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2018 ISEF Rulesbook

2018 ISEF Rulesbook

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0% found this document useful (0 votes)
91 views45 pages

2018 ISEF Rulesbook

2018 ISEF Rulesbook

Uploaded by

MarlouAganan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

Intel International Science

and Engineering Fair

International Rules
and Guidelines 2018
International Rules for Pre-college Science Research:
Guidelines for Science and Engineering Fairs
2017 – 2018
Table of Contents
For ALL Projects
Intel ISEF Ethics Statement..........................................................................................................................................................3
Intel ISEF Eligibility/Limitations....................................................................................................................................................3
Intel ISEF Requirements................................................................................................................................................................3
Continuation/Research Progression of Projects....................................................................................................................4
Team Projects....................................................................................................................................................................................4

Roles and Responsibilities of Students and Adults


1. The Student Researcher(s)....................................................................................................................................................5
2. The Adult Sponsor.....................................................................................................................................................................5
3. The Qualified Scientist.............................................................................................................................................................5
4. The Designated Supervisor....................................................................................................................................................5
5. The Institutional Review Board (IRB)..................................................................................................................................5
6. Affiliated Fair Scientific Review Committees (SRC).......................................................................................................6
7. Other Review Committees......................................................................................................................................................6
8. The Intel ISEF Scientific Review Committee....................................................................................................................7

Human Participants Rules


1. Exempt Studies...........................................................................................................................................................................8
2. Rules..............................................................................................................................................................................................8
3. Human Participant Risk Assessment................................................................................................................................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...................................................13

Potentially Hazardous Biological Agents Rules


Rules for ALL Projects Involving Potentially Hazardous Biological Agents................................................................15
Additional Rules for Projects Involving Unknown Microorganisms...............................................................................16
Additional Rules for Projects Involving Recombinant DNA (rDNA) Technologies....................................................16
Additional Rules for Projects Involving Tissues and Body Fluids Including Blood and Blood Products...........16

Potentially Hazardous Biological Agents Risk Assessment.........................................................................................18

Hazardous Chemicals, Activities or Devices Rules..........................................................................................................19


Sources of Information....................................................................................................................................................................21

Display & Safety Regulations......................................................................................................................................................24


Information on Required Abstract..............................................................................................................................................27
Categories & Sub-Categories.....................................................................................................................................................28
Forms......................................................................................................................................................................................................29

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 1
student.societyforscience.org/international-rules-pre-college-science-research

The International Rules and Guidelines for Science Fairs is available at student.societyforscience.org/intel-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 and Guidelines –  The full text of the International Rules and forms in html and as a
downloadable pdf.
• The Intel 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 the Intel ISEF. Read these to learn what NOT to do.

These Rules are applicable for:

The Intel International Science and Engineering Fair 2018


Pittsburgh, PA, USA, May 13 –18, 2018

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
• ensure adherence to federal regulations
• ensure use of safe laboratory practices
• protect the environment
• determine eligibility for competition in the Intel ISEF

For pre-review and approval of your project, find your fair at


https://apps2.societyforscience.org/StudentScience/Student/FindAFair

For rules questions, contact the Intel 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 2017 – 2018, student.societyforscience.org/intel-isef
ALL PROJECTS

Ethics Statement 4. Projects must adhere to local, state and U.S. Federal laws,
Scientific fraud and misconduct are not condoned at any level regulations and permitting conditions. In addition, projects conducted
of research or competition. This includes plagiarism, forgery, outside the U.S. must also adhere to the laws of the country and
use or presentation of other researcher’s work as one’s own jurisdiction in which the project was performed.
and fabrication of data. Fraudulent projects will fail to qualify for
5. The use of non-animal research methods and alternatives to
competition in affiliated fairs and the Intel ISEF. Society for
Science & the Public reserves the right to revoke recognition of animal research are strongly encouraged and must be explored
a project subsequently found to have been fraudulent. before conducting a vertebrate animal project.

6. Introduction or disposal of non-native, genetically altered


Eligibility/Limitations genetically-altered, and/or invasive species (e.g. insects,
1. Each Intel ISEF-affiliated fair may send the number of plants, invertebrates, vertebrates), pathogens, toxic
projects provided by their affiliation agreement. chemicals or foreign substances into the environment is
prohibited. It is recommended that students reference their
2. A student must be selected by an Intel ISEF-affiliated fair, and: local, state or national regulations and quarantine lists.
a. be in grades 9 –12 or equivalent;
b. not have reached age 20 on or before May 1 7. Intel ISEF exhibits must adhere to Intel ISEF Display &
preceding the Intel ISEF. Safety requirements.
3. English is the official language of the Intel ISEF. Student 8. All projects must adhere to the requirements of the affiliated
project boards and abstracts must be in English. fair(s) in which it competes to qualify for participation in the
Intel ISEF. Affiliated fairs may have additional restrictions or
4. Each student is only allowed to enter one project. That requirements. Knowledge of these requirements is the
project may include no more than 12 months of continuous responsibility of the student and Adult Sponsor.
research and may not include research performed before
January 2017. Approval and Documentation
1. Before experimentation begins, a local or regional Institutional
5. Team projects must have no more than three members. Review Board (IRB) or Scientific Review Committee (SRC)
Teams competing at Intel ISEF must be composed of associated with the Intel ISEF-affiliated fair must review and
members who all meet Intel ISEF eligibility. approve most projects involving human participants, vertebrate
animals, and potentially hazardous biological agents. Note: If a
6. Students may compete in only one Intel ISEF affiliated fair, project involves the testing of a student designed invention,
except when proceeding to a state/national fair affiliated with prototype or concept by a human, an IRB review and approval
the Intel ISEF from an affiliated regional fair.
may be required prior to experimentation. See Human
Participants Rules for details.
7. Projects that are demonstrations, ‘library’ research or
informational projects, ‘explanation’ models or kit building 2. Every student must complete the Student Checklist (1A), a
are not appropriate for the Intel ISEF.
Research Plan/Project Summary and Approval Form (1B)
and review the project with the Adult Sponsor in coordination
8. All sciences (physical, life, social) are represented at the with completion by the Adult Sponsor of the Checklist for
Intel ISEF. Review a complete list of categories and sub- Adult Sponsor (1).
categories with definitions.
3. A Qualified Scientist is required for all studies involving
9. A research project may be a part of a larger study performed
Biosafety Lab-2 (BSL-2) potentially hazardous biological
by professional scientists, but the project presented by the
agents and DEA-controlled substances and is also required
student must be only their own portion of the complete study.
for many human participant studies and many vertebrate
animal studies.
Requirements
General 4. After initial IRB/SRC approval (if required), any proposed
1. All domestic and international students competing in an Intel changes in the Student Checklist (1A) and Research Plan/
ISEF-affiliated fair must adhere to all rules as set forth in Project Summary must be re-approved before laboratory
this document. experimentation/data collection resumes.

2. All projects must adhere to the Ethics Statement above. 5. Projects which are continuations of a previous year’s
work and which require IRB/SRC approval must undergo
3. It is the responsibility of the student and the Adult Sponsor to
the review process with the current year proposal prior to
evaluate the study to determine if the research will require forms
experimentation/data collection for the current year.
and/or review and approval prior to experimentation, especially
projects that include human participants, vertebrate animals, or
6. Any continuing project must document that the additional
potentially hazardous biological agents.
research is new and different. (Continuation Projects Form (7)).

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 3
7. If work was conducted in a regulated research institution, industrial in the same field of study as a previous project. This form
setting or any work site other than home, school or field at any time must be displayed at the project booth. Retention of all prior
during the current Intel ISEF project year, the years’ paperwork is required and must be presented to the
Regulated Research Institutional/Industrial Setting Form Intel ISEF SRC upon request.
(1C) must be completed and displayed at the project booth.
Team Projects
8. After experimentation, each student or team must submit a 1. Team projects compete and are judged in the scientific category of
(maximum) 250-word, one-page abstract which summarizes the their research at the Intel ISEF. All team members must meet the
current year’s work. The abstract must describe research eligibility requirements for Intel ISEF.
conducted by the student, not by the supervising adult(s).
2. Teams must have no more than three members. A team with
9. A project data book and research paper are not required, members from different geographic regions may compete at an
but are strongly recommended for judging purposes. affiliated fair of one of its members, but not at multiple fairs.
Regional or local fairs may require a project data book However, each affiliated fair holds the authority to determine
and/or a research paper. whether teams with members outside of a fair’s geographic
territory are eligible to compete, understanding that if the team
10. All signed forms, certifications, and permits must be available for wins the right to attend Intel ISEF, all team members’ expenses
review by all regional, state, national and international affiliated fair must be supported by the fair.
SRCs in which the student(s) participate. a. Team membership cannot be changed during a given
This review must occur after experimentation and research year unless there are extenuating
before competition. circumstances and the local SRC reviews and approves
the change, including converting a team project to an
Continuation/Research Progression of Projects individual project or vice versa. Such conversions must
1. As in the professional world, research projects may build address rationale for the change and include a clear
on work performed previously. A valid continuation project delineation between research preceding the change and
is a sound scientific endeavor. Students will be judged only that which will follow. A memorandum documenting this
on laboratory experiment/data collection performed over review and approval should be attached to Form 1A.
12 continuous months beginning no earlier than January b. Once a project has competed in a science fair at any
2017 and ending May 2018. level, team membership cannot change and the project
cannot be converted from an individual project to a team
2. Any project based on the student’s prior research could be project or vice versa.
c. In a future year, any project may be converted from an
considered a continuation/research progression project.
individual to a team project, from a team to an individual
These projects must document that the additional research is
project and/or have a change in team membership.
a substantive expansion from prior work (e.g. testing a new
variable or new line of investigation). Repetition of previous 3. Each team is encouraged to appoint a team leader to coordinate the
experimentation with the same methodology and research
work and act as spokesperson. However, each member of the team
question, even with an increased sample size, is an example
should be able to serve as spokesperson, be fully involved with the
of an unacceptable continuation.
project, and be familiar with all aspects of the project. The final work
should reflect the coordinated efforts of all team members and will
3. The display board and abstract must reflect the current
be evaluated using the same judging criteria as individual projects.
year’s work only. The project title displayed in the finalist’s
booth may mention years (for example, “Year Two of an
Ongoing Study”). Previous year’s databooks, research 4. Each team member must submit an Approval Form (1B). Team
papers and supporting documents may be at the booth, but members must jointly submit the Checklist for Adult Sponsor
not openly displayed, if properly labeled as such. (1), one abstract, a Student Checklist (1A), a Research
Plan/ Project Summary and other required forms.
4. Longitudinal studies are permitted as an acceptable
continuation under the following conditions:
5. Full names of all team members must appear on the
a. The study is a multi-year study testing or documenting
abstract and forms.
the same variables in which time is a critical variable.
(Examples: Effect of high rain or drought on soil in a given
Contact the Science Education Programs or the
basin, return of flora and fauna in a burned area over
time.) Scientific Review Committee with questions.
b. Each consecutive year must demonstrate time-based
change.
c. The display board must be based on collective past Roles and Responsibilities of
conclusionary data and its comparison to the current
year data set. No raw data from previous years may Students and Adults
be displayed. The Student Researcher(s)
The student researcher is responsible for all aspects of the
5. All projects must be reviewed and approved each year research project including enlisting the aid of any required
and forms must be completed for the new year. supervisory adults (Adult Sponsor, Qualified Scientist, etc.),
obtaining necessary approvals (SRC, IRB, etc.), following the
6. NOTE: For competition in the Intel ISEF, the Continuation/ Rules & Guidelines of the Intel ISEF, and performing the
Research Progression Project Form (7) is required for projects experimentation, engineering, data analysis, etc.

Page 4 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
Scientific fraud and misconduct are not condoned at any level of influenced by humans, the Designated Supervisor must
research or competition. This includes plagiarism, forgery, use or be knowledgeable about the humane care and handling of
presentation of other researcher’s work as one’s own, and the animals.
fabrication of data. Fraudulent projects will fail to qualify for
competition in affiliated fairs and the Intel ISEF. Society for
Science & the Public reserves the right to revoke recognition of a
Review Committees
project subsequently found to have been fraudulent. The Institutional Review Board (IRB)
An Institutional Review Board (IRB), is a committee that, according to
The Adult Sponsor federal regulations (45-CFR-46), must evaluate the potential physical
An Adult Sponsor may be a teacher, parent, professor, and/or and/or psychological risk of research involving humans. All proposed
other professional scientist in whose lab the student is human research must be reviewed and approved by an IRB before
working. This individual must have a solid background in experimentation begins. This includes review of any surveys or
science and should have close contact with the student during questionnaires to be used in a project.
the course of the project.
Federal regulations require local community involvement.
The Adult Sponsor is responsible for working with the student to Therefore, it is advisable that an IRB be established at the school
evaluate any possible risks involved in order to ensure the health and level to evaluate human research projects. If necessary, the local
safety of the student conducting the research and the humans and/or or Intel ISEF-affiliated SRC can serve as an IRB as long as it has
animals involved in the study. The Adult Sponsor must review the the required membership. An IRB must consist of a minimum of
student’s Student Checklist (1A) and Research Plan/Project Summary three members including the following:
to insure that: a) experimentation is within local, state, and Federal • An educator
laws and Intel ISEF rules; b) forms are completed by other required • A school administrator (preferably principal or vice principal)
adults; and c) criteria for the Qualified Scientist adhere to those set • A medical or mental health professional. The medical or mental
forth below. health professional may be a medical doctor, nurse practitioner,
physician’s assistant, doctor of pharmacy, registered nurse,
The Adult Sponsor must be familiar with the regulations that psychologist, licensed social worker
govern potentially dangerous research as they apply to a or licensed clinical professional counselor. The medical or
specific student project. These may include chemical and mental health professional on the IRB may change
equipment usage, experimental techniques, research involving depending on the nature of the study. This person must be
human and/or vertebrate animals, and cell cultures, knowledgeable about and capable of evaluating the
microorganisms, or animal tissues. Some experiments involve physical and/or psychological risk involved in a given study.
procedures or materials that are regulated by state, federal or
non-U.S. national laws. If not thoroughly familiar with the Additional Expertise: If an expert is not available in the
regulations, the Adult Sponsor should help the student enlist the immediate area, documented contact with an external expert is
aid of a Qualified Scientist and/or a Designated Supervisor. recommended. A copy of all correspondence with the expert
(e.g. emails) must be attached to Form 4 and can be used in lieu
The Adult Sponsor is responsible for ensuring the of the signature of that expert.
student’s research is eligible for entry in the Intel ISEF.
To avoid conflict of interest, no Adult Sponsor, parent or
The Qualified Scientist other relative of the student, the Qualified Scientist, or
A Qualified Scientist should have earned a doctoral/professional Designated Supervisor who oversees the project may serve
degree in a scientific discipline that relates to the student’s area of on the IRB reviewing that project. Additional members are
research. Alternatively, the SRC may consider an individual with recommended to help avoid a potential conflict of interest
extensive experience and expertise in the student’s area of research and to increase the expertise of the committee.
as a Qualified Scientist. The Qualified Scientist must be thoroughly
familiar with local, state, and federal regulations that govern the Expedited Review: An expedited review by one member of the
student’s area of research. IRB may be conducted for projects that meet one of the criteria
listed below. The IRB member reviewing the project will
The Qualified Scientist and the Adult Sponsor may be the same determine whether appropriate safety precautions will be
person, if that person is qualified as described above. A student may employed and whether the project meets criteria for expedited
work with a Qualified Scientist in a city, state or country that is not review. If a project submitted for expedited review does not meet
where the student resides. In this case, the student must work locally the criteria specified below, the project must undergo full IRB
with a Designated Supervisor (see below) who has been trained in the review. The IRB member reviewing the project must have the
techniques to be applied by the student. expertise necessary to make such a decision and/or receive
advisement from the appropriate expert.
• Student-designed Invention, Prototype, Computer Application,
The Designated Supervisor or Engineering/Design Project: The data received in these
The Designated Supervisor is an adult who is directly types of projects must be in direct reference to the design.
responsible for overseeing student experimentation. The Personal data are not collected and the testing does not pose a
Designated Supervisor need not have an advanced degree, but health or safety hazard. NOTE: The expedited review process
must be thoroughly familiar with the student’s project, and must may not be used if the invention is tested medically for
be trained in the student’s area of research. The Adult Sponsor treatment, diagnosis or intervention.
may act as the Designated Supervisor.
IRBs exist at federally Regulated Research Institutions (e.g.,
If a student is experimenting with live vertebrates and the universities, medical centers, NIH, correctional facilities). Prisoner
animals are in a situation where their behavior or habitat is advocates must be included on the IRB when research

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 5
participants are incarcerated. The institutional IRB must initially A Scientific Review Committee (SRC) examines projects for
review and approve all proposed research conducted at or sponsored the following:
by that institution. The Adult Sponsor and the local IRB are • evidence of literature search and appropriate attribution
responsible for ensuring that the project is appropriate for a pre- • evidence of proper supervision
college student and adheres to the Intel ISEF rules. • use of accepted and appropriate research techniques
• completed forms, signatures and dates showing maximum
An IRB is responsible for assessing risk and documenting the of one year duration of research and appropriate
determination of risk level on Human Participant Form 4. preapproval dates (where required)
However, in reviewing projects just prior to a fair, if the SRC • evidence of search for alternatives to animal use
serving at that level of competition judges an IRB’s decision • humane treatment of animals
as inappropriate, thereby placing human participants in • compliance with rules and laws governing human and/or
jeopardy, they may override the IRB’s decision and the project animal research and research involving potentially
may fail to qualify for competition. It is advised that IRBs hazardous biological agents and hazardous chemicals,
consult with the local or affiliated fair SRCs and/or with the activities or devices
Intel ISEF SRC in questionable cases. • documentation of substantial expansion for continuation
projects
The Affiliated Fair Scientific Review Committee • compliance with the Intel ISEF ethics statement
A Scientific Review Committee (SRC) is a group of qualified individuals
that is responsible for evaluation of student research, certifications, Combined SRC/IRB Committee
research plans and exhibits for compliance with the rules, applicable A combined committee is allowed as long as the membership
laws and regulations at each level of science fair competition. Affiliated
meets both the SRC and IRB requirements listed above.
Fairs may authorize local SRCs to serve in this prior review capacity.
The operation and composition
Regulated Research Institutions/Industrial
of the local and Affiliated Fair SRCs must fully comply with the
International Rules. Directions for obtaining preapproval are Settings Review Committees
available from the affiliated fair. A list of fairs is at: Regulated Research Institution: A Regulated Research
https://apps2. societyforscience.org/ssp-affiliate-fair/. Institution within the U.S. is defined as a professional
research/teaching institution that is regularly inspected by the
Most proposed research projects involving vertebrate animals and/or USDA and is licensed to use animals covered by the Animal
potentially hazardous biological agents must be reviewed and Welfare Act and may also be subject to U.S. Public Health
approved BEFORE experimentation. Local or regional Service Policy. Also included are all federal laboratories such as
SRC prior review is not required for human studies previously National Institutes of Health, Veteran’s Affairs Medical Centers
reviewed and approved by a properly constituted IRB. and the Centers for Disease Control. In addition, pharmaceutical
and biotechnology companies and research institutions that
ALL projects, including those previously reviewed and approved by an utilize research animals that are not covered by the Animal
IRB must be reviewed and approved by the SRC after Welfare Act but have an operational Institutional Animal Care
experimentation and before competition in an Affiliated Fair. Projects and Use Committee and are in compliance with U.S. federal
which were conducted at a Regulated Research Institution, industrial laws are included in this definition. For projects conducted
setting or any work site other than home, school or field and which outside of the United States, a Regulated Research Institution
were reviewed and approved by the proper institutional board before would be a comparable research institution that adheres to
experimentation, must also be approved by the Affiliated Fair SRC. country laws governing the care and use of vertebrate animals.

Certain areas of research conducted in a regulated research


An SRC must consist of a minimum of three persons, institution or an industrial setting require review and approval by
including the following: federally mandated committees that have been established at
1. a biomedical scientist with an earned doctoral degree that institution. These committees include:
2. an educator
3. at least one additional member 1. Institutional Animal Care and Use Committee (IACUC); Animal Care
and Use Committee (ACUC); Animal Ethics Committee
Additional expertise: Many project evaluations require 2. Institutional Review Board (IRB); Human Subjects
additional expertise (e.g., on biosafety and/or of human risk Participant Program (HSPP)
groups). If the SRC needs an expert as one of its members and 3. Institutional Biosafety Committee (IBC)
one is not in the immediate area, all documented contact with 4. Embryonic Stem Cell Research Oversight Committee (ESCRO)
an external expert must be submitted. If animal research is 5. Safety Review Committee
involved, at least one member must be familiar with proper
animal care procedures. Depending on the nature of the study, The ISEF Scientific Review Committee (Intel ISEF SRC)
this person can be a veterinarian or animal care provider with All projects are reviewed by the Intel ISEF Scientific Review
training and/or experience in the species being studied. Committee prior to competition. The Intel ISEF SRC is the final
arbiter of the qualification of students to participate in the Intel
To avoid conflict of interest, no Adult Sponsor, parent or ISEF. Before the fair, committee members review research plans
other relative of the student(s), the Qualified Scientist, or and all required forms to confirm that applicable Intel ISEF rules
the Designated Supervisor who oversees the project may have been followed. The Intel ISEF SRC may request additional
serve on the SRC reviewing that project. Additional information from students prior to the Intel ISEF or may interview
members are recommended to diversify and to increase potential Intel ISEF participants at the fair to ensure that they
the expertise of the committee. qualify to compete.

Page 6 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
The Intel 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 the Intel ISEF, committee members
answer questions about the rules throughout the year from
students and teachers. The ISEF SRC can be contacted at
[email protected].

Members of the Intel ISEF Scientific Review Committee 2018:

Mrs. Christine Miller, Chair


Ms. Susan Appel
Mr. Henry Disston
Dr. Jennifer Green
Dr. Paula Johnson
Dr. Timothy Martin
Mrs. Evelyn Montalvo
Dr. Jason Shuffitt
Mrs. Andrea Spencer

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 7
Human Participants Rules
Rules involving human participants
Student researchers must follow federal guidelines (Code of a. Participants in physical activities (e.g., physical exertion,
Federal Regulations 45 CFR 46) to protect the human ingestion of any substance, any medical procedure)
research participant and the student researcher. When b. Psychological, educational and opinion studies (e.g.,
students conduct research with humans, the rights and welfare surveys, questionnaires, tests)
of the participants must be protected. Most human participant c. Studies in which the researcher is the subject of the
studies require preapproval from an Institutional Review Board research (Expedited Review may be used, see page 9)
(IRB)/Human Subjects Participant Program (HSPP) and d. Testing of student designed invention, prototype or
informed consent/ assent from the research participant. computer application by human participants other than
student researcher (Expedited Review may be used,
Exempt Studies (Do Not Require IRB Preapproval see page 9)
e. Testing of student designed invention or concept by
or Human Participants Paperwork) human participants other than student researcher
Some studies involving humans are exempt from IRB pre- f. Data/record review projects that include data that are not
approval or additional human participant forms. Exempt projects de-identified/anonymous (e.g., data set that includes
for the Intel ISEF and affiliated fairs are: name, birth date, phone number or other identifying
1. Student-designed Invention, Prototype, Computer Applications or variables).
Engineering/Design Project in which the student is the only person g. Behavioral observations that
testing the invention, prototype or computer application and the 1) involve any interaction with the observed individual(s)
testing does not pose a health or safety hazard. It is recommended or where the researcher has modified the environment
that a Risk Assessment Form (3) be completed. The use of human (e.g., post a sign, place an object).
participants (other than the student researcher him/herself) for this 2) occur in non-public or restricted access settings
testing requires IRB review and approval (see page 10). (e.g., day care setting, doctor’s office)
3) involve the recording of personally identifiable
information
2. Data/record review studies (e.g., baseball statistics, crime
statistics) in which the data are taken from preexisting 2. Student researchers must complete ALL elements of the Human
data sets that are publicly available and/or published and Participants portion of the Research Plan/Project Summary
do not involve any interaction with humans or the Instructions and evaluate and minimize the physical, psychological
collection of any data from a human participant for the and privacy risks to their human participants. See Risk Assessment
purpose of the student’s research project. information on page 11 and the online Risk Assessment Guide
(https://student.societyforscience.org/ human-participants#riskass)
3. Behavioral observations of unrestricted, public settings for additional guidance.
(e.g., shopping mall, public park) in which all of the
following apply: 3. The research study should be in compliance with all privacy laws
a. the researcher has no interaction with the individuals (e.g., U.S. Family Educational Rights and Privacy
being observed Act (FERPA) and U.S. Health Insurance Portability and
b. the researcher does not manipulate the environment in Accountability Act (HIPAA)) laws when they apply to the
any way and project (e.g. the project involves medical information).
c. the researcher does not record any personally identifiable
data. 4. All research projects involving human participants, including any
revisions, must be reviewed and approved by an Institutional
4. Projects in which the student receives pre-existing/ Review Board (IRB) before the student may begin recruiting and/or
retrospective data in a de-identified/anonymous format interacting with human participants. The IRB must assess the risk
which complies with both of the following conditions: and document its determination of risk on Form 4. After initial IRB
a. the professional providing the data certifies in writing approval, a student with any proposed changes in the Research
that the data have been appropriately de-identified Plan/Project Summary must repeat the approval process and
before being given to the student researcher and are in regain approval before laboratory experimentation/data collection
compliance with all privacy and HIPAA laws, and resumes.
b. the affiliated fair SRC ensures that the data were
appropriately de-identified by review of the written 5. Research conducted by a pre-college student at a Regulated
documentation provided by the supervising adult(s). Research Institution (e.g., university, college, medical center,
government lab, correctional institution) must be reviewed
Rules and approved by that institution’s IRB. A copy of the IRB
1. The use of human participants in science projects is allowable under approval for the entire project (which must include the
the conditions and rules in the following sections. Based upon the research procedures/measures the student is using) and/or
U.S. Code of Federal Regulations (45 CFR 46), the definition of a an official letter from the IRB attesting to approval is required.
human participant is a living individual about whom an investigator A letter from the mentor is not sufficient documentation of
conducting research obtains (1) data or samples through intervention IRB review and approval.
or interaction with individual(s), or (2) identifiable private information.
These projects require IRB review and preapproval and may also 6. Research participants must voluntarily give informed
require documentation of written informed consent/assent/parental consent/assent (in some cases with parental permission)
permission. Examples of studies that are considered “human before participating in the study. Adult research participants
participant research” requiring IRB preapproval include: may give their own consent. Research participants under

Page 8 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
18 years of age and/or individuals not able to give consent (e.g. 11. After experimentation and before Intel ISEF competition, the Intel
developmentally disabled individuals) give their assent, with the ISEF SRC reviews and approves previously-approved projects to
parent/guardian providing permission. The IRB will determine ensure that students followed the approved Research Plan/Project
whether the consent/assent/parental permission may be verbal or Summary and all of the Intel ISEF rules.
must be written depending on the level of risk and the type of
study, and will determine if a Qualified Scientist is required to 12. The following forms are required for studies involving
oversee the project. Risk Assessment information on page 11 and human participants:
the online Risk Assessment Guide a. Checklist for Adult Sponsor (1), Student Checklist (1A),
(https://student.societyforscience.org/human-participants#riskass) Research Plan/Project Summary, and Approval Form (1B)
for further explanation of informed consent. b. Human Participants Form (4) with applicable consents
and survey(s)
a. Informed consent requires that the researcher provides c. Regulated Research Institution Form (1C),
complete information to the participant (and where when applicable
applicable, parents or guardians) about the risks and d. Qualified Scientist Form (2), when applicable
benefits associated with participation in the research e. Risk Assessment (3) when applicable
study, which then allows the participants and parents or
guardians to make an informed decision about whether or IRB Waiver of Written Informed
not to participate. Consent/Parental Permission
b. Participants must be informed that their participation The IRB may waive the requirement for documentation of
is voluntary (i.e., they may participate or decline written informed consent/assent/parental permission if the
to participate, with no adverse consequences of research involves only minimal risk and anonymous data
nonparticipation or aborted participation) and that they
collection and if it is one of the following:
are free to stop participating at any time.
• Research involving normal educational practices
c. Informed consent may not involve coercion and is an
• Research on individual or group behavior or characteristics
on-going process, not a single event that ends with a
signature.
of individuals where the researcher does not manipulate
d. When written parental permission is required and the the participants’ behavior and the study does not involve
study includes a survey, the survey must be attached to more than minimal risk.
• Surveys, questionnaires, or activities that are determined by the
the consent form.
IRB to involve perception, cognition, or game theory, etc. and that
e. The student researcher may request that the IRB waive
the requirement for written informed consent/parental do NOT involve gathering personal information, invasion of privacy
permission in his/her research plan if the project meets or potential for emotional distress.
specific requirements. See section on IRB waivers for • Studies involving physical activity where the IRB determines
more information about situations in which written that no more than minimal risk exists and where the
parental permission and/or written informed consent can probability and magnitude of harm or discomfort anticipated
be waived by the IRB. in the research are not greater than those ordinarily
encountered in DAILY LIFE or during performance of
7. A student may observe and collect data for analysis of medical routine physical activities.
procedures and medication administration only under the direct
supervision of a medical professional. This medical professional If there is any uncertainty regarding the appropriateness of
must be named in the research protocol approved by the IRB. waiving written informed consent/assent/parental permission, it is
Students are prohibited from administering medication and/or strongly recommended that documentation of written informed
performing invasive medical procedures on human participants. The consent/assent/parental permission be obtained.
IRB must also confirm that the student is not violating the medical
practice act of the state or country in which he/she is conducting the Expedited Review
research. An expedited review by only one member of the IRB may be
conducted for projects that meet one of the criteria listed below.
8. Student researchers may NOT publish or display information The IRB member reviewing the project will determine whether
in a report that identifies the human participants directly or appropriate safety precautions will be employed and whether the
through identifiers linked to the participants (including project meets criteria for expedited review. If a project submitted
photographs) without the written consent of the participant(s) for expedited review does not meet the criteria specified below,
(Public Health Service Act, 42, USC 241 (d)). the project must undergo full IRB review. The IRB member
reviewing the project must have the expertise necessary to
9. All published instruments that are not in the public domain must make such a decision and/or receive advisement from an
be administered, scored and interpreted by a Qualified appropriate expert.
Scientist as required by the instrument publisher. Any and
all use and distribution of the test must be in accordance
with the publisher’s requirements, including procurement of
legal copies of the instrument.

10. Studies that involve the collection of data via use of the internet
(e.g., email, web-based surveys) are allowed, but researchers
should be aware that they can pose challenges in
a) collecting anonymous data, b) obtaining informed consent
and c) ensuring that participants are of the appropriate age
to give informed consent. See the Online Studies Section of
the Risk Assessment Guide.

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 9
Human Participant Involvement in Student-designed
Invention, Prototype, Computer Application &
Engineering/Design Projects
Student-designed invention, prototype, computer application
and engineering/design projects that involve testing of the
invention by any human participant require attention to the
potential risks to the individual(s) testing or trying out the
invention/prototype. To be considered for Exempt Status or
Expedited Review, the data collected/feedback received must be
a direct reference to the invention/prototype (i.e., personal data
cannot be collected) and the testing may not pose a health or
safety risk.
• Exempt Status can be used when the student researcher is the
only person testing the invention/prototype. It is recommended
that a Risk Assessment Form (3) be completed.
• Expedited Review process may only be used for projects
that involve human participants to test a student designed
intervention or prototype in which the feedback obtained is
only related to the invention.
• Full IRB Review is necessary if the activities involved in testing of
the invention or prototype are more than minimal risk or involve
collection of personal information from participants.
• Full IRB Review is necessary if the testing of the invention,
prototype or project involves a medical intervention (as
defined by the FDA or Medical Practices Act) and should
be conducted in a Registered Research Institution with
IRB approval from the institution.

Page 10 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
Human Participant Risk Assessment
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 (https://student.societyforscience.org/human-participants#riskass) and Online
Survey Consent Procedures (https://member.societyforscience.org/document.doc?id=40) for more detailed information on
risk assessment.

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 11
Vertebrate Animals Rules
Rules involving vertebrate animals
The following rules were developed to help pre-college affiliated fair SRC serves in this capacity for vertebrate
student researchers adhere to the federal regulations animals studies performed in a school, home or field. Any
governing professional scientists and to protect the welfare of SRC serving in this capacity must include a veterinarian or an
both animal subjects and the student researcher. Health and animal care provider with training and/or experience in the
well-being is of high priority when students conduct research species being studied.
with animal subjects.
4. All vertebrate animal studies must have a research plan
The Society strongly endorses the use of non-animal research that includes:
methods and encourages students to use alternatives to a. Justification why animals must be used, including the
animal research. If the use of vertebrate animals is necessary, reasons for the choice of species, the source of animals
students must consider additional alternatives to reduce and and the number of animals to be used; description,
refine the use of animals. explanation, or identification of alternatives to animal use
that were considered, and the reasons these alternatives
All projects involving vertebrate animals must adhere to the were unacceptable; explanation of the potential impact or
rules below AND to either Section A or Section B rules, contribution this research may have on the broad fields of
depending on the nature of the study and the research site. biology or medicine.
b. Description of how the animals will be used. Include
A project is considered a tissue study and not a vertebrate methods and procedures, such as experimental design
animal study if tissue is obtained from an animal that was and data analysis; description of the procedures that will
euthanized for a purpose other than the student’s project. (Use minimize the potential for discomfort, distress, pain and
of tissues obtained from research conducted at a Regulated injury to the animals during the course of experimentation;
Research Institution requires a copy of an IACUC certification identification of the species, strain, sex, age, weight,
with the name of the research institution, the title of the study, source and number of animals proposed for use.
the IACUC approval number and date of IACUC approval.) In
5. Studies involving behavioral observations of animals are exempt
tissue studies, a student may observe the vertebrate study, but
from prior SRC review if ALL of the following apply:
may not manipulate or have any direct involvement in the
vertebrate animal experimental procedures. a. There is no interaction with the animals being observed,
b. There is no manipulation of the animal environment in
any way, and
Rules for ALL Vertebrate Animal Studies c. The study meets all federal and state agriculture, fish,
1. The use of vertebrate animals in science projects is allowable
game and wildlife laws and regulations.
under the conditions and rules in the following sections.
Vertebrate animals, as covered by these rules, are defined as: 6. Students performing vertebrate animal research must satisfy US
a. Live, nonhuman vertebrate mammalian embryos or federal law as well as local, state, and country laws and regulations
fetuses
of the jurisdiction in which research is performed.
b. Tadpoles
c. Bird and reptile eggs up to three days (72 hours) prior to 7. Research projects which cause more than momentary or slight pain
hatching or distress are prohibited. Any illness or unexpected weight loss
d. All other nonhuman vertebrates (including fish) at
must be investigated and a veterinarian consulted to receive
hatching or birth.
required medical care. This investigation must
Exception: Because of their delayed cognitive neural
be documented by the Qualified Scientist or Designated
development, zebrafish embryos may be used up to
Supervisor, who is qualified to determine the illness, or by
seven days (168 hours) post-fertilization.
a veterinarian. If the illness or distress is caused by the
study, the experiment must be terminated immediately.
2. Alternatives to the use of vertebrate animals for research
must be explored and discussed in the research plan. The 8. No vertebrate animal deaths due to the experimental
guiding principles for the use of animals in research include procedures are permitted in any group or subgroup.
the following “Four Rs”: a. Studies that are designed or anticipated to cause
a. Replace vertebrate animals with invertebrates, lower life vertebrate animal death are prohibited.
forms, tissue/cell cultures and/or computer simulations b. Any death that occurs must be investigated by a
where possible. veterinarian, the Qualified Scientist or the Designated
b. Reduce the number of animals without compromising Supervisor who is qualified to determine if the cause
statistical validity. of death was incidental or due to the experimental
c. Refine the experimental protocol to minimize pain or procedures. The project must be suspended until the
distress to the animals. cause is determined and then the results must be
d. Respect animals and their contribution to research. documented in writing.
c. If death was the result of the experimental procedure, the
3. All vertebrate animal studies must be reviewed and approved study must be terminated, and the study will not qualify for
before experimentation begins. An Institutional Animal Care and competition.
Use Committee, known as an IACUC, is the institutional animal
9. All animals must be monitored for signs of distress. Because
oversight review and approval body for all animal studies at a
Regulated Research Institution. The local OR significant weight loss is one sign of stress, the maximum

Page 12 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
permissible weight loss or growth retardation (compared All vertebrate animal studies that do not meet the
to controls) of any experimental or control animal is 15%. above guidelines must be conducted in a Regulated
Research Institution (see Section B).
10. Students are prohibited from designing or participating in an
experiment associated with the following types of studies on 2. Animals must be treated kindly and cared for properly. Animals
vertebrate animals: must be housed in a clean, ventilated, comfortable environment
a. Induced toxicity studies with known toxic substances that appropriate for the species. They must be given a continuous,
could cause pain, distress, or death, including but not clean (uncontaminated) water and food supply.
limited to alcohol, acid rain, pesticides, or heavy metals or Cages, pens and fish tanks must be cleaned frequently.
studies with the intent to study toxic effects of a substance Proper care must be provided at all times, including
on a vertebrate animal. weekends, holidays, and vacation periods. Animals must be
b. Behavioral experiments using conditioning with aversive observed daily to assess their health and well-being. A
stimuli, mother/infant separation or induced helplessness. Designated Supervisor is required to oversee the daily
c. Studies of pain. husbandry of the animals. Any of the following U.S.
d. Predator/vertebrate prey experiments. documents provide further guidance for animal husbandry:
• Federal Animal Welfare Regulation
11. Justification is required for an experimental design that • Guide for the Care and Use of Laboratory Animals
involves food or fluid restriction and must be appropriate to • Guide for the Care and Use of Agricultural Animals
the species. If the restriction exceeds 18 hours, the project in Agricultural Research and Teaching (Ag-Guide)
must be reviewed and approved by an IACUC and • Quality Assurance Manuals (for the appropriate species)
conducted at a Regulated Research Institution.
3. The local or affiliated fair Scientific Review Committee must
12. Animals may not be captured from or released into the wild determine if a veterinarian’s certification of the research and
without approval of authorized wildlife or other regulatory animal husbandry plan is required. This certification, as well
officials. All appropriate methods and precautions must be as SRC approval, is required before experimentation and is
used to decrease stress. Fish may be obtained from the wild documented on Vertebrate Animal Form 5A. A veterinarian
only if the researcher releases the fish unharmed, has the must certify experiments that involve supplemental nutrition,
proper license, and adheres to state, local and national administration of prescription drugs and/or activities that
fishing laws and regulations. The use of electrofishing is would not be ordinarily encountered in the animal’s daily life.
permissible only if conducted by a trained supervisor;
students are prohibited from performing electrofishing. 4. If an illness or emergency occurs, the affected animal(s) must
receive proper medical or nursing care that is directed by a
13. A Qualified Scientist or Designated Supervisor must directly veterinarian. A student researcher must stop experimentation
supervise all research involving vertebrate animals, except if there is unexpected weight loss or death in the
for observational studies. experimental subjects. The experiment can only be resumed
if the cause of illness or death is not related to the
14. After initial SRC approval, a student with any proposed experimental procedures and if appropriate steps are taken
changes in the Research Plan/Project Summary of the to eliminate the causal factors. If death is the result of the
project must repeat the approval process before laboratory experimental procedure, the study must be terminated, and
experimentation/data collection resumes. the study will not qualify for competition.

A. Additional Rules for Projects Conducted at 5. The final disposition of the animals must be conducted in
School/ Home/Field a responsible and ethical manner, and must be described
Vertebrate animal studies may be conducted at a home, on Vertebrate Animal Form 5A.
school, farm, ranch, in the field, etc. This includes:
a. Studies of animals in their natural environment. 6. Euthanasia for tissue removal and/or pathological analysis is not
b. Studies of animals in zoological parks. permitted for a project conducted in a school/home/ field site.
c. Studies of livestock that use standard agricultural Livestock or fish raised for food using standard
practices. agricultural/aquacultural production practices may be euthanized
d. Studies of fish that use standard aquaculture practices by a qualified adult for carcass evaluation.

These projects must be reviewed and approved by an SRC in 7. The following forms are required:
which one member is either a veterinarian and/or an animal a. Checklist for Adult Sponsor (1), Student Checklist (1A),
care provider/expert with training and/or experience in the Research Plan/Project Summary, and Approval Form (1B)
species being studied. b. Vertebrate Animal Form (5A)
c. Qualified Scientist Form (2), when applicable
1. These projects must adhere to BOTH of the
following guidelines: B. Additional Rules for Projects Conducted in
a. The research involves only agricultural, behavioral, a Regulated Research Institution
observational or supplemental nutritional studies on All studies not meeting the criteria in Section A that are otherwise
animals. permissible under Intel ISEF rules must be conducted in a Regulated
AND
Research Institution (RRI). A Regulated Research Institution within the
b. The research involves only non-invasive and U.S. is defined as a professional research/ teaching institution that is
non-intrusive methods that do not negatively regularly inspected by the USDA and is licensed to use animals
affect an animal’s health or well-being. covered by the Animal Welfare Act

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 13
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.

Some protocols permitted in a Regulated Research Institution are


not permitted for participation in the Intel 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 Intel 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 Veterinarian Medical
Association (AVMA) Guidelines.

3. Research projects that cause more than momentary or


slight pain or distress to vertebrate animals that is not
mitigated by approved anesthetics, analgesics and/or
tranquilizers are prohibited.

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 2017 – 2018, student.societyforscience.org/intel-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 (rDNA) technologies or human or animal
fresh/frozen tissues, blood, or body fluids.
Research using microorganisms (including bacteria, viruses, viroids, 3. Prior review and approval is required for the use of potentially
prions, rickettsia, fungi, and parasites), recombinant DNA (rDNA) hazardous microorganisms (including bacteria, viruses,
technologies or human or animal fresh/frozen tissues, blood, or body viroids, prions, rickettsia, fungi, and parasites), recombinant
fluids may involve potentially hazardous biological agents. Students DNA (rDNA) technologies or human or animal fresh/frozen
are permitted to do some research projects with potentially hazardous tissues, blood, or body fluids:
biological agents meeting the conditions and rules described below a. An affiliated fair SRC, an IBC or an IACUC must approve
which were designed to protect students and to ensure adherence to all research before experimentation begins. The initial risk
federal and international biosafety regulations and guidelines. assessment determined by the student researcher and
adults supervising the project must be confirmed by the
SRC, IBC or IACUC.
When dealing with potentially hazardous biological agents, it is b. Experimentation involving the culturing of potentially
the responsibility of the student and all of the adults involved in hazardous biological agents, even BSL-1 organisms, is
a research project to conduct and document a risk assessment prohibited in a home environment. However, specimens
on Form (6A) to define the potential level of harm, injury or may be collected at home as long as they are immediately
disease to plants, animals and humans that may occur when transported to a laboratory with the BSL containment
working with biological agents. The risk assessment determined by the affiliated fair SRC.
determines a biosafety level which in turn determines if the c. Research determined to be at Biosafety Level 1 (BSL-1)
project can proceed, and if so, the laboratory facilities, must be conducted in a BSL-1 or higher laboratory. The
equipment, training, and supervision required. research must be supervised by a trained Designated
Supervisor or a Qualified Scientist. The student must be
properly trained in standard microbiological practices.
All projects involving microorganisms, recombinant DNA
d. Research determined to be a Biosafety Level 2 (BSL-2)
technologies and human or animal fresh/frozen tissues, blood
must be conducted in a laboratory rated BSL-2 or above
or body fluids must adhere to the rules below AND, depending
(commonly limited to a Regulated Research Institution).
on the study, to the additional rules in Section A, B or C.
The research must be reviewed and approved by the
Institutional Biosafety Committee (IBC) if the Regulated
Rules for ALL Studies with Potentially Research Institution requires the review. The research
Hazardous Biological Agents (PHBA) must be supervised by a Qualified Scientist. For a high
1. The following types of studies involve BSL-1 organisms school BSL-2 laboratory, the SRC must review and
and are exempt from prior SRC review and require no approve.
additional forms: e. Students are prohibited from designing or participating
a. Studies involving baker’s yeast and brewer’s yeast, in an experiment associated with the following types of
except in rDNA studies. PHBA studies:
b. Studies involving Lactobacillus, Bacillus thuringiensis, • BSL-3 or BSL-4 Research
nitrogen-fixing, oil-eating, and algae-eating bacteria • Culturing CRE (Carbapenem
introduced into their natural environment. (Not exempt if Resistant Enterobacteriacae)
cultured in a petri dish environment.) f. Insertion of antibiotic resistance markers for the clonal
c. Studies involving water or soil not concentrated in media selection of bioengineered organisms is permitted.
conducive to their microbial growth (please review all Students may not genetically engineer organisms with
rules below to ensure that there are not more specific multiple drug resistance traits for the intended purpose of
rules that may apply). investigation of the pathology or treatment of antibiotic-
d. Studies of mold growth on food items if the experiment is resistant infections. Insertion of antibiotic-resistance traits
terminated at the first evidence of mold. or selection of organisms expressing traits that may
e. Studies of slime molds and edible mushrooms. affect the ability to provide effective treatment of
f. Studies involving E. coli k–12 which are done at school infections acquired by humans, animals, or plants is
and are not recombinant DNA studies. strictly prohibited.
g. Laboratory studies culturing known MRSA (Methicillin-
2. The following types of studies are exempt from prior resistant Staphylococcus aureus), VRE (Vancomycin-
SRC review, but require a Risk Assessment Form 3: resistant enterococci) and KPC (Klebsiella pneumonia) must
a. Studies involving protists, archaea and known non- have a written justification for usage and be conducted at a
pathogenic microorganisms. Regulated Research Institution with
b. Research using manure for composting, fuel production, a minimum BSL-2 laboratory with documented
or other non-culturing experiments. IBC Committee review and approval.
c. Commercially-available color change coliform water test h. Extreme caution must be exercised when selecting and sub-
kits. These kits must remain sealed and must be properly culturing antibiotic-resistant organisms. Studies using such
disposed. organisms require at least BSL-2 containment.
d. Studies involving decomposition of vertebrate organisms i. Naturally-occurring plant pathogens may be studied
(such as in forensic projects). (not cultured) at home, but may not be introduced into a
e. Studies with microbial fuel cells. home/garden environment.
j. The culturing of human or animal waste, including
sewage sludge, is considered a BSL-2 study.

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 15
k. All potentially hazardous biological agents must be cloning of DNA in E. coli K–12, S. cerevesiae, and B.
properly disposed at the end of experimentation in subtilis host-vector systems.
accordance with their biosafety level. For BSL 1 or
BSL 2 organisms: Autoclave at 121 degrees Celsius 2. An rDNA technology study using BSL-1 agents that may convert to
for 20 minutes, use of a 10% bleach solution (1:10 BSL-2 agents during the course of experimentation must be
dilution of domestic bleach), incineration, alkaline conducted entirely in a BSL-2 facility.
hydrolysis, biosafety pick-up and other
manufacturer recommendations are acceptable. 3. All rDNA technology studies involving BSL-2 organisms
l. Any proposed changes in the Research Plan/Project and/or BSL-2 host vector systems must be conducted in a
Summary by the student after initial local or affiliated Regulated Research Institution and approved by the IBC
fair SRC approval must undergo subsequent SRC or prior to experimentation.
IBC review and approval before such changes are
made and before experimentation resumes. 4. Propagation of recombinants containing DNA coding for human,
plant or animal toxins (including viruses) is prohibited.
4. The following forms are required:
a. Checklist for Adult Sponsor (1), Student Checklist (1A), 5. All genome editing studies that include alteration of germline cells,
Research Plan/Project Summary, and Approval Form (1B) insertion of gene drives, use of rapid trait develpment systems
b. Regulated Research Institution Form (1C) - (RTDS®), etc., should be categorized as a BSL-2 study and must
when applicable be conducted at an RRI and approved by the
c. Qualified Scientist (2), when applicable IBC from the institution. Qualified scientists are expected
d. Risk Assessment (3), when applicable to ensure that student research protocols address
e. PHBA Risk Assessment Form (6A), when applicable appropriate intrinsic and extrinsic containment precautions.
f. Human and Vertebrate Animal Tissue Form (6B) – for all
studies involving tissues and body fluids. 6. Introduction or disposal of non-native, genetically-altered,
and/or invasive species (e.g. insects, plants, invertebrates,
A. Additional Rules for Projects Involving vertebrates), pathogens, toxic chemicals or foreign
Unknown Microorganisms substances into the environment is prohibited. Students and
Studies involving unknown microorganisms present a adult sponsors should reference their local, state and national
challenge because the presence, concentration and regulations and quarantine lists.
pathogenicity of possible agents are unknown. In science
fair projects, these studies typically involve the collection C. Additional Rules for Projects with Tissues and
and culturing of microorganisms from the environment (e.g. Body Fluids, including Blood and Blood Products
soil, household surfaces, skin.) Studies involving fresh/frozen tissue, blood or body fluids
obtained from humans and/or vertebrates may contain
1. Research with unknown microorganisms can be treated as microorganisms and have the potential of causing
a BSL-1 study under the following conditions: disease. Therefore, a proper risk assessment is required.
a. Organism is cultured in a plastic petri dish (or other
standard non-breakable container) and sealed. Other 1. The following types of tissue do not need to be treated
acceptable containment includes two heavy-duty sealed as potentially hazardous biological agents:
bags. a. Plant tissue (except those known to be toxic or hazardous)
b. Experiment involves only procedures in which the petri b. Plant and non-primate established cell lines and tissue
dish remains sealed throughout the experiment (e.g., culture collections (e.g., obtained from the American Type
counting presence of organisms or colonies). Culture Collection). The source and/or catalog number of
c. The sealed petri dish is disposed of via autoclaving or the cultures must be identified in the Research Plan/
disinfection under the supervision of the Designated Project Summary.
Supervisor. c. Fresh or frozen meat, meat by-products, pasteurized milk
or eggs obtained from food stores, restaurants, or packing
2. If a culture container with unknown microorganisms is houses
opened for any purpose, (except for disinfection for disposal), d. Hair, hooves, nails and feathers
it must be treated as a BSL-2 study and involve BSL-2 e. Teeth that have been sterilized to kill any blood-borne
laboratory procedures. pathogen that may be present.
f. Fossilized tissue or archeological specimens.
B. Additional Rules for Projects Involving g. Prepared fixed tissue
Recombinant DNA (rDNA) Technologies
2. Research involving human and/or non-human primate established
Studies involving rDNA technologies in which microorganisms,
cell lines and tissue culture collections (e.g., obtained from the
plants and/or animals have been genetically modified require close
American Type Culture Collection) must be considered a BSL-1 or
review to assess the risk level assignment. Some rDNA studies can
BSL-2 level organism as indicated by source information and
be safely conducted in a BSL-1 high school laboratory with prior
treated accordingly. The source and/ or catalog number of the
review by a knowledgeable SRC:
cultures must be identified in the
1. All rDNA technology studies involving BSL-1 organisms and BSL-1 Research Plan/Project Summary.
host vector systems, including commercially available kits, must be
conducted in a BSL-1 laboratory under the supervision of a 3. If tissues are obtained from an animal that was euthanized for a
Qualified Scientist or Designated Supervisor and must be approved purpose other than the student’s project, it may be considered a
by the SRC prior to experimentation. Examples include tissue study. Use of tissues obtained from

Page 16 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
research conducted at a Regulated Research Institution experimentation.
requires a copy of the IACUC certification with the name of
the research institution, the title of the study, the IACUC 12. Studies involving embryonic human stem cells must be
approval number and date of IACUC approval. Use of tissues conducted in a Registered Research Institution and
obtained from agricultural/aquacultural studies require prior reviewed and approved by the ESCRO (Embryonic
SRC approval. Stem Cell Research Oversight) Committee.

4. If the animal was euthanized solely for the student’s Sources of Information are available as a separate section
project, the study must be considered a vertebrate animal at the end of the document.
project and is subject to the vertebrate animal rules. (See
vertebrate animal rules.)

5. The collection and examination of fresh/frozen tissue


and/or body fluids, (not including blood or blood products;
see rule 8) from a non-infectious source with little likelihood
of microorganisms present must be considered Biosafety
level 1 studies and must be conducted in a BSL-1
laboratory or higher and must be supervised by a Qualified
Scientist or trained Designated Supervisor.

6. The collection and examination of fresh/frozen tissues or body fluids


or meat, meat by-products, pasteurized milk or eggs NOT obtained
from food stores, restaurants, or packing houses may contain
microorganisms. Because of the increased risk from unknown
potentially hazardous agents, these studies must be considered
biosafety level 2 studies conducted
in a BSL-2 laboratory under the supervision of a Qualified
Scientist.

7. Human breast milk of unknown origin, unless certified free of


HIV and Hepatitis C, and domestic unpasteurized animal
milk are considered BSL-2.

8. All studies involving human or wild animal blood or blood products


should be considered at a minimum a Biosafety level 2 study and
must be conducted in a BSL-2 laboratory under the supervision of a
Qualified Scientist. Known BSL-3 or BSL-4 blood is prohibited.
Studies involving domestic animal blood may be considered a BSL-1
level study. All blood must be handled in accordance with standards
and guidelines set forth in the OSHA, 29CFR, Subpart Z. Any tissue
or instruments with the potential of containing blood-borne
pathogens (e.g. blood, blood products, tissues that release blood
when compressed, blood contaminated instruments) must be
properly disposed after experimentation.

9. Studies of human body fluids, where the sample can be


identified with a specific person, must have IRB review
and approval, and informed consent.

10. Any study involving the collection and examination of body


fluids may contain biological agents belonging to BSL-3 or
BSL-4 is prohibited.

11. A project involving a student researcher using their own


body fluids (if not cultured)
a. can be considered a BSL-1 study
b. may be conducted in a home setting
c. must have IRB review if the body fluid is serving as a
measure of an effect of an experimental procedure on the
student researcher (e.g. Student manipulates diet and
takes a blood or urine sample). An example of a project
not needing IRB review would be collecting urine to serve
as a deer repellent.
d. must receive prior SRC review and approval prior to

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-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 group
disease to plants, animals and humans that may occur when of biological agent, level of biological containment available and
working with biological agents. The end result of a risk the expertise of the Qualified Scientist or
assessment is the assignment of a biosafety level which then Designated Supervisor who will be supervising the project
determines the laboratory facilities, equipment, training, and
supervision required. Risk assessment involves: 7. Documentation of review and approval of study prior to
1. Assignment of the biological agent to a risk group experimentation:
a. If a study is conducted at a non-regulated site (e.g.
school), the SRC reviews the Research
2. Studies involving a known microorganism must begin with an initial
Plan/Project Summary.
assignment of the microorganism to a biosafety level risk group based
b. If the study was conducted at a Regulated Research
on information available through a literature search.
Institution, and was approved by the appropriate
institutional board (e.g. IBC, IACUC), the SRC
3. The study of unknown microorganisms and the use of fresh
reviews the institutional forms provided and
tissues relies on the expertise of the supervising adult(s).
documents SRC approval (Form(6A)).
c. If a PHBA study was conducted at a Regulated
4. Determination of the level of biological containment available Research Institution but the institution does not require
to the student researcher to conduct the experimentation. review for this type of study. The SRC must review the
(See “Levels of Biological Containment” for details.) study and document approval on Form 6A that the
student received appropriate training and the project
5. Assessment of the experience and expertise of the
complies with Intel ISEF rules.
adult(s) supervising the student.

Classification of Biological Agents Levels of Biological Containment


Risk Groups There are four levels of biological containment (Biosafety
Biological agents, plant or animal, are classified according to Level 1–4). Each level has guidelines for laboratory facilities,
biosafety level risk groups. These classifications presume safety equipment and laboratory practices and techniques.
ordinary circumstances in the research laboratory, or growth
of agents in small volumes for diagnostic and experimental BSL-1 containment is normally found in water-testing
purposes. laboratories, in high schools, and in colleges teaching
introductory microbiology classes. Work is done on an open
BSL-1 risk group contains biological agents that pose low risk bench or in an appropriate biosafety hood. Standard
to personnel and the environment. These agents are highly microbiological practices are used when working in the
unlikely to cause disease in healthy laboratory workers, laboratory. Decontamination can be achieved by treating with
animals or plants. The agents require Biosafety Level 1 chemical disinfectants or by steam autoclaving. Lab coats and
containment. Examples of BSL-1 organisms are: gloves are required. The laboratory work is supervised by an
Agrobacterium tumefaciens, Micrococcus leuteus, individual with general training in microbiology or a related
Neurospora crassa, Bacillus subtilis. science.

BSL-2 risk group contains biological agents that pose BSL-2 containment is designed to maximize safety when
moderate risk to personnel and the environment. If exposure working with agents of moderate risk to humans and the
occurs in a laboratory situation, the risk of spread is limited environment. Access to the laboratory is restricted. Biological
and it rarely would cause infection that would lead to serious safety cabinets (Class 2, type A, BSC) must be available. An
disease. Effective treatment and preventive measures are autoclave should be readily available for decontaminating
available in the event that an infection occurs. The agents waste materials. Lab coats and gloves are required; eye
require Biosafety Level 2 containment. Examples of BSL-2 protection and face shields must also be worn as needed.
organisms are: Mycobacterium, Streptococcus pneumoniae, The laboratory work must be supervised by a scientist who
Salmonella choleraesuis. understands the risk associated with working with the agents
involved.
BSL-3 risk group contains biological agents that usually cause
serious disease (human, animal or plant) or that can result in BSL-3 containment is required for infectious agents that
serious economic consequences. Projects in the BSL-3 group may cause serious or potentially lethal diseases as a
are prohibited. result of exposure by inhalation. Projects in the BSL-3
group are prohibited.
BSL-4 risk group contains biological agents that usually
produce very serious disease (human, animal or plant) that is BSL-4 containment is required for dangerous/exotic agents
often untreatable. Projects in the BSL-4 group are prohibited. that pose high risk of life-threatening disease. Projects in the
BSL-4 group are prohibited.

Page 18 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-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 1. DEA-Controlled Substances


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

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 19
Environmentally Responsible Chemistry
The purchase of a firearm by a minor is generally unlawful. The
The mission of environmentally responsible (green) chemistry
use of a firearm, without proper state certification, is illegal.
is to avoid the use or production of hazardous substances
Students should check the training and certification
during chemical process. The principles of green chemistry
requirements of individual states and countries.
are described on the EPA website in the Sources of
a. Projects involving firearms and explosives are allowable
Information section. Whenever possible the following
when conducted with the direct supervision of a
principles should be incorporated into the research plan.
Designated Supervisor and when in compliance with all
• Waste prevention
federal, state and local laws.
• Use of the safest possible chemicals and products
b. A fully assembled rocket motor, reload kit or propellant
modules containing more than 62.5 grams of propellant • Design of the least possible hazardous chemical syntheses
are subject to the permitting, storage and other • Use renewable materials
requirements of federal explosive laws and regulations. • Use catalysts in order to minimize chemical usage
c. Potato guns and paintball guns are not considered • Use of solvents and reaction conditions that are safe
firearms unless they are intended to be used as weapons. as possible
However, they must be treated as hazardous devices. • Maximization of energy efficiency
• Minimization of accident potential
5. Drones
Projects involving unmanned aircraft systems (UAS)/drones
must follow all state, Federal and country laws. See the 2. Hazardous Devices
Federal Aviation Administration (FAA) for more details The documentation of risk assessment (Form 3) is required when
(www. faa.gov.uas/registration). a student researcher works with potentially hazardous/ dangerous
equipment and/or other devices, in or outside a laboratory setting
Guidance for Risk Assessment that require a moderate to high level of expertise to ensure their
Please find below guidance on conducting risk assessment safe usage. Some commonly used devices (Bunsen burners, hot
when using the following: plates, saws, drills, etc.) may not require a documented risk
• Hazardous Chemicals assessment, assuming that the student researcher has experience
• Hazardous Devices working with the device. Use of other potentially dangerous
• Radiation devices such as high vacuum equipment, heated oil baths, NMR
equipment, and high temperature ovens must have documentation
1. Hazardous Chemicals of a risk assessment. It is recommended that all student designed
A proper risk assessment of chemicals must include review inventions also have documentation of a risk assessment.
of the following factors:
a. Toxicity – the tendency of a chemical to be hazardous to
health when inhaled, swallowed, injected or in contact 3. Radiation
with the skin. A risk assessment must be conducted when a student’s project
b. Reactivity  -  the tendency of a chemical to undergo involves radiation beyond that normally encountered in everyday
chemical change. life. Non-ionizing radiation includes the spectrum of ultraviolet (UV),
c. Flammability  -  the tendency of a chemical to give off visible light, infrared (IR), microwave (NW), radiofrequency (RF)
vapors which readily ignite when used under normal and extremely low frequency (ELF). Ionizing radiation has enough
working conditions. energy to remove tightly bound electrons from atoms, thus creating
d. Corrosiveness  -  the tendency of a chemical, upon ions. Examples include high frequency UV, X-Rays, and gamma
physical contact, to harm or destroy living tissues or rays.
physical equipment.
Lasers usually emit visible, ultraviolet or infrared radiation.
When assessing risk, the type and amount of exposure to a Lasers are classified into four classes based upon their safety.
chemical must be considered. For example, an individual’s allergic Manufacturers are required to label Classes II – IV lasers
and genetic disposition may have an influence on the overall effect
of the chemical. The student researcher must refer to Safety Data Projects involving radionuclides (radioisotopes) and X-rays
Sheets provided by the vendor (SDS) to ensure that proper safety must involve a careful examination of the risks associated
precautions are taken. Some SDS sheets (e.g., Flinn) rank the with the study and appropriate safety precautions must be
degree of hazard associated with a chemical. This rating may assist taken. Depending upon the level of exposure, radiation
students and adult sponsors in determining risk associated with the released from these sources can be a health hazard.
use of a chemical.
A risk assessment must take into account the time of
A risk assessment must include proper disposal methods for the exposure, distance and shielding involved in the study.
chemicals used in an experiment. The Flinn Catalog (referenced in a. A study of natural radiation that is no more than
the Sources of Information section) provides information for the encountered in everyday life is exempt from the following
proper disposal of chemicals. If applicable, the student researcher requirements.
must incorporate in the research plan disposal procedure required b. All studies may not exceed the dose limits set by the
by federal and state guidelines. Nuclear Regulatory Commission of 0.5 mrem/hr or 100
mrem/year of exposure.
c. 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.

Page 20 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
d. A study using 10-25 kvolts must have a risk assessment 2. Dunn, C. M. and Chadwick, G. L., Protecting Study
conducted and must be preapproved by the SRC to Volunteers in Research, 3rd Edition (2004). Boston, MA:
assess safety. Such a study must be conducted in a metal Thomson Centerwatch. ISBN 1-930624-44-1.
chamber using a camera only, not direct view through Can be purchased from:
glass. A dosimeter or radiation survey meter is required to www.amazon.com
measure radiation exposure.
e. All studies using > 25 kvolts must be conducted at an 3. NIH tutorial, “Protecting Human Research Participants”
institution with a Licensed Radiation Program and must
http://phrp.nihtraining.com/users/PHRP.pdf
be preapproved by the Institutions’ Radiation Safety
Officer or the Committee which oversees the use of
4. Belmont Report, April 18, 1979
ionizing radiation to ensure compliance with state and
www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
federal regulations.
5. Standards for Educational and Psychological Testing.
(1999). Washington, DC: AERA, APA, NCME.
Sources of Information for All Projects
www.apa.org/science/programs/testing/standards.aspx
1. United States Patent and Trade Office
Customer Service: 1-800-786-9199 (toll-free);
6. American Psychological Association
571-272-1000 (local); 571-272-9950 (TTY)
750 First Street, NE Washington, DC 20002-4242
www.uspto.gov
phone: 202-336-5500; 800-374-2721
www.uspto.gov/patents/process/index.jsp
www.apa.org
2. European Patent Office
Information for students:
www.epo.org
www.apa.org/science/leadership/students/information.aspx
www.epo.org/applying/basics.html
Information regarding publications:
www.apa.org/pubs/index.aspx
3. The Mad Scientist Network at Washington University School
of Medicine:
www.madsci.org 7. Educational and Psychological Testing
Testing Office for the APA Science
Directorate phone: 202-336-6000
4. ANS Task Force
email: [email protected]
www.anstaskforce.gov
www.apa.org/science/programs/testing/index.aspx
Aquatic Nuisance Species (ANS) Task Force
8. The Children’s Online Privacy Protection Act of 1998
www.anstaskforce.gov
(COPPA) (15 U.S.C. §§ 6501–6506)
www.anstaskforce.gov/Documents/ISEF.pdf
www.ftc.gov/privacy/coppafaqs.shtm
5. APHIS
www.aphis.usda.gov/
Vertebrate Animals
Animal and Plant Health Inspection Animal Care and Use
Service Invasive Species List 1. Laboratory Animals, Institute of Laboratory Animal
Research (ILAR), Commission on Life Sciences, National
6. Invasive Species Specialist Research http://dels.nas.edu/ilar
Group www.issg.org
The Global Invasive Species database contains 2. Guide for the Care and Use of Laboratory Animals, 8th Edition
invasive species information supplied by experts from (2011) http://grants.nih.gov/grants/olaw/Guide-for-the-Care-
around the world. and-Use-of-Laboratory-Animals.pdf
www.nap.edu/catalog.php?record_id=12910
7. Invasive Species Information
www.invasivespeciesinfo.gov/resources/lists.shtml
Provides information for species declared invasive, 3. Guidelines for the Care and Use of Mammals in Neuroscience
noxious, prohibited, or harmful or potentially harmful. and Behavioral Research (2003), Institute for Laboratory Animal
Research (ILAR). https://www.nap.edu/catalog/10732/guidelines-
8. Success with Science: The Winner’s Guide to for-the-care-and-use-of-mammals-in-neuroscience-and-
behavioral-research
High School Research
http://www.successwithscience.org
Gaglani, S. and DeObaldia, G. (2011). Research Corporation
To order these ILAR publications contact:
for Science Advancement.
National Academies Press
ISBN 0-9633504-8-X 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 www.nap.edu
Welfare), Part 46-Protection of Human Subjects
(45CFR46) https://www.hhs.gov/ohrp/regulations-and- 4. Federal Animal Welfare Act (AWA)
policy/ regulations/45-cfr-46 7 U.S.C. 2131-2157
Subchapter A - Animal Welfare (Parts I, II, III)
https://www.nal.usda.gov/awic/animal-welfare-act

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 21
Document is available from: email: [email protected]
USDA/APHIS/AC https://www.sis.nlm.nih.gov
4700 River Road, Unit 84 http://toxnet.nlm.nih.gov/altbib.html
Riverdale, MD 20737-1234
email: [email protected] 5. Johns Hopkins Center for Alternatives to Animal Testing (CAAT)
phone: 301-734-7833; fax: 301-734-4978 has worked with scientists since 1981 to find new methods to
http://awic.nal.usda.gov replace the use of laboratory animals in experiments, reduce the
number of animals tested, and refine necessary tests to
5. Guide for the Care and Use of Agricultural Animals in eliminate pain and distress.
Agricultural Research and Teaching (Agri-Guide) Association email: [email protected]
for Assessment and Accreditation of Laboratory Animal Care http://caat.jhsph.edu/
International (AAALAC International) https://www.aaalac.org/
https://www.aaalac.org/about/Ag_Guide_3rd_ed.pdf 6. Quality Assurance Manuals (for appropriate species)
Such as:
Poultry: https://www.ams.usda.gov/?dDocName=STELDEV3002393
6. Guidelines for the Use of Fish in Research (2014), Beef: http://www.bqa.org/manuals.aspx
American Fisheries Society. Pork: http://old.pork.org/filelibrary/youthpqaplus/ypqamanual.pdf
www.fisheries.org
www.fisheries.org/afs/docs/policy_16.pdf Potentially Hazardous Biological Agents
1. American Biological Safety Association: ABSA Risk Group
7. Euthanasia Guidelines Classification – list of
AVMA Guidelines on Euthanasia (2013) American organisms www.absa.org
Veterinary Medical Association
www.avma.org/KB/Policies/Documents/euthanasia.pdf 2. American Type Culture Collection
(ATCC) www.atcc.org
Alternative Research and Animal Welfare
1. The National Library of Medicine provides computer searches 3. Bergey’s Manual of Systematic Bacteriology website – follow the
through MEDLINE: links for resources and microbial databases for a collection of
Reference & Customer international websites of microorganisms and cell cultures.
Services National Library of www.bergeys.org/resources.html
Medicine 8600 Rockville Pike
Bethesda, MD 20894 4. Biosafety in Microbiological and Biomedical Laboratories (BMBL)
888-FIND-NLM or 888-346-3656; 301-594-5983; - 4th Edition. Published by CDC-NIH
email: [email protected] www.nlm.nih.gov www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf
www.ncbi.nlm.nih.gov/sites/entrez
5. World Health Organization Laboratory Safety Manual
www.who.int/diagnostics_laboratory/guidance/en
2. National Agriculture Library (NAL) provides reference service for
materials that document a) Alternative Procedures to Animal Use 6. Canada – Agency of Public Health – list of non-pathogenic
and b) Animal Welfare. organisms http://www.phac-aspc.gc.ca/lab-bio/index-
Animal Welfare Information Center eng.php
National Agriculture Library
10301 Baltimore Avenue, Room 7. American Society for Microbiology
410 Beltsville, MD 20705-2351 https://www.asm.org/division/w/web-sites.htm
phone: 301-504-6212, fax: 301-504-7125
email: [email protected]
8. Microbiology Society
www.nal.usda.gov/awic Charles Darwin
House 12 Roger
3. Institute of Laboratory Animal Resources (ILAR) provides a Street London
variety of information on animal sources, housing and handling WC1N 2JU
standards, and alternatives to animal use through annotated UK
bibliographies published quarterly in ILAR Journal. [email protected]
ILAR  -  The Keck Center of the National http://microbiologyonline.org
Academies 500 Fifth Street, NW, Keck 687
Washington, DC 20001 9. NIH Guidelines for Research Involving Recombinant DNA
phone: 202-334-2590, fax: 202-334-1687 Molecules. Published by National Institutes of Health.
email: [email protected] http://osp.od.nih.gov/office-biotechnology-activities/oba/
http://dels.nas.edu/ilar index.html
4. Quarterly bibliographies of Alternatives to the Use of Live
10. OSHA – Occupational Health and Safety Administration
Vertebrates in Biomedical Research and Testing may be
www.osha.gov
obtained from:
Specialized Information Services
NLM/NIH Hazardous Chemicals, Activities or Devices
2 Democracy Plaza, Suite 510 General Lab/Chemical Safety
6707 Democracy Blvd., MSC 1. Safety in Academic Chemistry Laboratories, Volumes 1 and
5467 Bethesda, MD 20892-5467 2, 2003. Washington, DC: American Chemical Society.
phone: 301-496-1131; Fax: 301- 480-3537 Order from (first copy free of charge):
Page 22 International Rules: Guidelines for Science and Engineering Fairs 2017  – 2018, student.societyforscience.org/intel-isef
American Chemical Society 11. U.S. Nuclear Regulatory Commission
Publications Support Services Material Safety and Inspection Branch
1155 16th Street, NW One White Flint North
Washington, DC 20036 11555 Rockville Pike
phone: 202- 872-4000 or 800-227-5558 Rockville, MD 20852
email: [email protected] phone: 301-415-8200; 800-368-5642
www.acs.org/education www.nrc.gov

2. General
Howard Hughes Medical Institute has resources for working
with cell cultures, radioactive materials and other laboratory
materials.
www.hhmi.org/resources

3. Environmental Protection Agency (EPA) website for green


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 MSDS sheets.

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:
www.justice.gov/dea/index.htm
Controlled Substance Schedules – a list of
controlled substances:
www.deadiversion.usdoj.gov/schedules/

7. Alcohol, Tobacco, Firearms, and Explosives


Alcohol and Tobacco Tax and Trade Bureau
www.ttb.gov
Bureau of Alcohol, Tobacco, Firearms and
Explosives www.atf.gov

8. Radiation
Radiation Studies Information (CDC)
www.cdc.gov/nceh/radiation/default.htm

9. CDC Laboratory Safety Manuals


www.cdc.gov/biosafety/publications/index.htm

10. Occupational Safety and Health Administration


www.osha.gov
Safety and Health Topics: www.osha.gov/SLTC
www.osha.gov/SLTC/reactivechemicals/index.html
www.osha.gov/SLTC/laserhazards/index.html
www.osha.gov/SLTC/radiationionizing/index.html

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 23
Intel ISEF Display & Safety Regulations
Please address any questions regarding Intel ISEF Display & Safety Regulations to
Diane Hecht, Display & Safety Committee Chair at [email protected]

Display & Safety Authority


The Intel ISEF Display & Safety Committee is the final authority on Display & Safety issues for projects approved by the SRC to compete in the Intel
ISEF. Occasionally, the Intel ISEF Display & Safety Committee may require students to make revisions to conform to Display
& Safety regulations. The Regulations that follow have been divided into two main categories to separate those that deal
specifically with display regulations and those that pertain to safety regulations.

the component must be returned to the project and must fit


Display Regulations
within allowable dimensions.
The following regulations must be adhered to when a
finalist exhibits a project at Intel ISEF. All projects must Position of Project
adhere to the Display & Safety requirements of the Table or freestanding display must be parallel to, and
affiliated fair(s) in which they compete to qualify for positioned at, the back curtain of the booth. Projects may NOT
participation in the Intel ISEF. Affiliated fairs may have lean against the back curtain.
additional restrictions or requirements. Knowledge of
these requirements is the responsibility of the student and Forms Required to be Visible and Vertically
Adult Sponsor. Displayed at the Project Booth
The suggested placement of the required forms is on the
Maximum Size of Project front edge of the table, on the display board, or in a free-
Depth (front to back): 30 inches or 76 centimeters standing frame placed on the table top.
Width (side to side): 48 inches or 122 centimeters
Height (floor to top): 108 inches or 274 centimeters Forms required at all projects:
Please be aware when ordering posters that the 1. An original Official Abstract and Certification as approved and
mechanism that supports the poster should conform to stamped/embossed by the Intel ISEF Scientific Review
the maximum size limitations stated above. Committee.
a. Upon SRC approval, the stamped/embossed Official
1. All project materials and support mechanisms must fit within Abstract and Certification will be provided.
the project dimensions. • The Intel ISEF Scientific Review Committee defines
2. At the Intel ISEF, fair-provided tables will not exceed a the “official abstract and certification” as an
height of 36 inches (91 centimeters). UNALTERED original abstract and certification as
3. If a table is used it becomes part of the project and must stamped/embossed by the Intel ISEF Scientific
not exceed the allowed dimensions. Review Committee.
4. Nothing can be attached to the rear curtain for display. • If changes to the abstract and certification are
5. At the Intel ISEF, all demonstrations must be done within the revised, the most recent version that is stamped/
confines of the finalist booth. When not being demonstrated, embossed will replace all earlier versions.
• The D&S will have access to the electronic
version on record to confirm the correct version
is present at the project booth.
b. Abstract handouts to judges and to the public must be
limited to UNALTERED photocopies of the official abstract
and certification.
c. The term “abstract” may NOT be used as a title or
reference for any information on a finalist’s display or
materials at the project except as part of displaying the
official abstract.

2. Completed Intel ISEF Project Set-up Approval Form


(received on-site at the Fair)
Intel ISEF
Project
a. This form documents the project as approved by the
Abstract Set-up
Approval
Form
1C 7
Scientific Review Committee and is used to document the
Display & Safety review approval.

Forms required 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 Intel ISEF project
year, the Regulated Research Institutional/
Industrial Setting Form (1C) must be completed
and displayed at the project booth.
b. If Box 3 is checked YES on the official Intel ISEF Abstract

Page 24 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
and Certification, Regulated Research Institution/ d. It is a photograph or visual depiction of the finalist.
Industrial Setting Form 1C must be vertically displayed. e. It is a photograph or visual depiction for which a
c. The information provided on the Form 1C by the mentor signed consent form is at the project or in the booth.
may be referenced to confirm that the information
provided on the project board is that of the finalist. Only 2. Display of photographs other than that of the finalist must
minimal reference to mentor’s or other researcher’s work have a photo release signed by the subject, and if under
is allowable and must only reflect background 18 years of age, also by the guardian of the subject.
information or be used to clarify differences between a. Sample consent text: “I consent to the use of visual
finalist’s and others’ work. images (photos, videos, etc.) involving my participation/
my child’s participation in this research.”
2. Continuation Projects Form (7) b. (These forms must be available upon request by a Display
a. If a study is a continuation/research progression, the & Safety inspector, but shall not be displayed.)
Continuation Form 7 must be completed and displayed at
the project booth. 3. Finalists using audio-visual or multi-media presentations (for
b. The display board and abstract must reflect the current example, PowerPoint presentation, YouTube video, images,
year’s work only. The project title displayed in the finalist’s graphics, etc. displayed on computer monitors or other non-
booth may mention years (for example, “Year Two of an print presentation methods) must be prepared to show the
Ongoing Study”). entire presentation to the Display & Safety Inspectors
c. The display board must be based on collective past before the project is approved.
conclusionary data and its comparison to the current
year data set. No raw data from previous years may
be displayed. Safety Regulations
d. If Box 4 is checked YES on the official Intel ISEF The following regulations must be adhered to when a
Abstract and Certification, Continuation Form 7 must be Finalist exhibits a project at the Intel ISEF.
vertically displayed.
e. Supporting data books (not research papers) from Items/Materials Not Allowed on Display or at Project
previous related research may be exhibited if properly 1. Any information on the project display or items that
labeled as such. are acknowledgments, self-promotions or external
endorsements are not allowed in the project booth.
Forms Required at Project but not Displayed This includes:
Forms, excluding those listed above, that were required for the a. The use of logos including known commercial brands,
Scientific Review Committee review and approval do not have to be institutional crests or trademarks and/or a personalized
vertically displayed, but must be available in the booth in case asked for graphic/logo that is developed to indicate a commercial
by a judge or other Intel ISEF official. Forms include, but are not limited purpose or viability of an established or proposed
to, Checklist for Adult Sponsor (1), Student Checklist (1A), business.
Research Plan and Approval Form (1B). b. Any reference to an institution or mentor that supported
your research except as provided in the official Intel ISEF
A photograph/video release form signed by the subject is paperwork, most notably Form 1C or the Qualified
required for visual images of humans (other than the Scientist Form 2.
finalist) displayed as part of the project. c. Any reference to patent status of the project. This is
considered self-endorsement and is not allowable on the
Forms NOT to be Displayed display or at the project booth.
Completed informed consent forms for a human participant d. Any items intended for distribution such as disks, CDs,
study are NOT to be displayed and should NOT be present at flash drives, brochures, booklets, endorsements, give-
away items, business cards, or printed materials designed
the project display.
to be distributed to judges or the public.
2. Any awards or medals, except for past or present Intel
Photograph/Image Display Requirements ISEF medals that may be worn by the Finalist.
1. Any photograph/visual image/chart/table and/or graph is 3. Postal addresses, World Wide Web, email and/or social
allowed if: media addresses, QR codes, telephone and/or fax
a. It is not deemed offensive or inappropriate (which
numbers of a project or finalist.
includes images/photographs showing invertebrate or
4. Active Internet or email connections as part of displaying
vertebrate animals/humans in surgical, necrotizing or
or operating the project at the Intel ISEF.
dissection situations) by the Scientific Review Committee,
5. Any attempt to uncover, replenish or return removed
the Display & Safety Committee, or Society for Science &
the Public. The decision made by any one of the groups language or items from the display or project booth area
mentioned above is final. after Display & Safety Committee review is a violation of
the Ethics Statement and may result in the project failing
b. It has a credit line of origin (“Photograph taken by...”or
to qualify for competition.
“Image taken from...” or “Graph/Chart/Table taken
6. No changes, modifications, or additions to projects may be
from…”). (If all images, etc. being displayed were taken
made after approval by the Display & Safety Committee
or created by the finalist or are from the same source,
and the Scientific Review Committee.
one credit line prominently and vertically displayed on
a. Display & Safety inspections will include recording
the backboard/poster or tabletop is sufficient.)
photographic evidence of the approved Project
c. It is from the Internet, magazine, newspaper, journal,
Display and Project booth.
etc., and a credit line is attached. (If all photographs,
b. Finalists who do not adhere to this signed agreement on
etc. are from the same source, one credit prominently
the Intel ISEF Project Set-up Approval Form regarding
and vertically displayed is sufficient.)
this regulation will fail to qualify for competition.

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 25
Not Allowed at Project or Booth power must be disconnected, or power bars must be
1. Living organisms, including plants switched off (Exception: during pre-judging audio
2. Soil, sand, rock, cement and/or waste samples, even visual displays may be available).
if permanently encased in a slab of acrylic 5. An insulating grommet is required at the point where
3. Taxidermy specimens or parts any wire or cable enters any enclosure.
4. Preserved vertebrate or invertebrate animals 6. No exposed live circuits over 36 volts are allowed.
5. Human or animal food as part of the exhibitor demonstration 7. There must be an accessible, clearly visible on/off switch
of the project. or other means of quickly disconnecting from the 120 or
6. Human/animal parts or body fluids (for example, 220 Volt power source.
blood, urine)
7. Plant materials (living, dead, or preserved) that are in Laser/Laser Pointer Requirements
their raw, unprocessed, or non-manufactured state Any Class 1 or Class 2 lasers, along with only Class 3A or 3R
(Exception: manufactured construction materials used in lasers, are allowed to be used provided a finalist avoids
building the project or display) indiscriminate exposure to other finalists, judges, or visitors
8. All chemicals including water (projects may not use water (except if passed through magnifying optics such as microscopes
in any form in a demonstration) and telescopes, in which case they may not be used). No other
9. All hazardous substances or devices (Example: lasers may be used or displayed.
poisons, drugs, firearms, weapons, ammunition, 1. Any laser must be labeled by the manufacturer so that
reloading devices, and lasers) power output can be inspected. Lasers without labels will
10. Items that may have contained or been in contact with NOT be “cleared.”
hazardous chemicals (Exception: Item may be permitted 2. LED’s that consume over 1 watt, unless they are in a
if professionally cleaned and document for such cleaning commercial light bulb/ fixture or otherwise shielded, will not
is available) be allowed.
11. Dry ice or other sublimating solids 3. Lasers will be confiscated with no warning if not used in a safe
12. Sharp items (for example, syringes, needles, pipettes, knives) manner. Serious offenses may result in failure to qualify.
13. Flames or highly flammable materials (including
mangified light sources)
14. Batteries with open-top cells or wet cells
Other Safety Regulations
1. Any inadequately insulated apparatus producing extreme
15. Drones or any flight-capable apparatus should have
temperatures that may cause physical burns is not allowed.
the propulsion power source removed.
2. Any apparatus with unshielded belts, pulleys, chains, or
16. Glass or glass objects unless deemed by the Display &
moving parts with tension or pinch points must be for display
Safety Committee to be an integral and necessary part
only.
of the project (for example, glass that is an integral part
3. Society for Science & the Public, the Scientific Review
of a commercial product such as a computer screen)
Committee, and/or the Display & Safety Committee reserve
17. Any apparatus deemed unsafe by the Scientific Review
the right to remove any project for safety reasons or to protect
Committee, the Display & Safety Committee, or
the integrity of the Intel ISEF and its rules and regulations.
Society for Science & the Public (Example: large
4. Project sounds, lights, odors, or any other display items
vacuum tubes or dangerous ray-generating devices,
must not be distracting. Exceptions to this rule may be
empty tanks that previously contained combustible
permitted for judging demonstrations. Approval must be
liquids or gases, pressurized tanks, 3D printers etc.)
given prior to judging.
5. Projects can be continued under the table BUT this area
Electrical Regulations at Intel ISEF is not to be used for storage. No personal items or
1. Electrical power supplied to the project is 120 or 220 Volt, packaging materials may be stored underneath the booth.
AC, single phase, 60 cycle. No multi-phase will be available
or shall be used. Maximum circuit amperage/wattage
available is determined by the electrical circuit capacities of
the exhibit hall and may be adjusted on-site by the Display
& Safety Committee. For all electrical regulations, “120 Volt
AC” or “220 Volt AC” is intended to encompass the
corresponding range of voltage as supplied by the facility in
which the Intel ISEF is being held.
2. Electrical devices must be protectively enclosed. Any
enclosure must be non-combustible. All external non-
current carrying metal parts must be grounded.
3. Energized wiring, switches, and metal parts must have
adequate insulation and over-current safety devices (such
as fuses) and must be inaccessible to anyone other than
the finalist. Exposed electrical equipment or metal that
possibly may be energized must be shielded with a non-
conducting material or with a grounded metal box to
prevent accidental contact.
4. Decorative lighting or illumination is discouraged. If used,
lighting must be as low a voltage as possible and must be
LED lighting that does not generate heat. Light bulbs are
prohibited. When student is not at the exhibit, all electrical

Page 26 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
Information on Required Abstract & Certification for ALL Projects at the Intel 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 Intel ISEF Sample Abstract & Certification


After finishing research and Project ID
experimentation, you are required to Project Title
write a (maximum) 250 word, one-page
Finalist Name(s)
abstract. This is written on the Official Category
Pick one only-- mark an “X”
Abstract and Certification Form as Finalist School, City, State/Province, Country in box at right
provided by Society for Science & the Animal Sciences o
o
Public. It is recommended that it include Behavioral and Social

Abstract Body
Sciences
Biochemistry o
the following: Biomedical and Health
Sciences
o

a. purpose of the experiment Biomedical Engineering o


Cellular & Molecular Biology o
b. procedure Chemistry
Computational Biology and o
o

c. data Bioinformatics
Earth & Environmental o
Sciences
d. conclusions Embedded Systems o
Energy: Chemical o
Energy: Physical o
Engineering Mechanics o
It may also include any possible research Environmental Engineering o
Materials Science o
applications. Only minimal reference Mathematics
Microbiology
o
o

to previous work may be included. An Physics and Astronomy


Plant Sciences
o
o
Robotics & Intelligent o
abstract must not include the following: Machines
Systems Software o
a. acknowledgments (including naming Translational Medical
Science
o

the research institution and/or


mentor with which you were 1. As a part of this research project, the student directly handled, manipulated, or interacted with (check
all that apply):
working), or self-promotions and
external endorsements o human participants potentially hazardous biological agents:
b. work or procedures done by o vertebrate animals o microorganisms o rDNA o tissue

the mentor 2. This abstract describes only procedures performed by me/us, reflects my/our own independent re-
search, and represents one year’s work only. o yes o no

Completing the Certification 3. I/We worked or used equipment in a regulated research institution or industrial setting.
o yes o no
At the bottom of the Abstract & 4. This project is a continuation of previous research. o yes o no
Certification form there are six questions.
Please read each carefully and answer 5. My display board includes non-published photographs/visual depictions of FOR INTEL ISEF
appropriately. The Intel ISEF Scientific
Research Committee will review and humans (other than myself):
approve the abstract and answers to the o yes o no OFFICIAL USE
6. I/We hereby certify that the abstract and responses to the above state- ONLY
questions.
ments are correct and properly reflect my/our own work.
Revisions or questions will be resolved via o yes o no

a SRC appointment on site at the Intel


ISEF. Please bring an electronic copy of
your Abstract & Certification to the Fair.
Only after final Intel ISEF SRC approval NOTE: Your abstract must be on the Intel International Science
has been obtained via a stamped/ and Engineering Fair Abstract & Certification form and embossed/
embossed copy of this Abstract & stamped by the Intel ISEF Scientific Review Committee before
Certification may a Finalist make copies to it is displayed or handed out. No pasted or taped text will be
hand out to the judges and the public. (the permitted. No other format or version of your approved Abstract &
Society provides the first 20 copies.) Certification will be allowed for any purpose at the Intel ISEF.

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 27
Intel ISEF Categories and Subcategories
The categories have been established with the goal of better aligning judges and student projects for the judging at the Intel
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 the Intel ISEF categories:
ANIMAL SCIENCES CHEMISTRY ENERGY: PHYSICAL PHYSICS AND ASTRONOMY
Animal Behavior Analytical Chemistry Hydro Power Astronomy and Cosmology
Cellular Studies Computational Chemistry Nuclear Power Atomic, Molecular, and Optical
Development Environmental Chemistry Solar Physics
Ecology Inorganic Chemistry Sustainable Design Biological Physics
Genetics Materials Chemistry Thermal Power Condensed Matter and Materials
Nutrition and Growth Organic Chemistry Wind Mechanics
Physiology Physical Chemistry Other Other Nuclear and Particle Physics
Systematics and Evolution Theoretical, Computational and
Other ENGINEERING MECHANICS Quantum Physics
COMPUTATIONAL BIOLOGY Aerospace and Aeronautical Other
BEHAVIORAL AND AND BIOINFORMATICS Engineering
SOCIAL SCIENCES Computational Biomodeling Civil Engineering PLANT SCIENCES
Clinical and Developmental Computational Epidemiology Computational Mechanics Agriculture and Agronomy
Psychology Computational Evolutionary Control Theory Ecology
Cognitive Psychology Biology Ground Vehicle Systems Genetics/Breeding
Neuroscience Computational Neuroscience Industrial Engineering-Processing Growth and Development
Physiological Psychology Computational Pharmacology Mechanical Engineering Pathology
Sociology and Social Psychology Genomics Naval Systems Plant Physiology
Other Other Other Systematics and Evolution
Other
BIOCHEMISTRY EARTH AND ENVIRONMENTAL
Analytical Biochemistry ENVIRONMENTAL ENGINEERING ROBOTICS AND
General Biochemistry SCIENCES Bioremediation INTELLIGENT MACHINES
Medical Biochemistry Atmospheric Science Land Reclamation Biomechanics
Structural Biochemistry Climate Science Pollution Control Cognitive Systems
Other Environmental Effects on Recycling and Waste Management Control Theory
Ecosystems Water Resources Management Machine Learning
BIOMEDICAL AND Geosciences Other Robot Kinematics
HEALTH SCIENCES Water Science Other
Cell, Organ, and Systems Other MATERIALS SCIENCE
Physiology Biomaterials SYSTEMS SOFTWARE
Genetics and Molecular Biology EMBEDDED SYSTEMS Ceramic and Glasses Algorithms
of Disease Circuits Composite Materials Cybersecurity
Immunology Internet of Things Computation and Theory Databases
Nutrition and Natural Products Microcontrollers Electronic, Optical and Magnetic Human/Machine Interface
Pathophysiology Networking and Data Materials Languages and Operating
Other Communications Nanomaterials Systems
Optics Polymers Mobile Apps
BIOMEDICAL ENGINEERING Sensors Other Online Learning
Biomaterials and Regenerative Signal Processing Other
Medicine Other MATHEMATICS
Biomechanics Algebra TRANSLATIONAL
Biomedical Devices ENERGY: CHEMICAL Analysis MEDICAL SCIENCES
Biomedical Imaging Alternative Fuels Combinatorics, Graph Theory, and Disease Detection and Diagnosis
Cell and Tissue Engineering Computational Energy Science Game Theory Disease Prevention
Synthetic Biology Fossil Fuel Energy Geometry and Topology Disease Treatment and Therapies
Other Fuel Cells and Battery Number Theory Drug Identification and Testing
Development Probability and Statistics Pre-Clinical Studies
CELLULAR AND Microbial Fuel Cells Other Other
MOLECULAR BIOLOGY Solar Materials
Cell Physiology Other MICROBIOLOGY
Cellular Immunology Antimicrobials and Antibiotics
Genetics Applied Microbiology
Molecular Biology Bacteriology
Neurobiology Environmental Microbiology
Other Microbial Genetics
Virology
Other

Page 28 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-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 Intel ISEF Rules and Guidelines.

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 Institutional Biosafety Committee
(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) (have up with potentially hazardous biological agents.)
†† Qualified Scientist Form (2) (required for projects involving DEA-controlled substances or when applicable)

Adult Sponsor’s Printed Name Signature Date of Review

Phone Email
International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 29
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. Where will you conduct your experimentation? (check all that apply)

o Research Institution o o Field o Home o Other: ________________________


School

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 30 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
Research Plan/Project Summary Instructions
A complete Research Plan/Project Summary is required for ALL projects and
must accompany Student Checklist (1A).
1. 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.

2. 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.

3. 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. 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? 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 termination of the study.

3. 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.
International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 31
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 Intel ISEF Rules and Guidelines and will adhere to all International Rules when conducting
this research.
• I have read and will abide by the following Ethics statement
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 the Intel 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 Research
BEFORE experimentation (humans, vertebrates or potentially Institutions with no prior fair SRC/IRB approval.
hazardous biological agents). OR 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 Intel 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) Signature Date of Approval (mm/dd/yy)


(Must be prior to experimentation.)

3. Final Intel 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 Intel ISEF Rules.

Regional SRC Chair’s Printed Name Signature Date of Approval

State/National SRC Chair’s Printed Name Signature Date of Approval


(where applicable)

Page 32 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-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 remain on the form as it is required to be displayed at student’s project booth.)

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.

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


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

b. designed the methodology for his/her research project

c. analyzed and interpreted data

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 experi-


mentation)

Address Email/Phone

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 33
Qualified Scientist Form (2)
May be required for research involving human participants, vertebrate animals, potentially hazardous biological
agents, and DEA-controlled substances. 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 Intel ISEF rules relevant to this project? o Yes o No

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 tissues,
including blood and blood products) o Yes o No
d. DEA-controlled substances o Yes o No
3. Was this study 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 supervise.
I certify that I have reviewed and approved the Research Plan/
Project Summary prior to the start of the experimentation. If the I certify that I have reviewed the Research Plan/Project Summary
student or Designated Supervisor is not trained in the necessary and have been trained in the techniques to be used by this
procedures, I will ensure her/his training. I will provide advice and student, and I will provide direct supervision.
supervision during the research. I have 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 Designated Supervisor’s Printed Name
under my direct supervision.

Signature Date of Approval


Qualified Scientist’s Printed Name

Signature Date of Approval Phone Email

Page 34 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
Risk Assessment Form (3)
Required for projects using hazardous chemicals, activities or devices, and microorganisms
which are exempt from pre-approval. 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 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 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

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 35
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 experimentation.)

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: o Yes o No
3. Designated Supervisor (DS) Required: 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)
o Approved with Expedited Review (1 signature required). Study involves either of the following:
o Human participants will only provide feedback on project design/student-designed invention or prototype. etc., no personal
data will be collected and there are no health or safety hazards.
o Student is the only subject of the research and no more than minimal risk is involved.

IRB SIGNATURES (All 3 signatures required unless expedited review checked above) 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.)

Educator

Printed Name Degree

Signature Date of Approval (Must be prior to experimentation.)

School Administrator

Printed Name Degree/Professional License

Signature Date of Approval (Must be prior to experimentation.)

Page 36 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
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 any 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:

Research Participant Printed Name: Signature:


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

Parent/Guardian Printed Name: Signature:

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 37
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 Intel 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:
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 drugs
and/or nutritional supplements. accept primary responsibility for the care and handling of
the animals in this project.
o I will provide veterinary medical and nursing care in case of
o I will directly supervise the experiment.
illness or emergency.

Printed Name Email/Phone Printed Name Email/Phone

Signature Date of Approval Signature Date of Approval

Page 38 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
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

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 39
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 and MICROORGANISMS – To be completed by the QUALIFIED SCIENTIST or
DESIGNATED SUPERVISOR - Check the appropriate box(es) below:
o Experimentation on the cell line/microorganism used in this study was NOT conducted at a Regulated Research Institution, but was 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 cell line/microorganism used in this study was 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 (mm/dd/yy) ___________________________

o Experimentation on the cell line/microorganism used in this study was conducted at a Regulated Research Institution, which does not require
pre-approval for this type of study. The SRC has reviewed that the student received appropriate training and the project complies with Intel
ISEF rules.

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 pro-
vided 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/YYYY)

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/YYYY)

Page 40 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
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 number and
date 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


(Must be prior to experimentation.)

Title Phone/Email

Institution

International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018 student.societyforscience.org/intel-isef Page 41
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 previous
research. The information must be on the form; use an additional form for 2014–2015 and earlier projects.
Components Current Research Previous Research Project
Project
1. Title 2016–2017
2015–2016

2. Change in goal/ 2016–2017


purpose/objective
2015–2016

3. Changes in 2016–2017
methodology
2015–2016

4. Variable studied 2016–2017


2015–2016

5. Additional 2016–2017
changes
2015–2016

Attached are:
o 2016 – 2017 Abstract and Research Plan/Project Summary o 2015 – 2016 Abstract

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

Page 42 International Rules: Guidelines for Science and Engineering Fairs 2017 – 2018, student.societyforscience.org/intel-isef
The Intel 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


Society for Science & the Public (the Society) is one of the oldest nonprofit organizations in the U.S.
dedicated to public engagement in science and science education. Established in 1921, the Society
is a membership society and a leading advocate for the understanding and appreciation of science
and the vital role it plays in human advancement.

Through its acclaimed education competitions and its award-winning Science News Media
Group, the Society is committed to inform, educate, and inspire.
societyforscience.org

To learn more about the Intel International Science and Engineering Fair, visit:
student.societyforscience.org/intel-isef

Intel Corporation
The foundation of tomorrow’s innovation is education. That’s why making quality education available to
more students around the world - with the help of technology - has inspired Intel’s commitment to
education for 40 years. We do more than make contributions. Intel gets directly involved in developing
and helping to change policy, training teachers, offering free curricula, providing kids with a place
to explore technology, and encouraging young innovators. Intel believes that students at all levels
everywhere deserve to have the skills they need to become part of the next generation of innovators.

In the last decade, Intel has invested more than $1 billion, and Intel employees have donated more
than four million hours, toward improving education in more than 75 countries, regions, and
territories. We are actively involved in education programs, advocacy, and technology access to help
tomorrow’s innovators.
intel.com/education

Society for Science & the Public


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Washington, DC 20036-2801
202.785.2255 telephone
202.785.1243 fax
student.societyforscience.org/intel-isef

©2017 Society for Science & the Public. All rights reserved. Copyright ©2017 Intel Corporation.
All rights reserved. International Science and Engineering Fair is registered in the U.S. Patent
and Trademark Office as a trademark of Society for Science & the Public. Intel and the Intel
logo are trademarks of Intel Corporation in the U.S. and other countries. *Other names and
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