international science and engineering fair
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INTERNATIONAL SCIENCE AND ENGINEERING FAIR. Rules and Guidelines. Adult Roles and Responsibilities. Adult Sponsor Designated Supervisor Qualified Scientist IRB SRC. Adult Sponsor. Oversees project Completes Form 1 – Checklist for Adult Sponsor. Designated Supervisor. - PowerPoint PPT PresentationTRANSCRIPT
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INTERNATIONAL SCIENCE AND ENGINEERING FAIR
Rules 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 – Checklist for Adult Sponsor
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Designated Supervisor Supervises project when
Qualified Scientist cannot directly supervise
“Animal Care Supervisor” for animal projects
Supervises projects using Hazardous Chemicals, Activities or Devices
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Required for some projects
Possesses doctoral or professional degree related to student 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 or licensed 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 research institution/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 the same 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 living individuals where there isIntervention or interaction with subjects and/orCollection of identifiable private information
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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 a potentially 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 informed consent are noted on Form
4
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VERTEBRATE ANIMALS
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What is a vertebrate animal? Live, nonhuman vertebrate
mammalian embryos or fetus Bird and reptile eggs within 3
days of hatching 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 destroy life
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 or subgroup is not permitted
A death rate of 30% or greater in any group 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 wildlife
regulations are followed.
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Non-regulated vs. regulated sites Examples of
non-regulated sites Home School Farm Ranch Field
Examples of regulated sites (Have an IACUC Review and Approval process) Universities Government
research agencies
Private research laboratories
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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 standard
agricultural practices
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Requirements for studies at non-regulated sites Agricultural, behavioral,
observational or supplemental nutritional studies
and
Non-invasive and non-intrusive with no negative effect on animal’s health or well-being
and
Require SRC review and approval
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Adult Supervisors SRC determines requirement of
any or all of the following adults: Designated Supervisor Veterinarian Qualified Scientist
Form 5A required
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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 before experimentation
Experimentation must follow ISEF guidelines and adhere to restrictions regarding pain
Qualified Scientist completes Form 5B which includes documentation of IACUC approval
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POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS
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Potentially Hazardous Biological 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 risk
assessment
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Risk Assessment Defines potential level of harm,
injury or disease to plants, animals or humans
Involves Assignment of bio. 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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Overview BSL 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 biological agents form) required for all projects involving microorganisms, rDNA and fresh/frozen tissue
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All Studies Involving Potentially Hazardous 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 antibiotic resistance are prohibited
Biosafety level 3 and 4 studies are prohibited
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Exempt from prior SRC review – no additional forms required
Studies using baker’s and brewer’s yeast (except for rDNA studies)
Coliform water test kits Studies using Lactobacillus, B.
thurgensis, nitrogen-fixing bacteria, oil-eating bacteria and algae-eating bacteria in natural environment
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Exempt from prior SRC review – requires Risk Assessment Form 3
Studies involving protists, archae and similar microorganisms
Research involving manure for composting or other non-culturing experiments 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 can be done in BSL 1 lab with a Qualified Scientist or trained Designated Supervisor
Experiments with BSL 2 organisms must be done in a regulated research institution with a Qualified Scientist
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Tissues If animal euthanized solely for
student project – vertebrate animal study
If animal euthanized for a purpose other than student project – tissue study
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Classification as BSL 1 or 2 based on source and possibility of containing infectious agents
All studies with human or wild animal blood – BSL 2. Domestic animal blood – BSL 1
Human body fluids identified with individual 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, Activities or 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
and approval All studies require a Risk
Assessment documented on Form 3
DEA- controlled substances require a Qualified Scientist
All other studies require a Designated Supervisor
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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 ISEF animal guidelines
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Alcohol and Tobacco Must follow local laws for purchase,
possession and consumption Home production of ethyl alcohol
must follow U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations
Alcohol distillation for fuel production can be conducted at school with TTB permit obtained 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 and handling guidelines
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Hazardous Devices Involve level of risk beyond that
encountered in student’s everyday life
Radiation Non-ionizing Ionizing
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Form 3 Required for all projects involving
DEA-Controlled Substances Prescription Drugs Alcohol and Tobacco Hazardous Chemicals Hazardous Devices Radiation
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