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8/9/2019 Institutional Review Board Guidelines
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INTERNATIONAL SCIENCE AND
ENGINEERING FAIRRules and Guidelines
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Adult Roles and
Responsibilities
Adult Sponsor
Designated Supervisor Qualified Scientist
IRB
SRC
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Adult Sponsor
Oversees project
Completes Form 1 Checklistfor Adult Sponsor
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Designated Supervisor Supervises project when Qualified
Scientist cannot directly supervise
Animal Care Supervisor foranimal projects
Supervises projects using
Hazardous Chemicals, Activities orDevices
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Required for some projects
Possesses doctoral orprofessional degree related tostudent research
Completes Form 2 QS Form
Qualified Scientist
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IRB (Institutional Review
Board) Reviews human subject studies
Membership
science educator
school administrator
someone knowledgeable about evaluating
risk: MD, PA, RN, psychiatrist,psychologist, licensed social worker orlicensed clinical professional counselor
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SRC (Scientific Review
Committee) Reviews some projects before
experimentation
Reviews all projects just prior to competition Membership
biomedical scientist (Ph.D., M.D., D.V.M., D.D.S.,D.O.)
science educator At least one other member
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Forms required for all
projects
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Studies conducted at researchinstitution/industrial setting or
any work site other than home,school or field require Form 1C
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Project based on prior research in thesame field of study
Longitudinal studies are permitted Multi-year study
Studies time-based change
Require form 7
Continuation studies
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HUMAN SUBJECTS
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What are human subjects
studies?Human Subjects studies involve livingindividuals where there is
Intervention or interaction withsubjects
and/or
Collection of identifiable privateinformation
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What types of projects not
human subjects research? Product testing
No health hazards No personal data collected Feedback directly related to product
Pre-existing data/record review studies Behavioral observations of unrestricted
public settings
No interaction No manipulation of environment No recording of any personal identifiers
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Human Subjects Studies Require IRB review and approval of
research plan before experimentation
begins IRB evaluates and determines
Risk level
Requirement for informed consent Requirement for Qualified Scientist
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Requirements for projects
with pre-existing data sets Publicly available data no IRB review
Data not de-identified require IRB approval
and may require informed consent Data de-identified/anonymous will not
require IRB approval if:
Data provider certifies de-identification and
compliance with HIPAA Final SRC review confirms above
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Risk Evaluation for Human
Subjects Research
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Risk Groups (vulnerable to
coercion or undue influence) Naturally at risk because of disease
(AIDS, psychiatric disorders, cardiac
disorders, etc.) Members of vulnerable groups covered
by federal regulations Children/minors
Prisoners Pregnant women
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Risk activities (more than
minimal risk) Exercise
Ingestion, tasting, smelling, or
application of a substance of apotentially hazardous material
Emotional stress survey, stimuli
Invasion of privacy Breech of confidentiality
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When more than minimal risk
If IRB determines that potentially
there could be emotional stress When subjects belong to risk group
IRB can waive informed consent
Informed consent required
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IRB can waive requirement of
informed consent if study with minimal risk and,
anonymous data collection and,
one of the following Study of normal educational practices
Behavior study where no manipulation
Surveys of perception, cognition, game theory
Physical activity with no more than minimal risk(daily activity, routine physical activities)
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IRB decisions and
documentation of informedconsent are noted on Form 4
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VERTEBRATE ANIMALS
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W
hat is a vertebrate animal? Live, nonhuman vertebrate
mammalian embryos or fetus
Bird and reptile eggs within 3 days ofhatching
All other nonhuman vertebrates at
hatching or birth
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Prohibited studies Induced toxicity studies involving a poison
or toxin that could impair health or destroylife
Behavioral experiments with Operant conditioning with aversive stimuli
Mother/infant separation
Induced/learned helplessness
Studies of pain
Predator/vertebrate prey experiments
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Additional prohibitions:
A weight loss or growth retardation of
15% or more in any group orsubgroup is not permitted
A death rate of 30% or greater in anygroup or subgroup is not permitted
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Behavioral observations are exempt
from prior SRC review if:
No interaction with animals being observed
and No manipulations of environment
and
All federal/state fish, game, and wildliferegulations are followed.
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Non-regulated vs. regulated
sites Examples of non-
regulated sites Home
School
Farm
Ranch
Field
Examples ofregulated sites(Have an IACUC
Review and Approvalprocess)
Universities
Governmentresearch agencies
Private researchlaboratories
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Additional non-regulated research sites
may include those studies using
Animals in their natural environment
Animals in zoological parks
Livestock that employ standardagricultural practices
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Requirements for studies at
non-regulated sitesAgricultural, behavioral, observational
or supplemental nutritional studies
and
Non-invasive and non-intrusive withno negative effect on animals health
or well-being and
Require SRC review and approval
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Requirements for studies at
regulated sites Must be approved by IACUC (Institutional
Animal Care and Use Committee)
Local SRC should review project beforeexperimentation
Experimentation must follow ISEF guidelinesand adhere to restrictions regarding pain
Qualified Scientist completes Form 5Bwhich includes documentation of IACUCapproval
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POTENTIALLY HAZARDOUS
BIOLOGICAL AGENTS
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Potentially HazardousBiological Agents
Microorganisms (including bacteria,viruses, fungi, etc.)
Recombinant DNA technologies Human or animal fresh/frozen tissues,
blood or body fluids
All above studies require a riskassessment
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Risk Assessment
Defines potential level of harm, injuryor disease to plants, animals or
humans Involves
Assignment of bio. agent to risk group
Determination of level of biological
containmentAssessment of expertise of adult(s)
Assignment of final biosafety level
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Overview
BSL 1 studies can usually be conducted in ahigh 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 biological agents form)
required for all projects involvingmicroorganisms, rDNA and fresh/frozentissue
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All Studies Involving PotentiallyHazardous Biological Agents
Must have prior approval by SRC/IACUC
All studies are prohibited in a home
environment Studies intended to produce or genetically
engineer bacteria with multiple antibioticresistance are prohibited
Biosafety level 3 and 4 studies areprohibited
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Exempt from prior SRC review no additional forms required
Studies using bakers and brewersyeast (except for rDNA studies)
Coliform water test kits Studies using Lactobacillus, B.
thurgensis, nitrogen-fixing bacteria,
oil-eating bacteria and algae-eatingbacteria in natural environment
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Exempt from prior SRC review requires Risk Assessment Form 3
Studies involving protists, archae andsimilar microorganisms
Research involving manure forcomposting or other non-culturingexperiments and fuel production
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Unknown microorganisms
BSL 1 if
Organisms cultured in plastic petri dish or
petrifilm Culture dish remains sealed throughout
experiment
Culture dish disposed of in appropriate
manner
BSL 2 if petri dish is opened
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rDNA technologies
Experiments with BSL 1 organisms canbe done in BSL 1 lab with a Qualified
Scientist or trained DesignatedSupervisor
Experiments with BSL 2 organisms
must be done in a regulated researchinstitution with a Qualified Scientist
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Tissues
If animal euthanized solely for studentproject vertebrate animal study
If animal euthanized for a purposeother than student project tissuestudy
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Classification as BSL 1 or 2 based onsource and possibility of containinginfectious agents
All studies with human or wild animalblood BSL 2. Domestic animal blood
BSL 1
Human body fluids identified withindividual must have IRB approval
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Exempt
Plant tissues
Established cell and tissue cultures
Meat and meat by-products grocery stores,restaurants, packing houses
Hair
Sterilized teeth
Fossilized tissue/archeological specimens
Prepared fixed tissue slides
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Form 6B
Required for all projects using
Fresh/frozen tissue
Primary cell cultures Blood and blood products
Body fluids
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HAZARDOUS CHEMICALS,
ACTIVITIES OR DEVICES
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Hazardous Chemicals, Activitiesor Devices
Includes:
Chemicals
Equipment DEA-Controlled Substances
Prescription Drugs
Alcohol and Tobacco Firearms and Explosives
Radiation
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General Rules
Do not require prior SRC review andapproval
All studies require a Risk Assessmentdocumented on Form 3
DEA- controlled substances require aQualified Scientist
All other studies require a DesignatedSupervisor
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DEA-Controlled Sustances Consult DEA list of controlled substances
All studies require Qualified Scientist Schedule 1 requires DEA protocol review
Prescription Drugs Cannot administer to human subjects
Animal administation must follow ISEFanimal guidelines
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Alcohol and Tobacco Must follow local laws for purchase,
possession and consumption
Home production of ethyl alcohol mustfollow U.S. Alcohol and Tobacco Tax andTrade Bureau (TTB) regulations
Alcohol distillation for fuel production canbe conducted at school with TTB permitobtained by school officials
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Firearms and Explosives
Must check local training and certification
requirements Hazardous Chemicals
Refer to MSDS Sheets for safety andhandling guidelines
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Hazardous Devices
Involve level of risk beyond that
encountered in students everyday life Radiation
Non-ionizing
Ionizing
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Form 3
Required for all projects involving
DEA-Controlled Substances
Prescription DrugsAlcohol and Tobacco
Hazardous Chemicals
Hazardous Devices Radiation
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