22 Forms REQUIRED for Research Performed in an Institutional or Industrial Setting Registered Research Institutional/Industrial Setting Form (1C) Qualified Scientist Form (2) (Must be signed PRIOR to the start of student experimentation.) Designated Supervisor Form (3) (Provide ONLY if Qualified Scientist is unable to supervise the experiment.) Nonhuman Vertebrate Animal Form (5 A & B) (Must have PRIOR approval by a Scientific Review Committee [SRC] and if needed by content of research)

23 Forms REQUIRED for Research Performed in an Institutional or Industrial Setting Continued Human Participants More Than Minimal Risk An Institutional Review Board [IRB] MUST approve ALL projects involving surveys, professional tests, questionnaires, or studies in which the researcher is the subject BEFORE experimentation. If the IRB determines that this is more than minimal risk Qualified Scientist Form (2) (Must be signed PRIOR to the start of student experimentation.) Designated Supervisor Form (3) (Provide ONLY if Qualified Scientist is unable to supervise the experiment.) Human Participants Form (4) (Must be approved BEFORE experimentation.) (Required for all subjects under 18 years of age and projects of more than minimal risk. Use a separate form for each test subject.)

24 Forms REQUIRED for Research Performed in an Institutional or Industrial Setting Continued Human Participants Minimal Risk Informed Consent Form 4 (Use a separate form for each subject.) Recombinant DNA, Pathogenic Agents, Controlled Substances (Must have PRIOR approval of Scientific Review Committee [SRC]) Qualified Scientist Form (2) Potentially Hazardous Biological Agents Risk Assessment From (6A) Human Vertebrate and Animal Tissue Form (6B) (To be completed in addition to Form (6A) when using fresh or frozen tissue, primary cell cultures, blood, blood products, and body fluids.)

25 Forms REQUIRED for Research Performed in an Institutional or Industrial Setting Continued Hazardous Substances or Devices Project Designated Supervisor Form (3)

26 Continuation Studies Project based on prior research in the same field of study Longitudinal studies are permitted Multi-year study Studies time-based change or experimental redesign or changing emphasis Require Form (7)

27 Continuation Projects Form (7)

28 Human Participants

29 Who are human participants? Human Participants studies involve living individuals where there is: Intervention or interaction with subjects and/or Collection of identifiable private information

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

31 Additional exempt studies Behavioral observations in unrestricted public settings No interaction No manipulation of environment No recording of any personal identifiers Studies using certified de-identified/anonymous data Data/record review studies using only publicly available data

32 Human Participants Research Requirements 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 under 18 must give assent and their parents may be required to give permission

33 Human Participants Research - continued The IRB evaluates the project and determines Risk level Requirement for Qualified Scientist Requirement for written informed consent/assent/parental permission

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

35 Types of Risk Physical risks Exercise Ingestion, tasting, smelling, application of substances Exposure to potentially hazardous material Psychological risks Invasion of privacy Breach of confidentiality Subject member of a vulnerable population

36 IRB can waive requirement of written informed consent IF Study with minimal risk and Anonymous data collection and One of the following: Study of normal educational practices Behavioral study with no manipulation 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.)

37 IRB Descisions IRB decisions are documented on Form (4)

38 Human Participants Form (4)

39 Informed Consent If IRB determines that written informed consent/assent or parental permission is required, documentation is obtained on an informed consent document (p 2 of form 4)

40 Informed Consent Form

41 VERTEBRATE ANIMALS

42 What is a vertebrate animal? Rules govern traditional vertebrate definitions and include: Live, nonhuman vertebrate mammalian embryos or fetuses Bird and reptile eggs within 3 days of hatching Tadpoles All other nonhuman vertebrates (including fish) at hatching or birth Zebrafish embryos 7 days (168 hours) post fertilization

43 Prohibited Studies Induced toxicity studies involving a poison or toxin that could impair health or end life Behavioral experiments with Conditioning using aversive stimuli Mother/infant separation Induced helplessness Studies of pain Predator/vertebrate prey experiments

44 Additional restrictions Projects that cause more than momentary or slight pain or distress or which are designed to kill vertebrate animals are not permitted. A weight loss or growth retardation greater than 15% of any experimental or control animal is not permitted No animal deaths due to experimental procedures are permitted in any group or subgroup.

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

46 Research Sites Examples of non-regulated sites Home School Zoological parks Farm, ranch Field Examples of regulated sites Universities Government research agencies Private research laboratories (MUST have an IACUC review and approval process) *IACUC ( Institutional Animal Care and Use Committee)

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

48 Additional requirements for non-regulated sites (home/school/field) SRC determines level of supervision appropriate for the study: Designated supervisor Veterinarian Qualified scientist Form (5A) required

49 Vertebrate Animal Form (5A)

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

51 Vertebrate Animal Form (5B)

52 POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS

53 Potentially hazardous biological agents include Microorganisms (including bacteria, viruses, viroids, prions, fungi, and parasites. etc.) Recombinant DNA (rdna) Human or animal fresh/frozen tissues, blood or body fluids

54 ALL studies involving potentially hazardous biological agents (PHBA) Must have prior approval by SRC/IACUC Most studies are prohibited in a home environment Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited Lab studies utilizing MRSA(Methicillin resistant Staphlococcus aureus), VRE and KPC(Klebsiella pneumonia) must be conducted in a Regulated Research Institution with documented IBC review and approval

55 Risk Assessment Required of all PHBA projects Defines potential level of harm, injury or disease to plants, animals or humans 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 [BSL-#]

56 Risk Assessment - continued 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 3 and BSL 4 studies are prohibited 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

57 Potentially Hazardous Biological Agents Risk Assessment Form (6A)

58 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 Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and algae-eating bacteria in natural environment. Not exempt if cultured in a petri dish environment. Studies involving water or soil not concentrated in media conducive to their growth. Studies of mushrooms and amoebozoa (slime molds). Studies of mold growth on food items if experiment terminated at first sign of mold

59 Studies exempt from prior SRC review that require Form 3 Studies involving protists, archae, and similar microorganisms Research using manure for composting, fuel production, or other non-culturing experiments Studies using commercially available color change coliform water test kits Studies involving decomposition of vertebrate organisms Studies with microbial fuel cells

60 Studies involving unknown microorganisms BSL 1 IF: Organisms cultured in plastic petri dish and sealed Culture dish remains sealed throughout experiment Culture dish disposed of in appropriate manner BSL 2 IF petri dish is opened

61 rdna Technologies Experiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DS Examples include cloning of DNA in E. coli K12, S. cerevesiae, and B. subtilis host-vector systems. Experiments with BSL 2 organisms must be done in a regulated research institution with a QS

62 Tissues If animal is euthanized solely for student project considered subject to vertebrate animal study rules and requires IACUC approval If animal is euthanized for a purpose other than student project tissue study

63 Note Classification as BSL 1 or BSL 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. Studies with human body fluids which can be associated with a person must have IRB approval and informed consent

64 Exempt as PHBA Tissues 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 Self-sampling of capillary blood for analysis can be conducted in a home setting (e.g. glucometer reading)

65 Human and Vertebrate Animal Tissue Form (6B) Required for all projects using Fresh/frozen tissue Primary cell cultures Blood and blood products Body fluids

66 Human and Vertebrate Animal Tissue Form (6B)

67 HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICES

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

69 General Rules for Hazardous Materials All studies require a Risk Assessment documented on Form 3 DEA - controlled substances require a Qualified Scientist All other studies require a Designated Supervisor

70 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 federal, state, and local training and certification requirements and laws

71 Alcohol and Tobacco Must follow federal, state, and 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 and under parental supervision Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials

72 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

73 Hazardous Devices Involve level of risk beyond that encountered in student s everyday life may require additional supervision and requirements Risk assessment must take into account the time of exposure, distance, and shielding involved in the study. Radiation Non-ionizing Ionizing No study allows use of dose limits that exceed those set by the Nuclear Regulatory Commission

74 Non-Ionizing Radiation A risk assessment must be conducted when a student uses non-ionizing radiation beyond that normally encountered in everyday life. Non-ionizing radiation includes the spectrum of ultraviolet (UV), visible light, infrared (IR), microwave (MW), radiofrequency (RF) and extremely low frequency (ELF). Lasers usually emit visible, ultraviolet or infrared radiation. Lasers are classified into four classes based upon their safety. Manufacturers are required to label Classes II IV lasers.

75 Lasers Class I lasers are those found in CD players, laser printers, geological survey equipment and some laboratory equipment. There are no known risks associated with using a Class I laser. Class II lasers are found in laser pointers, aiming and range finding devices and pose a risk if the beam is directly viewed over a long period of time. Class III lasers are found in higher powered laser pointers, printers and spectrometers. They are to be considered hazardous devices which can cause eye damage when the beam is directly viewed even for a short period of time. Class IV lasers are high powered lasers used in surgery, research, and industrial settings. They are extremely hazardous and can cause eye and skin damage from both direct and indirect exposure. The beam is also a fire hazard.

76 Ionizing Radiation Projects involving radionuclides (radioisotopes) and X-rays must involve a careful examination of the risks associated with the study. Depending upon the level of exposure, radiation released from these sources can be a health hazard. Most research institutions have a Radiation Safety Officer or committee which oversees the use of ionizing radiation and ensures compliance with state and federal regulations.

77 Risk Assessment Form (3) Required for all projects involving DEA-Controlled Substances Prescription Drugs Alcohol and Tobacco Hazardous Chemicals Hazardous Devices Hazardous Activities Radiation

78 Risk Assessment Form (3)

79 Top 5 Paperwork Problems 1. Missing forms SPECIFIC to project 2. Incomplete Research Plan, missing Form (1A) and/or Approval From (1B) Missing Student Checklist Form (1A) for all members of a Team Missing paperwork for continuation projects 3. Missing signatures and/or dates prior to experimentation dates on ALL forms 4. Missing or Poorly Constructed Abstract 5. Missing Adult Sponsor Form (1) and/or Designated Supervisor Form (3)

80 Experiment Safely and within the Rules