INTEL INTERNATIONAL SCI

ENCE AND ENGINEERING F

AIR

2018
Rules and Guidelines
Adult roles and responsibilities

 Adult Sponsor
 Qualified Scientist
 Designated Supervisor
 Institutional Review Board (IRB)
 Scientific Review Committee (SRC)
Adult sponsor
 Oversees project to make sure that student
 is informed of ISEF Rules and Guidelines
 is aware of risks associated with project
 is aware of forms required for project
 will receive proper supervision during experimen
tation
 if required, submits project to IRB or SRC
 Teacher usually serves as Adult Sponsor
 Qualified Scientist

 Required for some projects

 Doctoral/professional degree related
to student research
or
Masters degree with SRC approval

 Completes Form 2 – QS Form

 Designated Supervisor
 Animal Care Supervisor for vertebrate anim
al projects
 Supervises projects involving hazardous che
micals, activities or devices
 Supervises projects requiring a Qualified Sci
entist when the Qualified Scientist cannot di
rectly supervise the student
IRB (Institutional Review Board
)
 Reviews human participants studies
 Membership must include:
 an educator
 a school administrator
 someone knowledgeable about evaluatin
g physical and/or psychological risk: MD,
PA, RN, psychiatrist, psychologist, license
d social worker or licensed clinical profes
sional counselor
SRC (Scientific Review Committ
ee)
 Reviews some projects before experim
entation
 Reviews all projects just prior to comp
etition
 Membership must include:
 a biomedical scientist (Ph.D., M.D., D.V.
M., D.D.S., D.O.)
 an educator
 one other member
 Combined IRB/SRC
 a biomedical scientist (Ph.D., M.D., D.V.
M., D.D.S., D.O.)
 a school administrator
 an educator
 someone knowledgeable about evaluatin
g physical and/or psychological risk: MD,
PA, RN, psychiatrist, psychologist, license
d social worker or licensed clinical profes
sional counselor
Forms required for all projects
A Research Plan is required for
all projects. It must incorporate
all of the relevant topics listed in
the Research Plan Instructions.
Studies conducted at a researc
h institution, industrial setting
or any work site other than ho
me, school or field require For
m 1C
 Continuation studies

 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 PARTICIPANTS
What are human participants st
udies?
Human participants studies involve livin
g individuals where there is

 Intervention or interaction with partic

ipants
and/or
 Collection of identifiable private infor
mation
Exempt studies – do not requi
re IRB review nor human parti
cipants 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 av

ailable human data
 Additional exempt studies

 Behavioral observations in unrestricted

public settings
 No interaction
 No manipulation of environment
 No recording of any personal identifiers
 Studies using certified de-identified/ an
onymous data
 Human participants research
 The IRB must review and approve the
research plan before experimentation
begins
 Research participants 18 years of age
or older must give informed consen
t
 Research participants under 18 must
give assent and their parents may be
required to give permission
Human participants research, cont’d

 The IRB evaluates the project and det

ermines
 Risk level
 Requirement for Qualified Scientist
 Requirement for written informed consen
t/assent/parental permission
 Risk evaluation

 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 requi
re written consent/assent and parental per
mission. Final determination for this requir
ement made by the IRB
 Types of Risk
 Physical risks
 Exercise
 Ingestion, tasting, smelling, application of subst
ances
 Exposure to potentially hazardous material
 Psychological risks
 Invasion of privacy
 Participant is a member of an at-risk g
roup
IRB decisions are document
ed on Form 4
If IRB determines that written inf
ormed consent/assent or parenta
l permission is required, documen
tation is obtained on an “informe
d consent” document
VERTEBRATE ANIMALS
What is a vertebrate animal?
 Live, nonhuman vertebrate mammalia
n embryos or fetuses
 Bird and reptile eggs within 3 days of
hatching
 All other nonhuman vertebrates (inclu
ding fish) at hatching or birth
 Zebrafish embryos 7 days (168 hours)
post fertilization
 Prohibited studies
 Induced toxicity studies involving kno
wn toxic substances that could impair
health or destroy life
 Behavioral experiments with
 Conditioning using aversive stimuli
 Mother/infant separation
 Induced/learned helplessness
 Studies of pain
 Predator/vertebrate prey experiments
 Additional restrictions
 Projects that cause more than momen
tary or slight pain or distress or which
are designed to kill vertebrate animals
are not permitted.
 A weight loss or growth retardation gr
eater than 15% of any experimental
or control animal 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
 There is no interaction with the animal
s
and
 There is no manipulation of the enviro
nment
and
 All federal or state fish, game and wild
life regulations are followed
 Research sites

 School/Home/Field

 Regulated Research Institution (must have

an IACUC review and approval process)
 Universities
 Government research agencies
 Private research laboratories
Requirements for studies at sch
ool/home/field
 Agricultural, behavioral, observational
or supplemental nutritional studies
and
 Non-invasive and non-intrusive with n
o negative effect on animal’s health or
well-being
and
 Require SRC pre-review and approval
Additional requirements for studies
at school/home/field
 SRC determines level of supervision a
ppropriate for the study:
 Designated supervisor
 Veterinarian
 Qualified scientist
 Form 5A required
Requirements for studies at reg
ulated research institutions
 Must be approved by IACUC (Institution
al Animal Care and Use Committee)
 Local SRC should review project before exp
erimentation
 Experimentation must follow ISEF guideline
s
 QS completes Form 5B which includes docu
mentation of IACUC approval
POTENTIALLY HAZARDOUS BIOLO
GICAL AGENTS
Potentially hazardous biological
agents include
 Microorganisms (including bacteria, vir
uses, fungi, etc.)
 Recombinant DNA
 Human or animal fresh/frozen tissues,
blood or body fluids
All studies involving potentially
hazardous biological agents
 Studies must have prior approval by SRC/IA
CUC/IBC
 Most studies are prohibited in a home envir
onment
 Studies intended to genetically engineer ba
cteria with multiple antibiotic resistance are
prohibited
 Lab studies utilizing MRSA, VRE and KPC m
ust be conducted in a Regulated Research I
nstitution under documented IBC review an
d approval
 Risk assessment
 Required of all PHBA projects
 Defines potential level of harm, injury
or disease to plants, animals or huma
ns
 Involves
 Assignment of biological agent to risk gro
up
 Determination of level of biological contai
nment
 Assessment of expertise of adult(s)
 Assignment of final biosafety level
 Risk assessment, cont’d

 BSL 1 studies can usually be conducted in a

high school or college teaching laboratory.
 BSL 2 studies are usually conducted in a re
gulated research institution
 BSL 3 and BSL 4 studies are prohibited for I
SEF projects
 Form 6A (Potentially Hazardous Biological A
gents form) required for most projects invol
ving microorganisms, and for all projects in
volving rDNA and fresh human and vertebra
te animal tissues
Studies exempt from prior SRC
review and no additional PHBA
forms required
 Studies using baker’s and brewer’s yeast (e
xcept rDNA studies)
 Studies using Lactobacillus, B. thurgensis, n
itrogen-fixing bacteria, oil-eating bacteria,
and algae-eating bacteria in natural environ
ment. Not exempt if cultured in a petri dish
environment
 Studies of mold growth on food items if exp
eriment terminated at first sign of mold
Studies exempt from prior SRC
review that require Form 3
 Studies involving protists, archae and
similar microorganisms
 Research using manure for compostin
g, fuel production, or other non-culturi
ng experiments
 Studies using commercially available c
olor change coliform water test kits
 Studies involving unknown mic
roorganisms
 BSL 1 if
 Organisms cultured in plastic petri dish
 Culture dish remains sealed throughout e
xperiment
 Culture dish disposed of in appropriate m
anner
 BSL 2 if petri dish is opened
 rDNA technologies

 Experiments with BSL 1 organisms ca

n be done in BSL 1 lab with a QS or tr
ained DS
 Experiments with BSL 2 organisms mu
st be done in a regulated research inst
itution with a QS
 Tissues

 If animal is euthanized solely for stud

ent project – vertebrate animal study
which requires IACUC approval
 If animal is euthanized for a purpose
other than student project – tissue stu
dy
 Classification as BSL 1 or 2 based on s
ource of tissue and possibility of conta
ining infectious agents
 All studies with human or wild animal
blood are BSL 2. Studies with domesti
c 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
 Plant tissues
 Established cell and tissue cultures
 Fresh or frozen meat, meat by-products,
pasteurized milk, eggs – from grocery sto
res, restaurants, packing houses
 Hair
 Sterilized teeth
 Fossilized tissue/archeological specimens
 Prepared fixed tissue slides
 Form 6B

 Required for all projects using

 Fresh/frozen tissue
 Primary cell cultures
 Blood and blood products
 Body fluids
HAZARDOUS CHEMICALS, ACTIVI
TIES OR DEVICES
Hazardous chemicals, activities
or devices include
 Chemicals
 Equipment
 DEA-Controlled Substances
 Prescription Drugs
 Alcohol and Tobacco
 Firearms and Explosives
 Radiation
 General Rules
 Studies do not require prior SRC revie
w 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
 Consult DEA list of controlled substances
 All studies require Qualified Scientist
 Controlled substances on Schedule 1 req
uire DEA protocol review

Firearms and Explosives

 Must adhere to local training and certifica
tion requirements
 Alcohol and Tobacco
 Must follow local laws for purchase, poss
ession and consumption
 Home production of ethyl alcohol (wine o
r beer) must follow U.S. Alcohol and Tob
acco Tax and Trade Bureau (TTB) regula
tions
 Alcohol distillation for fuel production can
be conducted at school with TTB permit
obtained by school officials
Prescription Drugs
 Cannot be administered to human subjec
ts
 Animal administration must follow ISEF v
ertebrate animal guidelines

Hazardous Chemicals
 Refer to MSDS Sheets for safety and han
dling guidelines
Hazardous Devices
 Involve level of risk beyond that encount
ered in student’s everyday life

Radiation
 Non-ionizing
 Ionizing
 Form 3
 Required for all projects involving
 DEA-Controlled Substances
 Prescription Drugs
 Alcohol and Tobacco
 Hazardous Chemicals
 Hazardous Devices
 Hazardous Activities
 Radiation
 For more information:

 Visit the SSP website: www.societyforscienc

e.org/isef/rulesandguidelines

 Email the Intel ISEF SRC or SSP Staff:

 src@societyforscience.org
 sciedu@societyforscience.org