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Research Plan. Science Fair. Human Subjects. BSL2. District Regional State. IRB. Sponsor. BSL1. Abstract. Independent. SRC. Rules and Regulations. Variable. Biological Hazards. Dependent. Safety. Forms. PHBA. BSL3. Risk Assessment. INTERNATIONAL SCIENCE AND ENGINEERING FAIR.

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Science fair

Research Plan

Science Fair

Human Subjects

BSL2

DistrictRegionalState

IRB

Sponsor

BSL1

Abstract

Independent

SRC

Rules and Regulations

Variable

Biological Hazards

Dependent

Safety

Forms

PHBA

BSL3

Risk Assessment


International science and engineering fair

INTERNATIONAL SCIENCE AND ENGINEERING FAIR

Rules and Guidelines


Src scientific review committee
SRC Scientific Review Committee

  • Reviews some projects before experimentation

  • Reviews all projects just prior to competition

  • Membership must include:

    • a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., D.O.)

    • an educator

    • one other member


Irb institutional review board
IRB Institutional Review Board

  • Reviews human subject studies

  • Membership must include:

    • an educator

    • a school administrator

    • someone 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 projects


Forms required for all projects1
Forms Required for All Projects

1 Checklist for Adult Sponsor

1A Student Checklist

1A Research Plan

7 Abstract

1B Approval Form


To be completed by Adult Sponsor in collaboration with the student researcher.



Part of Form 1A student researcher.

A guideline explaining components of Research Plan which must be attached to 1A




Adult roles and r esponsibilities
Adult and IRB are completed here.Roles and Responsibilities

  • Adult Sponsor

  • Qualified Scientist

  • Designated Supervisor

  • Institutional Review Board (IRB)

  • Scientific Review Committee (SRC)


Adult sponsor
Adult and IRB are completed here.Sponsor

  • Oversees project

  • Completes Form 1 – Checklist for Adult Sponsor

  • Parents DO NOT sign this form


Qualified scientist
Qualified Scientist and IRB are completed here.

  • Required for some projects

  • QS must have a Doctoral professional degree related to student research

  • Master’s degree with SRC approval

  • Completes Form 2 – QS Form


Designated supervisor
Designated Supervisor and IRB are completed here.

  • Animal Care Supervisor for vertebrate animal projects

  • Supervises projects involving hazardous chemicals, activities or devices

  • Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student



Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C


Continuation projects
Continuation Projects setting or any work site other than home, school or field require Form 1C

  • 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


Human subjects

HUMAN SUBJECTS setting or any work site other than home, school or field require Form 1C


What are human subjects studies
What are human subjects studies? setting or any work site other than home, school or field require Form 1C

  • Human Subjects studies involve living individuals where there is:

    • Intervention or interaction with subjects

      and/or

    • Collection of identifiable private information


Exempt studies do not require irb review nor human subjects forms
Exempt setting or any work site other than home, school or field require Form 1C Studiesdo not require IRB review nor human subjects forms

  • Product testing of a student invention, program, concept, etc.

    • No health hazards

    • No personal data collected

    • Feedback directly related to product

  • Studies using pre-existing, publicly available human data


Additional exempt studies
Additional Exempt Studies setting or any work site other than home, school or field require Form 1C

  • Behavioral observations in unrestricted public settings

    • No interaction

    • No manipulation of environment

    • No recording of any personal identifiers

  • Studies using certified de-identified/ anonymous data


Human subjects research
Human setting or any work site other than home, school or field require Form 1CSubjects Research

  • The IRB must review and approve the research plan before experimentation begins

  • Research subjects 18 years of age or older must give informed consent

  • Research subjects under 18 must give assent and their parents may be required to give permission


Human subjects research1
Human setting or any work site other than home, school or field require Form 1CSubjects Research

  • The IRB evaluates the project and determines

    • Risk level

    • Requirement for Qualified Scientist

    • Requirement for written informed consent/assent/parental permission


Risk evaluation
Risk Evaluation setting or any work site other than home, school or field require Form 1C

  • No more than minimal risk

    Anticipated harm and discomfort not

    greater than encountered in daily life

  • More than minimal risk

    Anticipated harm or discomfort is

    greater 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


Types of risk
Types of Risk setting or any work site other than home, school or field require Form 1C

  • Physical risks

    • Exercise

    • Ingestion, tasting, smelling, application of substances

    • Exposure to potentially hazardous material

  • Psychological risks

  • Invasion of privacy

  • Subject member of an at-risk group


Irb can waive requirement of written informed consent if
IRB can waive requirement of written informed consent if setting or any work site other than home, school or field require Form 1C

  • study is of minimal risk

    and

  • data collection is anonymous

    and

  • one of the following

    • Study of normal educational practices

    • Behavioral study with no manipulation

    • Surveys of perception, cognition, game theory

    • Physical activity with no more than minimal risk (routine physical activities, tasting of commonly available food or drink, etc.)


IRB decisions are documented on setting or any work site other than home, school or field require Form 1C

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 Form

All Forms must be present at all fairs.


Vertebrate animals

VERTEBRATE ANIMALS Consent Form


What is a vertebrate animal
What is a vertebrate animal? Consent Form

  • Live, nonhuman vertebrate mammalian embryos or fetuses

  • Bird and reptile eggs within 3 days of hatching

  • All other nonhuman vertebrates (including fish) at hatching or birth


Prohibited studies
Prohibited studies Consent Form

  • 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


Additional restrictions
Additional restrictions Consent Form

  • A weight loss or growth retardation greater than 15% is not permitted

  • A death rate of 30% or greater in any group or subgroup is not permitted


Behavioral observations of animals are exempt from src review if
Behavioral observations of animals are exempt from SRC review if

  • There is no interaction with the animals

    and

  • There is no manipulation of the environment

    and

  • All federal or state fish, game and wildlife regulations are followed


Research sites

Examples of non-regulated sites review if

Home

School

Farm, ranch

Zoological parks

Field

Examples of regulated sites (musthave an IACUC review and approval process)

Universities

Government research agencies

Private research laboratories

Research Sites


Requirements for studies at non regulated sites
Requirements for studies at non-regulated sites review if

  • 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 pre-review and approval


Additional requirements for non regulated sites
Additional requirements for non-regulated sites review if

  • SRC determines level of supervision appropriate for the study:

    • Designated supervisor

    • Veterinarian

    • Qualified scientist

  • Form 5A required


Requirements for studies at regulated sites
Requirements for studies at regulated sites review if

  • 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

  • QS completes Form 5B which includes documentation of IACUC approval



Potentially hazardous biological agents include
Potentially hazardous biological agents include review if

  • Microorganisms (including bacteria, viruses, fungi, etc.)

  • Recombinant DNA

  • Human or animal fresh/frozen tissues, blood or body fluids


All studies involving potentially hazardous biological agents
All studies involving potentially hazardous biological agents

  • Must have prior approval by SRC/IACUC

  • Most studies are prohibited in a home environment

  • Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited


Risk assessment
Risk assessment agents

  • Required of all PHBA projects

  • Defines potential level of harm, injury or disease to plants, animals or humans

  • Involves

    • Assignment of biological agent to risk group

    • Determination of level of biological containment

    • Assessment of expertise of adult(s)

    • Assignment of final biosafety level


Risk assessment cont d
Risk assessment, cont’d agents

  • 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 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 required
Studies exempt from prior SRC review and no additional PHBA forms required

  • Studies using baker’s and brewer’s 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 3
Studies exempt from prior SRC review that require Form 3 forms required

  • Studies involving protists, archae and similar microorganisms

  • Research using manure for composting, fuel production, or other non-culturing experiments

  • Studies using commercially available color change coliform water test kits


Studies involving unknown microorganisms
Studies Involving Unknown Microorganisms forms required

  • BSL 1 if

    • Organisms cultured in plastic petri dish

    • Culture dish remains sealed throughout experiment

    • Culture dish disposed of in appropriate manner

  • BSL 2 if petri dish is opened


Rdna technologies
rDNA technologies forms required

  • Experiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DS

  • Experiments with BSL 2 organisms must be done in a regulated research institution with a QS


Tissues
Tissues forms required

  • If 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


Tissues1
Tissues forms required

  • 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


Exempt as phba tissues potentially hazardous biological agents
Exempt as PHBA tissues forms requiredPotentially Hazardous Biological Agents

  • 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


Form 6b
Form 6B forms required

  • Required for all projects using

    • Fresh/frozen tissue

    • Primary cell cultures

    • Blood and blood products

    • Body fluids



Hazardous chemicals activities or devices include
Hazardous chemicals, activities or devices include forms required

  • Chemicals

  • Equipment

  • DEA-Controlled Substances

  • Prescription Drugs

  • Alcohol and Tobacco

  • Firearms and Explosives

  • Radiation


General rules
General Rules forms required

  • Studies 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


DEA-Controlled Substances forms required

  • Consult DEA list of controlled substances

  • All studies require Qualified Scientist

  • Controlled substances on Schedule 1 require DEA protocol review

    Firearms and Explosives

  • Must adhere to local training and certification requirements


Alcohol and tobacco
Alcohol and Tobacco forms required

  • Must follow local laws for purchase, possession and consumption

  • Home production of ethyl alcohol (wine or beer) 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


Prescription Drugs forms required

  • Cannot be administered to human subjects

  • Animal administration must follow ISEF vertebrate animal guidelines

    Hazardous Chemicals

  • Refer to MSDS Sheets for safety and handling guidelines


Hazardous Devices forms required

  • Involve level of risk beyond that encountered in student’s everyday life

    Radiation

  • Non-ionizing

  • Ionizing


Form 3
Form 3 forms required

  • Required for all projects involving

    • DEA-Controlled Substances

    • Prescription Drugs

    • Alcohol and Tobacco

    • Hazardous Chemicals

    • Hazardous Devices

    • Hazardous Activities

    • Radiation


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