rules and guidelines 2016. adult roles and responsibilities adult sponsor qualified scientist...
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Rules and Guidelines
2016
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Adult roles and responsibilities
Adult SponsorQualified ScientistDesignated SupervisorInstitutional Review Board (IRB)Scientific Review Committee (SRC)
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Adult sponsorOversees project to make sure that
studentis informed of ISEF Rules and Guidelinesis aware of risks associated with projectis aware of forms required for projectwill provide proper supervision during
experimentationif required, submits project to IRB or SRC
Teacher usually serves as Adult Sponsor
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Qualified Scientist Required for some projects Should have a doctoral/professional degree
related to student researchOr
Have applicable experience and expertise with review and approval by the SRC
Completes Form 2 – QS Form
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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
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IRB (Institutional Review Board)Reviews human participants studiesMembership must include:
an educatora school administratorsomeone knowledgeable about evaluating
physical and/or psychological risk: MD, PA, RN, psychologist, licensed social worker or licensed clinical professional counselor
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SRC (Scientific Review Committee)Reviews some projects before
experimentationReviews all projects just prior to competitionMembership must include:
a biomedical scientist with an earned doctoral degree
an educatorone other member
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Combined IRB/SRCa biomedical scientist with an earned doctoral
degree a school administratoran educatorsomeone knowledgeable about evaluating
physical and/or psychological risk: MD, PA, RN, psychologist, licensed social worker or licensed clinical professional counselor
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Research Plan/Project SummaryRequired for all projectsShould incorporate all of the relevant
topics listed in the InstructionsShould summarize what was actually
done in the project
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Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C
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Continuation/Research Progression StudiesProject based on prior research in the same
field of studyLongitudinal studies are permitted
Multi-year studyStudies time-based change
Require Form 7
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What are human participant studies?
Human participant studies involve living individuals where there is
Intervention or interaction with participants
and/orCollection of identifiable private
information
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Exempt studies that do not require IRB review or human participant formsTesting of a student-designed invention
or prototypeStudent researcher is only one doing the
testingNo health hazardsNo personal data collectedFeedback directly related to product
Studies using pre-existing, publicly available human data
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Additional exempt studiesBehavioral observations in unrestricted
public settingsNo interactionNo manipulation of environmentNo recording of any personal identifiers
Studies using certified de-identified/ anonymous data
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Human participants researchThe IRB must review and approve the
research plan before experimentation begins
Research participants 18 years of age or older must give informed consent
Research participants under 18 must give assent and their parents may be required to give written permission
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Human participants research, cont’dThe IRB evaluates the project and
determinesRisk levelRequirement for Qualified Scientist and/or
Designated SupervisorRequirement for written informed
consent/assent/parental permission
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Risk evaluationNo more than minimal risk
Anticipated harm and discomfort notgreater than encountered in daily life
More than minimal riskAnticipated harm or discomfort isgreater than encountered in daily life
More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB
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Types of RiskPhysical risks
ExerciseIngestion, tasting, smelling, application of
substancesExposure to potentially hazardous
materialPsychological risksInvasion of privacyParticipant is a member of an at-risk
group
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Expedited ReviewIRB may elect to do an expedited (one
member) reviewCan only be used for projects where
Human participants test the functionality of a student-designed invention or prototype with no health of safety hazards and no personal data is collected
The student researcher is the only subject of the research that involves no more than minimal risk
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IRB decisions are documented 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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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 birthTadpolesZebrafish embryos 7 days (168 hours)
post fertilization
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Prohibited studiesInduced toxicity studies involving known
toxic substances that cause pain, distress or death
Behavioral experiments withConditioning using aversive stimuliMother/infant separationInduced/learned helplessness
Studies of painPredator/vertebrate prey experiments
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No vertebrate animal deaths due to the experimental procedures are permitted
Studies designed or anticipated to cause vertebrate animal death are prohibited.
Any deaths must be investigated by a qualified individual
If death was the result of experimental procedure the study must be terminated and the study will not qualify for competition.
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Behavioral observations of animals are exempt from SRC review if
There is no interaction with the animals and
There is no manipulation of the environmentand
All federal or state fish, game and wildlife regulations are followed
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Research sitesSchool/Home/Field
Regulated Research Institution (must have an IACUC review and approval process)
UniversitiesGovernment research agenciesPrivate research laboratories
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Vertebrate Animal Studies conducted at school/home/field may include
Studies of animals in their natural environment
Studies of animals in zoological parksStudies of livestock that incorporate standard
agricultural practices Studies of fish that incorporate standard
aquaculture practices
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Requirements for studies at school/home/field Agricultural, behavioral, observational or
supplemental nutritional studiesand
Non-invasive and non-intrusive with no negative effect on animal’s health or well-being
andRequire SRC pre-review and approval
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SRC determines level of supervision appropriate for the study:Designated supervisorVeterinarianQualified scientist
Form 5A required
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Requirements for studies at regulated research institutionsMust be approved by IACUC (Institutional
Animal Care and Use Committee)Local SRC should review project before
experimentationExperimentation must follow ISEF rulesQS completes Form 5B which includes
documentation of IACUC approval
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Potentially hazardous biological agents includeMicroorganisms (including bacteria, viruses,
fungi, etc.)Recombinant DNAHuman or animal fresh/frozen tissues, blood
or body fluids
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All studies involving potentially hazardous biological agentsStudies must have prior approval by
SRC/IACUC/IBCMost studies are prohibited in a home
environmentStudies intended to genetically
engineer bacteria with multiple antibiotic resistance are prohibited
Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated Research Institution under documented IBC review and approval. Students are prohibited from culturing CRE.
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Risk assessmentRequired of all PHBA projects Defines potential level of harm, injury or
disease to plants, animals or humansInvolves
Assignment of biological agent to risk group
Determination of level of biological containment
Assessment of expertise of adult(s)Assignment of final biosafety level
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Risk assessment, cont’dBSL 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 for ISEF projects
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
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Sites to find BSL levelAmerican Biological Safety Association
website: www.absa.org
American Type Culture Collection website: www.atcc.org
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Studies exempt from prior SRC review and do not require PHBA forms
Studies using baker’s and brewer’s yeast (except rDNA studies)
Studies using Lactobacillus, nitrogen-fixing bacteria, B.thuringinensis, oil-eating bacteria, and algae-eating bacteria in natural environment. Not exempt if cultured in a petri dish environment
Studies of mold growth on food items if experiment terminated at first sign of mold
Studies involving water or soil not concentrated in media conducive to growth
Studies of mushrooms and slime moldStudies with E.coli K-12 done at school, except in
rDNA studies
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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 decomposition of vertebrate organisms (forensic studies)
Studies with microbial fuel cells
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Studies involving unknown microorganisms
BSL 1 ifOrganisms cultured in plastic petri dishCulture dish remains sealed throughout
experimentCulture dish disposed of in appropriate manner
BSL 2 if petri dish is opened
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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
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TissuesIf animal is euthanized solely for student
project – vertebrate animal study which requires IACUC approval
If animal is euthanized for a purpose other than student project – tissue study
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Classification as BSL 1 or 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
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Exempt as PHBA tissuesPlant tissuesPlant and non-primate established cell
and tissue culturesFresh or frozen meat, meat by-products,
pasteurized milk, eggs – from grocery stores, restaurants, packing houses
Hair, hooves, nails and feathersSterilized teethFossilized tissue/archeological specimens Prepared fixed tissue slides
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Form 6BRequired for all projects using
Fresh/frozen tissuePrimary cell culturesHuman and other primate established cell lines
and tissue culturesBlood and blood productsBody fluids
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Hazardous chemicals, activities or devices includeChemicalsEquipmentDEA-Controlled SubstancesPrescription DrugsAlcohol and TobaccoFirearms and ExplosivesRadiation
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General RulesStudies do not require prior SRC review and
approvalAll studies require a Risk Assessment
documented on Form 3DEA - controlled substances require a
Qualified ScientistAll other studies require a Designated
Supervisor
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DEA-Controlled SubstancesConsult DEA list of controlled substancesAll studies require Qualified ScientistControlled substances on Schedule 1
require DEA protocol review
Firearms and ExplosivesMust adhere to local training and
certification requirements
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Alcohol and TobaccoStudents must adhere to U.S. regulations
as well as local and country lawsProduction of wine or beer by adults is
allowable. Parents must directly supervise any student research involving legal home production
Alcohol distillation for fuel production or other non consumable products can be conducted at school with TTB permit obtained by school officials
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Prescription DrugsCannot be administered to human
subjectsAnimal administration must follow ISEF
vertebrate animal guidelines
Hazardous ChemicalsRefer to MSDS Sheets for safety and disposal information
Hazardous DevicesInvolve level of risk beyond that
encountered in student’s everyday lifeFollow handling guidelines
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RadiationStudies using non-ionizing radiation and studies
of ionizing radiation using voltage < 10 kvolts require a documented risk assessment on Form 3
Studies of ionizing radiation using voltage between 10 and 25 kvolts must be preapproved by the SRC and have a documented risk assessment
Studies of ionizing radiation using voltage exceeding 25 kvolts must be conducted in a site with a Licensed Radiation Program and preapproved by the institution
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Form 3Required for all projects involving
DEA-Controlled SubstancesPrescription DrugsAlcohol and TobaccoHazardous ChemicalsHazardous DevicesHazardous ActivitiesRadiation
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Questions