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Feb 05, 2016
Science FairIndependentDependentVariableRules and RegulationsAbstractSRCBiological HazardsIRBSponsorDistrict RegionalStateSafetyPHBARisk AssessmentHuman SubjectsBSL1BSL2BSL3FormsResearch Plan
INTERNATIONAL SCIENCE AND ENGINEERING FAIRRules and Guidelines
SRC Scientific Review CommitteeReviews some projects before experimentationReviews all projects just prior to competitionMembership must include:a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.)an educatorone other member
IRB Institutional Review BoardReviews human subject studiesMembership must include:an educatora school administratorsomeone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor
Forms REQUIRED for ALL projects
Forms Required for All Projects1 Checklist for Adult Sponsor1AStudent Checklist1A Research Plan7Abstract1BApproval Form
To be completed by Adult Sponsor in collaboration with the student researcher.
This form is required of ALL projects; to be completed by student researcher.
Part of Form 1AA guideline explaining components of Research Plan which must be attached to 1A
Abstract to be completed after experimentation; one page, 250 words.
To be completed by student and parent. If necessary, SRC and IRB are completed here.
Adult Roles and ResponsibilitiesAdult SponsorQualified ScientistDesignated SupervisorInstitutional Review Board (IRB)Scientific Review Committee (SRC)
Adult SponsorOversees project
Completes Form 1 Checklist for Adult Sponsor
Parents DO NOT sign this form
Qualified ScientistRequired for some projectsQS must have a Doctoral professional degree related to student researchMasters degree with SRC approvalCompletes Form 2 QS Form
Designated SupervisorAnimal Care Supervisor for vertebrate animal projectsSupervises projects involving hazardous chemicals, activities or devicesSupervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student
When applicable, the DS signs the Risk Assessment Form 3
Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C
Continuation ProjectsProject based on prior research in the same field of studyLongitudinal studies are permittedMulti-year studyStudies time-based changeRequire form 7
What are human subjects studies?Human Subjects studies involve living individuals where there is:
Intervention or interaction with subjectsand/orCollection of identifiable private information
Exempt Studiesdo not require IRB review nor human subjects formsProduct testing of a student invention, program, concept, etc.No health hazardsNo personal data collectedFeedback directly related to productStudies using pre-existing, publicly available human data
Additional Exempt StudiesBehavioral observations in unrestricted public settingsNo interactionNo manipulation of environmentNo recording of any personal identifiersStudies using certified de-identified/ anonymous data
Human Subjects ResearchThe IRB must review and approve the research plan before experimentation beginsResearch subjects 18 years of age or older must give informed consentResearch subjects under 18 must give assent and their parents may be required to give permission
Human Subjects ResearchThe IRB evaluates the project and determinesRisk levelRequirement for Qualified ScientistRequirement for written informed consent/assent/parental permission
Risk EvaluationNo more than minimal riskAnticipated harm and discomfort notgreater than encountered in daily lifeMore than minimal riskAnticipated harm or discomfort isgreater than encountered in daily lifeMore than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB
Types of RiskPhysical risksExerciseIngestion, tasting, smelling, application of substancesExposure to potentially hazardous materialPsychological risksInvasion of privacySubject member of an at-risk group
IRB can waive requirement of written informed consent ifstudy is of minimal risk anddata collection is anonymousandone of the followingStudy of normal educational practicesBehavioral study with no manipulationSurveys of perception, cognition, game theoryPhysical activity with no more than minimal risk (routine physical activities, tasting of commonly available food or drink, etc.)
IRB decisions are documented on Human Subjects Form 4
Must be completed prior to experimentation.
Written informed consent is obtained from the research subject on a form like the sample provided
Each research subject is required to sign the Informed Consent FormAll Forms must be present at all fairs.
What is a vertebrate animal?Live, nonhuman vertebrate mammalian embryos or fetusesBird and reptile eggs within 3 days of hatchingAll other nonhuman vertebrates (including fish) at hatching or birth
Prohibited studiesInduced toxicity studies involving a poison or toxin that could impair health or destroy lifeBehavioral experiments withOperant conditioning with aversive stimuliMother/infant separationInduced/learned helplessnessStudies of painPredator/vertebrate prey experiments
Additional restrictionsA weight loss or growth retardation greater than 15% is not permittedA death rate of 30% or greater in any group or subgroup is not permitted
Behavioral observations of animals are exempt from SRC review ifThere is no interaction with the animals andThere is no manipulation of the environmentandAll federal or state fish, game and wildlife regulations are followed
Research SitesExamples of non-regulated sitesHomeSchoolFarm, ranchZoological parksField Examples of regulated sites (must have an IACUC review and approval process)UniversitiesGovernment research agenciesPrivate research laboratories
Requirements for studies at non-regulated sites Agricultural, behavioral, observational or supplemental nutritional studiesandNon-invasive and non-intrusive with no negative effect on animals health or well-beingandRequire SRC pre-review and approval
Additional requirements for non-regulated sitesSRC determines level of supervision appropriate for the study:Designated supervisorVeterinarianQualified scientistForm 5A required
Requirements for studies at regulated sitesMust be approved by IACUC (Institutional Animal Care and Use Committee)Local SRC should review project before experimentationExperimentation must follow ISEF guidelines and adhere to restrictions regarding painQS completes Form 5B which includes documentation of IACUC approval
POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS
Potentially hazardous biological agents includeMicroorganisms (including bacteria, viruses, fungi, etc.)Recombinant DNAHuman or animal fresh/frozen tissues, blood or body fluids
All studies involving potentially hazardous biological agentsMust have prior approval by SRC/IACUCMost studies are prohibited in a home environmentStudies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited
Risk assessmentRequired of all PHBA projects Defines potential level of harm, injury or disease to plants, animals or humansInvolvesAssignment of biological agent to risk groupDetermination of level of biological containmentAssessment of expertise of adult(s)Assignment of final biosafety level
Risk assessment, contdBSL 1 studies can usually be conducted in a high school or college teaching laboratory.BSL 2 studies are usually conducted in a regulated research institutionBSL 3 and BSL 4 studies are prohibited for ISEF projectsForm 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
Studies exempt from prior SRC review and no additional PHBA forms requiredStudies using bakers and brewers yeast (except rDNA studies)Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, slime mold and algae-eating bacteria in natural environment. No exempt if cultured in a petri dish environment.
Studies exempt from prior SRC review that require Form 3Studies involving protists, archae and similar microorganismsResearch using manure for composting, fuel production, or other non-culturing experiments Studies using commercially available color change coliform water test kits
Studies Involving Unknown MicroorganismsBSL 1 ifOrganisms cultured in plastic petri dishCulture dish remains sealed throughout experimentCulture dish disposed of in appropriate mannerBSL 2 if petri dish is opened
rDNA technologiesExperiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DSExperiments with BSL 2 organisms must be done in a regulated research institution with a QS
TissuesIf animal is euthanized solely for student project vertebrate animal study which requires IACUC approvalIf animal is euthanized for a purpose other than student project tissue study
TissuesClassification as BSL 1 or 2 based on source of tissue and possibility of containing infectious agentsAll studies with human or wild animal blood are BSL 2. St