RESEARCH ISEF ○​ Professional research/teaching

institution that is regularly

COMMITTEES AND inspected by the USDA
○​ Licensed to use animals covered
INSTITUTIONS by the Animal Welfare Act
○​ May also be subject to U.S.
REVIEW COMMITTEE Public Health Service Policy
➔​ To avoid any conflict in the research
project V.​ ISEF SCIENTIFIC REVIEW COMMITTEE
➔​ Responsible for reviewing the project (ISEF SRC)
○​ Review research plans and all
I.​ AFFILIATED FAIR SCIENTIFIC REVIEW required forms to confirm that
COMMITTEE (SRC) applicable ISEF rules have been
○​ Responsible for the evaluation of followed
other student research,
certifications, research plans VI.​ Institutional Animal Care and Use
and exhibits Committee (IACUC)
○​ For compliance with the rules, ○​ Responsible for oversight of the
applicable laws and regulations animal care
at each level of science fair
competition VII.​ Institutional Biosafety Committee
(IBC)
II.​ INSTITUTIONAL REVIEW BOARD (IRB) ○​ Reviewing projects that involve
○​ Research involving humans recombinant DNA, RNAi,
○​ Evaluate the potential physical pathogens, human materials,
and/or psychological risk etc.
○​ All proposed human research
must be reviewed and approved
by them

III.​ COMBINED SRC/IRB COMMITTEE

○​ the membership meets both the
SRC and IRB requirements listed
previously

IV.​ REGULATED RESEARCH INSTITUTIONS

(RRI)
○​ Within the US
 6.​ Human Participant Protection -
RESEARCH ISEF highest priority is the health and
well-being of the student
RULES FOR ALL researcher(s) and human participants
7.​ Potentially Hazardous Biological
PROJECTS Agents (PHBAs) - responsibility of the
student and adults to conduct and
ETHICS STATEMENT document a risk assessment
1.​ Integrity - Honesty, objectivity, and
avoidance of conflicts ELIGIBILITY/LIMITATIONS
○​ Reflect independent research 1.​ Each Regeneron ISEF-affiliated fair may
done by the student(s), and send to Regeneron ISEF the number of
represent only one year’s work projects provided by their affiliation
2.​ Legality - compliance with all federal, agreement.
state and local laws and regulations is 2.​ A student must meet both of the
essential following:
○​ All projects must be approved a.​ be in grades 9-12 or equivalent;
by a Scientific Review and
Committee (SRC) b.​ not have reached age 20 on or
○​ When necessary must also be before May 1 preceding the
approved by IRB, IACUC, and/or Regeneron ISEF.
IBC 3.​ English is the official language of the
3.​ Respect for Confidentiality and Regeneron ISEF.
Intellectual Property - patents, 4.​ Each student is only allowed to enter
copyrights, and other forms of one project.
intellectual property must be honored a.​ No more than 12 months of
○​ Unpublished data, methods, or continuous research
results may not be used without b.​ May not include research
permission performed before January 2022
○​ Credit must be given to all 5.​ Team projects must have no more
contributions to research than three members; must be
4.​ Stewardship of the Environment - composed of members who all meet
responsibility of the researcher and the Regeneron ISEF eligibility.
adults involved to protect the 6.​ Students may compete in only one
environment from harm Regeneron ISEF affiliated fair.
5.​ Animal Care - proper care and a.​ Except when proceeding to a
respect must be given to vertebrate state/national fair affiliated with
animals the Regeneron ISEF from an
affiliated regional fair.
 7.​ Projects that are demonstrations, 1.5.​ The use of non-animal research
‘library’ research or informational methods and alternatives to
projects, and/or ‘explanation’ models animal research are strongly
or kit building are not appropriate for encouraged and must be
the Regeneron ISEF. explored before conducting a
8.​ All sciences and engineering vertebrate animal project.
disciplines are represented at ISEF and 1.6.​ Introduction or disposal of
projects compete in one of the 21 non-native, genetically-altered,
categories. and/or invasive species,
9.​ A research project may be a part of a pathogens, toxic chemicals or
larger study performed by professional foreign substances into the
scientists, but must be only their own environment is prohibited.
portion of the complete study. ■​ Students are
recommended to
REQUIREMENTS reference their local, state
1.​ GENERAL or national regulations
1.1.​ All domestic and international and quarantine lists.
students must adhere to all 1.7.​ Projects must have an exhibit
rules as set forth in this that adheres to Regeneron ISEF
document. Display & Safety requirements
1.2.​ All projects must adhere to the and is visible during all operable
Ethics Statement above. hours of the exhibit hall.
1.3.​ It is the responsibility of the 1.8.​ All projects must adhere to the
student and the Adult Sponsor requirements of the affiliated
to evaluate the study to fair(s) in which it competes to
determine if the research will qualify for participation in
require forms and/or review and Regeneron ISEF.
approval prior to
experimentation. 2.​ APPROVAL AND DOCUMENTATION
1.4.​ Projects must adhere to local, 2.1.​ Project documentation should
state and U.S. Federal laws, begin before experimentation
regulations, and permitting with the current forms available
conditions. 2.2.​ Every student must complete
■​ Projects outside the U.S. the Student Checklist (1A), a
must also adhere to the Research Plan/Project Summary
laws of the country in and Approval Form (1B)
which the project was 2.3.​ A Qualified Scientist is required
performed. for all studies involving Biosafety
 Lab-2 (BSL-2) potentially 3.2.​ Digital signatures must have a
hazardous biological agents verification system via login and
2.4.​ Any proposed changes in the have a time and date stamp.
Student Checklist (1A) and 3.3.​ Paperwork submitted to the
Research Plan/Project Summary Society for Science & the Public
must be re-approved for Regeneron ISEF must be
2.5.​ Projects which are continuations scanned and submitted via the
of a previous year’s work and online portal.
which require IRB/SRC approval
must undergo the review CONTINUATION OR RESEARCH
process with the current year PROGRESSION OF PROJECTS
2.6.​ Any continuing project must 1.​ Students will be judged only on
document that the additional laboratory experiment/data collection
research is new and different performed over 12 continuous months
2.7.​ If conducted in a research beginning no earlier than January 2022
institution, industrial setting, or and ending May 2023.
any work site other than home, 2.​ Any project based on the student’s
school or field Regulated prior research could be considered a
Research Institutional/Industrial continuation/research progression
Setting Form (1C) must be project.
completed ○​ The additional research is a
2.8.​ Each student or team must substantive expansion from
submit a (maximum) 250-word, prior work.
one-page abstract which ○​ Repetition of previous
summarizes the current year’s experimentation is an example
work after experimentation of an unacceptable
2.9.​ A project data book and continuation.
research paper are not required, 3.​ The display board and abstract must
but are strongly recommended reflect the current year’s work only.
for judging purposes 4.​ Longitudinal studies are permitted as
2.10.​ All signed forms, certifications, an acceptable continuation under the
and permits must be available following conditions:
for review by SRCs ○​ Test the same variables in which
time is a critical variable
3.​ DIGITAL PAPERWORK AND SIGNATURES ○​ Demonstrate time-based
3.1.​ The forms must have the same change
content and order as the ○​ Display board must be based on
Regeneron ISEF forms. collective past conclusionary
data
 5.​ All projects must be reviewed and
approved each year and forms must
be completed for the new year.
6.​ Continuation Research Progression
Project Form (7) is required for projects
in the same field of study as a previous
project.

TEAM PROJECTS
1.​ All team members must meet the
eligibility requirements for Regeneron
ISEF.
2.​ Teams must have no more than three
members.
a.​ Team membership cannot be
changed during a given
research year unless there are
extenuating circumstances
b.​ The project cannot be converted
from an individual project to a
team project or vice versa
c.​ In a future research year, any
project may be converted from
an individual to a team project
3.​ Each team is encouraged to appoint a
team leader to coordinate the work
and act as spokesperson.
4.​ Each team member must submit an
Approval Form (1B).
a.​ Team members must jointly
submit the Checklist for Adult
Sponsor (1), one abstract, a
Student Checklist (1A), a
Research Plan/Project Summary
and other required forms.
5.​ Full names of all team members must
appear on the abstract and forms.
RESEARCH ISEF ➔​ Thoroughly familiar with the following
regulations that govern the area of
ROLES AND study
➔​ Can also serve as the Adult Sponsor, if
RESPONSIBILITIES OF that person meets both sets of

STUDENTS & ADULTS qualifications

➔​ Reviews the ISEF rules relevant to the
project
THE STUDENT RESEARCHER(S)
➔​ Approves the student’s research plan
➔​ Performs the project prior to the start of experimentation
➔​ Understands and abides by the Ethics ➔​ Provides direct supervision
Statement ➔​ Ensures the proper training of the
➔​ Follows the international rules and Student Researcher and/or Designated
guidelines Supervisor
➔​ Obtains all necessary approvals from ➔​ Completes the required
the review committees documentation needed
➔​ Completes all the appropriate
documents needed DESIGNATED SUPERVISOR
➔​ Does not need an advanced degree
ADULT SPONSOR
but must be familiar with the student’s
➔​ May be a teacher, parent, professor, project
and/or other professional scientist ➔​ Only needed when the Qualified
➔​ Should be knowledgeable and familiar Scientist lives far
in the area of student research ➔​ May also serve as the Adult Sponsor for
➔​ Should have close contact with the the project
student throughout the project ➔​ Should be knowledgeable with
➔​ Works with the student to evaluate any handling of animals when the project
possible risks involved involves vertebrate animals
➔​ Reviews the student’s Student ➔​ Provides direct supervision
Checklist (1A) and Research ➔​ Completes the required
Plan/Project Summary documentation needed

QUALIFIED SCIENTIST
➔​ Earned a doctoral/professional degree
in a scientific discipline related to the
student's area of research
○​ With extensive experience and
expertise in that field of study
RESEARCH ISEF Adult research participants may give
their own consent.
HUMAN PARTICIPANTS a.​ Complete information about the
risks and benefits of

RULES participating in a research study

b.​ Participation is voluntary and
1.​ Student researchers must complete
they are free to decline
the Human Participants portion of the
c.​ Not involve coercion
Research Plan/Project Summary
d.​ Survey must be attached to the
Instructions and evaluate and
consent form
minimize risks to their human
e.​ Researchers can request that
participants.
the IRB waive the requirement
2.​ Student research involving human
5.​ The research study must comply with
participants must be reviewed and
all privacy laws, such as FERPA and
approved by an Institutional Review
HIPAA, when it involves medical
Board (IRB).
information.
a.​ Projects conducted at school,
6.​ Students are prohibited from
home, or in the community must
performing medical procedures on
be reviewed and approved by
human participants
the School IRB
a.​ Under the supervision of a
b.​ Projects conducted at a
licensed healthcare
Regulated Research Institution
provider/professional
(RRI) must have IRB approval
b.​ The IRB must approve the
from the RRI
research plan/protocol
3.​ Must comply with all determinations
c.​ Students are prohibited from
made by the School or RRI IRB before
providing diagnostic or medical
beginning any interaction with human
information to participants
participants
without direct supervision
a.​ Qualified Scientist - Form 2 must
7.​ Public Health Service Act - Student
be completed by the QS before
researchers must not publish
any interaction with human
information without consent
participants
8.​ All published instruments must be
b.​ Designated Supervisor - Form 3
administered, scored and interpreted
must be completed before any
by a Qualified Scientist
interaction with human
9.​ Studies that involve the collection of
participants
data via the internet are allowed
4.​ Research participants must voluntarily
a.​ use of minors in online surveys
give informed consent/assent (in
must have Informed Consent
some cases with parental permission)
and written parental permission
 b.​ IP addresses and data provided and the probability of harm or
must be safeguarded discomfort
10.​ A student with any proposed changes
in the Research Plan must repeat the HUMAN PARTICIPANT INVOLVEMENT
approval process and regain approval 1.​ RB review and pre-approval is required
11.​ After experimentation and before when student-designed inventions,
competition, the Affiliated Fair SRC will prototypes, applications are tested by
review for compliance with all rules. human participants
12.​ The following forms are required: 2.​ Must adhere to Rule 6 of the Human
a.​ Checklist for Adult Sponsor (1), Participant Rules regarding prohibition
Student Checklist (1A), Research of medical procedures and be
Plan/Project Summary, and supervised by a healthcare
Approval Form (1B) professional
b.​ Human Participants Form (4) 3.​ A Risk Assessment Form 3 is required
c.​ Regulated Research Institution for all student-designed projects that
Form (1C), when applicable involve human testing.
d.​ Qualified Scientist Form (2),
when applicable EXEMPT STUDIES
e.​ Risk Assessment (3), when ➔​ The student is the only person testing
applicable and the testing does not pose a health
or safety hazard
INFORMED CONSENT ➔​ Do not involve any interaction with
➔​ The research involves only minimal risk humans or the collection of data from
and anonymous data collection a human participant
a.​ Research involving normal ➔​ Behavioral observations of
educational practices unrestricted;
b.​ Research on individual or group a.​ has no interaction
behavior or characteristics b.​ does not manipulate
without manipulating the c.​ does not record any personally
participants and involving more identifiable data
than minimal risk ➔​ Anonymous data must comply with
c.​ Surveys, questionnaires, or two conditions:
activities to involve perception, a.​ In compliance with privacy and
cognition, or game theory HIPAA laws
without personal information or b.​ SRC ensures that data is
emotional distress. de-identified
d.​ Involving physical activity where RESEARCH ISEF
the IRB determines minimal risk
PHBAs: POTENTIALLY 10.​ Use of prions must be conducted at a
Regulated Research Institution under

HAZARDOUS the supervision of a Qualified Scientist.

11.​ The culturing of human or animal
BIOLOGICAL AGENTS waste, including sewage sludge, is
considered a BSL-2 study.
RULES 12.​ Naturally-occurring plant pathogens
1.​ Prior review and approval is required. may be studied (not cultured) at home
2.​ An affiliated fair SRC, an IBC or an 13.​ PHBA must be properly disposed of at
IACUC must approve all research the end of experimentation.
before experimentation begins. 14.​ Any proposed changes in the Research
3.​ Experimentation involving the culturing Plan by the student after initial
of PHBA is prohibited in a home approval must undergo subsequent
environment. SRC or IBC review and approval
4.​ Research determined to be at 15.​ Forms required:
Biosafety Level 1 (BSL-1) must be a.​ Checklist for Adult Sponsor (1),
conducted in a BSL-1 or higher Student Checklist (1A), Research
laboratory. Plan, and Approval Form (1B)
5.​ Research determined to be a Biosafety b.​ Regulated Research Institution
Level 2 (BSL-2) must be conducted in a Form (1C) – when applicable.
laboratory rated BSL-2 or above. c.​ Qualified Scientist (2), when
6.​ Students are prohibited from designing applicable
or participating in BSL- 3 or BSL-4 d.​ Risk Assessment (3), when
Research. applicable
7.​ Studies designed to culture multidrug e.​ PHBA Risk Assessment Form
resistant organisms (MDROs) must (6A), when applicable
have a written justification for usage. f.​ Human and Vertebrate Animal
8.​ Insertion of antibiotic resistance Tissue Form (6B) – for all studies
markers for the clonal selection of involving tissues and body
bioengineered organisms is permitted. fluids.
a.​ Students are prohibited from the
insertion of antibiotic-resistance ADDITIONAL RULES FOR PROJECTS
traits or selection of organisms INVOLVING UNKNOWN
b.​ Students are prohibited from MICROORGANISM
designing or selecting for 1.​ Can be treated as a BSL-1 study under
multiple drug resistant the following conditions:
organisms (MDROs) a.​ Organisms are cultured in a
9.​ Extreme caution must be exercised. plastic petri dish and sealed.
 b.​ The petri dish remains sealed 6.​ Human breast milk of unknown origin
throughout the experiment and domestic unpasteurized animal
c.​ The sealed petri dish is disposed milk are considered BSL-2.
of via autoclaving or disinfection 7.​ All studies involving blood or blood
under the supervision of the products should be considered at a
Designated Supervisor. minimum a Biosafety level 2 study.
2.​ If a culture container is opened for any 8.​ Studies of human body fluids must
purpose, it must be treated as a BSL-2 have IRB review and approval, and
study. informed consent.
9.​ Collection and examination of body
ADDITIONAL RULES FOR PROJECTS fluids containing BSL-3 or -4 is
INVOLVING TISSUES AND BODY prohibited.
FLUIDS 10.​ A project involving a student
1.​ Research involving cell lines and tissue researcher using their own body fluids
culture collections must be considered (if not cultured)
a BSL-1 or BSL-2 level organism. a.​ can be considered a BSL-1 study
2.​ If tissues are obtained from an animal b.​ may be conducted in a home
that was euthanized for a purpose, it setting
may be considered a tissue study. c.​ must have IRB review if the body
a.​ Regulated Research Institution - fluid is serving as a measure of
Requires documentation of the an effect of an experimental
IACUC approval for the original procedure on the student
animal study. researcher
b.​ Agricultural/Aquacultural - d.​ must receive prior SRC review
require prior SRC approval. and approval
3.​ If the animal was euthanized solely for 11.​ Studies involving embryonic human
the student’s project, the study must stem cells must be conducted in a
be considered a vertebrate animal Registered Research Institution;
project. reviewed and approved by ESCRO
4.​ The collection and examination of
fresh/frozen tissue and/or body fluids EXEMPT STUDIES
from a non-infectious source is 1.​ The following types of studies are
considered BSL-1. exempt from prior SRC review, but
5.​ The collection and examination of require a Risk Assessment Form 3:
fresh/frozen tissues or body fluids NOT a.​ Studies involving protists and
obtained from food stores, restaurants, archaea.
or packing houses may contain b.​ Research using manure for
microorganisms. composting, fuel production, or
 other non-culturing ➔​ BSL-2 risk group contains biological
experiments. agents that pose moderate risk to
c.​ Commercially-available color personnel and the environment.
change coliform water test kits. ➔​ BSL-3 risk group contains biological
d.​ Studies involving decomposition agents that usually cause serious
of vertebrate organisms. disease; can result in serious economic
e.​ Studies with microbial fuel cells. consequences.
2.​ The following types of studies involve ➔​ BSL-4 risk group contains biological
BSL-1 organisms and are exempt from agents that usually produce very
prior SRC review and require no serious diseases often untreatable.
additional forms:
a.​ Studies involving fermentation LEVELS OF BIOLOGICAL
of baker’s yeast and brewer’s CONTAINMENT
yeast. ➔​ BSL-1 containment is normally found in
b.​ Studies involving Lactobacillus, water-testing laboratories, in high
Bacillus thuringiensis, schools, and in colleges teaching
nitrogen-fixing, oil-eating introductory microbiology classes.
bacteria, and algae-eating ➔​ BSL-2 containment is designed to
bacteria introduced into their maximize safety when working with
natural environment. agents of moderate risk to humans
c.​ Studies involving water or soil and the environment.
microbes not concentrated in ➔​ BSL-3 containment is required for
media conducive to their infectious agents that may cause
microbial growth. serious or potentially lethal diseases as
d.​ Studies of mold growth on food a result of exposure by inhalation.
items if the experiment is ○​ Projects in the BSL-3 group are
terminated at the first evidence prohibited.
of mold. ➔​ BSL-4 containment is required for
e.​ Studies of slime molds and dangerous/exotic agents that pose
edible mushrooms. high risk of life-threatening disease.
f.​ Studies involving E. coli k-12 that ○​ Projects in the BSL-4 group are
are performed at school. prohibited.

CLASSIFICATION OF BIOLOGICAL
AGENTS
➔​ BSL-1 risk group contains biological
agents that pose low risk to personnel
and the environment.
 B.​ PRESCRIPTION DRUGS
RESEARCH ISEF a.​ Students are prohibited from the
use of prescription drugs in their
HAZARDOUS CHEMICALS, study outside of the authority.
i.​ Must be conducted with a
ACTIVITIES, OR DEVICES
Qualified Scientist and
include a risk assessment
RULES FOR ALL PROJECT
ii.​ Students are further
1.​ Risk assessment in collaboration with a
prohibited from providing
Designated Supervisor/Qualified
prescription drugs to
Scientist prior to experimentation.
human participants
2.​ Hazardous activities require direct
b.​ Prescription of drugs to
supervision by a Designated
vertebrate animals is done
Supervisor.
under a veterinarian’s
○​ Involving DEA-controlled
supervision
substances require supervision
by a Qualified Scientist
C.​ ALCOHOL AND TOBACCO
3.​ Use regulated substances in
a.​ Ethyl alcohol production is
accordance with all country laws.
permitted.
4.​ The student/supervisor must obtain
b.​ The Designated Supervisor is
the permit prior to experiment.
responsible for the acquisition,
5.​ Minimize the impact of an experiment
usage and appropriate disposal.
on the environment.
c.​ Production of wine or beer by
6.​ The following forms are required:
adults is allowable in the home.
○​ Checklist for Adult Sponsor (1),
d.​ Students are prohibited from
Student Checklist (1A), Research
conducting experiments where
Plan, and Approval Form (1B)
consumable ethyl alcohol is
○​ Regulated Research Institution
produced by distillation.
Form (1C), when applicable
○​ Qualified Scientist Form (2),
D.​ FIREARMS AND EXPLOSIVES
when applicable
a.​ Conducted with the direct
○​ Risk Assessment Form (3)
supervision of a Designated
Supervisor
ADDITIONAL RULES FOR SPECIFIC
b.​ Modules containing more than
REGULATED SUBSTANCES
62.5 grams of propellant are
A.​ DEA-CONTROLLED SUBSTANCES subject to the permitting
a.​ Must be supervised by Qualified c.​ Potato guns and paintball guns
Scientist at a RRI are not firearms unless intended
b.​ Must have the research protocol to be used as weapons.
approved by DEA
 E.​ REGULATED DRONES
a.​ Must follow all state, Federal,
and country laws

F.​ RADIATION
a.​ Not exceed the dose limits set
by the Nuclear Regulatory
Commission (0.5 mrem/hr or
100 mrem/year).
b.​ If the voltage needed in the
study is <10 kv, a risk assessment
must be conducted.
c.​ Using 10-25 kv must have a risk
assessment conducted and
preapproved by the SRC.
d.​ >25 kv must be conducted at a
Licensed Radiation Program and
preapproved by the Radiation
Safety Officer.

GUIDANCE FOR RISK ASSESSMENT

➔​ Hazardous Chemicals - risk
assessment (documented on Form 3)
must include proper disposal methods
a.​ Toxicity - hazardous to health
when inhaled, swallowed,
injected or in contact with the
skin
b.​ Reactivity - undergo chemical
change
c.​ Flammability - give off vapors
which readily ignite
d.​ Corrosiveness - harm or destroy
living tissues or physical
equipment
➔​ Hazardous Devices - documentation
of risk assessment (Form 3) is required
➔​ Radiation - risk assessment (Form 3)
must be conducted
RESEARCH ISEF VB. VERTEBRATE ANIMAL FORM -
Qualified Scientist; details the
ISEF FORMS incident and the findings of the
investigation
I.​ CHECKLIST FOR ADULT SPONSOR -
Adult sponsor can review what
VI.​ PHBA FORMS
information must be provided

VIA. PHBA RISK ASSESSMENT

IA. THE STUDENT CHECKLIST -
FORM - potential level of harm
students should outline what the
to plants, animals and humans
project is about
that may occur when working
with biological agents
IB. APPROVAL FORM - parents
and student; acknowledge the
VIB. HUMAN AND VERTEBRATE
risks of the proposed study
ANIMAL TISSUE FORM - involving
fresh/frozen tissue, blood, blood
IC. REGULATED RESEARCH
products and body fluids
INSTITUTION - supervising
adults; make sure that the
VII.​ CONTINUATION PROJECTS FORM -
adults supervised/direct the
confirm that the current research is
students
different; comparing current and
previous projects
II.​ QUALIFIED SCIENTIST FORM - what will
be done to oversee the project
VIII.​ ABSTRACT FORM - review the research
to ensure that it’s complying with the
III.​ RISK ASSESSMENT FORM - student;
ISEF rules and laws and regulations
states all the risks and hazards,
precautions, disposing procedures,
and sources of safety information

IV.​ HUMAN PARTICIPANTS - student in

collaboration with adult sponsor;
involving human participants

V.​ ANIMAL FORMS

VA. VERTEBRATE ANIMAL FORM -

details the housing and care of
the animals