Index

The Student Researcher(s)
The Adult Sponsor
The Qualified Scientist
The Designated Supervisor
The Institutional Review Board (IRB)
The Affiliated Fair Scientific Review Committee (SRC)
Other Review Committees
The ISEF Scientific Review Committee

The Student Researcher(s)

The student researcher is responsible for all aspects of the research project:

• Enlisting the aid of any required supervisory adults (Adult Sponsor, Qualified Scientist, etc.), obtaining necessary approvals (SRC, IRB, etc.)
• Following the International Rules & Guidelines and obtaining all necessary approvals (SRC, IRB, etc.) and completing all appropriate documentation
• Performing the project (which may include, but is not limited to) experimentation, data collection, engineering, data analysis, and any other process or procedures related to the project
• Understanding and abiding by the Ethics Statement and attesting to this understanding on Approval Form 1B.

To avoid conflict of interest, no Adult Sponsor, parent or other relative of the student, the Qualified Scientist, or Designated Supervisor who oversees the project, may serve on the SRC or IRB reviewing that project.

The Adult Sponsor

Qualifications:

• An Adult Sponsor may be a teacher, parent, professor, and/or other professional scientist
• Should be knowledgeable in the area of student research, be familiar with the regulations around procedures and materials that apply to the student project, particularly when involving human participants, vertebrate animals, potentially hazardous biological agents or hazardous chemicals, devices or activities.
• Should have close contact with the student throughout the timeline of the project.

Responsibilities:
The Adult Sponsor is responsible for:

• Working with the student to evaluate any possible risks involved in order to ensure the health and safety of the student conducting the research and the humans and/or animals involved in the study.
• Reviewing the student’s Student Checklist (1A) and Research Plan/Project Summary to ensure that:
  • experimentation follows local, state, and Federal laws and ISEF rules
  • forms are completed by other required adults
  • any required Qualified Scientist meets the criteria as set forth in the ISEF Rules and Guidelines
  • the student’s research is eligible for entry in ISEF

The Qualified Scientist

Qualifications:

• Earned a doctoral/professional degree in a scientific discipline related to student’s area of research

AND/OR

• Individual with extensive experience and expertise in the student’s area of research
• Must be thoroughly familiar with the following regulations that govern the student’s area of research including all local, state, Federal and if applicable, non-U.S. national regulations and laws.
• Can also serve as the Adult Sponsor, if that person meets both sets of qualifications
• May live elsewhere and not be local to the student, in which case, a Designated Supervisor has been appointed and trained to serve as the onsite supervision as necessary for the specific student project.

Responsibilities:
The Qualified Scientist is responsible for:

• Reviewing the ISEF rules relevant to the project and approving the student’s research plan or engineering design prior to the start of experimentation
• Providing direct supervision throughout the timeline of the project or coordinating with a Designated Supervisor to serve in this capacity
• Ensuring the proper training of the Student Researcher and/or Designated Supervisor in the necessary procedures
• Completing the required documentation which may include the Regulated Research Institutional Setting Form (1C), the Qualified Scientist Form (2) and the Risk Assessment Form (3), when applicable.

The Designated Supervisor

Qualifications:

• Does not need an advanced degree
• Must be familiar with the student’s project and agree to any training necessary
• May also serve as the Adult Sponsor for the project
• If the project involves the use of Vertebrate Animals (where behavior/habitat is influenced by humans), must be knowledgeable about the humane care and handling of the animals

Responsibilities:

• Providing direct supervision of the student experimentation
• Completing the required documentation — the Designated Supervisor box on the Qualified Scientist Form (2) when applicable
• Reviewing and completing the Risk Assessment Form (3) when needed.

Review Committees

The Affiliated Fair Scientific Review Committee (SRC)

A Scientific Review Committee (SRC) is a group of qualified individuals that is responsible for evaluation of student research, certifications, research plans and exhibits for compliance with the rules, applicable laws and regulations at each level of science fair competition. Affiliated Fairs may authorize local SRCs to serve in this prior review capacity. The operation and composition of the local and Affiliated Fair SRCs must fully comply with the International Rules. Directions for obtaining preapproval are available from the affiliated fair. A list of fairs is at: https://findafair.societyforscience.org/.

Most proposed research projects involving vertebrate animals and/or potentially hazardous biological agents must be reviewed and approved BEFORE experimentation. Local or regional SRC prior review is not required for human studies previously reviewed and approved by a properly constituted IRB.

ALL projects, including those previously reviewed and approved by an IRB must be reviewed and approved by the SRC after experimentation and before competition in an Affiliated Fair. Projects which were conducted at a Regulated Research Institution, industrial setting or any work site other than home, school or field and which were reviewed and approved by the proper institutional board before experimentation, must also be approved by the Affiliated Fair SRC.

An SRC must consist of a minimum of three persons, including the following:

• a biomedical scientist with an earned graduate degree
• an educator
• at least one additional member

Additional expertise: Many project evaluations require additional expertise (e.g., on biosafety and/or of human risk groups). If the SRC needs an expert as one of its members and one is not in the immediate area, all documented contact with an external expert must be submitted. If animal research is involved, at least one member must be familiar with proper animal care procedures. Depending on the nature of the study, this person can be a veterinarian or animal care provider with training and/or experience in the species being studied.

To avoid conflict of interest, no Adult Sponsor, parent or other relative of the student(s), the Qualified Scientist, or the Designated Supervisor who oversees the project may serve on the SRC reviewing that project. Additional members are recommended to diversify and to increase the expertise of the committee.

A Scientific Review Committee (SRC) examines projects for the following:

• Evidence of proper supervision
• Completed forms, signatures, research dates, and preapproval dates (when required)
• Evidence of proper team composition
• Compliance with rules and laws governing human and/or animal research and research involving potentially hazardous biological agents and/or hazardous chemicals, activities or devices
• Compliance with ISEF ethics statement
• Use of accepted and appropriate research techniques
• Evidence that risks have been properly assessed
• Evidence of search for alternatives to animal use
• Humane treatment of animals
• Documentation of substantial expansion for continuation projects
• Evidence of appropriate literature search and attribution

For Human Participant Projects Reivew – The Institutional Review Board (IRB)

An Institutional Review Board (IRB), is a committee that, according to federal regulations (45-CFR-46), must evaluate the potential physical and/or psychological risk of research involving humans. All proposed human research must be reviewed and approved by an IRB before experimentation begins. This includes review of any surveys or questionnaires to be used in a project.

Federal regulations require local community involvement. Therefore, it is advisable that an IRB be established at the school level to evaluate human research projects. If necessary, the local or ISEF-affiliated SRC can serve as an IRB as long as it has the required membership. A School IRB must consist of a minimum of three members including the following:

• An educator
• A school administrator (preferably principal or vice principal)
• A medical or mental health professional. The medical or mental health professional may be a medical doctor, nurse practitioner, physician’s assistant, doctor of pharmacy, registered nurse, psychologist, licensed social worker or licensed clinical professional counselor. The medical or mental health professional on the IRB may change depending on the nature of the study. This person must be knowledgeable about and capable of evaluating the physical and/or psychological risk involved in a given study.

Additional Expertise: If an expert is not available in the immediate area, documented contact with an external expert is recommended. A copy of all correspondence with the expert (e.g. emails) must be attached to Form 4 and can be used in lieu of the signature of that expert.

To avoid conflict of interest, no Adult Sponsor, parent or other relative of the student, the Qualified Scientist, or Designated Supervisor who oversees the project, may serve on the IRB reviewing that project. Additional members are recommended to help avoid a potential conflict of interest and to increase the expertise of the committee.

IRBs exist at federally Regulated Research Institutions (e.g., universities, medical centers, NIH, correctional facilities). Prisoner advocates must be included on the IRB when research participants are incarcerated. The institutional IRB must initially review and approve all proposed research conducted at or sponsored by that institution. The Adult Sponsor and the local IRB are responsible for ensuring that the project is appropriate for a pre-college student and adheres to ISEF rules.

An IRB is responsible for assessing risk and documenting the determination of risk level on Human Participant Form 4. However, in reviewing projects just prior to a fair, if the SRC serving at that level of competition judges an IRB’s decision as inappropriate, thereby placing human participants in jeopardy, they may override the IRB’s decision and the project may fail to qualify for competition. It is advised that IRBs consult with the local or affiliated fair SRCs and/or with ISEF SRC in questionable cases.

Combined SRC/ IRB Committee

A combined committee is allowed as long as the membership meets both the SRC and IRB requirements listed above.

Regulated Research Institutions/Industrial Settings Review Committees (RRI)

Regulated Research Institution: A Regulated Research Institution within the U.S. is defined as a professional research/teaching institution that is regularly inspected by the USDA and is licensed to use animals covered by the Animal Welfare Act and may also be subject to U.S. Public Health Service Policy. Also included are all federal laboratories such as National Institutes of Health, Veteran’s Affairs Medical Centers and the Centers for Disease Control. In addition, pharmaceutical and biotechnology companies and research institutions that utilize research animals that are not covered by the Animal Welfare Act but have an operational Institutional Animal Care and Use Committee and are in compliance with U.S. federal laws are included in this definition. For projects conducted outside of the United States, a Regulated Research Institution would be a comparable research institution that adheres to country laws governing the care and use of vertebrate animals.

Certain areas of research conducted in a regulated research institution or an industrial setting require review and approval by federally mandated committees that have been established at that institution. These committees include:

• Institutional Animal Care and Use Committee (IACUC); Animal Care and Use Committee (ACUC); Animal Ethics Committee
• Institutional Review Board (IRB); Human Subjects Participant Program (HSPP)
• Institutional Biosafety Committee (IBC)
• Embryonic Stem Cell Research Oversight Committee (ESCRO)
• Safety Review Committee

Independent or private laboratories, such as those established to support student researchers do not meet the requirements of oversight or committee infrastructure to be considered Regulated Research Institutions (RRI). Therefore, such laboratories should be considered the same as high school laboratories as it pertains to the International Rules and the types of projects able to be conducted in this setting. For purposes of documentation, such facilities must complete the Regulated Research Institution/Industrial Setting Form 1C to address the adult supervision and conditions of research.

The ISEF Scientific Review Committee (Regeneron ISEF SRC)

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

ISEF SRC, like an Affiliated Fair SRC, is made up of adults knowledgeable about research regulations. In addition to the review of all projects at ISEF, committee members answer questions about the rules throughout the year from students and teachers. The ISEF SRC can be contacted at
SRC@societyforscience.org.

Members of ISEF Scientific Review Committee 2024:

• Ms. Susan Appel
• Mr. Henry Disston
• Dr. Jennifer Green
• Dr. Paula Johnson
• Dr. Timothy Martin
• Mrs. Evelyn Montalvo
• Mr. Joseph Scott
• Mrs. Lisa Scott
• Dr. Jason Shuffitt
• Mrs. Andrea Spencer
• Mrs. Jeanne Waggener