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INTEL INTEL INTERNATIONAL INTERNATIONAL SCIENCE AND SCIENCE AND ENGINEERING FAIRENGINEERING FAIR
20122012
Rules and Rules and GuidelinesGuidelines
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Adult roles and Adult roles and responsibilitiesresponsibilities
Adult SponsorAdult Sponsor Qualified ScientistQualified Scientist Designated SupervisorDesignated Supervisor Institutional Review Board (IRB)Institutional Review Board (IRB) Scientific Review Committee Scientific Review Committee
(SRC)(SRC)
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Adult Adult sponsorsponsor
Oversees project to make sure that Oversees project to make sure that studentstudent is informed of ISEF Rules and Guidelinesis informed of ISEF Rules and Guidelines is aware of risks associated with projectis aware of risks associated with project is aware of forms required for projectis aware of forms required for project will receive proper supervision during will receive proper supervision during
experimentationexperimentation if required, submits project to IRB or SRCif required, submits project to IRB or SRC
Teacher usually serves as Adult Sponsor Teacher usually serves as Adult Sponsor
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Required for Required for somesome projects projects Doctoral/professional degree Doctoral/professional degree
related to student researchrelated to student research
oror
Masters degree with SRC approvalMasters degree with SRC approval
Completes Form 2 – QS FormCompletes Form 2 – QS Form
Qualified ScientistQualified Scientist
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Designated SupervisorDesignated Supervisor
Animal Care Supervisor for vertebrate Animal Care Supervisor for vertebrate animal projectsanimal projects
Supervises projects involving Supervises projects involving hazardous chemicals, activities or hazardous chemicals, activities or devicesdevices
Supervises projects requiring a Supervises projects requiring a Qualified Scientist when the Qualified Qualified Scientist when the Qualified Scientist cannot directly supervise the Scientist cannot directly supervise the studentstudent
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IRB IRB (Institutional Review (Institutional Review Board)Board)
Reviews human participants studiesReviews human participants studies Membership must include:Membership must include:
an educatoran educator a school administratora school administrator someone knowledgeable about someone knowledgeable about
evaluating physical and/or evaluating physical and/or psychological risk: MD, PA, RN, psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed psychiatrist, psychologist, licensed social worker or licensed clinical social worker or licensed clinical professional counselorprofessional counselor
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SRC SRC (Scientific Review (Scientific Review CommitteeCommittee))
Reviews Reviews somesome projects before projects before experimentationexperimentation
Reviews Reviews allall projects just prior to projects just prior to competitioncompetition
Membership must include:Membership must include: a biomedical scientist (Ph.D., M.D., a biomedical scientist (Ph.D., M.D.,
D.V.M., D.D.S., D.O.)D.V.M., D.D.S., D.O.) an educatoran educator one other memberone other member
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Combined IRB/SRCCombined IRB/SRC
a biomedical scientist (Ph.D., M.D., a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.)D.V.M., D.D.S., D.O.)
a school administratora school administrator an educatoran educator someone knowledgeable about someone knowledgeable about
evaluating physical and/or evaluating physical and/or psychological risk: MD, PA, RN, psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed psychiatrist, psychologist, licensed social worker or licensed clinical social worker or licensed clinical professional counselorprofessional counselor
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Forms required for all Forms required for all projectsprojects
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A Research Plan is required for all projects. It must incorporate all of the relevant topics listed in the Research Plan Instructions.
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Studies conducted at a Studies conducted at a research institution, research institution, industrial setting or any industrial setting or any work site other than home, work site other than home, school or field require school or field require Form 1CForm 1C
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Project based on prior research in Project based on prior research in the same field of studythe same field of study
Longitudinal studies are Longitudinal studies are permittedpermitted Multi-year studyMulti-year study Studies time-based changeStudies time-based change
Require form 7Require form 7
Continuation studiesContinuation studies
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HUMAN PARTICIPANTSHUMAN PARTICIPANTS
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What are human What are human participants studies?participants studies?
Human participants studies involve Human participants studies involve living individuals where there isliving individuals where there is
Intervention or interaction with Intervention or interaction with participantsparticipants
and/orand/or Collection of identifiable private Collection of identifiable private
informationinformation
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ExemptExempt studies – do not studies – do not require IRB review nor require IRB review nor
human participants formshuman participants forms Product testing of a student Product testing of a student
invention, program, concept, etc.invention, program, concept, etc. No health hazardsNo health hazards No personal data collectedNo personal data collected Feedback directly related to Feedback directly related to
productproduct Studies using pre-existing, publicly Studies using pre-existing, publicly
available human dataavailable human data
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Additional exempt studiesAdditional exempt studies
Behavioral observations in Behavioral observations in unrestricted public settingsunrestricted public settings No interactionNo interaction No manipulation of environmentNo manipulation of environment No recording of any personal No recording of any personal
identifiersidentifiers Studies using certified de-Studies using certified de-
identified/ anonymous dataidentified/ anonymous data
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Human participantsHuman participants researchresearch
The IRB must review and approve The IRB must review and approve the research plan the research plan before before experimentation beginsexperimentation begins
Research participants 18 years of Research participants 18 years of age or older must give age or older must give informed informed consentconsent
Research participants under 18 Research participants under 18 must give must give assentassent and their and their parents may be required to give parents may be required to give permissionpermission
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Human Human participants research, participants research, cont’dcont’d
The IRB evaluates the project and The IRB evaluates the project and determinesdetermines Risk levelRisk level Requirement for Qualified ScientistRequirement for Qualified Scientist Requirement for written informed Requirement for written informed
consent/assent/parental permissionconsent/assent/parental permission
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Risk evaluationRisk evaluation
No more than minimal riskNo more than minimal riskAnticipated harm and discomfort notAnticipated harm and discomfort notgreater than encountered in daily lifegreater than encountered in daily life
More than minimal riskMore than minimal riskAnticipated harm or discomfort isAnticipated harm or discomfort isgreater than encountered in daily lifegreater than encountered in daily life
More than minimal risk studies should More than minimal risk studies should require require writtenwritten consent/assent and consent/assent and parental permission. Final parental permission. Final determination for this requirement determination for this requirement made by the IRBmade by the IRB
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Types of RiskTypes of Risk
Physical risksPhysical risks ExerciseExercise Ingestion, tasting, smelling, application of Ingestion, tasting, smelling, application of
substancessubstances Exposure to potentially hazardous materialExposure to potentially hazardous material
Psychological risksPsychological risks Invasion of privacyInvasion of privacy Participant is a member of an at-Participant is a member of an at-
risk grouprisk group
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IRB decisions are IRB decisions are documented on Form 4documented on Form 4
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If IRB determines that written informed consent/assent or parental permission is required, documentation is obtained on an “informed consent” document
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VERTEBRATE ANIMALSVERTEBRATE ANIMALS
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What is a vertebrate What is a vertebrate animal?animal?
Live, nonhuman vertebrate Live, nonhuman vertebrate mammalian embryos or fetusesmammalian embryos or fetuses
Bird and reptile eggs within 3 days Bird and reptile eggs within 3 days of hatchingof hatching
All other nonhuman vertebrates All other nonhuman vertebrates (including fish) at hatching or birth(including fish) at hatching or birth
Zebrafish embryos 7 days (168 Zebrafish embryos 7 days (168 hours) post fertilizationhours) post fertilization
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Prohibited studiesProhibited studies Induced toxicity studies involving Induced toxicity studies involving
known toxic substances that could known toxic substances that could impair health or destroy lifeimpair health or destroy life
Behavioral experiments withBehavioral experiments with Conditioning using aversive stimuliConditioning using aversive stimuli Mother/infant separationMother/infant separation Induced/learned helplessnessInduced/learned helplessness
Studies of painStudies of pain Predator/vertebrate prey Predator/vertebrate prey
experimentsexperiments
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Additional restrictionsAdditional restrictions Projects that cause more than Projects that cause more than
momentary or slight pain or distress momentary or slight pain or distress or which are designed to kill or which are designed to kill vertebrate animals are not vertebrate animals are not permitted.permitted.
A weight loss or growth retardation A weight loss or growth retardation greater than 15% of any greater than 15% of any experimental or control animal is not experimental or control animal is not permittedpermitted
A death rate of 30% or greater in any A death rate of 30% or greater in any group or subgroup is not permittedgroup or subgroup is not permitted
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Behavioral observations of Behavioral observations of animals are exempt from SRC animals are exempt from SRC
review ifreview if There is no interaction with the There is no interaction with the
animals animals andand
There is no manipulation of the There is no manipulation of the environmentenvironment
andand All federal or state fish, game and All federal or state fish, game and
wildlife regulations are followedwildlife regulations are followed
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Research sitesResearch sites
School/Home/FieldSchool/Home/Field
Regulated Research InstitutionRegulated Research Institution ((mustmust have an IACUC review and approval have an IACUC review and approval process)process) UniversitiesUniversities Government research agenciesGovernment research agencies Private research laboratoriesPrivate research laboratories
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Requirements for studies at Requirements for studies at school/home/field school/home/field
Agricultural, behavioral, observational or Agricultural, behavioral, observational or supplemental nutritional studiessupplemental nutritional studies
andand
Non-invasive and non-intrusive with no Non-invasive and non-intrusive with no negative effect on animal’s health or well-negative effect on animal’s health or well-beingbeing
andand
Require SRC pre-review and approvalRequire SRC pre-review and approval
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Additional requirements for Additional requirements for studies at school/home/field studies at school/home/field
SRC determines level of SRC determines level of supervision appropriate for the supervision appropriate for the study:study: Designated supervisorDesignated supervisor VeterinarianVeterinarian Qualified scientistQualified scientist
Form 5A requiredForm 5A required
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Requirements for studies at Requirements for studies at regulated research regulated research
institutionsinstitutions Must be approved by IACUC Must be approved by IACUC
(Institutional Animal Care and Use (Institutional Animal Care and Use Committee)Committee)
Local SRC should review project Local SRC should review project before experimentationbefore experimentation
Experimentation must follow ISEF Experimentation must follow ISEF guidelinesguidelines
QS completes Form 5B which includes QS completes Form 5B which includes documentation of IACUC approvaldocumentation of IACUC approval
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POTENTIALLY HAZARDOUS POTENTIALLY HAZARDOUS BIOLOGICAL AGENTSBIOLOGICAL AGENTS
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Potentially hazardous Potentially hazardous biological agents includebiological agents include Microorganisms (including Microorganisms (including
bacteria, viruses, fungi, etc.)bacteria, viruses, fungi, etc.) Recombinant DNARecombinant DNA Human or animal fresh/frozen Human or animal fresh/frozen
tissues, blood or body fluidstissues, blood or body fluids
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All studies involving All studies involving potentially hazardous potentially hazardous
biological agentsbiological agents Studies must have prior approval by Studies must have prior approval by
SRC/IACUC/IBCSRC/IACUC/IBC Most studies are prohibited in a home Most studies are prohibited in a home
environmentenvironment Studies intended to genetically Studies intended to genetically
engineer bacteria with multiple engineer bacteria with multiple antibiotic resistance are prohibitedantibiotic resistance are prohibited
Lab studies utilizing MRSA, VRE and Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated KPC must be conducted in a Regulated Research Institution under Research Institution under documented IBC review and approvaldocumented IBC review and approval
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Risk assessmentRisk assessment Required of all PHBA projects Required of all PHBA projects Defines potential level of harm, Defines potential level of harm,
injury or disease to plants, injury or disease to plants, animals or humansanimals or humans
InvolvesInvolves Assignment of biological agent to Assignment of biological agent to
risk grouprisk group Determination of level of biological Determination of level of biological
containmentcontainment Assessment of expertise of adult(s)Assessment of expertise of adult(s) Assignment of final biosafety levelAssignment of final biosafety level
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Risk assessment, cont’dRisk assessment, cont’d
BSL 1 studies can usually be conducted BSL 1 studies can usually be conducted in a high school or college teaching in a high school or college teaching laboratory.laboratory.
BSL 2 studies are usually conducted in a BSL 2 studies are usually conducted in a regulated research institutionregulated research institution
BSL 3 and BSL 4 studies are prohibited BSL 3 and BSL 4 studies are prohibited for ISEF projectsfor ISEF projects
Form 6A (Potentially Hazardous Form 6A (Potentially Hazardous Biological Agents form) required for most Biological Agents form) required for most projects involving microorganisms, and projects involving microorganisms, and for all projects involving rDNA and fresh for all projects involving rDNA and fresh human and vertebrate animal tissueshuman and vertebrate animal tissues
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Studies exempt from prior Studies exempt from prior SRC review and no SRC review and no
additional PHBA forms additional PHBA forms requiredrequired
Studies using baker’s and brewer’s yeast Studies using baker’s and brewer’s yeast (except rDNA studies)(except rDNA studies)
Studies using Lactobacillus, B. thurgensis, Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating nitrogen-fixing bacteria, oil-eating bacteria, and algae-eating bacteria in bacteria, and algae-eating bacteria in natural environment. Not exempt if natural environment. Not exempt if cultured in a petri dish environmentcultured in a petri dish environment
Studies of mold growth on food items if Studies of mold growth on food items if experiment terminated at first sign of experiment terminated at first sign of moldmold
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Studies exempt from prior Studies exempt from prior SRC review that require SRC review that require
Form 3Form 3 Studies involving protists, archae Studies involving protists, archae
and similar microorganismsand similar microorganisms Research using manure for Research using manure for
composting, fuel production, or composting, fuel production, or other non-culturing experiments other non-culturing experiments
Studies using commercially Studies using commercially available color change coliform available color change coliform water test kits water test kits
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Studies involving unknown Studies involving unknown microorganismsmicroorganisms
BSL 1 ifBSL 1 if Organisms cultured in plastic petri Organisms cultured in plastic petri
dishdish Culture dish remains sealed Culture dish remains sealed
throughout experimentthroughout experiment Culture dish disposed of in Culture dish disposed of in
appropriate mannerappropriate manner BSL 2 if petri dish is openedBSL 2 if petri dish is opened
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rDNA technologiesrDNA technologies
Experiments with Experiments with BSL 1BSL 1 organisms can be done in BSL 1 organisms can be done in BSL 1 lab with a QS or trained DSlab with a QS or trained DS
Experiments with Experiments with BSL 2BSL 2 organisms must be done in a organisms must be done in a regulated research institution regulated research institution with a QSwith a QS
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TissuesTissues
If animal is euthanized solely for If animal is euthanized solely for student project – vertebrate student project – vertebrate animal study which requires animal study which requires IACUC approvalIACUC approval
If animal is euthanized for a If animal is euthanized for a purpose other than student purpose other than student project – tissue studyproject – tissue study
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Classification as BSL 1 or 2 based Classification as BSL 1 or 2 based on source of tissue and possibility on source of tissue and possibility of containing infectious agentsof containing infectious agents
All studies with human or wild All studies with human or wild animal blood are BSL 2. Studies animal blood are BSL 2. Studies with domestic animal blood are with domestic animal blood are BSL 1.BSL 1.
Studies with human body fluids Studies with human body fluids which can be associated with a which can be associated with a person must have IRB approvalperson must have IRB approval
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Plant tissuesPlant tissues Established cell and tissue culturesEstablished cell and tissue cultures Fresh or frozen meat, meat by-products, Fresh or frozen meat, meat by-products,
pasteurized milk, eggs – from grocery pasteurized milk, eggs – from grocery stores, restaurants, packing housesstores, restaurants, packing houses
HairHair Sterilized teethSterilized teeth Fossilized tissue/archeological Fossilized tissue/archeological
specimens specimens Prepared fixed tissue slidesPrepared fixed tissue slides
Exempt as PHBA tissuesExempt as PHBA tissues
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Form 6BForm 6B
Required for all projects using Required for all projects using Fresh/frozen tissueFresh/frozen tissue Primary cell culturesPrimary cell cultures Blood and blood productsBlood and blood products Body fluidsBody fluids
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HAZARDOUS CHEMICALS, HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICESACTIVITIES OR DEVICES
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Hazardous chemicals, Hazardous chemicals, activities or devices includeactivities or devices include
ChemicalsChemicals EquipmentEquipment DEA-Controlled SubstancesDEA-Controlled Substances Prescription DrugsPrescription Drugs Alcohol and TobaccoAlcohol and Tobacco Firearms and ExplosivesFirearms and Explosives RadiationRadiation
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General RulesGeneral Rules
Studies do not require prior SRC Studies do not require prior SRC review and approvalreview and approval
All studies require a Risk All studies require a Risk Assessment documented on Form Assessment documented on Form 33
DEA - controlled substances DEA - controlled substances require a Qualified Scientistrequire a Qualified Scientist
All other studies require a All other studies require a Designated SupervisorDesignated Supervisor
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DEA-Controlled SubstancesDEA-Controlled Substances Consult DEA list of controlled substancesConsult DEA list of controlled substances All studies require Qualified ScientistAll studies require Qualified Scientist Controlled substances on Schedule 1 Controlled substances on Schedule 1
require DEA protocol review require DEA protocol review
Firearms and ExplosivesFirearms and Explosives Must adhere to local training and Must adhere to local training and
certification requirements certification requirements
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Must follow local laws for purchase, Must follow local laws for purchase, possession and consumptionpossession and consumption
Home production of ethyl alcohol Home production of ethyl alcohol (wine or beer) must follow U.S. (wine or beer) must follow U.S. Alcohol and Tobacco Tax and Trade Alcohol and Tobacco Tax and Trade Bureau (TTB) regulationsBureau (TTB) regulations
Alcohol distillation for fuel production Alcohol distillation for fuel production can be conducted at school with TTB can be conducted at school with TTB permit obtained by school officialspermit obtained by school officials
Alcohol and TobaccoAlcohol and Tobacco
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Prescription DrugsPrescription Drugs Cannot be administered to human Cannot be administered to human
subjectssubjects Animal administration must follow Animal administration must follow
ISEF vertebrate animal guidelinesISEF vertebrate animal guidelines
Hazardous ChemicalsHazardous Chemicals Refer to MSDS Sheets for safety and Refer to MSDS Sheets for safety and
handling guidelineshandling guidelines
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Hazardous DevicesHazardous Devices Involve level of risk beyond that Involve level of risk beyond that
encountered in student’s everyday encountered in student’s everyday lifelife
RadiationRadiation Non-ionizingNon-ionizing IonizingIonizing
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Form 3Form 3
Required for all projects involvingRequired for all projects involving DEA-Controlled SubstancesDEA-Controlled Substances Prescription DrugsPrescription Drugs Alcohol and TobaccoAlcohol and Tobacco Hazardous ChemicalsHazardous Chemicals Hazardous DevicesHazardous Devices Hazardous ActivitiesHazardous Activities RadiationRadiation
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For more information:For more information:
Visit the SSP website: Visit the SSP website: www.societyforscience.org/isef/rulesandguidelines
Email the Intel ISEF SRC or SSP Email the Intel ISEF SRC or SSP Staff:Staff: [email protected] [email protected]