INTEL INTEL INTERNATIONAL INTERNATIONAL SCIENCE AND SCIENCE AND ENGINEERING FAIRENGINEERING FAIR

20122012

Rules and Rules and GuidelinesGuidelines

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)

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

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

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

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

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

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

Forms required for all Forms required for all projectsprojects

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

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

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

HUMAN PARTICIPANTSHUMAN PARTICIPANTS

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

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

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

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

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

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

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

IRB decisions are IRB decisions are documented on Form 4documented on Form 4

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

VERTEBRATE ANIMALSVERTEBRATE ANIMALS

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

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

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

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

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

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

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

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

POTENTIALLY HAZARDOUS POTENTIALLY HAZARDOUS BIOLOGICAL AGENTSBIOLOGICAL AGENTS

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

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

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

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

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

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

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

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

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

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

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

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

HAZARDOUS CHEMICALS, HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICESACTIVITIES OR DEVICES

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

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

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

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

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

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

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

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: src@societyforscience.org sciedu@societyforscience.org