Institutional Review Board Guidelines

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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Documents

Institutional Review Board Guidelines