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INTERNATIONAL RULES

FOR PRE-COLLEGE SCIENCE RESEARCH


GUIDELINES FOR SCIENCE AND ENGINEERING FAIRS 2020–2021
INTERNATIONAL RULES FOR PRE-COLLEGE SCIENCE RESEARCH:
GUIDELINES FOR SCIENCE AND ENGINEERING FAIRS
2020–2021
TABLE OF CONTENTS
General Requirements for All Projects
1. ISEF Ethics Statement................................................................................................................................................................................ 3
2. ISEF Eligibility/Limitations.......................................................................................................................................................................... 3
3. ISEF Requirements...................................................................................................................................................................................... 3
4. Continuation/Research Progression of Projects....................................................................................................................................... 4
5. Team Projects.............................................................................................................................................................................................. 4

Roles and Responsibilities of Students and Adults


6. The Student Researcher(s)......................................................................................................................................................................... 5
7. The Adult Sponsor...................................................................................................................................................................................... 5
8. The Qualified Scientist............................................................................................................................................................................... 5
9. The Designated Supervisor........................................................................................................................................................................ 5
10. The Institutional Review Board (IRB).......................................................................................................................................................... 6
11. The Affiliated Fair Scientific Review Committees (SRC).......................................................................................................................... 6
12. Regulated Research Institution/Industrial Settings Review Committees................................................................................................7
13. ISEF Scientific Review Committee.............................................................................................................................................................7

Human Participants Rules


1. Rules............................................................................................................................................................................................................ 8
2. Exempt Studies........................................................................................................................................................................................... 9
3. Human Participant & IRB Resources..........................................................................................................................................................11

Vertebrate Animals Rules


1. Rules for ALL Vertebrate Animal Studies ................................................................................................................................................. 12
2. Additional Rules for Projects Conducted at School/Home/Field...........................................................................................................13
3. Additional Rules for Projects Conducted in a Regulated Research Institution ..................................................................................... 14

Potentially Hazardous Biological Agents Rules
1. Rules for ALL Projects Involving Potentially Hazardous Biological Agents............................................................................................ 15
2. Additional Rules for Projects Involving Unknown Microorganisms........................................................................................................16
3. Additional Rules for Projects Involving Recombinant DNA (rDNA) Technologies.................................................................................16
4. Additional Rules for Projects Involving Tissues and Body Fluids Including Blood and Blood Products.............................................. 17
5. Potentially Hazardous Biological Agents Risk Assessment ....................................................................................................................18

Hazardous Chemicals, Activities or Devices Rules


1. Rules for ALL Projects Involving Hazardous Chemicals, Activities or Devices......................................................................................19
2. Additional Rules for Specific Regulated Areas......................................................................................................................................19
3. Hazardous Chemicals, Activities or Devices Risk Assessment............................................................................................................... 21
Engineering & Inventions Projects Guide ...................................................................................................................................... 22
Sources of Information ....................................................................................................................................................................... 23
Display & Safety Regulations ............................................................................................................................................................ 26
Categories & Sub-Categories............................................................................................................................................................ 29
Information on Required Abstract ...................................................................................................................................................30
Forms ........................................................................................................................................................................................................31

The International Rules and Guidelines for Science Fairs is available at societyforscience.org/ISEF in multiple formats. Familiarity with the
rules is critical for students, parents, teachers, mentors, fair directors and local and affiliated fair Scientific Review Committees (SRC)
and Institutional Review Boards (IRB).

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 1
INTERNATIONAL RULES AND GUIDELINES
The full text of the International Rules and forms in html and as
a downloadable pdf.

ISEF RULES WIZARD


An interactive tool which asks questions about your intended project
and provides a list of forms required.

COMMON SRC PROBLEMS


Frequent problems that emerge during Scientific Review Committee
review for qualification at ISEF. Read these to learn what NOT to do.

THESE RULES ARE APPLICABLE FOR


Society for Science & the Public affiliated science fairs and
the Regeneron International Science & Engineering Fair 2021.
The purpose of these rules is to:
• protect the rights and welfare of the student researcher
• protect the rights and welfare of human participants
• protect the health and welfare of vertebrate animal subjects
• protect and promote good stewardship of the environment
• ensure adherence to federal regulations
• ensure use of safe laboratory practices
• determine eligibility for competition in ISEF
For pre-review and approval of your project, find your fair at:
https://findafair.societyforscience.org/
For rules questions, contact the ISEF Scientific Review Committee:
[email protected]
For general questions, contact:
Society for Science & the Public
Science Education Programs
1719 N Street, NW, Washington, DC 20036
office: 202-785-2255, fax: 202-785-1243
email: [email protected]

Page 2 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
ALL PROJECTS
Ethics Statement Eligibility/Limitations
Student researchers, as well as adults who have a role in their 1. Each ISEF-affiliated fair may send to ISEF the number of
projects, are expected to maintain the highest ethical standards. projects allocated and committed to within their affiliation
These standards include, but are not limited to: agreement.

• Integrity. Honesty, objectivity, and avoidance of conflicts of 2. A student must be selected by an ISEF-affiliated fair, and meet
interest are expected during every phase of the project. The both of the following:
project should reflect independent research done by the a. be in grades 9–12 or equivalent; and
student(s) and be free of fraudulent data and/or plagiarism and b. not have reached age 20 on or before May 1 preceding
represent only one year’s work. ISEF.
• Legality. Compliance with all federal, state and local laws
and regulations is essential. In addition, projects conducted 3. English is the official language of ISEF. Student project boards
outside the U.S. must also adhere to the laws of the country and abstracts must be in English.
and jurisdiction in which the project was performed. All
projects must be approved by a Scientific Review Committee 4. Each student is only allowed to enter one project. That project
(SRC), and when necessary must also be approved by an may include no more than 12 months of continuous research
Institutional Review Board (IRB), Institutional Animal Care and may not include research performed before January 2020.
and Use Committee (IACUC), and/or Institutional Biosafety NOTE: Projects that were conducted between January 2020
Committee (IBC). Native, genetically-altered, and/or invasive and March 2020 that competed at an ISEF-affiliate fair, may
species, (e.g. insects, plants, invertebrates, vertebrates), not be presented in 2021 without meeting the continuation
pathogens, toxic chemicals or foreign substances criteria.
reintroduced into the environment is prohibited. It is
recommended that students reference their local, state or 5. Team projects must have no more than three members. Teams
national laws and regulations. competing at ISEF must be composed of the original members
• Respect for Confidentiality and Intellectual Property. who competed at the ISEF-affiliated fair and must all meet ISEF
Confidential communications, as well as patents, copyrights, eligibility.
and other forms of intellectual property must be honored.
Unpublished data, methods, or results may not be used 6. Students may compete in only one ISEF affiliated fair, except
without permission, and credit must be given for all when proceeding to a state/national fair affiliated with ISEF
contributions to the research. from an affiliated regional fair.
• Stewardship of the Environment. It is the responsibility
of the researcher and the adults involved to protect the 7. Projects that are demonstrations, ‘library’ research or
environment from harm. Introduction or disposal of native, informational projects, ‘explanation’ models are not
genetically-altered, and/or invasive species, (e.g. insects, recommended or appropriate for ISEF.
plants, invertebrates, vertebrates), pathogens, toxic chemicals
or foreign substances into the environment is prohibited. It 8. All sciences and engineering disciplines are represented
is recommended that students reference their local, state or at ISEF and projects compete in one of the 22 categories.
national regulations and quarantine lists. Review a complete list of categories and sub-categories with
• Acknowledgment of Risks. All projects involve some amount definitions.
of risk. Everyone is expected to recognize the hazards, assess
the risks, minimize the risks, and prepare for emergencies. 9. A research project may be a part of a larger study performed
• Animal Care. Proper care and respect must be given to by professional scientists, but the project presented by the
vertebrate animals. The use of non-animal research methods student must be only their own portion of the complete study.
and alternatives to animal research are strongly encouraged
and must be explored before conducting a vertebrate animal REQUIREMENTS
project. The guiding principles for the use of animals in General
research includes the following “Four R’s:’ Replace, Reduce, 1. All domestic and international students competing in an
Refine, Respect. ISEF-affiliated fair must adhere to all rules as set forth in this
• Human Participant Protection. The highest priority is the document.
health and well-being of the student researcher(s) and human
participants. 2. All projects must adhere to all of the tenets of the Ethics
• Potentially Hazardous Biological Agents (PHBAs). It is the Statement.
responsibility of the student and adults involved in the project
to conduct and document a risk assessment, and to safely 3. It is the responsibility of the student and the Adult Sponsor
handle and dispose of organisms and materials. to evaluate the study to determine if the research will require
forms and/or review and approval prior to experimentation.
Scientific fraud and misconduct are not condoned at any level
of research or competition. This includes plagiarism, forgery, 4. Projects competing at ISEF must have an exhibit that adheres
use or presentation of other researcher’s work as one’s own and to ISEF Display & Safety requirements and is visible during
fabrication of data. Fraudulent projects will fail to qualify for all operable hours of the exhibit hall without reliance on
competition in affiliated fairs and ISEF. Society for Science and electricity or internet connections.
the Public reserves the right to revoke recognition of a project
subsequently found to have been fraudulent.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 3
5. All projects must adhere to the requirements of the affiliated 10. All signed forms, certifications, and permits must be available
fair(s) in which it competes to qualify for participation in for review by all regional, state, national and international
ISEF. Affiliated fairs may have additional restrictions or affiliated fair SRCs in which the student(s) participate.
requirements. Knowledge of these requirements is the This review must occur after experimentation and before
responsibility of the student and Adult Sponsor. competition.
Approval and Documentation Digital Paperwork and Signatures
1. Project documentation should begin before experimentation Submission of forms generated by a digital system are allowable
with the current forms available. Projects involving human under the following conditions:
participants, vertebrate animals, and potentially hazardous 1. The forms must have the same content and order as ISEF
biological agents must be reviewed and approved by a local or forms.
regional Institutional Review Board (IRB) or Scientific Review
Committee (SRC) prior to the start of experimentation. At the 2. Digital signatures must have a verification system via login and
start of the project, which may in some cases be prior to have a time and date stamp to indicate this authentication.
experimentation begins, a local or regional Institutional Review
Board (IRB) or Scientific Review Committee (SRC) with the 3. Paperwork submitted to Society for Science & the Public for
ISEF-affiliated fair must review and approve most projects ISEF must be scanned and submitted via the online portal.
involving human participants, vertebrate animals, and
Continuation/Research Progression of Projects
potentially hazardous biological agents. Note: If a project
1. As in the professional world, research projects may build on
involves the testing of a student designed invention,
work performed previously. A valid continuation project is a
prototype or concept by a human, an IRB review and
sound scientific endeavor. Students will be judged only on
approval may be required prior to experimentation. See
laboratory experiment/data collection performed over 12
Human Participants Rules for details.
continuous months beginning no earlier than January 2020
and ending May 2021.
2. Every student must complete the Student Checklist (1A), a
Research Plan/Project Summary and Approval Form (1B) and
2. Any project based on the student’s prior research could be
review the project with the Adult Sponsor in coordination with
considered a continuation/research progression project.
completion by the Adult Sponsor of the Checklist for Adult
These projects must document that the additional research
Sponsor (1).
is a substantive expansion from prior work (e.g. testing a new
variable or new line of investigation). Repetition of previous
3. A Qualified Scientist is required for all studies involving
experimentation with the same methodology and research
Biosafety Level 2 (BSL-2) potentially hazardous biological
question, even with an increased sample size, is an example of
agents and DEA-controlled substances and is also required for
an unacceptable continuation.
many human participant studies and many vertebrate animal
studies.
3. The display board and abstract must reflect the current year’s
work only. The project title displayed in the finalist’s booth may
4. After initial IRB/SRC approval (if required), any proposed
mention years (for example, “Year Two of an Ongoing Study”).
changes in the Student Checklist (1A) and Research Plan/
Previous year’s databooks, research papers and supporting
Project Summary must be re-approved before laboratory
documents may be at the booth if properly labeled as such.
experimentation/data collection resumes.
4. Longitudinal studies are permitted as an acceptable
5. Projects which are continuations of a previous year’s work and
continuation under the following conditions:
which require IRB/SRC approval must undergo the review
a. The study is a multi-year study testing or documenting
process with the current year ResearchPlan/Project Summary
the same variables in which time is a critical variable.
prior to experimentation/data collection for the current year.
(Examples: Effect of high rain or drought on soil in a given
basin, return of flora and fauna in a burned area over
6. Any continuing project must document that the additional
time.)
research is new and different. (Continuation/Research
b. Each consecutive year must demonstrate time-based
Progression Projects Form (7)).
change.
7. If work was conducted in a regulated research institution, c. The display board must be based on collective past
conclusionary data and its comparison to the current
industrial setting or any work site other than home, school
or field at any time during the current ISEF project year, the year data set. No raw data from previous years may be
Regulated Research Institutional/Industrial Setting Form (1C) displayed.
must be completed and displayed at the project booth.
5. All projects must be reviewed and approved each year and
8. After experimentation, each student or team must submit a forms must be completed for the new year.
(maximum) 250-word, one-page abstract which summarizes Team Projects
the current year’s work. The abstract must describe research 1. Team projects compete and are judged in the category of their
conducted by the student, not by the supervising adult(s). research at ISEF. All team members must meet the eligibility
requirements for ISEF.
9. A project data book and research paper are not required, but
are strongly recommended for judging purposes. Regional or 2. Teams must have no more than three members. A team with
local fairs may require a project data book and/or a research members from different geographic regions may compete at
paper. an affiliated fair of one of its members, but not at multiple fairs.
However, each affiliated fair holds the authority to determine

Page 4 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
whether teams with members outside of a fair’s geographic be familiar with the regulations around procedures and
territory are eligible to compete, understanding that if materials that apply to the student project, particularly when
the team wins the right to attend ISEF, all team members’ involving human participants, vertebrate animals, potentially
expenses must be supported by the fair. hazardous biological agents or hazardous chemicals, devices
a. Team membership cannot be changed during a given or activities.
research year unless there are extenuating circumstances • Should have close contact with the student throughout the
and the local SRC reviews and approves the change, timeline of the project.
including converting a team project to an individual
project or vice versa. Such conversions must address Responsibilities:
rationale for the change and include a clear delineation The Adult Sponsor is responsible for:
between research preceding the change and that which • Working with the student to evaluate any possible risks
will follow. A memorandum documenting this review and involved in order to ensure the health and safety of the
approval should be attached to Form 1A. student conducting the research and the humans and/or
b. Once a project has competed in a science fair at any level, animals involved in the study.
team membership cannot change and the project cannot • Reviewing the student’s Student Checklist (1A) and Research
be converted from an individual project to a team project Plan/Project Summary to ensure that:
or vice versa. • experimentation follows local, state, and Federal laws
c. In a future research year, any project may be converted and ISEF rules
from an individual to a team project, from a team to • forms are completed by other required adults
an individual project and/or have a change in team • any required Qualified Scientist meets the criteria as set
membership. forth in the ISEF Rules and Guidelines
• the student’s research is eligible for entry in ISEF
3. Each team is encouraged to appoint a team leader to
The Qualified Scientist (QS)
coordinate the work and act as spokesperson. However, each
Qualifications:
member of the team should be able to serve as spokesperson,
• Earned a doctoral/professional degree in a scientific discipline
be fully involved with the project, and be familiar with all
related to student’s area of research
aspects of the project. The final work should reflect the
AND/OR
coordinated efforts of all team members and will be evaluated
• Individual with extensive experience and expertise in the
using the same judging criteria as individual projects.
student’s area of research
• Must be thoroughly familiar with the following regulations that
4. Each team member must submit an Approval Form (1B). Team
govern the student’s area of research including all local, state,
members must jointly submit the Checklist for Adult Sponsor
Federal and if applicable, non-U.S. national regulations and
(1), one abstract, a Student Checklist (1A), a Research Plan/
laws.
Project Summary and other required forms.
• Can also serve as the Adult Sponsor, if that person meets both
sets of qualifications
5. Full names of all team members must appear on the abstract
• May live elsewhere and not be local to the student, in which
and forms.
case, a Designated Supervisor has been appointed and trained
ROLES AND RESPONSIBILITIES OF to serve as the onsite supervision as necessary for the specific
student project.
STUDENTS AND ADULTS
The Student Researcher(s) Responsibilities:
The student researcher is responsible for all aspects of the research The Qualified Scientist is responsible for:
project : • Reviewing the ISEF rules relevant to the project and approving
• Enlisting the aid of any required supervisory adults (Adult the student’s research plan or engineering design prior to the
Sponsor, Qualified Scientist, etc.), obtaining necessary start of experimentation
approvals (SRC, IRB, etc.) • Providing direct supervision throughout the timeline of the
• Following the International Rules & Guidelines and obtaining project or coordinating with a Designated Supervisor to serve
all necessary approvals (SRC, IRB, etc.) and completing all in this capacity
appropriate documentation • Ensuring the proper training of the Student Researcher and/or
• Performing the project (which may include, but is not limited Designated Supervisor in the necessary procedures
to) experimentation, data collection, engineering, data • Completing the required documentation which may include
analysis, and any other process or procedures related to the the Regulated Research Institutional Setting Form (1C), the
project Qualified Scientist Form (2) and the Risk Assessment Form (3),
• Understanding and abiding by the Ethics Statement and when applicable.
attesting to this understanding on Approval Form 1B. The Designated Supervisor (DS)
Qualifications:
To avoid conflict of interest, no Adult Sponsor, parent or other • Does not need an advanced degree
relative of the student, the Qualified Scientist, or Designated • Must be familiar with the student’s project and agree to any
Supervisor who oversees the project, may serve on the SRC or IRB training necessary
reviewing that project. • May also serve as the Adult Sponsor for the project
The Adult Sponsor • If the project involves the use of Vertebrate Animals
Qualifications: (where behavior/habitat is influenced by humans), must be
• An Adult Sponsor may be a teacher, parent, professor, and/or knowledgeable about the humane care and handling of the
other professional scientist animals
• Should be knowledgeable in the area of student research,

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 5
Responsibilities: animal research and research involving potentially hazardous
• Providing direct supervision of the student experimentation biological agents and/or hazardous chemicals, activities or
• Completing the required documentation — the Designated devices
Supervisor box on the Qualified Scientist Form (2) when • Compliance with ISEF ethics statement
applicable • Use of accepted and appropriate research techniques
• Reviewing and completing the Risk Assessment Form (3) • Evidence that risks have been properly assessed
when needed • Evidence of search for alternatives to animal use
• Humane treatment of animals
REVIEW COMMITTEES • Documentation of substantial expansion for continuation
To avoid conflict of interest, no Adult Sponsor, parent or other projects
relative of the student, the Qualified Scientist, or Designated • Evidence of appropriate literature search and attribution
Supervisor who oversees the project, may serve on the IRB
reviewing that project or any other committee. Additional FOR HUMAN PARTICIPANT PROJECTS
members are recommended to help avoid a potential conflict of REVIEW — THE INSTITUTIONAL REVIEW
interest and to increase the expertise of the committee. BOARD (IRB)
An Institutional Review Board (IRB), is a committee that, according
Affiliated Fair Scientific Review Committee (SRC) to federal regulations (45-CFR-46), must evaluate the potential
A Scientific Review Committee (SRC) is a group of qualified physical and/or psychological risk of research involving humans.
individuals that is responsible for evaluation of student research, All proposed human research must be reviewed and approved by
certifications, research plans and exhibits for compliance with the an IRB before experimentation begins. This includes review of any
rules, applicable laws and regulations at each level of science surveys or questionnaires to be used in a project.
fair competition. Affiliated Fairs may authorize local SRCs to serve
in this prior review capacity. The operation and composition Federal regulations require local community involvement.
of the local and Affiliated Fair SRCs must fully comply with the Therefore, it is advisable that an IRB be established at the school
International Rules. Directions for obtaining preapproval are level to evaluate human research projects. If necessary, the local
available from the affiliated fair. A list of fairs can be found at or ISEF-affiliated SRC can serve as an IRB as long as it has the
https://findafair. societyforscience.org. required membership. An IRB must consist of a minimum of three
members including the following:
Most proposed research projects involving vertebrate animals • An educator
and/or potentially hazardous biological agents must be reviewed • A school administrator (preferably principal or vice principal)
and approved BEFORE experimentation. Local or regional SRC • A medical or mental health professional. The medical or
prior review is not required for human studies previously reviewed mental health professional may be a medical doctor, nurse
and approved bya properly constituted IRB. practitioner, physician’s assistant, doctor of pharmacy, registered
nurse, psychologist, licensed social worker or licensed
ALL projects, including those previously reviewed and approved clinical professional counselor. The medical or mental health
by an IRB must be reviewed and approved by the SRC after professional on the IRB may change depending on the nature
experimentation and before competition in an Affiliated Fair. of the study. This person must be knowledgeable about and
Projects which were conducted at a Regulated Research capable of evaluating the physical and/or psychological risk
Institution, industrial setting or any work site other than home, involved in a given study.
school or field and which were reviewed and approved by the
proper institutional board before experimentation, must also be Additional Expertise: If an expert is not available in the
approved by the Affiliated Fair SRC. immediate area, documented contact with an external expert is
An SRC must consist of a minimum of three persons, including recommended. A copy of all correspondence with the expert (e.g.
the following: emails) must be attached to Form 4 and can be used in lieu of the
• a biomedical scientist with an earned graduate degree signature of that expert.
• an educator
• at least one additional member IRBs exist at federally Regulated Research Institutions (e.g.,
universities, medical centers, NIH, correctional facilities).
Additional expertise: Many project evaluations require additional Prisoner advocates must be included on the IRB when research
expertise (e.g., on biosafety and/or of human risk groups). If the participants are incarcerated. The institutional IRB must initially
SRC needs an expert as one of its members and one is not in review and approve all proposed research conducted at or
the immediate area, all documented contact with an external sponsored by that institution. The Adult Sponsor and the local IRB
expert must be submitted. If animal research is involved, at are responsible for ensuring that the project is appropriate for a
least one member must be familiar with proper animal care pre-college student and adheres to ISEF rules.
procedures. Depending on the nature of the study, this person
can be a veterinarian or animal care provider with training and/or It is the responsibility of the members of the IRB to thoroughly
experience in the species being studied. review the Research Plan and collectively decide whether to
approve the project, request revisions to the methodology/require
A Scientific Review Committee (SRC) examines projects for the more oversight (e.g., QS) to reduce risk to participants, or to
following: determine that the project is not appropriate for student research.
• Evidence of proper supervision An IRB documents the determination of risk level on Human
• Completed forms, signatures, research dates, and preapproval Participant Form 4.
dates (when required)
• Evidence of proper team composition In reviewing projects just prior to a fair, if the SRC serving at that
• Compliance with rules and laws governing human and/or level of competition judges an IRB’s decision as inappropriate,

Page 6 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
thereby placing human participants in jeopardy, they may Members of ISEF Scientific Review Committee 2020:
override the IRB’s decision and the project may fail to qualify
for competition. It is advised that IRBs consult with the local or Ms. Susan Appel
affiliated fair SRCs and/or with ISEF SRC in questionable cases. Mr. Henry Disston
Dr. Jennifer Green
Dr. Paula Johnson
Combined SRC/IRB Committee
Dr. Timothy Martin
A combined committee is allowed as long as the membership
Mrs. Evelyn Montalvo
meets both the SRC and IRB requirements listed previously.
Mr. Joseph Scott
Dr. Jason Shuffitt
Regulated Research Institutions/ (RRI) Review Mrs. Andrea Spencer
Committees
Regulated Research Institution: A Regulated Research
Institution within the U.S. is defined as a professional research/
teaching institution that is regularly inspected by the USDA and
is licensed to use animals covered by the Animal Welfare Act
and may also be subject to U.S. Public Health Service Policy.
Also included are all federal laboratories such as National
Institutes of Health, Veteran’s Affairs Medical Centers and the
Centers for Disease Control. In addition, pharmaceutical and
biotechnology companies and research institutions that utilize
research animals that are not covered by the Animal Welfare
Act but have an operational Institutional Animal Care and Use
Committee and are in compliance with U.S. federal laws are
included in this definition. For projects conducted outside of
the United States, a Regulated Research Institution would be a
comparable research institution that adheres to country laws
governing the care and use of vertebrate animals.

Certain areas of research conducted in a regulated research


institution or an industrial setting require review and approval by
federally mandated committees that have been established at
that institution. These committees include:
• Institutional Animal Care and Use Committee (IACUC); Animal
Care and Use Committee (ACUC); Animal Ethics Committee
• Institutional Review Board (IRB); Human Subjects Participant
Program (HSPP)
• Institutional Biosafety Committee (IBC)
• Embryonic Stem Cell Research Oversight Committee (ESCRO)
• Safety Review Committee

The ISEF Scientific Review Committee (ISEF SRC)


All projects are reviewed by ISEF Scientific Review Committee
prior to competition. ISEF SRC is the final arbiter of the
qualification of students to participate in ISEF. Before the fair,
committee members review research plans and all required forms
to confirm that applicable ISEF rules have been followed. ISEF
SRC may request additional information from students prior to
ISEF or may interview potential ISEF participants at the fair to
ensure that they qualify to compete.

ISEF SRC, like an Affiliated Fair SRC, is made up of adults


knowledgeable about research regulations. In addition to the review
of all projects at ISEF, committee members answer questions about
the rules throughout the year from students and teachers. The ISEF
SRC can be contacted at [email protected].

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 7
HUMAN PARTICIPANTS RULES
Rules involving human participants
The following rules were developed to help pre-college student A letter from an adult mentor and/or Qualified Scientist
researchers adhere to the federal regulations governing is not sufficient documentation of the RRI IRB review and
professional scientists and to protect the welfare of both human approval process.
participants and the student researcher. Health and well-being
is of the highest priority when students conduct research with 3. The student must comply with all determinations made by the
human participants. School or RRI IRB before beginning any interaction with human
participants (e.g., recruitment, data collection).
According to Code of Federal Regulation 45, CFR 46, a human a. If the IRB requires a Qualified Scientist (QS), Form 2
participant is a living individual about whom an investigator must be completed by the QS before any interaction
conducting research obtains (1) data or samples through with human participants. The School IRB will review this
intervention or interaction with individuals(s) or (2) identifiable completed form before approving the project.
private information. b. If the IRB requires a Designated Supervisor (DS), Form 3
must be completed before any interaction with human
Examples of projects that are considered “human participant participants. The School IRB will review this completed
research” include: form before approving the project.
• Participants in physical activities (e.g., physical exertion, c. See rule #4 below regarding required procedures for
ingestion of any substance, any medical procedure) obtaining informed consent/assent and/or parental
• Psychological, educational and opinion studies (e.g., surveys, permission.
questionnaires, tests)
• Studies in which the researcher is the subject of the research 4. Participation in research may begin only after research
• Testing of student designed invention, prototype or computer participants have voluntarily given informed consent/assent
application by human participants other than student (in some cases with parental permission). Adult research
researcher participants may give their own consent. Research participants
• Data/record review projects that include data that are not de- under 18 years of age and/or individuals not able to give
identified/anonymous (e.g., data set that includes name, birth consent (e.g. developmentally disabled individuals) give their
date, phone number or other identifying variables) assent, with the parent/guardian providing permission.
• Behavioral observations that
a. involve any interaction with the observed individual(s) or The School IRB will determine whether the consent/assent/
where the researcher has modified the environment (e.g., parental permission may be a) verbal or implicit or b) must be
post a sign, place an object). written. See the Risk Assessment information on page 9 and
b. occur in non-public or restricted access settings (e.g., day the online Risk Assessment Guide for further explanation of
care setting, doctor’s office) informed consent.
c. involve the recording of personally identifiable a. Informed consent requires that the researcher provides
information. complete information to the participant (and where
applicable, parents or guardians) about the risks and
Rules
benefits associated with participation in the research
1. Student researchers must complete ALL elements of the
study, which then allows the participants and parents or
Human Participants portion of the Research Plan/Project
guardians to make an informed decision about whether or
Summary Instructions and evaluate and minimize the physical,
not to participate.
psychological and privacy risks to their human participants.
b. Participants must be informed that their participation
See Risk Assessment information on page 11 and the online
is voluntary and that they are free to stop participating
Risk Assessment Guide (https://student.societyforscience.org/
at any time (i.e., they may participate or decline to
human-participants#riskassess) for additional guidance.
participate, with no adverse consequences of non-
participation or aborted participation).
2. Student research involving human participants must be
c. Informed consent may not involve coercion.
reviewed and approved by an Institutional Review Board
d. When written parental permission is required and the
(IRB) (See page 5) before any interaction (e.g., recruitment,
study includes a survey, the survey must be attached to
data collection) with human participants may begin. It is the
the consent form.
responsibility of the IRB to evaluate potential physical and/or
e. The student researcher may request that the IRB waive
psychological risks of the project and make a determination
the requirement for written informed consent/parental
about whether the project is appropriate for student research
permission in his/her research plan if the project meets
and safe for the student researcher and participants.
specific requirements. See section on IRB waivers for
a. Projects that are conducted at school, at home or in
more information about situations in which written
the community that are not affiliated with a Regulated
parental permission and/or written informed consent can
Research Institution (RRI) must be reviewed and approved
be waived by the IRB.
by the School IRB before the student may begin recruiting
and/or interacting with human participants. The School
5. The research study must be in compliance with all privacy laws
IRB must assess the risk and document its determination
(e.g., U.S. Family Educational Rights and Privacy Act (FERPA)
of risk on Form 4.
and the U.S. Health Insurance Portability and Accountability
b. Projects that are conducted at a Regulated Research
Act (HIPAA)) when they apply to the project (e.g. the project
Institution (RRI) (e.g., university, hospital, medical center,
involves medical information).
government lab) must have IRB approval from the RRI. A
copy of the IRB approval for the project must be obtained.

Page 8 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
6. Students are prohibited from independently diagnosing 3. Surveys, questionnaires, or activities that are determined
disease, administering medication, and/or performing medical by the IRB to involve perception, cognition, or game theory,
procedures on human participants. etc. and that do NOT involve gathering personal information,
a. A student may observe and collect data for analysis of invasion of privacy or potential for emotional distress.
medical procedures, medication/treatment efficacy, and
diagnosis of illness, only under the direct supervision of a 4. Studies involving physical activity where the IRB determines
licensed health care provider/professional. that no more than minimal risk exists and where the probability
b. This Healthcare provider/professional must be named in and magnitude of harm or discomfort anticipated in the
the research plan/ protocol approved by the IRB. The IRB research are not greater than those ordinarily encountered in
must also confirm that the student is not violating the DAILY LIFE or during performance of routine physical activities.
appropriate practice act (medical, nursing, pharmacy, etc)
of the state or country in which he/she is conducting the
If there is any uncertainty regarding the appropriateness of
research.
waiving written informed consent/assent/parental permission,
it is strongly recommended that documentation of written
7. Student researchers may NOT publish or display information
informed consent/assent/parental permission be obtained.
in a report that identifies the human participants directly
or through identifiers linked to the participants (including
photographs) without the written consent of the participant(s) Human Participant Involvement in Student-
(Public Health Service Act, 42, USC 241 (d)). designed Invention, Prototype, Computer Application
& Engineering/Design Projects
8. All published instruments that are not in the public domain Student-designed invention, prototype, computer application and
must be administered, scored and interpreted by a Qualified engineering/design projects that involve testing of the invention
Scientist as required by the instrument publisher. Any and all by any human participant require attention to the potential risks
use and distribution of the test must be in accordance with to the individual(s) testing or trying out the invention/prototype.
the publisher’s requirements, including procurement of legal 1. IRB review and pre-approval is necessary when the student-
copies of the instrument. designed invention, prototype, application, etc. is tested
by human participants other than the student researcher(s)
9. Studies that involve the collection of data via use of the or a single adult guardian or Adult Sponsor/QS/DS when
internet (e.g., email, web-based surveys) are allowed, but the testing requires an adult tester. This includes surveys
researchers should be aware that they can pose challenges in conducted regarding potential use, review of the product
a) collecting anonymous data, b) obtaining informed consent and/or opinions regarding the project as defined by the FDA
and c) ensuring that participants are of the appropriate age or Medical Practices Act) and is tested on human participants
to give informed consent. See the Online Survey Consent must be supervised by a Qualified Scientist.
Procedures.
2. A Risk Assessment Form 3 is recommended for all student-
10. After initial IRB approval, a student with any proposed changes designed inventions or prototypes.
in the Research Plan must repeat the approval process and Exempt Studies (Do Not Require IRB Preapproval or
regain approval before resuming interaction (recruitment, data Human Participants Paperwork)
collection) with human participants. Some studies involving humans are exempt from IRB pre-approval
or additional human participant forms. Exempt projects for ISEF
11. After experimentation and before competition, the Affiliated and affiliated fairs are:
Fair SRC will review for compliance with all rules. 1. Student-designed Invention, Prototype, Computer
Applications or Engineering/Design Project in which the
12. The following forms are required for studies involving human student researcher is the only person testing the invention,
participants: prototype or computer application and the testing does
a. Checklist for Adult Sponsor (1), Student Checklist (1A), not pose a health or safety hazard. The only exception is
Research Plan/Project Summary, and Approval Form (1B) a single adult guardian or Adult Sponsor/QS/DS when the
b. Human Participants Form (4) for projects reviewed by testing requires an adult tester. It is recommended that a Risk
school IRB or IRB approval documentation from an RRI Assessment Form (3) be completed.
and all applicable consents and survey(s)
c. Regulated Research Institution Form (1C), when applicable 2. Data/record review studies (e.g., baseball statistics, crime
d. Qualified Scientist Form (2), when applicable statistics) in which the data are taken from preexisting data
e. Risk Assessment (3) when applicable sets that are publicly available and/or published and do not
involve any interaction with humans or the collection of
IRB Waiver of Written Informed Consent/Parental any data from a human participant for the purpose of the
Permission student’s research project.
The IRB may waive the requirement for documentation of written
informed consent/assent/parental permission if the research 3. Behavioral observations of unrestricted, public settings (e.g.,
involves only minimal risk and anonymous data collection and if it shopping mall, public park) in which all of the following apply:
is one of the following: a. the researcher has no interaction with the individuals
1. Research involving normal educational practices being observed
b. the researcher does not manipulate the environment in
2. Research on individual or group behavior or characteristics any way and
of individuals where the researcher does not manipulate the c. the researcher does not record any personally identifiable
participants’ behavior and the study does not involve more data.
than minimal risk.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 9
4. Projects in which the student receives pre-existing/
retrospective data in a de-identified/anonymous format which
complies with both of the following conditions:
a. the professional providing the data certifies in writing
that the data have been appropriately de-identified
before being given to the student researcher and are in
compliance with all privacy and HIPAA laws, and
b. the affiliated fair SRC ensures that the data were
appropriately de-identified by review of the written
documentation provided by the supervising adult(s).

Page 10 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
HUMAN PARTICIPANT & IRB RESOURCES
Use this information to help determine the level of risk involved in a study involving human participants.

All human participant projects are considered to have some level of risk.

No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not
greater (in and of themselves) than those ordinarily encountered in everyday life or during performance of routine physical or
psychological examinations or tests.

More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality
or invasion of privacy is greater than what is typically encountered in everyday life. Most of these studies require documented
informed consent or minor assent with the permission of parent or guardian (as applicable).

1. Examples of Greater than Minimal Physical Risk


a. Exercise other than ordinarily encountered in everyday life
b. Ingestion, tasting, smelling, or application of a substance. However, ingestion or tasting projects that involve commonly
available food or drink will be evaluated by the IRB which determines risk level based upon the nature of the study and local
norms.
c. Exposure to any potentially hazardous material.

2. Examples of Greater than Minimal Psychological Risk


A research activity (e.g. survey, questionnaire, viewing of stimuli) or experimental condition that could potentially result in
emotional stress. Some examples include: answering questions related to personal experiences such as sexual or physical
abuse, divorce, depression, anxiety; answering questions that could result in feelings of depression, anxiety, or low self
esteem; or viewing violent or distressing video images.

3. Privacy Concerns
a. The student researcher and IRB must consider whether an activity could potentially result in negative consequences for the
participant due to invasion of privacy or breach of confidentiality. Protecting confidentiality requires measures to ensure
that identifiable research data are not disclosed to the public or unauthorized individuals.
b. Risk level can be reduced by protecting confidentiality or collecting data that is strictly anonymous. This requires the
collection of research in such a way that it is impossible to connect research data with the individual who provided the data.

4. Risk Groups
If the research study includes participants from any of the following groups, the IRB and student research must consider
whether the nature of the study requires special protections or accommodations:
a. Any member of a group that is naturally at-risk (e.g. pregnant women, developmentally disabled persons, economically or
educationally disadvantaged persons, individuals with diseases such as cancer, asthma, diabetes, AIDS, dyslexia, cardiac
disorders, psychiatric disorders, learning disorders, etc.)
b. Special groups that are protected by federal regulations or guidelines (e.g. children/minors, prisoners, pregnant women,
students receiving services under the Individuals with Disabilities Education Act (IDEA).
See the online Risk Assessment Guide and Online Survey Consent Procedures for more detailed information on risk
assessment.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 11
VERTEBRATE ANIMALS RULES
Rules involving vertebrate animals
The following rules were developed to help pre-college student that were considered, and the reasons these alternatives
researchers adhere to the federal regulations governing were unacceptable; explanation of the potential impact or
professional scientists and to protect the welfare of both animal contribution this research may have on the broad fields of
subjects and the student researcher. Health and well-being is biology or medicine.
of high priority when students conduct research with animal b. Description of how the animals will be used. Include
subjects. methods and procedures, such as experimental design
and data analysis; description of the procedures that
The Society for Science & the Public strongly endorses the use will minimize the potential for discomfort, distress,
of non-animal research methods and encourages students to pain and injury to the animals during the course of
use alternatives to animal research, which must be explored and experimentation; identification of the species, strain,
discussed in the research plan. The guiding principles for the use sex, age, weight, source and number of animals proposed
of animals in research include the following “Four R’s”: for use.
• Replace vertebrate animals with invertebrates, lower life
forms, tissue/cell cultures and/or computer simulations where 2. All vertebrate animal studies must be reviewed and approved
possible. before experimentation begins. An Institutional Animal Care
• Reduce the number of animals without compromising and Use Committee, known as an IACUC, is the institutional
statistical validity. animal oversight review and approval body for all animal
• Refine the experimental protocol to minimize pain or distress studies at a Regulated Research Institution. The local OR
to the animals. affiliated fair SRC serves in this capacity for vertebrate animals
• Respect animals and their contribution to research. studies performed in a school, home or field. Any SRC serving
in this capacity must include a veterinarian or an animal care
If the use of vertebrate animals is necessary, students must provider with training and/or experience in the species being
consider additional alternatives to reduce and refine the use of studied.
animals.
3. Students performing vertebrate animal research must satisfy
All projects involving vertebrate animals must adhere to the US federal law as well as local, state, and country laws and
rules for all vertebrate animal studies AND to either Section A or regulations of the jurisdiction in which research is performed.
Section B rules, depending on the nature of the study and the
research site. 4. Research projects which cause more than momentary or slight
pain or distress are prohibited. Any illness or unexpected
A project is considered a tissue study and not a vertebrate animal weight loss must be investigated and a veterinarian consulted
study if tissue is obtained from an animal that was euthanized to receive required medical care. This investigation must
for a purpose other than the student’s project. (Use of tissues be documented by the Qualified Scientist or Designated
obtained from research conducted at a Regulated Research Supervisor, who is qualified to determine the illness, or by a
Institution requires a copy of an IACUC certification with the veterinarian. If the illness or distress is caused by the study, the
name of the research institution, the title of the study, the IACUC experiment must be terminated immediately.
approval number and date of IACUC approval.) In tissue
studies, a student may observe the vertebrate study, but may 5. No vertebrate animal deaths due to the experimental
not manipulate or have any direct involvement in the vertebrate procedures are permitted in any group or subgroup.
animal experimental procedures. a. Studies that are designed or anticipated to cause
vertebrate animal death are prohibited.
b. Any death that occurs must be investigated by a
Vertebrate animals, as covered by these rules, are defined as:
veterinarian, the Qualified Scientist or the Designated
1. Live, nonhuman vertebrate mammalian embryos or fetuses
Supervisor who is qualified to determine if the cause
2. Tadpoles
of death was incidental or due to the experimental
3. Bird and reptile eggs starting three days (72 hours) prior to
procedures. The project must be suspended until the
hatching
cause is determined and then the results must be
4. All other nonhuman vertebrates (including fish) at hatching or
documented in writing.
birth.
c. If death was the result of the experimental procedure, the
Exception: Because of their delayed cognitive neural
study must be terminated, and the study will not qualify
development, zebrafish embryos may be used up to seven days
for competition.
(168 hours) post-fertilization and not be considered a vertebrate.
However, regardless of time of treatment, survival past the 7 days
6. All animals must be monitored for signs of distress. Because
must be considered a vertebrate animal and the entire study is
significant weight loss is one sign of stress, weight must
subject to all of the rules below.
be recorded at least weekly with 15% being the maximum
permissible weight loss or growth retardation (compared to
Rules for ALL Vertebrate Animal Studies controls) of any experimental or control animal. Additionally,
1. All vertebrate animal studies must have a research plan that body conditioning scoring (BCS) systems are available for
includes: most species of animals utilized in research and are an
a. Justification why animals must be used, including the objective method for assessing the overall health status of the
reasons for the choice of species, the source of animals research subject, with or without weight loss. A BCS system
and the number of animals to be used; description, should be included in the design of any study utilizing live
explanation, or identification of alternatives to animal use vertebrate animals and results regularly recorded.

Page 12 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
7. Students are prohibited from designing or participating in an 2. Animals must be treated kindly and cared for properly.
experiment associated with the following types of studies on Animals must be housed in a clean, ventilated, comfortable
vertebrate animals: environment appropriate for the species. They must be given
a. Induced toxicity studies with known toxic substances a continuous, clean (uncontaminated) water and food supply.
that could cause pain, distress, or death, including but Cages, pens and fish tanks must be cleaned frequently. Proper
not limited to alcohol, acid rain, pesticides, or heavy care must be provided at all times, including weekends,
metals or studies with the intent to study toxic effects of a holidays, and vacation periods. Animals must be observed
substance on a vertebrate animal. daily to assess their health and well-being. A Designated
b. Behavioral experiments using conditioning with aversive Supervisor is required to oversee the daily husbandry of the
stimuli, mother/infant separation or induced helplessness. animals. Any of the following U.S. documents provide further
c. Studies of pain. guidance for animal husbandry:
d. Predator/vertebrate prey experiments. • Federal Animal Welfare Regulation
• Guide for the Care and Use of Laboratory Animals
8. Justification is required for an experimental design that • Guide for the Care and Use of Agricultural Animals in
involves food or fluid restriction and must be appropriate to Agricultural Research and Teaching (Ag-Guide)
the species. If the restriction exceeds 18 hours, the project • Quality Assurance Manuals (for the appropriate species)
must be reviewed and approved by an IACUC and conducted
at a Regulated Research Institution (RRI). 3. The local or affiliated fair Scientific Review Committee must
determine if a veterinarian’s certification of the research and
9. Animals may not be captured from or released into the wild animal husbandry plan is required. This certification, as well
without approval of authorized wildlife or other regulatory as SRC approval, is required before experimentation and is
officials. All appropriate methods and precautions must be documented on Vertebrate Animal Form 5A. A veterinarian
used to decrease stress. Fish may be obtained from the wild must certify experiments that involve supplemental nutrition,
only if the researcher releases the fish unharmed, has the administration of prescription drugs and/or activities that
proper license, and adheres to state, local and national fishing would not be ordinarily encountered in the animal’s daily life.
laws and regulations. The use of electrofishing is permissible
only if conducted by a trained supervisor; students are 4. If an illness or emergency occurs, the affected animal(s) must
prohibited from performing electrofishing. receive proper medical or nursing care that is directed by a
veterinarian. A student researcher must stop experimentation
10. A Qualified Scientist or Designated Supervisor must directly if there is unexpected weight loss or death in the experimental
supervise all research involving vertebrate animals, except for subjects. The experiment can only be resumed if the cause of
observational studies. illness or death is not related to the experimental procedures
and if appropriate steps are taken to eliminate the causal
11. After initial SRC approval, a student with any proposed factors. If death is the result of the experimental procedure,
changes in the Research Plan/Project Summary of the the study must be terminated, and the study will not qualify for
project must repeat the approval process before laboratory competition.
experimentation/data collection resumes.
5. The final disposition of the animals must be conducted in a
responsible and ethical manner, and must be described on
A. Additional Rules for Projects Conducted at School/
Vertebrate Animal Form 5A.
Home/Field
Vertebrate animal studies may be conducted at a home,
6. Euthanasia for tissue removal and/or pathological analysis is
school, farm, ranch, in the field, etc. This includes:
not permitted for a project conducted in a school/home/field
1. Studies of animals in their natural environment.
site.
2. Studies of animals in zoological parks.
3. Studies of livestock that use standard agricultural
7. Livestock or fish raised for food using standard agricultural/
practices.
aquacultural production practices may be euthanized by a
4. Studies of fish that use standard aquaculture practices
qualified adult for carcass evaluation.
These projects must be reviewed and approved by an SRC in
8. The following forms are required:
which one member is either a veterinarian and/or an animal care
a. Checklist for Adult Sponsor (1), Student Checklist (1A),
provider/expert with training and/or experience in the species
Research Plan/Project Summary, and Approval Form (1B)
being studied.
b. Vertebrate Animal Form (5A)
1. These projects must adhere to BOTH of the following
c. Qualified Scientist Form (2), when applicable
guidelines:
a. The research involves only agricultural, behavioral,
observational or supplemental nutritional studies on B. Additional Rules for Projects Conducted in a
animals. Regulated Research Institution
AND All studies not meeting the criteria in Section A that are
b. The research involves only non-invasive and non- intrusive otherwise permissible under ISEF rules must be conducted in
methods that do not negatively affect an animal’s health or a Regulated Research Institution (RRI). A Regulated Research
well-being. Institution within the U.S. is defined as a professional
research/teaching institution that is regularly inspected
All vertebrate animal studies that do not meet the criteria by the USDA and is licensed to use animals covered by
in Section A. must be conducted in a Regulated Research the Animal Welfare Act and may also be subject to U.S.
Institution (see Section B). Public Health Service Policy. Also included are all federal
laboratories such as National Institutes of Health, Veteran’s

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 13
Affairs Medical Centers and the Centers for Disease Control. Exempt Studies (Do Not Require SRC Preapproval)
In addition, pharmaceutical and biotechnology companies 1. Studies involving behavioral observations of animals are
and research institutions that utilize research animals that exempt from prior SRC review if ALL of the following apply:
are not covered by the Animal Welfare Act but have an a. There is no interaction with the animals being observed,
operational Institutional Animal Care and Use Committee b. There is no manipulation of the animal environment in any
(IACUC) and are in compliance with U.S. federal laws are way, and
included in this definition. For projects conducted outside c. The study meets all federal and state agriculture, fish,
of the United States, a Regulated Research Institution would game and wildlife laws and regulations.
be a comparable research institution that adheres to country
laws governing the care and use of vertebrate animals.

Some protocols permitted in a Regulated Research Institution are


not permitted for participation in ISEF; adherence to RRI rules is
necessary but may not be sufficient.
1. The Institutional Animal Care and Use Committee (IACUC) or
the comparable animal oversight committee must approve
all student research projects before experimentation
begins. Such research projects must be conducted under
the responsibility of a principal investigator. The local and
affiliated fair SRCs must also review the project to certify that
the research project complies with ISEF Rules. This local and
regional SRC review should occur before experimentation
begins, if possible.

2. Student researchers are prohibited from performing


euthanasia. Euthanasia at the end of experimentation for tissue
removal and/or pathological analysis is permitted. All methods
of euthanasia must adhere to current American Veterinary
Medical Association (AVMA) Guidelines.

3. Research projects that cause more than momentary or slight


pain or distress to vertebrate animals are prohibited unless
mitigated by IACUC-approved anesthetics, analgesics and/or
tranquilizers.

4. Research in nutritional deficiency or research involving


substances or drugs of unknown effect is permitted to the
point that any clinical sign of distress is noted. In the case
that distress is observed, the project must be suspended and
measures must be taken to correct the deficiency or drug
effect. A project can only be resumed if appropriate steps are
taken to correct the causal factors.

5. The following forms are required:


a. Checklist for Adult Sponsor (1), Student Checklist (1A),
Research Plan/Project Summary, and Approval Form (1B)
b. Regulated Research Institution Form (1C)
c. Qualified Scientist Form (2)
d. Vertebrate Animal Form (5B)
e. PHBA Risk Assessment Form (6A) – for all studies involving
tissues and body fluids.
f. Human and Vertebrate Animal Tissue Form (6B) – for all
studies involving tissues and body fluids.

Sources of Information are available as a separate section at the


end of the document.

Page 14 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS (PHBA) RULES
Potentially Hazardous Biological Agents Rules for use of microorganisms (including bacteria, viruses, viroids, prions,
rickettsia, fungi and parasites), recombinant DNA technologies or human or animal fresh/frozen tissues, blood, or
body fluids.

Students are permitted to do research projects with potentially 7. Laboratory studies designed to culture known clinically
hazardous biological agents meeting the conditions and rules significant multidrug resistant organisms (MDROs) must
described below which were designed to protect students have a written justification for usage and be conducted at a
and to ensure adherence to federal and international biosafety Regulated Research Institution laboratory with a minimum
regulations and guidelines. of BSL-2 containment and documented IBC review and
approval. Representative examples include, but are not
When dealing with potentially hazardous biological agents, it is limited to the following known agents: MRSA (Methicillin-
the responsibility of the student and all of the adults involved in a Resistant Staphylococcus aureus), VISA/VRSA (Vancomycin
research project to conduct and document a risk assessment on Intermediate or Resistant Staphylococcus aureus), VRE
Form (6A) to define the potential level of harm, injury or disease (Vancomycin-Resistant Enterococci), CRE (Carbapenem
to plants, animals and humans that may occur when working with Resistant Enterobacteriacae), ESBLs (Extended Spectrum Beta-
biological agents. The risk assessment determines a biosafety Lactamase producing gram negative organisms), and fungi
level which in turn determines if the project can proceed, and if (yeasts or molds) with known resistance to antifungal agents.
so, the proposed laboratory facility is properly equipped and all
personnel are trained and appropriate supervision is planned. 8. Insertion of antibiotic resistance markers for the clonal
selection of bioengineered organisms is permitted, with the
All projects involving microorganisms, recombinant DNA following exceptions:
technologies and human or animal fresh/frozen tissues, blood or a. Students are prohibited from the insertion of antibiotic-
body fluids must adhere to the rules below AND, depending on resistance traits or selection of organisms expressing traits
the study, to the additional rules in Section A, B or C. that may affect the ability to provide effective treatment of
infections acquired by humans, animals, or plants.
b. Students are prohibited from designing or selecting for
Rules for ALL Studies with Potentially Hazardous
multiple drug resistant organisms (MDROs) to investigate
Biological Agents (PHBA) the pathology, development, or treatment of antibiotic-
1. Prior review and approval is required for the use of potentially resistant infections.
hazardous microorganisms (including bacteria, viruses,
viroids, prions, rickettsia, fungi, and parasites), recombinant 9. Extreme caution must be exercised when selecting and sub-
DNA (rDNA) technologies or human or animal fresh/frozen culturing antibiotic-resistant organisms. Studies using such
tissues, blood, or body fluids. organisms, including BSL-1 organisms that may have originally
been exempt from prior SRC approval, require at least BSL-2
2. An affiliated fair SRC, an IBC or an IACUC must approve containment.
all research before experimentation begins. The initial risk
assessment determined by the student researcher and adults 10. The culturing of human or animal waste, including sewage
supervising the project must be confirmed by the SRC, IBC or sludge, is considered a BSL-2 study.
IACUC.
11. Naturally-occurring plant pathogens may be studied (not
3. Experimentation involving the culturing of potentially cultured) at home, but may not be introduced into a home/
hazardous biological agents, even BSL-1 organisms, is garden environment.
prohibited in a home environment. However, specimens
may be collected at home as long as they are immediately 12. All potentially hazardous biological agents must be properly
transported to a laboratory with the BSL containment disposed at the end of experimentation in accordance with
determined by the affiliated fair SRC. their biosafety level. For BSL 1 or BSL 2 organisms: Autoclave
at 121 degrees Celsius for 20 minutes, use of a 10% bleach
4. Research determined to be at Biosafety Level 1 (BSL-1) must solution (1:10 dilution of domestic bleach), incineration,
be conducted in a BSL-1 or higher laboratory. The research alkaline hydrolysis, biosafety pick-up and other manufacturer
must be supervised by a trained Designated Supervisor or a recommendations are acceptable.
Qualified Scientist. The student must be properly trained in
standard microbiological practices. 13. Any proposed changes in the Research Plan/Project Summary
by the student after initial local or affiliated fair SRC approval
5. Research determined to be a Biosafety Level 2 (BSL-2) must must undergo subsequent SRC or IBC review and approval
be conducted in a laboratory rated BSL-2 or above (commonly before such changes are made and before experimentation
limited to a Regulated Research Institution). The research resumes.
must be reviewed and approved by the Institutional Biosafety
Committee (IBC) if the Regulated Research Institution requires 14. The following forms are required:
the review. For a high school BSL-2 laboratory, the SRC must a. Checklist for Adult Sponsor (1), Student Checklist (1A),
review and approve. The research must be supervised by a Research Plan/Project Summary, and Approval Form (1B)
Qualified Scientist. b. Regulated Research Institution Form (1C) - when
applicable
6. Students are prohibited from designing or participating in BSL- c. Qualified Scientist (2), when applicable
3 or BSL-4 Research.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 15
d. Risk Assessment (3), when applicable 6. Introduction or disposal of non-native, genetically-altered,
e. PHBA Risk Assessment Form (6A), when applicable and/or invasive species (e.g. insects or other invertebrates,
f. Human and Vertebrate Animal Tissue Form (6B) – for all plants, vertebrates), pathogens, toxic chemicals or foreign
studies involving tissues and body fluids. substances into the environment is prohibited. Students and
adult sponsors should reference their local, state and national
A. Additional Rules for Projects Involving Unknown
regulations and quarantine lists.
Microorganisms
Studies involving unknown microorganisms present a
challenge because the presence, concentration and C. Additional Rules for Projects with Tissues and Body
pathogenicity of possible agents are unknown. In science Fluids, including Blood and Blood Products
fair projects, these studies typically involve the collection Studies involving fresh/frozen tissue, blood or body fluids
and culturing of microorganisms from the environment obtained from humans and/or vertebrates may contain
(e.g. soil, household surfaces, skin.) microorganisms and have the potential of causing disease.
Therefore, a proper risk assessment is required.
1. Research with unknown microorganisms can be treated as a
BSL-1 study under the following conditions: 1. Research involving human and/or non-human primate
a. Organism is cultured in a plastic petri dish (or other established cell lines and tissue culture collections (e.g.,
standard sterile non-breakable container) and sealed. obtained from the American Type Culture Collection) must be
b. Experiment involves only procedures in which the petri considered a BSL-1 or BSL-2 level organism as indicated by
dish remains sealed throughout the experiment (e.g., source information and treated accordingly. The source and/
counting presence of organisms or colonies). or catalog number of the cultures must be identified in the
c. The sealed petri dish is disposed of via autoclaving or Research Plan/Project Summary.
disinfection under the supervision of the Designated
Supervisor. 2. If tissues are obtained from an animal that was euthanized
for a purpose other than the student’s project, it may be
2. If a culture container with unknown microorganisms is opened considered a tissue study.
for any purpose, (except for disinfection/disposal), it must a. Use of tissues obtained from research conducted at
be treated as a BSL-2 study and involve BSL-2 laboratory a Regulated Research Institution requires a copy of
precautions. the IACUC certification with the name of the research
institution, the title of the study, the IACUC approval
B. Additional Rules for Projects Involving Recombinant number and date of IACUC approval.
b. Use of tissues obtained from agricultural/aquacultural
DNA (rDNA) Technologies
studies require prior SRC approval.
Studies involving rDNA technologies in which
microorganisms, plants and/or animals have been
3. If the animal was euthanized solely for the student’s project,
genetically modified require close review to assess the
the study must be considered a vertebrate animal project
risk level assignment. Some rDNA studies can be safely
and is subject to the vertebrate animal rules. (See vertebrate
conducted in a BSL-1 high school laboratory with prior
animal rules.)
review by a SRC.
4. The collection and examination of fresh/frozen tissue
1. All rDNA technology studies involving BSL-1 organisms and
and/or body fluids, (not including blood or blood products;
BSL-1 host vector systems, including commercially available kits,
see rule 7) from a non-infectious source with little likelihood of
must be conducted in a BSL-1 laboratory under the supervision
microorganisms present must be considered Biosafety level 1
of a Qualified Scientist or Designated Supervisor and must be
studies and must be conducted in a BSL-1 laboratory or higher
approved by the SRC prior to experimentation. Examples include
and must be supervised by a Qualified Scientist or trained
cloning of DNA in E. coli K–12, S. cerevesiae, and B. subtilis host-
Designated Supervisor.
vector systems.
5. The collection and examination of fresh/frozen tissues or
2. An rDNA technology study using BSL-1 agents that may
body fluids or meat and meat by-products NOT obtained
convert to BSL-2 agents during the course of experimentation
from food stores, restaurants, or packing houses may
must be conducted entirely in a BSL-2 facility.
contain microorganisms. Because of the increased risk from
unknown potentially hazardous agents, these studies must
3. All rDNA technology studies involving BSL-2 organisms
be considered biosafety level 2 studies conducted in a BSL-2
and/or BSL-2 host vector systems must be conducted in a
laboratory under the supervision of a Qualified Scientist.
Regulated Research Institution and approved by the IBC prior
to experimentation, where applicable.
6. Human breast milk of unknown origin, unless certified free of
HIV and Hepatitis C, and domestic unpasteurized animal milk
4. Propagation of recombinants containing DNA coding for
are considered BSL-2.
human, plant or animal toxins (including viruses) is prohibited.
7. All studies involving human or wild animal blood or blood
5. All genome editing studies that include alteration of germline
products should be considered at a minimum a Biosafety
cells, insertion of gene drives, use of rapid trait development
level 2 study and must be conducted in a BSL-2 laboratory
systems (RTDS®), etc., should be categorized as a BSL-2 study
under the supervision of a Qualified Scientist. Known BSL-3 or
and must be conducted at an RRI and approved by the IBC
BSL-4 blood is prohibited; human capillary blood is exempt.
from the institution. Qualified scientists are expected to ensure
Studies involving domestic animal blood may be considered
that student research protocols address appropriate intrinsic
a BSL-1 level study. All blood must be handled in accordance
and extrinsic containment precautions.
with standards and guidelines set forth in the OSHA, 29CFR,

Page 16 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Subpart Z. Any tissue or instruments with the potential f. Studies involving E. coli k–12 (and other strains of
of containing blood-borne pathogens (e.g. blood, blood E. coli used solely as a food source for C. elegans)
products, tissues that release blood when compressed, blood that are performed at school and are not subject to
contaminated instruments) must be properly disposed after additional rules for recombinant DNA studies or use of
experimentation. antibiotic resistant organisms.

8. Studies of human body fluids, where the sample can be Exempt Tissues (no SRC pre-approval required)
identified with a specific person, must have IRB review and 1. The following types of tissue do not need to be treated as
approval, and informed consent. potentially hazardous biological agents:
a. Plant tissue (except those known to be toxic or
9. Any study involving the collection and examination of body hazardous)
fluids that may contain biological agents belonging to BSL-3 or b. Plant and non-primate established cell lines and tissue
BSL-4 is prohibited. culture collections (e.g., obtained from the American
Type Culture Collection). The source and/or catalog
10. A project involving a student researcher using their own body number of the cultures must be identified in the
fluids (if not cultured) Research Plan/Project Summary.
a. can be considered a BSL-1 study c. Human capillary/blood collection (.e. finger stick).
b. may be conducted in a home setting d. Fresh or frozen meat, meat by-products obtained from
c. must have IRB review if the body fluid is serving as a food stores, restaurants, or packing houses and eggs
measure of an effect of an experimental procedure on the or pasteurized milk.
student researcher (e.g. Student manipulates diet and e. Hair, hooves, nails and feathers
takes a blood or urine sample). An example of a project f. Teeth that have been sterilized to kill any blood-borne
not needing IRB review would be collecting urine to serve pathogen that may be present.
as a deer repellent. g. Fossilized tissue or archeological specimens.
d. must receive prior SRC review and approval prior to h. Prepared fixed tissue
experimentation.
Sources of Information are available as a separate section at
11. Studies involving embryonic human stem cells must be the end of the document.
conducted in a Registered Research Institution and reviewed
and approved by the ESCRO (Embryonic Stem Cell Research
Oversight) Committee.

Exempt Studies (no SRC pre-approval required)


The following types of studies are exempt from requiring SRC pre-
approval as listed below, but may be subject to additional rules
dependent upon the design of the project. Student researchers
and adult sponsors are required to refer to sections A, B, and C
of this section to review additional rules for projects that involve
unknown organisms, recombinant DNA (rDNA) technologies,
tissues, fluids, blood, or blood products before deciding upon a
final biosafety level (BSL) designation for projects.

1. The following types of studies are exempt from prior SRC


review, but require a Risk Assessment Form 3:
a. Studies involving protists and archaea.
b. Research using manure for composting, fuel production,
or other non-culturing experiments.
c. Commercially-available color change coliform detection
test kits. These kits must remain sealed and must be
properly disposed.
d. Studies involving decomposition of vertebrate organisms
(such as in forensic projects).
e. Studies with microbial fuel cells.

• The following types of studies involve BSL-1 organisms and are


exempt from prior SRC review and require no additional forms:
a. Studies involving baker’s yeast and brewer’s yeast, except
in rDNA studies.
b. Studies involving Lactobacillus, Bacillus thuringiensis,
nitrogen-fixing, oil-eating, and algae-eating bacteria
introduced into their natural environment. (Not exempt if
cultured in a petri dish environment.)
c. Studies involving water or soil microbes not concentrated
in media conducive to their microbial growth
d. Studies of mold growth on food items if the experiment is
terminated at the first evidence of mold.
e. Studies of slime molds and edible mushrooms.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 17
POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS RISK ASSESSMENT
Use this information to complete PHBA Risk Assessment Form (6A)

Risk assessment defines the potential level of harm, injury or 6. Assignment of a biosafety level for the study based on risk
disease to plants, animals and humans that may occur when group of biological agent, level of biological containment
working with biological agents. The end result of a risk assessment available and the expertise of the Qualified Scientist or
is the assignment of a biosafety level which then determines the Designated Supervisor who will be supervising the project
laboratory facilities, equipment, training, and supervision required.
7. Documentation of review and approval of study prior to
Risk assessment involves:
experimentation:
1. Assignment of the biological agent to a risk group
a. If a study is conducted at a non-regulated site (e.g.
school), the SRC reviews the Research Plan/Project
2. Studies involving a known microorganism must begin with an
Summary.
initial assignment of the microorganism to a biosafety level risk
b. If the study was conducted at a Regulated Research
group based on information available through a literature search.
Institution, and was approved by the appropriate
institutional board (e.g. IBC, IACUC), the SRC reviews the
3. The study of unknown microorganisms and the use of fresh
institutional forms provided and documents SRC approval
tissues relies on the expertise of the supervising adult(s).
(Form(6A)).
c. If a PHBA study was conducted at a Regulated Research
4. Determination of the level of biological containment available Institution but the institution does not require review for
to the student researcher to conduct the experimentation. (See this type of study, the SRC must review the study and
“Levels of Biological Containment” for details.) document approval on Form 6A that the student received
appropriate training and the project complies with ISEF
5. Assessment of the experience and expertise of the adult(s)
rules.
supervising the student.

Classification of Biological Agents Levels of Biological Containment


There are four levels of biological containment (Biosafety
Risk Groups Level 1–4). Each level has guidelines for laboratory facilities,
Biological agents, plant or animal, are classified according safety equipment and laboratory practices and techniques.
to biosafety level risk groups. These classifications presume
ordinary circumstances in the research laboratory, or
BSL-1 containment is normally found in water-testing
growth of agents in small volumes for diagnostic and
laboratories, in high schools, and in colleges teaching
experimental purposes.
introductory microbiology classes. Work is done on an
open bench or in an appropriate biosafety hood. Standard
BSL-1 risk group contains biological agents that pose
microbiological practices are used when working in the
low risk to personnel and the environment. These agents
laboratory. Decontamination can be achieved by treating
are highly unlikely to cause disease in healthy laboratory
with chemical disinfectants or by steam autoclaving.
workers, animals or plants. The agents require Biosafety
Lab coats and gloves are required. The laboratory work
Level 1 containment. Examples of BSL-1 organisms
is supervised by an individual with general training in
are: Agrobacterium tumefaciens, Micrococcus leuteus,
microbiology or a related science.
Neurospora crassa, Bacillus subtilis.
BSL-2 containment is designed to maximize safety when
BSL-2 risk group contains biological agents that pose
working with agents of moderate risk to humans and
moderate risk to personnel and the environment. If
the environment. Access to the laboratory is restricted.
exposure occurs in a laboratory situation, the risk of spread
Biological safety cabinets (Class 2, type A, BSC) must be
is limited and it rarely would cause infection that would
available. An autoclave should be readily available for
lead to serious disease. Effective treatment and preventive
decontaminating waste materials. Lab coats and gloves are
measures are available in the event that an infection occurs.
required; eye protection and face shields must also be worn
The agents require Biosafety Level 2 containment. Examples
as needed. The laboratory work must be supervised by a
of BSL-2 organisms are: Mycobacterium, Streptococcus
scientist who understands the risk associated with working
pneumoniae, Salmonella choleraesuis.
with the agents involved.
BSL-3 risk group contains biological agents that usually
BSL-3 containment is required for infectious agents that
cause serious disease (human, animal or plant) or that can
may cause serious or potentially lethal diseases as a result
result in serious economic consequences. Projects in the
of exposure by inhalation. Projects in the BSL-3 group are
BSL-3 group are prohibited.
prohibited.
BSL-4 risk group contains biological agents that usually
BSL-4 containment is required for dangerous/exotic agents
produce very serious disease (human, animal or plant)
that pose high risk of life-threatening disease. Projects in
that is often untreatable. Projects in the BSL-4 group are
the BSL-4 group are prohibited.
prohibited.

Page 18 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
HAZARDOUS CHEMICALS, ACTIVITIES OR DEVICES RULES
Includes DEA-controlled substances, prescription drugs, alcohol & tobacco, firearms and explosives, radiation,
lasers, etc.
The following rules apply to research using hazardous chemicals, Additional Rules for Specific Regulated Areas
devices and activities. These include substances and devices There are additional rules for the following regulated areas:
that are regulated by local, state, country, or international law, A. DEA-controlled Substances
most often with restrictions of their use by minors such as DEA- B. Prescription Drugs
controlled substances, prescription drugs, alcohol, tobacco, C. Alcohol & Tobacco
firearms and explosives. Hazardous activities are those that D. Firearms and Explosives
involve a level of risk above and beyond that encountered in the E. Regulated Drones
student’s everyday life. F. Radiation

These rules are intended to protect the student researcher by A. DEA-Controlled Substances
ensuring proper supervision and the consideration of all potential The U.S. Drug Enforcement Administration (DEA) regulates
risks so that the appropriate safety precautions are taken. chemicals that can be diverted from their intended use
Students are required to meet all standards imposed by ISEF, to make illegal drugs. Other countries may have similar
school, local, and/or regional fair(s). regulatory bodies; students outside of the U.S. must
adhere to their own country’s drug regulatory agency
Rules for ALL Projects Involving Hazardous Chemicals, requirements in addition to U.S. DEA regulations. DEA-
controlled substances and their schedule number are at
Activities and Devices
the DEA website under Sources of Information. It is the
1. The student researcher must conduct a risk assessment
responsibility of the student to consult this list if there is a
in collaboration with a Designated Supervisor or Qualified
possibility that substances used in experimentation could
Scientist prior to experimentation. This risk assessment
be regulated.
should be documented in the research plan to include the
1. All studies using DEA-controlled substances must be
risk assessment process, supervision, safety precautions and
supervised by a Qualified Scientist who is licensed by the
appropriate methods of disposal. This risk assessment is also
DEA (or other international regulatory body) for use of the
documented on Risk Assessment Form 3.
controlled substance.
2. The use of hazardous chemicals and devices and involvement
2. All studies using DEA Schedule 1 substances (including
in hazardous activities require direct supervision by a
marijuana) must have the research protocol approved
Designated Supervisor, except those involving DEA-controlled
by DEA before research begins. Schedule 2, 3 and 4
substances, which require supervision by a Qualified Scientist.
substances do not require protocol approval by DEA.
3. Student researchers must acquire and use regulated
substances in accordance with all local, state, U.S. federal
B. Prescription Drugs
Prescription drugs are regulated by federal or country laws
and country laws. For further information or classification for
to protect against inappropriate or unsafe use. Special
these laws and regulations, contact the appropriate regulatory
agencies.
precautions must be taken in their use for a science project
as follows:
4. For all chemicals, devices or activities requiring a Federal and/ 1. Students are prohibited from administering prescription
or State Permit, the student/supervisor must obtain the permit drugs to human participants.
prior to the onset of experimentation. A copy of the permit
must be available for review by adults supervising the project 2. A veterinarian must supervise student administration of
and the local, affiliated, and ISEF SRCs in their review prior to any prescription drugs to vertebrate animals.
competition.
C. Alcohol and Tobacco
The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB)
5. The student researcher must minimize the impact of
regulates the production of alcohol and distribution of
an experiment on the environment. Examples include
alcohol and tobacco products. Many such products are
using minimal quantities of chemicals that will require
restricted by age for purchase, possession and consumption.
subsequent disposal; ensuring that all disposal is done in an
1. Fermentation studies in which minute quantities of ethyl
environmentally safe manner and in accordance with good
alcohol are produced are permitted.
laboratory practices.
2. The Designated Supervisor is responsible for the
acquisition, usage and appropriate disposal of the alcohol
6. The following forms are required:
or tobacco used in the study.
a. Checklist for Adult Sponsor (1), Student Checklist (1A),
3. Production of wine or beer by adults is allowable in the
Research Plan/Project Summary and Approval Form (1B)
home and must meet TTB home production regulations.
b. Regulated Research Institution Form (1C), when applicable
Students are allowed to design and conduct a research
c. Qualified Scientist Form (2), when applicable
project, under direct parental supervision, involving the
d. Risk Assessment Form (3)
legal production of the wine or beer.
4. Students are prohibited from conducting experiments
where consumable ethyl alcohol is produced by

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 19
distillation. However, students are allowed to distill alcohol 4. All studies using > 25 kvolts must be conducted at an
for fuel or other non-consumable products. To do so, institution with a Licensed Radiation Program and must be
the work must be conducted at school or a Regulated preapproved by the Institutions’ Radiation Safety Officer
Research Institution and follow all local and country laws. or the Committee which oversees the use of ionizing
See Alcohol and Tobacco Tax and Trade Bureau (TTB) radiation to ensure compliance with state and federal
website for details. regulations.

D. Firearms and Explosives


The U.S. Bureau of Alcohol, Tobacco, Firearms and
Explosives (ATF), along with state agencies, regulates the
purchase and use of firearms and explosives. A firearm is
defined as a small arms weapon from which a projectile
is fired by gunpowder. An explosive is any chemical
compound, mixture or device, the primary purpose of
which is to function by explosion. Explosives include, but
are not limited to, dynamite, black powder, pellet powder,
detonators, and igniters.

The purchase of a firearm by a minor is generally unlawful.


The use of a firearm, without proper state certification, is
illegal. Students should check the training and certification
requirements of individual states and countries.
1. Projects involving firearms and explosives are allowable
when conducted with the direct supervision of a
Designated Supervisor and when in compliance with all
federal, state and local laws.

2. A fully assembled rocket motor, reload kit or propellant


modules containing more than 62.5 grams of propellant
are subject to the permitting, storage and other
requirements of federal explosive laws and regulations.

3. Potato guns and paintball guns are not considered


firearms unless they are intended to be used as weapons.
However, they must be treated as hazardous devices.

E. Regulated Drones
Projects involving unmanned aircraft systems (UAS)/drones
must follow all state, Federal and country laws. See the
Federal Aviation Administration (FAA) for more details
(https://faadronezone.faa.gov/#/).

F. Radiation
Projects involving radionuclides (radioisotopes) and X-rays
must involve a careful examination of the risks associated
with the study and appropriate safety precautions must
be taken. Depending upon the level of exposure, radiation
released from these sources can be a health hazard.
1. All studies may not exceed the dose limits set by the
Nuclear Regulatory Commission of 0.5 mrem/hr or 100
mrem/year of exposure.

2. If the voltage needed in the study is <10 kvolts, a risk


assessment must be conducted. The study may be done
at home or school, and SRC preapproval is not required.

3. A study using 10–25 kvolts must have a risk assessment


conducted and must be preapproved by the SRC to
assess safety. Such a study must be conducted in a
metal-lined chamber using a camera only, not direct view
through glass. A dosimeter or radiation survey meter is
required to measure radiation exposure.

Page 20 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
GUIDANCE FOR RISK ASSESSMENT
Please find below guidance on conducting risk assessment when using the following:
Hazardous Chemicals
Hazardous Devices
Radiation

1. Hazardous Chemicals d. Corrosiveness — the tendency of a chemical, upon


A proper risk assessment of chemicals must include physical contact, to harm or destroy living tissues or
review of the following factors: physical equipment.
a. Toxicity — the tendency of a chemical to be hazardous
to human or environmental health When assessing risk, the type and amount of exposure
• Human health toxicity includes acute and chronic to a chemical must be considered. For example, an
hazards when inhaled, swallowed, injected or in individual’s allergic and genetic disposition may have
contact with the skin. an influence on the overall effect of the chemical. The
• Environmental health includes aquatic toxicity (both student researcher must refer to Safety Data Sheets
acute and chronic), toxicity to mammals and birds, provided by the vendor (SDS) to ensure that proper safety
and impact on ecosystems. precautions are taken. Some SDS sheets (e.g., Flinn)
b. Reactivity — the tendency of a chemical to undergo rank the degree of hazard associated with a chemical.
chemical change, including instability and reactivity This rating may assist students and adult sponsors in
with other substances or conditions (i.e., reaction with determining risk associated with the use of a chemical.
water, air, temperature, pressure).
A risk assessment (documented on Form 3) must include
Environmentally Responsible Chemistry proper disposal methods for the chemicals used in an
The mission of environmentally responsible (green) experiment. The Flinn Catalog (referenced in the Sources
chemistry is to avoid the use or production of hazardous of Information section) provides information for the
substances during chemical process. The principles of proper disposal of chemicals. If applicable, the student
green chemistry are described on the EPA website in researcher must incorporate in the research plan disposal
the Sources of Information section. Whenever possible procedure required by federal and state guidelines.
the following principles should be incorporated into the
research plan. 2. Hazardous Devices
• Waste prevention The documentation of risk assessment (Form 3) is
• Use of the safest possible chemicals and products required when a student researcher works with potentially
• Design of the least possible hazardous chemical hazardous/dangerous equipment and/or other devices,
syntheses in or outside a laboratory setting that require a moderate
• Use renewable materials to high level of expertise to ensure their safe usage.
• Use catalysts in order to minimize chemical usage Some commonly used devices (Bunsen burners, hot
• Use of solvents and reaction conditions that are safe plates, saws, drills, etc.) may not require a documented
as possible risk assessment, assuming that the student researcher
• Maximization of energy efficiency has experience working with the device. Use of other
• Minimization of accident potential and avoiding the potentially dangerous devices such as high vacuum
use of reactive substances equipment, heated oil baths, NMR equipment, and high
temperature ovens must have documentation of a risk
assessment. It is recommended that all student designed
c. Flammability — the tendency for a chemical substance inventions also have documentation of a risk assessment.
to be ignited at ambient temperatures. Combustible
substances can include: 3. Radiation
• Chemical solvents that produce vapors which A risk assessment (documented on Form 3) must be
readily ignite when used under normal working conducted when a student’s project involves radiation
conditions. beyond that normally encountered in everyday life. Non-
• Combustible solids (small particles, powders, or ionizing radiation includes the spectrum of ultraviolet
substances easily ignited by fire or an ignition (UV), visible light, infrared (IR), microwave (NW),
source) radiofrequency (RF) and extremely low frequency (ELF).

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 21
ENGINEERING AND INVENTION PROJECTS GUIDE
Use this information to help determine the requirements of Engineering Projects and potential areas that will
require pre-approval and/or extra safety precautions. A Guide to Engineering & Invention Projects has been
developed as an additional resource and provides a series of questions to consider as you begin and design an
engineering or invention project.

Engineering and Invention Project Checklist


Consider the answers to the questions below. If the response is yes, then the project may fall under more specific
rules and those sections of the International Rules & Guidelines should be consulted.

Hazardous Chemicals, Activities and Devices


Will your project involve any of the following:
† DEA-controlled Substances
† Firearms and Explosives
† Prescription Drugs
† Alcohol & Tobacco
† Regulated Drones
† Radiation

Device Testing with Human Participants


† Are you going to test your project (device, app, invention, prototype, etc.)? If yes, does it require persons to
interact with it other than yourself or adult sponsor/supervisor?
† Do you intend to gather background knowledge through a survey or interviews to understand the potential use
and needs for your project design?
† Are you going to ask for opinions or suggestions on your project design at any point of the project?
† Does your project intend to gather personal data/have a health benefit to the user?

Vertebrate Animals
† Does your project include any interaction with vertebrate animals in any phase of the project? If yes, please
refer to the full Vertebrate Animal Rules.

Potentially Hazardous Biological Agents


† Does your project include any collection, examination or handling of microorganisms, and/or fresh or frozen
tissue, primary cell cultures, blood, blood products or body fluids?
† Are you going to culture or isolate any substance, known or unknown? If yes, please refer to the full Potentially
Hazardous Biological Agents Rules.

Page 22 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
SOURCES OF INFORMATION FOR ALL PROJECTS
1. United States Patent and Trade Office 2. NIH tutorial, “Protecting Human Research Participants”
Customer Service: 1-800-786-9199 (toll-free); http://phrp.nihtraining.com/files/PHRP.pdf
571-272-1000 (local); 571-272-9950 (TTY)
www.uspto.gov 3. Belmont Report, April 18, 1979
www.uspto.gov/patents/process/index.jsp www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
• Conducting a Patent Search -
• https://patents.google.com/ 4. Standards for Educational and Psychological Testing. (1999).
• http://www.freepatentsonline.com/ Washington, DC: AERA, APA, NCME.
• https://worldwide.espacenet.com/ www.apa.org/science/programs/testing/standards.aspx

2. USPTO Resources 5. American Psychological Association


• 7 Step Search Strategy Guide and Video Tutorial 750 First Street, NE Washington, DC 20002-4242
https://www.uspto.gov/learning-and-resources/support- phone: 202-336-5500; 800-374-2721
centers/patent-and-trademark-resource-centers-ptrc/ www.apa.org
resources/seven
• https://www.youtube.com/playlist?list=PL9BtHzl4w- Information for students:
dl2ia9lgtZ3o8KJYh_JPVQF www.apa.org/science/leadership/students/information.aspx
• https://www.uspto.gov/video/cbt/ptrcsearching/ Information regarding publications:
• Pro Bono Program www.apa.org/pubs/index.aspx
https://www.uspto.gov/patents-getting-started/using-
legal-services/pro-bono/patent-pro-bono-program 6. Educational and Psychological Testing
• Law School Clinic Certification Program Testing Office for the APA Science Directorate
https://www.uspto.gov/learning-and-resources/ip-policy/ phone: 202-336-6000
public-information-about-practitioners/law-school-clinic-1 email: [email protected]
• USPTO Pro Se Assistance Program www.apa.org/science/programs/testing/index.aspx
https://www.uspto.gov/patents-getting-started/using-
legal-services/pro-se-assistance-program 7. The Children’s Online Privacy Protection Act of 1998 (COPPA)
(15 U.S.C. §§ 6501–6506)
3. European Patent Office www.ftc.gov/privacy/coppafaqs.shtm
www.epo.org
www.epo.org/applying/basics.html
Vertebrate Animals
4. ANS Task Force Animal Care and Use
www.anstaskforce.gov 1. Laboratory Animals, Institute of Laboratory Animal Research
Aquatic Nuisance Species (ANS) Task Force (ILAR), Commission on Life Sciences, National Research
www.anstaskforce.gov http://dels.nas.edu/ilar
www.anstaskforce.gov/Documents/ISEF.pdf
2. Guide for the Care and Use of Laboratory Animals, 8th Edition
5. APHIS (2011)
aphis.usda.gov/aphis/home http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-
Animal and Plant Health Inspection Service Use-of-Laboratory-Animals.pdf
Invasive Species List www.nap.edu/catalog.php?record_id=12910
6. Invasive Species Specialist Group 3. Guidelines for the Care and Use of Mammals in Neuroscience
www.issg.org and Behavioral Research (2003), Institute for Laboratory
The Global Invasive Species database contains invasive Animal Research (ILAR)
species information supplied by experts from around the https://www.nap.edu/catalog/10732/guidelines-for-the-
world. care-and-use-of-mammals-in-neuroscience-and-behavioral-
research
7. Invasive Species Information
www.invasivespeciesinfo.gov/resources/lists.shtml To order these ILAR publications contact:
Provides information for species declared invasive, noxious, National Academies Press
prohibited, or harmful or potentially harmful. 500 Fifth Street, NW
Washington, DC 20055
Human Participants phone: 888-624-8373 or 202-334-3313; fax: 202-334-2451
1. Code of Federal Regulation (CFR), Title 45 (Public Welfare), www.nap.edu
Part 46-Protection of Human Subjects (45CFR46)
https://www.hhs.gov/ohrp/regulations-and-policy/
regulations/45-cfr-46

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 23
4. Federal Animal Welfare Act (AWA)
7 U.S.C. 2131-2157 4. Quarterly bibliographies of Alternatives to the Use of Live
Subchapter A - Animal Welfare (Parts I, II, III) Vertebrates in Biomedical Research and Testing may be
https://www.nal.usda.gov/awic/animal-welfare-act obtained from:
Specialized Information Services
Document is available from: NLM/NIH
USDA/APHIS/AC 2 Democracy Plaza, Suite 510
4700 River Road, Unit 84 6707 Democracy Blvd., MSC 5467
Riverdale, MD 20737-1234 Bethesda, MD 20892-5467
email: [email protected] phone: 301-496-1131; Fax: 301- 480-3537
phone: 301-734-7833; fax: 301-734-4978 email: [email protected]
http://awic.nal.usda.gov https://www.sis.nlm.nih.gov
http://toxnet.nlm.nih.gov/altbib.html
5. Guide for the Care and Use of Agricultural Animals in
Agricultural Research and Teaching (Agri-Guide) 5. Johns Hopkins Center for Alternatives to Animal Testing (CAAT)
Association for Assessment and Accreditation of Laboratory has worked with scientists since 1981 to find new methods to
Animal Care International (AAALAC International) replace the use of laboratory animals in experiments, reduce
https://www.aaalac.org/ the number of animals tested, and refine necessary tests to
https://www.aaalac.org/about/Ag_Guide_3rd_ed.pdf eliminate pain and distress.
email: [email protected]
6. Guidelines for the Use of Fish in Research (2014), American http://caat.jhsph.edu/
Fisheries Society.
www.fisheries.org 6. Quality Assurance Manuals (for appropriate species)
https://fisheries.org/docs/wp/Guidelines-for-Use-of- Such as:
Fishes.pdf Poultry: https://www.bordbia.ie/industry/farmers/quality/
PoultrySchemeStandards/Poultry%20Producer.pdf
7. Euthanasia Guidelines Beef: https://www.bqa.org/Media/BQA/Docs/
AVMA Guidelines on Euthanasia (2020) nationalmanual.pdf
American Veterinary Medical Association Pork: http://www.pork.org/
www.avma.org/KB/Policies/Documents/euthanasia.pdf
Potentially Hazardous Biological Agents
Alternative Research and Animal Welfare 1. American Biological Safety Association: ABSA Risk Group
1. The National Library of Medicine provides computer searches Classification — list of organisms
through MEDLINE: www.absa.org
Reference & Customer Services
National Library of Medicine 2. American Type Culture Collection (ATCC)
8600 Rockville Pike www.atcc.org
Bethesda, MD 20894
888-FIND-NLM or 888-346-3656; 301-594-5983; 3. Bergey’s Manual of Systematic Bacteriology website — follow
email: [email protected] the links for resources and microbial databases for a collection
www.nlm.nih.gov of international websites of microorganisms and cell cultures.
ncbi.nlm.nih.gov/pubmed https://www.bergeys.org

2. National Agriculture Library (NAL) provides reference service 4. Biosafety in Microbiological and Biomedical Laboratories
for materials that document a) Alternative Procedures to (BMBL) — 4th Edition. Published by CDC-NIH
Animal Use and b) Animal Welfare. https://www.cdc.gov/labs/BMBL.html
Animal Welfare Information Center
National Agriculture Library 5. World Health Organization Laboratory Safety Manual
10301 Baltimore Avenue, Room 410 www.who.int/diagnostics_laboratory/guidance/en
Beltsville, MD 20705-2351
phone: 301-504-6212, fax: 301-504-7125 6. Canada — Agency of Public Health — list of non-pathogenic
email: [email protected] organisms
www.nal.usda.gov/awic https://www.canada.ca/en/public-health/services/laboratory-
biosafety-biosecurity/pathogen-safety-data-sheets-risk-
3. Institute of Laboratory Animal Resources (ILAR) provides assessment.html
a variety of information on animal sources, housing and
handling standards, and alternatives to animal use through • American Society for Microbiology
annotated bibliographies published quarterly in ILAR Journal. https://www.asm.org
ILAR — The Keck Center of the National Academies
500 Fifth Street, NW, Keck 687 • Microbiology Society
Washington, DC 20001 Charles Darwin House
phone: 202-334-2590, fax: 202-334-1687 12 Roger Street
email: [email protected] London
http://dels.nas.edu/ilar WC1N 2JU
UK
[email protected]
http://microbiologyonline.org

Page 24 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
7. NIH Guidelines for Research Involving Recombinant DNA 7. Alcohol, Tobacco, Firearms, and Explosives
Molecules. Published by National Institutes of Health. Alcohol and Tobacco Tax and Trade Bureau
https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_ www.ttb.gov
Guidelines.pdf Bureau of Alcohol, Tobacco, Firearms and Explosives
www.atf.gov
8. OSHA — Occupational Health and Safety Administration
www.osha.gov 8. Radiation
Radiation Studies Information (CDC)
www.cdc.gov/nceh/radiation/default.htm
Hazardous Chemicals, Activities or Devices
General Lab/Chemical Safety
9. CDC Laboratory Safety Manuals
1. Safety in Academic Chemistry Laboratories, Volumes 1 and 2,
www.cdc.gov/biosafety/publications/index.htm
2003. Washington, DC: American Chemical Society.
Order from (first copy free of charge):
10. Occupational Safety and Health Administration
American Chemical Society
Publications Support Services www.osha.gov
1155 16th Street, NW Safety and Health Topics:
Washington, DC 20036 www.osha.gov/SLTC
phone: 202- 872-4000 or 800-227-5558 www.osha.gov/SLTC/reactivechemicals/index.html
email: [email protected] www.osha.gov/SLTC/laserhazards/index.html
www.acs.org/education www.osha.gov/SLTC/radiationionizing/index.html

2. General 11. U.S. Nuclear Regulatory Commission


Howard Hughes Medical Institute has resources for working Material Safety and Inspection Branch
with cell cultures, radioactive materials and other laboratory One White Flint North
materials. 11555 Rockville Pike
http://www.hhmi.org/developing-scientists/resources Rockville, MD 20852
phone: 301-415-8200; 800-368-5642
3. Environmental Protection Agency (EPA) website for green www.nrc.gov
chemistry
www.epa.gov/greenchemistry

4. Safety and Data Sheets (SDS)


www.flinnsci.com/msds-search.aspx
A directory of SDS sheets from Flinn Scientific Inc. that
includes a ranking of hazard level and disposal methods.

www.ilpi.com/msds/index.html - A listing of numerous sites


that have free downloads of SDS sheets.

NFPA (National Fire Protection Association) 704 Standard for


guidance on Chemical Reactivity and Instability:
https://en.wikipedia.org/wiki/NFPA_704

5. Pesticides
National Pesticide Information Center
http://npic.orst.edu/ingred/products.html
Describes the various types of pesticides and the legal
requirements for labelling. Provides links and phone numbers
to get additional information.

Environmental Protection Agency


http://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1
A database of product labels. Enter the product name or
company name to view the approved label information of
pesticides which are registered with the agency.

6. DEA Controlled Substances


Drug Enforcement Agency website:
https://www.dea.gov
Controlled Substance Schedules – a list of controlled
substances:
www.deadiversion.usdoj.gov/schedules

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 25
ISEF DISPLAY & SAFETY REGULATIONS
Please address any questions regarding ISEF Display & Safety Regulations to
[email protected]

Display & Safety Committee Mission


The mission of this committee is to ensure that all competitors qualify for competition according to the rules established in conjunction
with the Scientific Review Committee and Society for Science & the Public.

The ISEF Display & Safety inspection process can be initiated only when all items are present at the display. The Display & Safety
Committee Committee will offer guidance on Display & Safety issues for projects approved by the SRC to compete in ISEF. Occasionally,
the ISEF Display & Safety Committee may require students to make revisions to conform to Display & Safety regulations. Persistent
issues will be directed to a committee of individuals which may include Society for Science & the Public (SSP) personnel, Display &
Safety (D & S) and/or Scientific Review Committee (SRC) executive committee members.

The following regulations must be adhered to when a finalist exhibits a project at ISEF. All projects must adhere to the Display & Safety
requirements of the affiliated fair(s) in which they compete to qualify for participation in ISEF. Affiliated fairs may have additional
restrictions or requirements. Knowledge of these requirements is the responsibility of the Finalist, Adult Sponsor, and Fair Director.

DISPLAY REGULATIONS
Maximum Size of Project Forms required at all projects:
Depth (front to back): 30 inches or 76 centimeters 1. An original Official Abstract and Certification as approved
Width (side to side): 48 inches or 122 centimeters (stamped/embossed) by the ISEF Scientific Review
Height (floor to top): 108 inches or 274 centimeters Committee.
a. Upon SRC approval, the stamped/embossed Official
Please be aware when ordering posters that the mechanism Abstract and Certification will be provided.
that supports the poster should conform to the maximum size • The abstract must be the official International Science
limitations stated above. and Engineering Fair Abstract and embossed/
• All project materials and support mechanisms must fit within stamped by the ISEF Scientific Review Committee.
the project dimensions (including table covers). • No other format or version of your approved Abstract
& Certification will be allowed for any purpose at
• Fair-provided tables at ISEF will not exceed a height of 36 ISEF. Abstract handouts to judges and to the public
inches (91 centimeters). are limited to UNALTERED photocopies of the official
abstract and certification.
• If a table is used it becomes part of the project and must not b. The term “abstract” may NOT be used as a title or
exceed the allowed dimensions. reference for any information on a finalist’s display or
materials at the project except as part of displaying the
• Nothing can be attached to the rear curtain. official stamped/embossed abstract.
• It is the recommendation of the Display & Safety
• All demonstrations must be done within the confines of the Committee to NOT include the word “abstract” nor
finalist’s booth space. When not being demonstrated, all the abstract itself when preparing backboards or
project components must be returned to the project display posters prior to the fair. However, it is reasonable to
and must fit within allowable dimensions as defined above. leave a blank space (8 ½” x 11”) on the backboard/
poster so as to facilitate the addition of the official
• Projects can be continued under the table BUT this area is not abstract. Keep in mind this document can also be
to be used for storage. displayed vertically on the front edge of the table or
Position of Project in a free-standing acrylic frame.
The fair provided table or freestanding display must be parallel
to, and positioned at, the back curtain of the booth. Projects may 2. ISEF Project Set-up Approval Form (received on-site at the Fair)
NOT lean against the back curtain. a. This form documents the project as approved by the
Scientific Review Committee and is used to document
the Display & Safety Committee’s review process and final
Forms Required to be Visible and Vertically Displayed at approval.
the Project Booth b. This form must be signed by the finalist and the Display &
The placement of the required forms may include the front edge Safety Committee member at the time of inspection.
of the table, the display board, or in a free-standing acrylic frame
placed on the table top. Additional Forms required (only when applicable):
1. Regulated Research Institutional/Industrial Setting Form (1C)
a. If work was conducted in a regulated research institution,
industrial setting or any work site other than home, school
or field at any time during the current ISEF project year,
the Regulated Research Institutional/Industrial Setting
Form (1C) must be completed and vertically displayed at
the project booth.

Page 26 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
b. The information provided by the mentor on Form 1C may must be available upon request during the set-up and
be referenced to confirm that the information provided inspection process, but may not be displayed
on the project board is that of the finalist. Only minimal c. Sample release text: “I consent to the use of visual images
reference to a mentor’s or another researcher’s work is (photos, videos, etc.) involving my participation/my child’s
allowable and must only reflect background information participation in this research.”
or be used to clarify differences between finalist’s and
others’ work. 2. Finalists using any presentation or demonstration outside
of a project board must be prepared to show the entire
2. Continuation/Research Progression Projects Form (7) presentation to the Display & Safety Inspectors before the
a. If a study is a continuation/research progression, the project is approved. All aforementioned rules apply to this
Continuation/Research Progression Projects Form (7) presentation and the presentation may not be altered in any
must be completed and vertically displayed at the project way after the final Display & Safety inspection. Examples of
booth. presentations that require approval include, but are not limited
b. The display board and abstract must reflect only the to PowerPoint, Prezi, Keynote, software program/simulation
current year’s work. The project title displayed in the and other images and/or graphics displayed on a computer
finalist’s booth may mention years of continuing research screen or other non-print delivery method.
(for example, “Year Two of an Ongoing Study”).
c. Reference to past work on the display board must be
limited to summative past conclusory data and its Items/Materials Not Allowed on Display or at
comparison to the current year data set. No raw data from Project Booth
previous years may be publicly displayed; however, it may 1. Any information on the project display or items that
be included in the student research notebooks and/or are acknowledgments, self-promotions or external
logbooks if properly labeled. endorsements are not allowed in the project booth.
a. The use of logos including known commercial brands,
Forms Required at Project but not Displayed
institutional crests or trademarks, flags unless integral to
1. Forms, excluding those listed above, that were required for
the project and approved by the SRC via inclusion in the
the Scientific Review Committee approval should not be
Official Abstract and Certification.
vertically displayed, but must be available in the booth in
b. Personalized graphic/logos that are developed to indicate
case asked for by a judge or other ISEF official. These forms
a commercial purpose or viability of an established or
include, but are not limited to, Checklist for Adult Sponsor
proposed business associated with the project. The only
(1), Student Checklist (1A), Research Plan, Approval Form (1B),
exception is a student-created logo may be displayed at
and a photograph/video release form.
the project once.
c. Any reference to an institution or mentor that supported
2. A photograph/video release form signed by the subject is
the finalist’s research except as provided in the official
required for visual images of humans (other than the finalist)
ISEF paperwork, most notably Form 1C.
displayed as part of the project.
d. Any reference to patent status of the project.
e. Any items intended for distribution such as disks, CDs,
Forms NOT to be at the Project Display Booth or in the flash drives, brochures, booklets, endorsements, give-
Exhibit Hall away items, business cards, printed materials or food
Completed informed consent/assent forms for a human items designed to be distributed to judges or the public.
participant study are NOT to be displayed and should NOT be Once again, handouts to judges and to the public are
present at the project display. The Finalist may include a sample limited to UNALTERED photocopies of the official abstract
(incomplete) form in their logbook or research notebook but and certification.
under NO CIRCUMSTANCE should the completed informed
consent/assent forms for a human participant be in the Exhibit Hall. 2. Any awards or medals, except for past or present ISEF medals
that may be worn by the finalist.
Photograph/Image Display Requirements
3. Postal addresses, World Wide Web, email and/or social media
1. Any photograph/visual image/chart/table and/or graph is
addresses, QR codes, telephone and/or fax numbers of a
allowed if:
project or finalist. Note: The only personal information that
a. It is not deemed offensive or inappropriate (which
is permissible to include on the display is information that is
includes images/photographs showing invertebrate or
also included on the Official Abstract and Certification (Finalist
vertebrate animals/humans in surgical, necrotizing or
Name, School, City, State, Country). Information regarding
dissection situations) by the Scientific Review Committee,
finalist’s age and grade are not permitted.
the Display & Safety Committee, or Society for Science &
the Public.
4. Active Internet or email connections as part of displaying or
b. It has a credit line of origin (“Photograph taken by...”
operating the project at ISEF.
or “Image taken from...” or “Graph/Chart/Table taken
from…”). If all images, etc. displayed were created by
5. Any changes, modifications, or additions to projects including
the finalist or are from the same source, one credit line
any attempt to uncover, replenish or return removed language
prominently and vertically displayed on the backboard/
or items after the approval by the Display & Safety Committee
poster or tabletop is sufficient. All images MUST BE
and the Scientific Review Committee has been received is
properly cited. This includes background graphics,
prohibited.
photographs and/or visual depictions of the finalist or
a. Display & Safety inspections will include recording
photographs and/or visual depictions of others for which
photographic evidence of the approved Project Display
a signed photo/video release form is in a notebook or
and Project booth.
logbook at the project booth. These signed release forms

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 27
b. Finalists who do not adhere to this signed agreement 18. Any apparatus with belts, pulleys, chains, or moving parts with
on the ISEF Project Set-up Approval Form regarding tension or pinch points that are not appropriately shielded
this regulation may fail to qualify for competition. I/we
understand that the initial Display & Safety Inspection 19. Any display items that are deemed distracting (i.e. sounds,
has been completed, but that additional reviews occur lights, odors, etc.)
and that I/we should check back regularly. I/we will
vertically display this signed form at our project at all 20. Personal items or packaging materials stored underneath the
times. I/we have not and will not store packing material booth
under the booth. I/we further understand that returning
items that have been removed by the SRC or D&S and/or 21. Any apparatus or project material deemed unsafe by the
adding items that are not permitted after final clearance Scientific Review Committee, the Display & Safety Committee,
are grounds for failing to qualify for competition and/or or the Society
forfeiture of all awards received.
Electrical Regulations
SAFETY REGULATIONS 1. Electrical power supplied to the project is 120 or 220 Volt,
AC, single phase, 60 Hz. No multi-phase will be available or
Not Allowed at Project or Booth shall be used. Maximum circuit amperage/wattage available
Note: In the case in which a Finalist’s Project includes an item that is determined by the electrical circuit capacities of the exhibit
is prohibited from display, please consider taking photographs hall and may be adjusted on-site by the Display & Safety
and/or documenting the significance of the prohibited item Committee. For all electrical regulations, “120 Volt AC” or “220
through video. Volt AC” is intended to encompass the corresponding range of
1. Living organisms, including plants voltage as supplied by the facility in which ISEF is being held.

2. Glass 2. Electrical devices must be protectively enclosed. Any


enclosure must be non-combustible. All external non-current
3. Soil, sand, rock, cement and/or waste samples, even if carrying metal parts must be grounded.
permanently encased in a slab of acrylic
3. Energized wiring, switches, and metal parts must have
4. Taxidermy specimens or parts adequate insulation and over-current safety devices (such
as fuses) and must be inaccessible to anyone other than the
5. Preserved vertebrate or invertebrate animals finalist. Exposed electrical equipment or metal that may be
energized must be shielded with a non-conducting material or
6. Human or animal food with a grounded metal box to prevent accidental contact.

7. Human/animal parts or body fluids (for example, blood, urine) 4. Decorative lighting or illumination is discouraged. If used,
lighting must be as low a voltage as possible and must be
8. Plant materials (living, dead, or preserved) that are in their raw, LED lighting that does not generate heat. Incandescent and
unprocessed, or non-manufactured state fluorescent light bulbs are prohibited. When student is not
at the exhibit, all electrical power must be disconnected, or
9. All chemicals including water. Absolutely no liquids can be power bars must be switched off (Exception: during pre-
utilized in the Project Display judging audio visual displays may be available.)

10. All hazardous substances or devices (Example: poisons, drugs, 5. An insulating grommet is required at the point where any wire
firearms, weapons, ammunition, reloading devices, grease/oil or cable enters any enclosure.
and sublimating solids such as dry ice)
6. No exposed live circuits over 36 volts are allowed.
11. Items that may have contained or been in contact with
hazardous chemicals (Exception: Item may be permitted if 7. There must be an accessible, clearly visible on/off switch or
professionally cleaned and documentation for such cleaning other means of quickly disconnecting from the 120 or 220 Volt
is available). Filters (including microbial) may not be displayed power source.
unless the Display & Safety Committee can reasonably
determine that the device was cleaned or was never used Laser/Laser Pointer Regulations
(please include receipts in your notebooks and/or logbooks) Any Class 1, Class 2, Class 3A, or Class 3R lasers are allowed to be
used responsibly. No other lasers may be used or displayed.
12. Sharp items (for example, syringes, needles, pipettes, knives) 1. Laser beams may not pass through magnifying optics such as
microscopes and telescopes. Lasers must be labeled by the
13. Flames and highly flammable materials manufacturer so that power output can be inspected. Lasers
without labels will NOT be permitted.
14. Batteries with open-top cells or wet cells
2. Lasers must be labeled by the manufacturer so that power
15. Drones or any flight-capable apparatus unless the propulsion output can be inspected. Lasers without labels will NOT be
power source removed. permitted.

16. 3D Printers unless the power source is removed. 3. Handheld lasers are NOT permitted.

17. Inadequately insulated apparatus capable of producing 4. Lasers will be confiscated with no warning if not used in a safe
dangerous temperatures are not permitted manner.

Page 28 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
ISEF CATEGORIES AND SUBCATEGORIES
The categories have been established with the goal of better aligning judges and student projects for the judging at
ISEF. Local, regional, state and country fairs may or may not choose to use these categories, dependent on the needs
of their area. Please check with your affiliated fair(s) for the appropriate category listings at that level of competition.

Please visit our website at student.societyforscience.org/intel-isef-categories-and-subcategories for a full


description and definition of ISEF categories:
ANIMAL SCIENCES (ANIM) CHEMISTRY (CHEM) ENGINEERING MECHANICS PHYSICS AND
Animal Behavior Analytical Chemistry (ENMC) ASTRONOMY (PHYS)
Cellular Studies Computational Chemistry Aerospace and Aeronautical Astronomy and Cosmology
Development Environmental Chemistry Engineering Atomic, Molecular, and Optical
Ecology Inorganic Chemistry Civil Engineering Physics
Genetics Materials Chemistry Computational Mechanics Biological Physics
Nutrition and Growth Organic Chemistry Control Theory Condensed Matter and
Physiology Physical Chemistry Ground Vehicle Systems Materials
Systematics and Evolution Other Industrial Engineering- Mechanics
Other Processing Nuclear and Particle Physics
COMPUTATIONAL BIOLOGY Mechanical Engineering Theoretical, Computational and
BEHAVIORAL AND SOCIAL AND BIOINFORMATICS Naval Systems Quantum Physics
SCIENCES (BEHA) (CBIO) Other Other
Clinical and Developmental Computational Biomodeling
Psychology Computational Epidemiology ENVIRONMENTAL PLANT SCIENCES (PLNT)
Cognitive Psychology Computational Evolutionary ENGINEERING (ENEV) Agriculture and Agronomy
Neuroscience Biology Bioremediation Ecology
Physiological Psychology Computational Neuroscience Land Reclamation Genetics/Breeding
Sociology and Social Psychology Computational Pharmacology Pollution Control Growth and Development
Other Genomics Recycling and Waste Pathology
Other Management Plant Physiology
BIOCHEMISTRY (BCHM) Water Resources Management Systematics and Evolution
Analytical Biochemistry EARTH AND Other Other
General Biochemistry ENVIRONMENTAL
Medical Biochemistry SCIENCES (EAEV) MATERIALS SCIENCE ROBOTICS AND
Structural Biochemistry Atmospheric Science (MATS) INTELLIGENT MACHINES
Other Climate Science Biomaterials (ROBO)
Environmental Effects on Ceramic and Glasses Biomechanics
BIOMEDICAL AND HEALTH Ecosystems Composite Materials Cognitive Systems
SCIENCES (BMED) Geosciences Computation and Theory Control Theory
Cell, Organ, and Systems Water Science Electronic, Optical and Magnetic Machine Learning
Physiology Other Materials Robot Kinematics
Genetics and Molecular Biology Nanomaterials Other
of Disease EMBEDDED SYSTEMS (EBED) Polymers
Immunology Circuits Other SYSTEMS SOFTWARE
Nutrition and Natural Products Internet of Things (SOFT)
Pathophysiology Microcontrollers MATHEMATICS (MATH) Algorithms
Other Networking and Data Analysis Cybersecurity
Communications Combinatorics, Graph Theory, Databases
BIOMEDICAL ENGINEERING Optics and Game Theory Human/Machine Interface
(ENBM) Sensors Geometry and Topology Languages and Operating
Biomaterials and Regen Medicine Signal Processing Number Theory Systems
Biomechanics Other Probability and Statistics Mobile Apps
Biomedical Devices Other Online Learning
Biomedical Imaging ENERGY: SUSTAINABLE Other
Cell and Tissue Engineering MATERIALS AND DESIGN MICROBIOLOGY (MCRO)
Synthetic Biology Antimicrobials and Antibiotics TRANSLATIONAL MEDICAL
(EGSD)
Other Biological Process and Design
Applied Microbiology SCIENCES (TMED)
Energy Storage Bacteriology Disease Detection and
CELLULAR AND Hydrogen Generation and Storage Environmental Microbiology Diagnosis
MOLECULAR BIOLOGY OtherThermal Power Microbial Genetics Disease Prevention
Solar Process, Materials, and Design Virology
(CELL) Disease Treatment and
Thermal Generation and Design Other Therapies
Cell Physiology
Cellular Immunology Triboelectricity and Electrolysis Drug Identification and Testing
Genetics Wind Pre-Clinical Studies
Wind and Water Movement Power Other
Molecular Biology
Generation
Neurobiology
Other
Other

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 29
INFORMATION ON REQUIRED ABSTRACT & CERTIFICATION FOR ALL PROJECTS AT ISEF
* This form may not be relevant for your regional or state fair; please refer to instructions from your affiliated fair.*
In ADDITION to the basic form requirements for ALL Projects and any other requirements due to specific areas of
research, an Abstract & Certification is required at the conclusion of research. Details on this requirement follow.

Completing the Abstract ISEF Sample Abstract & Certification


After finishing research and
PROJECT ID
experimentation, you are required to write PROJECT TITLE
a (maximum) 250 word, one-page abstract. FINALIST NAME(S)
For ISEF, this abstract is written in the Category
Pick one only-- mark an “X”
online Finalist Questionnaire portal and FINALIST SCHOOL, CITY, STATE/PROVINCE, COUNTRY
in box at right
submitted electronically.
Animal Sciences o
It is recommended that it include the ABSTRACT BODY Behavioral and Social
Sciences
o

following: Biochemistry
Biomedical and Health
o
o
a. purpose of the experiment Sciences
Biomedical Engineering o
b. procedure Cellular & Molecular Biology o
Chemistry o
c. data Computational Biology and o
Bioinformatics
d. conclusions Earth & Environmental
Sciences
o

Embedded Systems o
Energy: Sustainable o
It may also include any possible research Materials and Design
Engineering Mechanics o
applications. Only minimal reference to Environmental Engineering o
Materials Science o
previous work may be included. Mathematics
Microbiology
o
o
Physics and Astronomy o
Plant Sciences o
An abstract must not include the Robotics & Intelligent
Machines
o

following: Systems Software


Translational Medical
o
o
a. acknowledgments (including naming Science

the research institution and/or mentor 1. As a part of this research project, the student directly handled, manipulated,
with which you were working), or self- or interacted with (check all that apply):
promotions and external endorsements
b. logos or proper names of commercial o human participants o potentially hazardous biological agents
products o vertebrate animals o microorganisms o rDNA o tissue
b. work or procedures done by the
mentor 2. This abstract describes only procedures performed by me/us, reflects my/
our own independent research, and represents one year’s work only.
Completing the Certification o yes o no

At the bottom of the Abstract & 3. I/We worked or used equipment in a regulated research institution or
Certification form there are six questions. industrial setting.
Please read each carefully and answer o yes o no
appropriately. The ISEF Scientific Research
Committee will review and approve the 4. This project is a continuation of previous research.
abstract and answers to the questions. o yes o no
Revisions are permitted via the online
portal through late April (please reference
the system for current year deadlines.) 5. My display board includes non-published photographs/visual depictions of
humans (other than myself):
Once approved, two copies of the ISEF o yes o no
Abstract & Certification will be provided
6. I/We hereby certify that the abstract and responses to the above statements
with a gold embossed seal; only this
are correct and properly reflect my/our own work.
version of the abstract may be displayed or o yes o no
distributed.
NOTE: Your abstract must be on the
International Science and Engineering Fair
Abstract & Certification form and have the
FOR ISEF
ISEF Scientific Review Committee approval OFFICIAL USE
seal before it is displayed or handed ONLY
out. No other format or version of your
approved Abstract will be allowed for any
purpose at the ISEF.

Page 30 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Checklist for Adult Sponsor (1)
This completed form is required for ALL projects.

To be completed by the Adult Sponsor in collaboration with the student researcher(s):

Student’s Name(s):
Project Title:
1. o I have reviewed the ISEF Rules and Guidelines, including the science fair ethics statement.

2. o I have reviewed the student’s completed Student Checklist (1A) and Research Plan/Project Summary.

3. o I have worked with the student and we have discussed the possible risks involved in the project.

4. o The project involves one or more of the following and requires prior approval by an SRC, IRB, IACUC or IBC:
o Humans Potentially Hazardous Biological Agents
o Vertebrate Animals o Microorganisms o rDNA o Tissues

5. o Items to be completed for ALL PROJECTS


o Adult Sponsor Checklist (1) o Research Plan/Project Summary
o Student Checklist (1A) o Approval Form (1B)
o Regulated Research Institutional/Industrial Setting Form (1C) (when applicable; after completed experiment)
o Continuation/Research Progression Form (7) (when applicable)

Additional forms required if the project includes the use of one or more of the following (check all that apply):
† Humans, including student designed inventions/prototypes. (Requires prior approval by an Institutional Review Board (IRB);
see full text of the rules.)
† Human Participants Form (4) or appropriate Institutional IRB documentation
† Sample of Informed Consent Form (when applicable and/or required by the IRB)
† Qualified Scientist Form (2) (when applicable and/or required by the IRB)

† Vertebrate Animals (Requires prior approval, see full text of the rules.)
† Vertebrate Animal Form (5A) ‑ for projects conducted in a school/home/field research site (SRC prior approval required.)
† Vertebrate Animal Form (5B) ‑ for projects conducted at a Regulated Research Institution. (Institutional Animal Care and
Use Committee (IACUC) approval required prior experimentation.)
† Qualified Scientist Form (2) (Required for all vertebrate animal projects at a regulated research site or when applicable)

† Potentially Hazardous Biological Agents (Requires prior approval by SRC, IACUC or IBC, see full text of the rules.)
† Potentially Hazardous Biological Agents Risk Assessment Form (6A)
† Human and Vertebrate Animal Tissue Form (6B) ‑ to be completed in addition to Form 6A when project involves the use of
fresh or frozen tissue, primary cell cultures, blood, blood products and body fluids.
† Qualified Scientist Form (2) (when applicable)
† The following are exempt from prior review but require a Risk Assessment Form 3: projects involving protists, archae and
similar microorganisms, for projects using manure for composting, fuel production or other non-culturing experiments,
projects using color change coliform water test kits, microbial fuel cells, and projects involving decomposing vertebrate
organisms.

† Hazardous Chemicals, Activities and Devices (No SRC prior approval required, see full text of the rules.)
† Risk Assessment Form (3)
† Qualified Scientist Form (2) (required for projects involving DEA-controlled substances or when applicable)

† Other
† Risk Assessment Form (3)

† I attest to the information checked above and that I have read and agree to abide by the science fair ethics statement.

Adult Sponsor’s Printed Name Signature Date of Review (mm/dd/yy)

Phone Email
International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 31
Student Checklist (1A)
This form is required for ALL projects.

1. a. Student/Team Leader: Grade:

Email: Phone:

b. Team Member: c. Team Member: ______________________________

2. Title of Project:

3. School: School Phone:

School Address:

4.
Adult Sponsor: Phone/Email:

5. Does this project need SRC/IRB/IACUC or other pre-approval? o Yes o No Tentative start date: ___________

6. Is this a continuation/progression from a previous year? o Yes o No


If Yes:
a. Attach the previous year’s o Abstract and o Research Plan/Project Summary
b. Explain how this project is new and different from previous years on
o Continuation/Research Progression Form (7)

7. This year’s laboratory experiment/data collection:

Actual Start Date: (mm/dd/yy) End Date: (mm/dd/yy)

8. Source of Data:
Collected self/mentor o Other Describe/url: _____________________________________________
o

9. List name and address of all non-home and non-school work site(s):

Name:
Address:

Phone/
email
10. Complete a Research Plan/Project Summary following the Research Plan/Project Summary instructions
and attach to this form.

11. An abstract is required for all projects after experimentation.

Page 32 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Research Plan/Project Summary Instructions
A complete Research Plan/Project Summary is required for ALL projects and
must accompany Student Checklist (1A).

• All projects must have a Research Plan/Project Summary


a. Written prior to experimentation following the instructions below to detail the rationale, research question(s), methodology, and
risk assessment of the proposed research.
b. If changes are made during the research, such changes can be added to the original research plan as an addendum, recognizing
that some changes may require returning to the IRB or SRC for appropriate review and approvals. If no additional approvals are
required, this addendum serves as a project summary to explain research that was conducted.
c. If no changes are made from the original research plan, no project summary is required.

• Some studies, such as an engineering design or mathematics projects, will be less detailed in the initial project plan and will change
through the course of research. If such changes occur, a project summary that explains what was done is required and can be
appended to the original research plan.

• The Research Plan/Project Summary should include the following:


a. RATIONALE: Include a brief synopsis of the background that supports your research problem and explain why this research is
important and if applicable, explain any societal impact of your research.
b. RESEARCH QUESTION(S), HYPOTHESIS(ES), ENGINEERING GOAL(S), EXPECTED OUTCOMES: How is this based on the
rationale described above?
c. Describe the following in detail:
• Procedures: Detail all procedures and experimental design including methods for data collection, and when applicable, the source
of data used. Describe only your project. Do not include work done by mentor or others.
• Risk and Safety: Identify any potential risks and safety precautions needed.
• Data Analysis: Describe the procedures you will use to analyze the data/results.
d. BIBLIOGRAPHY: List major references (e.g. science journal articles, books, internet sites) from your literature review. If you plan
to use vertebrate animals, one of these references must be an animal care reference.

Items 1–4 below are subject-specific guidelines for additional items to be included in your research plan/project summary as
applicable.
1. Human participants research:
a. Participants: Describe age range, gender, racial/ethnic composition of participants. Identify vulnerable populations (minors,
pregnant women, prisoners, mentally disabled or economically disadvantaged).
b. Recruitment: Where will you find your participants? How will they be invited to participate?
c. Methods: What will participants be asked to do? Will you use any surveys, questionnaires or tests? If yes and not your own, how
did you obtain? Did it require permissions? If so, explain. What is the frequency and length of time involved for each subject?
d. Risk Assessment: What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc.) to
participants? How will you minimize risks? List any benefits to society or participants.
e. Protection of Privacy: Will identifiable information (e.g., names, telephone numbers, birth dates, email addresses) be collected?
Will data be confidential/anonymous? If anonymous, describe how the data will be collected. If not anonymous, what procedures
are in place for safeguarding confidentiality? Where will data be stored? Who will have access to the data? What will you do with
the data after the study?
f. Informed Consent Process: Describe how you will inform participants about the purpose of the study, what they will be asked to
do, that their participation is voluntary and they have the right to stop at any time.

2. Vertebrate animal research:


a. Discuss potential ALTERNATIVES to vertebrate animal use and present justification for use of vertebrates.
b. Explain potential impact or contribution of this research.
c. Detail all procedures to be used, including methods used to minimize potential discomfort, distress, pain and injury to the
animals and detailed chemical concentrations and drug dosages.
d. Detail animal numbers, species, strain, sex, age, source, etc., include justification of the numbers planned.
e. Describe housing and oversight of daily care.
f. Discuss disposition of the animals at the end of the study.

• Potentially hazardous biological agents research:


a. Give source of the organism and describe BSL assessment process and BSL determination.
b. Detail safety precautions and discuss methods of disposal.

4. Hazardous chemicals, activities & devices:


• Describe Risk Assessment process, supervision, safety precautions and methods of disposal.
• Material Safety Data Sheets are not necessary to submit with paperwork.

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 33
Approval Form (1B)
A completed form is required for each student, including all team members.

1. To Be Completed by Student and Parent


a. Student Acknowledgment:
• I understand the risks and possible dangers to me of the proposed research plan.
• I have read the ISEF Rules and Guidelines and will adhere to all International Rules when conducting
this research.
• I have read and will abide by the science fair ethics statement.
Student researchers are expected to maintain the highest standards of honesty and integrity. Scientific fraud and
misconduct are not condoned at any level of research or competition. Such practices include but are not limited to
plagiarism, forgery, use or presentation of other researcher’s work as one’s own, and fabrication of data. Fraudulent
projects will fail to qualify for competition in affiliated fairs and ISEF.

Student’s Printed Name Signature Date Acknowledged (mm/dd/yy)


(Must be prior to experimentation.)
b. Parent/Guardian Approval: I have read and understand the risks and possible dangers involved in the
Research Plan/Project Summary. I consent to my child participating in this research.

Parent/Guardian’s Printed Name Signature Date Acknowledged (mm/dd/yy)


(Must be prior to experimentation.)

2. To be completed by the local or affiliated Fair SRC


(Required for projects requiring prior SRC/IRB APPROVAL. Sign 2a or 2b as appropriate.)

a. Required for projects that need prior SRC/IRB approval b. Required for research conducted at all Regulated
BEFORE experimentation (humans, vertebrates or Research Institutions with no prior fair SRC/IRB
potentially hazardous biological agents). OR approval.
This project was conducted at a regulated research institution
The SRC/IRB has carefully studied this project’s Research Plan/ (not home or high school, etc.), was reviewed and approved
Project Summary and all the required forms are included. My by the proper institutional board before experimentation and
signature indicates approval of the Research Plan/Project complies with the ISEF Rules. Attach (1C) and any required
Summary before the student begins experimentation. institutional approvals (e.g. IACUC, IRB).

SRC/IRB Chair’s Printed Name


SRC Chair’s Printed Name
Signature Date of Approval (mm/dd/yy)
(Must be prior to experimentation.)
Signature Date of Signature (mm/dd/yy)
(May be after experimentation)

3. Final ISEF Affiliated Fair SRC Approval (Required for ALL Projects)

SRC Approval After Experimentation and Before Competition at Regional/State/National Fair


I certify that this project adheres to the approved Research Plan/Project Summary and complies with all ISEF Rules.

Regional SRC Chair’s Printed Name Signature Date of Approval (mm/dd/yy)

State/National SRC Chair’s Printed Name Signature Date of Approval (mm/dd/yy)


(where applicable)

Page 34 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Regulated Research Institutional/Industrial Setting Form (1C)
This form must be completed AFTER experimentation by the adult supervising the student research conducted
in a regulated research institution, industrial setting or any work site other than home, school or field.

Student’s Name(s)

Title of Project
To be completed by the Supervising Adult in the Setting (NOT the Student(s)) after experimentation:
(Responses must be on the form as it is required to be displayed at student’s project booth; please do not print double-
sided.)

The student(s) conducted research at my work site:


1. Did you or your proxy (e.g. graduate student, postdoc, employee) mentor or provide
substantial guidance to the student researcher? o Yes o No
a. If no, describe your and/or your institution’s role with the student researcher and
his/her project (e.g. supervised use of equipment on site without ongoing mentorship
and sign below.

b. If yes, complete questions 2 –5.

2. Is the student’s research project a subset of your ongoing research or work? o Yes o No
Use questions 3, 4 and 5 to detail how the student’s project was similar and/or
different from ongoing research or work at your site. If this project is under a grant and needs
to be acknowledged, please list the grant statement here.

3. Describe the independence and creativity with which the student:


a. developed the hypotheses or engineering goals for the research project

b. designed the methodology for his/her research project

c. analyzed and interpreted data

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 35
Regulated Research Institutional/Industrial Setting Form (1C)
Continued

Student’s Name(s)

(Continued on next page)

4. Detail the student’s role in conducting the research (e.g. data collection, specific procedures
performed). Differentiate what the student observed and what the student actually did.

5. Did the student(s) work on the project as part of a group? o Yes o No


If yes, how many individuals were in the group and who were they (e.g. high school
students, graduate students, faculty, professional researchers)?

I attest that the student has conducted the work as indicated above and that any required review and approval
by institutional regulatory board (IRB/IACUC/IBC) has been obtained. Copies are attached if applicable. I further
acknowledge that the student will be presenting this work publicly in competition and I have communicated with
the student research regarding any requirements for my review and/or restrictions of what is publicized.

Supervising Adult’s Printed Name Signature Title

Institution Date Signed (must be after experimenta-


tion) (mm/dd/yy)

Address Email/Phone

Page 36 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Qualified Scientist Form (2)
May be required for research involving human participants, vertebrate animals, potentially hazardous
biological agents, and hazardous substances and devices. Must be completed and signed before the start
of student experimentation.

Student’s Name(s)

Title of Project

To be completed by the Qualified Scientist:


Scientist Name:
Educational Background: Degree(s):
Experience/Training as relates to the student’s area of research

Position: Institution:

Address: Email/Phone:
1. Have you reviewed the ISEF rules relevant to this project and the science o Yes o No
fair ethics statement relevant to this project?

2. Will any of the following be used?


a. Human participants o Yes o No
b. Vertebrate animals o Yes o No
c. Potentially hazardous biological agents (microorganisms, rDNA and o Yes o No
tissues, including blood and blood products)
d. Hazardous substances and devices o Yes o No

3. Will this study be a sub-set of a larger study? o Yes o No


4. Will you directly supervise the student? o Yes o No
a. If no, who will directly supervise and serve as the Designated Supervisor?
b. Experience/Training of the Designated Supervisor:

To be completed by the Qualified Scientist: To be completed by the Designated Supervisor


when the Qualified Scientist cannot directly
I certify that I have reviewed and approved the Research Plan/
Project Summary prior to the start of the experimentation. supervise.
If the student or Designated Supervisor is not trained in the
I certify that I have reviewed the Research Plan/Project
necessary procedures, I will ensure her/his training. I will
Summary and have been trained in the techniques to be used
provide advice and supervision during the research. I have
by this student, and I will provide direct supervision.
a working knowledge of the techniques to be used by the
student in the Research Plan/Project Summary. I understand
that a Designated Supervisor is required when the student is
not conducting experimentation under my direct supervision. Designated Supervisor’s Printed Name

Qualified Scientist’s Printed Name


Signature Date of Approval (mm/dd/yy)

Signature Date of Approval (mm/dd/yy)


Phone Email

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 37
Risk Assessment Form (3)
Must be completed before experimentation.

Student’s Name(s)
Title of Project

To be completed by the Student Researcher(s) in collaboration with Designated Supervisor/Qualified


Scientist: (All questions must be answered; additional page(s) may be attached.)

1. List all hazardous chemicals, activities, or devices that will be used; identify microorganisms exempt from pre-approval
(see Potentially Hazardous Biological Agent rules).

2. Identify and assess the risks and hazards involved in this project.

3. Describe the safety precautions and procedures that will be used to reduce the risks.

4. Describe the disposal procedures that will be used (when applicable).

5. List the source(s) of safety information.

To be completed and signed by the Designated Supervisor (or Qualified Scientist, when applicable):
I agree with the risk assessment and safety precautions and procedures described above. I certify that I have reviewed the
Research Plan/Project Summary and the International Rules, including the science fair ethics statement and will provide
direct supervision.

Designated Supervisor’s Printed Name Signature Date of Review (mm/dd/yy)

Position & Institution Phone or email contact information

Experience/Training as relates to the student’s area of research

Page 38 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Human Participants Form (4)
Required for all research involving human participants not at a Regulated Research Institution. If at a Regulated Research Institution,
use institutional approval forms for documentation of prior review and approval.
(IRB approval required before recruitment or data collection.)

Student’s Name(s) Title of Project

Adult Sponsor Phone/Email


MUST BE COMPLETED BY STUDENT RESEARCHER(S) IN COLLABORATION WITH THE ADULT SPONSOR/DESIGNATED SUPERVISOR/QUALIFIED
SCIENTIST:
1. o I have submitted my Research Plan/Project Summary which addresses ALL areas indicated in the Human Participants Section of the
Research Plan/Project Summary Instructions.
2. o I have attached any surveys or questionnaires I will be using in my project or other documents provided to human participants.
o Any published instrument(s) used was /were legally obtained.
3. o I have attached an informed consent that I would use if required by the IRB.
4. o ����Yes o ��� No Are you working with a Qualified Scientist? If yes, attach the Qualified Scientist Form 2.

BELOW  ‑  IRB USE ONLY


MUST BE COMPLETED BY INSTITUTIONAL REVIEW BOARD (IRB) AFTER REVIEW OF THE RESEARCH PLAN. ALL QUESTIONS
MUST BE ANSWERED FOR THE APPROVAL TO BE VALID. (IF NOT APPROVED, RETURN PAPERWORK TO THE STUDENT WITH
INSTRUCTIONS FOR MODIFICATIONS.)
o Approved with Full Committee Review (3 signatures required) and the following conditions: (All 6 must be answered)
1. Risk Level (check one) : o Minimal Risk o More than Minimal Risk
2. Qualified Scientist (QS) Required (Form 2): o Yes o No
3. Designated Supervisor (DS) Required (Form 3): o Yes o No
4. Written Minor Assent required for minor participants:
o Yes o No o Not applicable (No minors in this study)
5. Written Parental Permission required for minor participants:
o Yes o No o Not applicable (No minors in this study)
6. Written Informed Consent required for participants 18 years or older:
o Yes o No o Not applicable (No participants 18 yrs or older in this study)

IRB SIGNATURES (All 3 signatures required) None of these individuals may be the adult sponsor, designated supervisor, qualified
scientist or related to (e.g., mother, father of) the student (conflict of interest).
I attest that I have reviewed the student’s project, that the checkboxes above have been completed to indicate the IRB
determination and that I agree with the decisions above.

Medical or Mental Health Professional (a psychologist, medical doctor, licensed social worker, licensed clinical professional counselor,
physician’s assistant, doctor of pharmacy, or registered nurse) with expertise related to this project.

Printed Name Degree/Professional License

Signature Date of Approval (Must be prior to experimentation.) (mm/dd/yy)

Educator

Printed Name Degree/Professional License

Signature Date of Approval (Must be prior to experimentation.) (mm/dd/yy)

School Administrator

Printed Name Degree/Professional License

Signature Date of Approval (Must be prior to experimentation.) (mm/dd/yy)

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 39
Human Informed Consent Form

Instructions to the Student Researcher(s): An informed consent/assent/permission form should be developed in


consultation with the Adult Sponsor, Designated Supervisor or Qualified Scientist.
This form is used to provide information to the research participant (or parent/guardian) and to document written
informed consent, minor assent, and/or parental permission.
• When written documentation is required, the researcher keeps the original, signed form.
• Students may use this sample form or may copy ALL elements of it into a new document.
If the form is serving to document parental permission, a copy of any survey or questionnaire must be attached.

Student Researcher(s):
Title of Project:

I am asking for your voluntary participation in my science fair project. Please read the following information about the
project. If you would like to participate, please sign in the appropriate area below.

Purpose of the project:

If you participate, you will be asked to:

Time required for participation:

Potential Risks of Study:

Benefits:

How confidentiality will be maintained:

If you have any questions about this study, feel free to contact:

Adult Sponsor/QS/DS: ____________________________________ Phone/email: _____________________________________________________________

Voluntary Participation:
Participation in this study is completely voluntary. If you decide not to participate there will not be negative
consequences. Please be aware that if you decide to participate, you may stop participating at any time and you may
decide not to answer any specific question.

By signing this form I am attesting that I have read and understand the information above and I freely give my consent/
assent to participate or permission for my child to participate.

Adult Informed Consent or Minor Assent Date Reviewed & Signed: ________________________________________________
(mm/dd/yy)

Research Participant Printed Name: Signature:

Parental/Guardian Permission (if applicable) Date Reviewed & Signed:


(mm/dd/yy)

Parent/Guardian Printed Name: Signature:


Page 40 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Vertebrate Animal Form (5A)
Required for all research involving vertebrate animals that is conducted in a school/home/field research site.
(SRC approval required before experimentation.)

Student’s Name(s)

Title of Project

To be completed by Student Researcher:


1. Common name (or Genus, species) and number of animals used.

2. Describe completely the housing and husbandry to be provided. Include the cage/pen size, number of animals
per cage, environment, bedding, type of food, frequency of food and water, how often animal is observed, etc.
Add an additional page as necessary.

3. What will happen to the animals after experimentation?

4. Attach a copy of wildlife licenses or approval forms, as applicable

5. The ISEF Vertebrate Animal Rules require that any death, illness or unexpected weight loss be investigated and
documented by a letter from the qualified scientist, designated supervisor or a veterinarian. If applicable, attach
this letter with this form when submitting your paperwork to the SRC prior to competition.

To be completed by Local or Affiliate Fair Scientific Review Committee (SRC) BEFORE experimentation.
Level of Supervision Required for agricultural, behavioral or nutritional studies (select one):
o
Designated Supervisor REQUIRED. Please have applicable person sign below.

o
Veterinarian and Designated Supervisor REQUIRED. Please have applicable persons sign below.

o
Veterinarian, Designated Supervisor and Qualified Scientist REQUIRED. Please have applicable persons sign below and have the
Qualified Scientist complete Form (2).
The SRC has carefully reviewed this study and finds it is an appropriate study that may be conducted in a non-regulated research site.
Local or Affiliate Fair SRC Pre-Approval Signature:

SRC Chair Printed Name Signature Date of Approval (must be prior to


experimentation) (mm/dd/yy)

To be completed by Veterinarian: To be completed by Designated Supervisor or


Qualified Scientist when applicable:
o I have reviewed this research and animal husbandry with
the student before the start of experimentation. o I have reviewed this research and animal husbandry with
the student before the start of experimentation and I
o I have approved the use and dosages of prescription accept primary responsibility for the care and handling
drugs and/or nutritional supplements. of the animals in this project.
o I will provide veterinary medical and nursing care in case o I will directly supervise the experiment.
of illness or emergency. (Fees may apply.)

Printed Name Email/Phone Printed Name Email/Phone

Signature Date of Approval (mm/dd/yy) Signature Date of Approval (mm/dd/yy)

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 41
Vertebrate Animal Form (5B)
Required for all research involving vertebrate animals that is conducted in at a Regulated Research Institution.
(IACUC approval required before experimentation. Form must be completed and signed after experimentation.)

Student’s Name(s)

Title of Project
Title and Protocol Number of IACUC Approved Project

To be completed by Qualified Scientist or Principal Investigator:


1. Species of animals used: Number of animals used:

2. Describe, in detail, the role of the student in this project: animal procedures and related equipment that
were involved, oversight provided and safety precautions employed. (Attach extra pages if necessary.)

3. Was there any weight loss or death of any animal? If yes, attach a letter obtained from the qualified scientist,
designated supervisor or a veterinarian documenting the situation and the results of the investigation.

4. Did the student’s project also involve the use of tissues?


p No
p Yes; complete Forms 6A and 6B

5. What laboratory training, including dates, was provided to the student?

6. Attach a copy of the Regulated Research Institution IACUC Approval. A letter from the Qualified Scientist
or Principal Investigator is not sufficient.

Qualified Scientist/Principal Investigator

Printed Name

Signature Date (mm/dd/yy)

Page 42 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Potentially Hazardous Biological Agents Risk Assessment Form (6A)
Required for research involving microorganisms, rDNA, fresh/frozen tissue (including primary cell lines, human
and other primate established cell lines and tissue cultures), blood, blood products and body fluids.
SRC/IACUC/IBC approval required before experimentation.

Student’s Name(s)

Title of Project
To be completed by the QUALIFIED SCIENTIST/DESIGNATED SUPERVISOR in collaboration with the student
researcher(s). All questions are applicable and must be answered; additional page(s) may be attached.
SECTION 1: PROJECT ASSESSMENT
1. Identify potentially hazardous biological agents to be used in this experiment. Include the source, quantity and the
biosafety level risk group of each microorganism.

2. Describe the site of experimentation including the level of biological containment.

3. Describe the procedures that will be used to minimize risk (personal protective equipment, hood type, etc.).

4. What final biosafety level do you recommend for this project given the risk assessment you conducted?

5. Describe the method of disposal of all cultured materials and other potentially hazardous biological agents.

SECTION 2: TRAINING
1. What training will the student receive for this project?

2. Experience/training of Designated Supervisor as it relates to the student’s area of research (if applicable).

SECTION 3: For ALL CELL LINES, MICROORGANISMS AND TISSUES – To be completed by the QUALIFIED SCIENTIST or
DESIGNATED SUPERVISOR - Check the appropriate box(es) below:
o Experimentation on the microorganisms/cell lines/tissues to be used in this study will NOT be conducted at a Regulated Research
Institution, but will be conducted at a (check one) ___BSL-1 or ___BSL-2 laboratory. [This study has been reviewed by the local SRC and the
procedures have been approved prior to experimentation.]

o Experimentation on the microorganisms/cell lines/tissues to be used in this study will be conducted at a Regulated Research Institution and
was approved by the appropriate institutional board prior to experimentation; institutional approval forms are attached.
Origin of cell lines:__________________________________________ Date of IACUC/IBC approval ___________________________

o Experimentation on the microorganisms/cell lines/tissues to be used in this study will be conducted at a Regulated Research Institution,
which does not require pre-approval for this type of study. The SRC has seen and approved the research plan and supporting
documentation and acknowledges the accuracy of the responses above.

CERTIFICATION – To be SIGNED by the QUALIFIED SCIENTIST or DESIGNATED SUPERVISOR


The QS/DS has seen this project’s research plan and supporting documentation and acknowledges the accuracy of the information
provided above. This study has been approved as a (check one) o BSL-1/ o  
BSL-2 study, and will be conducted in an appropriate
laboratory.

QS/DS Printed Name Signature

Date of review (mm/dd/yy)

SECTION 4: CERTIFICATION – To be completed by the LOCAL or AFFILIATED FAIR SRC


The SRC has seen this project’s research plan and supporting documentation and acknowledges the accuracy of the information provided above.

SRC Printed Name Signature

Date of review (mm/dd/yy)

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 43
Human and Vertebrate Animal Tissue Form (6B)
Required for research involving fresh/frozen tissue (including primary cell lines, human and other primate established cell lines
and tissue cultures), blood, blood products and body fluids. If the research involves living organisms please ensure that the
proper human or animal forms are completed. All projects using any tissue listed above must also complete Form 6A.

Student’s Name(s)

Title of Project

To be completed by Student Researcher(s):

1. What vertebrate animal tissue will be used in this study? Check all that apply.
o Fresh or frozen tissue sample
o Fresh organ or other body part
o Blood
o Body fluids
o Primary cell/tissue cultures
o Human or other primate established cell lines

2. Where will the above tissue(s) be obtained? If using an established cell line include source and catalog number.

3. If the tissue will be obtained from a vertebrate animal study conducted at a research institution attach a copy of
the IACUC certification with the name of the research institution, the title of the study, the IACUC approval num-
ber and a of IACUC approval.

To be completed by the Qualified Scientist or Designated Supervisor:


o I verify that the student will work solely with organs, tissues, cultures or cells that will be supplied to him/her by myself
or qualified personnel from the laboratory; and that if vertebrate animals were euthanized they were euthanized for a
purpose other than the student’s research.
AND/OR
o I certify that the blood, blood products, tissues or body fluids in this project will be handled in accordance with the
standards and guidance set forth in U.S. Occupational Safety and Health Act, 29CFR, Subpart Z, 1910.1030 - Blood Borne
Pathogens.

Printed Name Signature Date of Approval (mm/dd/yy)


(Must be prior to experimentation.)

Title Phone/Email

Institution

Page 44 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
Continuation/Research Progression Projects Form (7)
Required for projects that are a continuation/progression in the same field of study as a previous project.
This form must be accompanied by the previous year’s abstract and Research Plan/Project Summary.
Student’s Name(s)

To be completed by Student Researcher: List all components of the current project that make it new and different from previ-
ous research. The information must be on the form; use an additional form for previous year and earlier projects.

Components Current Research Project Previous Research Project: Year: ________


1. Title

2. Change in goal/
purpose/objec-
tive

3. Changes in
methodology

4. Variable studied

5. Additional
changes

Attached are:
o Abstract and Research Plan/Project Summary, Year _________

I hereby certify that the above information is correct and that the current year Abstract & Certification and project display
board properly reflect work done only in the current year.

Student’s Printed Name(s) Signature Date of Signature (mm/dd/yy)

International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF Page 45
Page 46 International Rules: Guidelines for Science and Engineering Fairs 2020–2021, societyforscience.org/ISEF
The Regeneron International Science and Engineering Fair encourages students to tackle
challenging scientific questions and develop the skills needed to solve the problems of
tomorrow.

Society for Science & the Public


The Society for Science & the Public is a champion for science, dedicated to expanding scientific
literacy, effective STEM education and scientific research. Founded in 1921, we are a nonprofit
501(c)(3) membership organization focused on promoting the understanding and appreciation of
science and the vital role it plays in human advancement. Through its acclaimed science research
competitions, including the Regeneron Science Talent Search, the Regeneron International
Science and Engineering Fair and the Broadcom MASTERS, and its award-winning magazine,
Science News and digital media properties, Science News for Students, the Society is committed
to inform, educate and inspire.

Learn more at:


www.societyforscience.org
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