INTERNATIONAL SCIENCE AND ENGINEERING FAIR

Rules and Guidelines

Adult Roles and Responsibilities

n  Adult Sponsor n  Designated Supervisor n  Qualified Scientist n  IRB n  SRC

Adult Sponsor

n Oversees project n Completes Form 1 – Checklist for Adult Sponsor

Designated Supervisor n  Supervises project when Qualified

Scientist cannot directly supervise n  “Animal Care Supervisor” for

animal projects n  Supervises projects using

Hazardous Chemicals, Activities or Devices

n  Required for some projects n  Possesses doctoral or

professional degree related to student research

n  Completes Form 2 – QS Form

Qualified Scientist

IRB (Institutional Review Board)

n  Reviews human subject studies n  Membership

n  science educator n  school administrator n  someone knowledgeable about evaluating

risk: MD, PA, RN, psychiatrist, psychologist, licensed social worker or licensed clinical professional counselor

SRC (Scientific Review Committee)

n  Reviews some projects before experimentation

n  Reviews all projects just prior to competition n  Membership

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

n  science educator n  At least one other member

Forms required for all projects

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

n  Project based on prior research in the same field of study

n  Longitudinal studies are permitted n  Multi-year study n  Studies time-based change

n  Require form 7

Continuation studies

HUMAN SUBJECTS

What are human subjects studies?

Human Subjects studies involve living individuals where there is n Intervention or interaction with subjects and/or

n Collection of identifiable private information

What types of projects not human subjects research? n  Product testing

n  No health hazards n  No personal data collected n  Feedback directly related to product

n  Pre-existing data/record review studies n  Behavioral observations of unrestricted

public settings n  No interaction n  No manipulation of environment n  No recording of any personal identifiers

Human Subjects Studies n  Require IRB review and approval of

research plan before experimentation begins

n  IRB evaluates and determines n  Risk level n  Requirement for informed consent n  Requirement for Qualified Scientist

Requirements for projects with pre-existing data sets

n  Publicly available data – no IRB review n  Data not de-identified require IRB approval

and may require informed consent n  Data de-identified/anonymous will not

require IRB approval if: n  Data provider certifies de-identification and

compliance with HIPAA n  Final SRC review confirms above

Risk Evaluation for Human Subjects Research

Risk Groups (vulnerable to coercion or undue influence)

n  Naturally at risk because of disease (AIDS, psychiatric disorders, cardiac disorders, etc.)

n  Members of vulnerable groups covered by federal regulations n  Children/minors n  Prisoners n  Pregnant women

Risk activities (more than minimal risk)

n  Exercise n  Ingestion, tasting, smelling, or

application of a substance of a potentially hazardous material

n  Emotional stress – survey, stimuli n  Invasion of privacy n  Breech of confidentiality

n  When more than minimal risk n  If IRB determines that potentially

there could be emotional stress n  When subjects belong to risk group

IRB can waive informed consent

Informed consent required

IRB can waive requirement of informed consent if

n  study with minimal risk and, n  anonymous data collection and, n  one of the following

n  Study of normal educational practices n  Behavior study where no manipulation n  Surveys of perception, cognition, game theory n  Physical activity with no more than minimal risk

(daily activity, routine physical activities)

IRB decisions and documentation of informed

consent are noted on Form 4

VERTEBRATE ANIMALS

What is a vertebrate animal?

n  Live, nonhuman vertebrate mammalian embryos or fetus

n  Bird and reptile eggs within 3 days of hatching

n  All other nonhuman vertebrates at hatching or birth

Prohibited studies n  Induced toxicity studies involving a poison

or toxin that could impair health or destroy life

n  Behavioral experiments with n  Operant conditioning with aversive stimuli n  Mother/infant separation n  Induced/learned helplessness

n  Studies of pain n  Predator/vertebrate prey experiments

Additional prohibitions:

n  A weight loss or growth retardation of 15% or more in any group or subgroup is not permitted

n  A death rate of 30% or greater in any

group or subgroup is not permitted

Behavioral observations are exempt from prior SRC review if:

n  No interaction with animals being observed and

n  No manipulations of environment and

n  All federal/state fish, game, and wildlife regulations are followed.

Non-regulated vs. regulated sites

n  Examples of non-regulated sites n  Home n  School n  Farm n  Ranch n  Field

n  Examples of regulated sites (Have an IACUC Review and Approval process) n  Universities n  Government

research agencies n  Private research

laboratories

Additional non-regulated research sites

may include those studies using

n  Animals in their natural environment n  Animals in zoological parks n  Livestock that employ standard

agricultural practices

Requirements for studies at non-regulated sites

n  Agricultural, behavioral, observational or supplemental nutritional studies

and

n  Non-invasive and non-intrusive with no negative effect on animal’s health or well-being

and

n  Require SRC review and approval

Adult Supervisors

n  SRC determines requirement of any or all of the following adults: n  Designated Supervisor n  Veterinarian n  Qualified Scientist

n  Form 5A required

Requirements for studies at regulated sites

n  Must be approved by IACUC (Institutional Animal Care and Use Committee)

n  Local SRC should review project before experimentation

n  Experimentation must follow ISEF guidelines and adhere to restrictions regarding pain

n  Qualified Scientist completes Form 5B which includes documentation of IACUC approval

POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS

Potentially Hazardous Biological Agents

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

n  Recombinant DNA technologies n  Human or animal fresh/frozen tissues,

blood or body fluids n  All above studies require a risk

assessment

Risk Assessment

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

n  Involves n  Assignment of bio. agent to risk group n  Determination of level of biological

containment n  Assessment of expertise of adult(s) n  Assignment of final biosafety level

Overview n  BSL 1 studies can usually be conducted in a

high school or college teaching laboratory. n  BSL 2 studies are usually conducted in a

regulated research institution n  BSL 3 and BSL 4 studies are prohibited for

ISEF projects n  Form 6A (potentially biological agents form)

required for all projects involving microorganisms, rDNA and fresh/frozen tissue

All Studies Involving Potentially Hazardous Biological Agents

n  Must have prior approval by SRC/IACUC n  All studies are prohibited in a home

environment n  Studies intended to produce or genetically

engineer bacteria with multiple antibiotic resistance are prohibited

n  Biosafety level 3 and 4 studies are prohibited

Exempt from prior SRC review – no additional forms required

n  Studies using baker’s and brewer’s yeast (except for rDNA studies)

n  Coliform water test kits n  Studies using Lactobacillus, B.

thurgensis, nitrogen-fixing bacteria, oil-eating bacteria and algae-eating bacteria in natural environment

Exempt from prior SRC review – requires Risk Assessment Form 3

n  Studies involving protists, archae and similar microorganisms

n  Research involving manure for composting or other non-culturing experiments and fuel production

Unknown microorganisms

n  BSL 1 if n  Organisms cultured in plastic petri dish or

petrifilm n  Culture dish remains sealed throughout

experiment n  Culture dish disposed of in appropriate

manner

n  BSL 2 if petri dish is opened

rDNA technologies

n  Experiments with BSL 1 organisms can be done in BSL 1 lab with a Qualified Scientist or trained Designated Supervisor

n  Experiments with BSL 2 organisms must be done in a regulated research institution with a Qualified Scientist

Tissues

n  If animal euthanized solely for student project – vertebrate animal study

n  If animal euthanized for a purpose other than student project – tissue study

n  Classification as BSL 1 or 2 based on source and possibility of containing infectious agents

n  All studies with human or wild animal blood – BSL 2. Domestic animal blood – BSL 1

n  Human body fluids identified with individual must have IRB approval

n  Exempt n  Plant tissues n  Established cell and tissue cultures n  Meat and meat by-products – grocery stores,

restaurants, packing houses n  Hair n  Sterilized teeth n  Fossilized tissue/archeological specimens n  Prepared fixed tissue slides

Form 6B

n  Required for all projects using n  Fresh/frozen tissue n  Primary cell cultures n  Blood and blood products n  Body fluids

HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICES

Hazardous Chemicals, Activities or Devices

n  Includes: n  Chemicals n  Equipment n  DEA-Controlled Substances n  Prescription Drugs n  Alcohol and Tobacco n  Firearms and Explosives n  Radiation

General Rules

n  Do not require prior SRC review and approval

n  All studies require a Risk Assessment documented on Form 3

n  DEA- controlled substances require a Qualified Scientist

n  All other studies require a Designated Supervisor

n  DEA-Controlled Sustances n  Consult DEA list of controlled substances n  All studies require Qualified Scientist n  Schedule 1 requires DEA protocol review

n  Prescription Drugs n  Cannot administer to human subjects n  Animal administation must follow ISEF

animal guidelines

n  Alcohol and Tobacco n  Must follow local laws for purchase,

possession and consumption n  Home production of ethyl alcohol must

follow U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations

n  Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials

n  Firearms and Explosives n  Must check local training and certification

requirements

n  Hazardous Chemicals n  Refer to MSDS Sheets for safety and

handling guidelines

n  Hazardous Devices n  Involve level of risk beyond that

encountered in student’s everyday life

n  Radiation n  Non-ionizing n  Ionizing

Form 3

n  Required for all projects involving n  DEA-Controlled Substances n  Prescription Drugs n  Alcohol and Tobacco n  Hazardous Chemicals n  Hazardous Devices n  Radiation