science fair

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Science Science Fair Fair Independent Independent Dependent Dependent Variable Variable Rules and Rules and Regulations Regulations A b s t r a c t A b s t r a c t SRC SRC B i o l o g i c a l B i o l o g i c a l H a z a r d s H a z a r d s I R B I R B Sponsor Sponsor D i s t r i c t D i s t r i c t R e g i o n a l R e g i o n a l S t a t e S t a t e Safety Safety P H B A P H B A Risk Assessment Risk Assessment Human Subjects Human Subjects B S L 1 B S L 1 BSL2 BSL2 BSL3 BSL3 F o r m s F o r m s Research Plan Research Plan

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Research Plan. Science Fair. Human Subjects. BSL2. District Regional State. IRB. Sponsor. BSL1. Abstract. Independent. SRC. Rules and Regulations. Variable. Biological Hazards. Dependent. Safety. Forms. PHBA. BSL3. Risk Assessment. INTERNATIONAL SCIENCE AND ENGINEERING FAIR. - PowerPoint PPT Presentation

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Page 1: Science  Fair

ScienceScience Fair FairIndependentIndependent

DependentDependent

VariableVariableRules and Rules and

RegulationsRegulations

Abstra

ctA

bstra

ct

SRCSRC Bio

log

ical

Bio

log

ical

Haza

rds

Haza

rds

IRB

IRB

SponsorSponsorD

istrictD

istrict Regio

nal

Regio

nal

Sta

teS

tate

SafetySafety PH

BA

PH

BA

Risk AssessmentRisk Assessment

Human SubjectsHuman SubjectsB

SL1

BS

L1

BSL2BSL2

BSL3BSL3

Form

sFo

rms

Research PlanResearch Plan

Page 2: Science  Fair

INTERNATIONAL INTERNATIONAL SCIENCE SCIENCE

AND AND ENGINEERING ENGINEERING

FAIRFAIR

Rules and GuidelinesRules and Guidelines

Page 3: Science  Fair

SRC SRC Scientific Review CommitteeScientific Review Committee

Reviews some projects before Reviews some projects before experimentationexperimentation

Reviews all projects just prior to Reviews all 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

Page 4: Science  Fair

IRB IRB Institutional Review BoardInstitutional Review Board Reviews human subject studiesReviews human subject 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

Page 5: Science  Fair

Forms Forms REQUIRED REQUIRED

for for ALL ALL

projectsprojects

Page 6: Science  Fair

Forms Required for All Forms Required for All ProjectsProjects

1 1 Checklist for Adult SponsorChecklist for Adult Sponsor

1A1A Student ChecklistStudent Checklist

1A 1A Research PlanResearch Plan

77 AbstractAbstract

1B1B Approval FormApproval Form

Page 7: Science  Fair

To be completed by Adult

Sponsor in collaboration with the student

researcher.

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This form is required of

ALL projects; to

be completed by student researcher.

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Part of Form 1A

A guideline explaining

components of Research Plan which

must be attached to

1A

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Abstract to be completed

after experimentatio

n; one page, 250 words.

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To be completed by student and parent.

If necessary, SRC and IRB are

completed here.

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Adult Adult Roles and RRoles and Responsibilitiesesponsibilities

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)

Page 13: Science  Fair

Adult Adult SponsorSponsor Oversees projectOversees project

Completes Form 1 – Checklist Completes Form 1 – Checklist for Adult Sponsorfor Adult Sponsor

Parents DO NOT sign this formParents DO NOT sign this form

Page 14: Science  Fair

Required for Required for somesome projects projects QS must have a Doctoral QS must have a Doctoral

professional degree related to professional degree related to student researchstudent research

Master’s degree with SRC Master’s degree with SRC approvalapproval

Completes Form 2 – QS FormCompletes Form 2 – QS Form

Qualified ScientistQualified Scientist

Page 15: Science  Fair
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Designated SupervisorDesignated Supervisor

Animal Care Supervisor for Animal Care Supervisor for vertebrate animal projectsvertebrate animal 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 Scientist when the Qualified Scientist cannot directly Qualified Scientist cannot directly supervise the studentsupervise the student

Page 17: Science  Fair

When applicable,

the DS signs the

Risk Assessment

Form 3

Page 18: Science  Fair

Studies conducted at Studies conducted at a research institution, a research institution, industrial setting or industrial setting or any work site other any work site other

than home, school or than home, school or field require Form 1Cfield require Form 1C

Page 19: Science  Fair
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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 ProjectsContinuation Projects

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Page 22: Science  Fair

HUMAN SUBJECTSHUMAN SUBJECTS

Page 23: Science  Fair

What are human subjects What are human subjects studies?studies?

Human Subjects studies involve Human Subjects studies involve living individuals where there is:living individuals where there is:

Intervention or interaction with Intervention or interaction with subjectssubjects

and/orand/or Collection of identifiable private Collection of identifiable private

informationinformation

Page 24: Science  Fair

ExemptExempt Studies Studiesdo not require IRB review nor do not require IRB review nor

human subjects formshuman subjects 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

Page 25: Science  Fair

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 Human Subjects Subjects 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 subjects 18 years of Research subjects 18 years of age or older must give informed age or older must give informed consentconsent

Research subjects under 18 must Research subjects under 18 must give assent and their parents give assent and their parents may be required to give may be required to give permissionpermission

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Human Human Subjects ResearchSubjects Research

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 Subject member of an at-risk Subject member of an at-risk

groupgroup

Page 30: Science  Fair

IRB can waive requirement IRB can waive requirement of written informed consent of written informed consent

ifif study is of minimal risk study is of minimal risk

andand data collection is anonymousdata collection is anonymous

andand one of the followingone of the following

Study of normal educational practicesStudy of normal educational practices Behavioral study with no manipulationBehavioral study with no manipulation Surveys of perception, cognition, game theorySurveys of perception, cognition, game theory Physical activity with no more than minimal risk Physical activity with no more than minimal risk

(routine physical activities, tasting of commonly (routine physical activities, tasting of commonly available food or drink, etc.)available food or drink, etc.)

Page 31: Science  Fair

IRB decisions are documented on IRB decisions are documented on Human Subjects Form 4Human Subjects Form 4

Must be completed prior to Must be completed prior to experimentation.experimentation.

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Written informed consent is obtained from the research

subject on a form like the sample provided

Page 34: Science  Fair

Each research subject is required to sign the Informed Consent Form

All Forms must be present at all fairs.

Page 35: Science  Fair

VERTEBRATE ANIMALSVERTEBRATE ANIMALS

Page 36: Science  Fair

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 Bird and reptile eggs within 3 days of hatchingdays of hatching

All other nonhuman vertebrates All other nonhuman vertebrates (including fish) at hatching or (including fish) at hatching or birthbirth

Page 37: Science  Fair

Prohibited studiesProhibited studies Induced toxicity studies involving a Induced toxicity studies involving a

poison or toxin that could impair poison or toxin that could impair health or destroy lifehealth or destroy life

Behavioral experiments withBehavioral experiments with Operant conditioning with aversive stimuliOperant conditioning with aversive stimuli Mother/infant separationMother/infant separation Induced/learned helplessnessInduced/learned helplessness

Studies of painStudies of pain Predator/vertebrate prey Predator/vertebrate prey

experimentsexperiments

Page 38: Science  Fair

Additional restrictionsAdditional restrictions

A weight loss or growth A weight loss or growth retardation greater than 15% is retardation greater than 15% is not permittednot permitted

A death rate of 30% or greater in A death rate of 30% or greater in any group or subgroup is not any group or subgroup is not permittedpermitted

Page 39: Science  Fair

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

Page 40: Science  Fair

Research SitesResearch Sites

Examples of Examples of non-regulated non-regulated sitessites HomeHome SchoolSchool Farm, ranchFarm, ranch Zoological parksZoological parks Field Field

Examples of Examples of regulated sitesregulated sites ((mustmust have an IACUC have an IACUC review and approval review and approval process)process) UniversitiesUniversities Government Government

research research agenciesagencies

Private research Private research laboratorieslaboratories

Page 41: Science  Fair

Requirements for studies at Requirements for studies at non-regulated sites non-regulated sites

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

Page 42: Science  Fair

Additional requirements for Additional requirements for non-regulated sitesnon-regulated sites

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

Page 43: Science  Fair
Page 44: Science  Fair

Requirements for studies at Requirements for studies at regulated sitesregulated sites

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 before Local SRC should review project before experimentationexperimentation

Experimentation must follow ISEF Experimentation must follow ISEF guidelines and adhere to restrictions guidelines and adhere to restrictions regarding painregarding pain

QS completes Form 5B which includes QS completes Form 5B which includes documentation of IACUC approvaldocumentation of IACUC approval

Page 45: Science  Fair
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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

Page 48: Science  Fair

All studies involving All studies involving potentially hazardous potentially hazardous

biological agentsbiological agents Must have prior approval by Must have prior approval by

SRC/IACUCSRC/IACUC Most studies are prohibited in a Most studies are prohibited in a

home environmenthome environment Studies intended to genetically Studies intended to genetically

engineer bacteria with multiple engineer bacteria with multiple antibiotic resistance are antibiotic resistance are prohibitedprohibited

Page 49: Science  Fair

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

Page 50: Science  Fair

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 Studies using baker’s and brewer’s yeast (except rDNA studies)yeast (except rDNA studies)

Studies using Lactobacillus, B. Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and oil-eating bacteria, slime mold and algae-eating bacteria in natural algae-eating bacteria in natural environment. No exempt if cultured environment. No exempt if cultured in a petri dish environment.in a petri dish environment.

Page 53: Science  Fair

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

Page 54: Science  Fair

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

Page 55: Science  Fair

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

Page 56: Science  Fair

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

Page 57: Science  Fair

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

TissuesTissues

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Plant tissuesPlant tissues Established cell and tissue Established cell and tissue

culturescultures Meat and meat by-products – Meat and meat by-products –

grocery stores, restaurants, grocery stores, restaurants, packing housespacking 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 tissuesPotentially Hazardous Biological AgentsPotentially Hazardous Biological Agents

Page 59: Science  Fair

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

Page 63: Science  Fair

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

Page 68: Science  Fair

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

Page 69: Science  Fair