School-based Review Committees

Please understand that ALL forms and reviews are for the safety of the student, subjects, and the adult sponsor.

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 Intel ISEF-affiliated SRC can serve as an IRB as long as it has the required membership. An 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.

NOTE: The medical or mental health professional may be a medical doctor, nurse practitioner, physician’s assistant, registered nurse, psychologist, licensed social worker or licensed clinical professional counselor. The medical or mental health professional ont he 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.

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.

• Most projects require review by the full three member IRB.
• 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 SSEF of Florida and Intel 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 the Intel ISEF SRC in questionable cases.

IRB Waiver of Written Informed Consent: The IRB may waive the requirement for documentation of written informed consent/assent/parental permission if the research involved only minimal risk and anonymous data collection and if it is one of the following:

1. Research involving normal educational practices.
2. Research on individual or group behavior or characteristics of individuals where the researcher does not manipulate the participants’ behavior and the study does not involve more than minimal risk.
3. Surveys, questionnaires, or activities that are determined by the IRB to involve perception, cognition, or game theory, etc. and that do NOT involve gathering personal information, invasion of privacy or potential for emotional distress.
4. Studies involving physical activity where the IRB determines that no more than minimal risk exists and where the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities.

If there is an uncertainty regarding the appropriateness of waiving written informed consent/assent/parental permission, it is strongly recommended that documentation of written informed consent/assent/parental permission be obtained.

Expedited Review: An expedited review by one member of the IRB may be conducted for projects that meet one of the criteria listed below. The IRB member reviewing the project will determine whether appropriate safety precautions will be employed and whether the project meets criteria for expedited review. If a project submitted for expedited review does not meet the criteria specified below, the project must undergo full IRB review. The IRB member reviewing the project must have the expertise necessary to make such a decision and/or receive advisement from the appropriate expert.

• Student-designed Invention, Prototype, Computer Application, or Engineering/Design Project: The data received in these types of projects must be in direct reference to the design. Personal data are not collected and the testing does not pose a health or safety hazard.

OR

• Projects in which the student is the subject of his/her own research study and the project does not involve more than minimal risk.

The Affiliated Fair Scientific Review Committee

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 pre-approval are available from the affiliated fair. A list of fairs is available from the Society for Science website.

Most proposed research projects involving vertebrate animals and/or potentially hazardous biological agents must be reviewed and approved BEFORE experimentation. Local (School-based) 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 (not home, high 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 Affiliated Fair SRC must consist of a minimum of three persons, including the following:

1. a biomedical scientist with an earned doctoral degree;
2. an educator; and
3. at least one additional member (preferably a School Administrator)

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 literature search and appropriate attribution
• evidence of proper supervision
• use of accepted and appropriate research techniques
• completed forms, signatures and dates showing maximum of one year duration of research and appropriate preapproval dates (where required)
• evidence of search for alternatives to animal use
• humane treatment of animals
• compliance with rules and laws governing human and/or animal research and research involving potentially hazardous biological agents and hazardous chemicals, activities, or devices
• documentation of substantial expansion for continuation projects
• compliance with the ISEF ethics statement

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

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 project 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:

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

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