The SLVSEF Scientific Review Committee (SRC) is a group of adults knowledgeable about regulations concerning experimentation especially in the following areas:

1. Vertebrate animals
2. Pathogenic agents
3. Controlled substances
4. Recombinant DNA

The SRC must evaluate all projects in these areas before experimentation may begin. The SLVSEF SRC will also review the documentation for ALL projects shortly before competition to ensure that students have followed all applicable rules and that the project is eligible to compete.

1. The SLVSEF SRC consists of a minimum of three members. The SRC includes at least:
   
   • biomedical scientist (e.g., Ph.D., M.D., D.V.M., D.D.S., D.O.)
   • science teacher
   • one other member
2. At least one member will be familiar with proper animal care procedures when reviewing projects using vertebrate animals. In order to eliminate conflict of interest, the Adult Sponsor, parents, the Qualified Scientist, and the Designated Supervisor who oversee a specific project must not serve on the SRC reviewing that project.
3. The SLVSEF SRC will function on the local, regional, and/or state level. The Intel ISEF has a permanent SRC that reviews projects prior to competition at the Intel ISEF.The SLVSEF SRC will also serve as the Institutional Review Board (IRB) and will review projects involving human subjects.
4. The Operational Guidelines for SRCs/IRBs will be used in conjunction with the International Rules. The Rules are intended to ensure the safety of students, to protect the subjects and environments studied, and to limit the liability of the adults who assist with the projects.
5. All SRC members will be familiar with the International Rules and the Operational Guidelines for SRCs/IRBs, as well as any pertinent federal regulations. When reviewing research plans, members are urged to use their best professional judgment coupled with good common sense. Members should counsel and instruct students and help them correct violations whenever possible.

Registration of SRC Members

1. The SLVSEF director is responsible for appointing members to the SRC. The Intel ISEF-affiliated fair director will also register the members’ names with Science Service when submitting the affiliation paperwork.
2. The SLVSEF director is responsible for overseeing the local SRC and the IRB.
3. If you would like to become a member of the SLVSEF SRB, please contact us at sciencefair@utahsciencecenter.org.

Approval Before Experimentation

1. The SLVSEF SRC will pay special attention to the following items:
• Evidence of library search
• Evidence of proper supervision
• Use of accepted research techniques
• Completed forms, signatures and dates
• Evidence of search for alternatives to animal use
• Humane treatment of animals
• Compliance with rules and laws governing proper care and housing of animals
• Appropriate use of recombinant DNA, pathogenic organisms, controlled substances, tissues and hazardous substances and devices
• Adequate documentation of the substantial expansion of continuing projects
  
2. The SRC will deliberate, resulting in one of the following decisions:

Approval: If a project is approved, the SRC chairperson signs the appropriate box on the Approval Form (1B). The approved forms will be returned to students as soon as possible, so that they can begin experimentation.

Disapproval: The SRC Chairperson will provide the student and sponsor with a list of reasons for disapproval and suggestions for changes needed for approval. If suitable corrections are made, the revised project forms should be re-reviewed. If the project is approved, the student and sponsor will be notified immediately so that the student can begin experimentation.

Projects that are not allowed: Some projects are unethical or should not be done by pre-college students. Examples would be projects designed to kill vertebrate animals, toxicity studies using vertebrate animals, improper treatment of animals, proposed use of pathogens at home, violations in the use of controlled substances, and lack of appropriate supervision. The SRC will notify the student and sponsor promptly and provide them with a complete list of reasons the project may not be done.

SRC Review Shortly Before Competition

1. The SLVSEF SRC is required to reconvene before the fair to review and approve all projects with supporting documentation.
2. The SLVSEF members will carefully review all documentation, particularly for research that required prior review and approval. If the project documentation does not attest to this prior review and approval, the project is in violation of the International Rules. Such projects should only be approved if an acceptable written explanation is provided.

The SLVSEF Institutional Review Board (IRB)

1. The SLVSEF 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 human subjects. All proposed human research must be reviewed and approved by the SLVSEF IRB before experimentation begins. This includes review of any surveys or questionnaires to be used in a project.
2. Federal regulations require local community involvement, therefore the SLVSEF IRB can be established at the school level to evaluate human research projects. An IRB at the school or the SLVSEF IRB will consist of a minimum of three members. In order to eliminate conflict of interest, the Adult Sponsor, parents, the Qualified Scientist, and the Designated Supervisor who oversee a specific project must not serve on the IRB reviewing that project. Additional members will help avoid this conflict of interest and will increase the expertise of the committee. The IRB must include:
   1. A science teacher
   2. A school administrator (preferably, a principal or vice principal),
   3. One of the following who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study: a medical doctor, physician’s assistant, registered nurse, a psychiatrist, licensed psychologist, or licensed social worker.
3. If the SLVSEF IRB needs an expert as one of its members and one is not in the immediate area, then documented contact with an external expert will be appropriate. A copy of the correspondence (e.g. email, fax, etc.) will be be attached to Form 4 and can be used as the signature of that expert.
4. IRBs exist at federally registered institutions (e.g., universities, medical centers, NIH, correctional facilities). The internal IRB will initially review and approve all proposed research conducted. at or sponsored by that institution. The Adult Sponsor is responsible for ensuring that the project is appropriate for a pre-college student and adheres to the ISEF rules.

 Informed Consent

1. The process of obtaining informed consent provides information to the subject about the risks and benefits associated with participation in the research study and allows the subject to make an educated decision about whether or not to participate. Informed consent is an on-going process, not a single event that ends with a signature on a page. It must incorporate procedures that do not involve coercion or deception.
2. Documentation of informed consent is required:
   1. When the IRB determines that a research study involves physical or psychological activities with more than minimal risk
   2. When the IRB determines that the project could potentially result in emotional stress to a research subject.
   3. When the IRB determines that the research subjects belong to a risk group and the study does not meet any of the criteria below for a waiver.
3. Documentation of informed consent is required for most research projects. However, the IRB may waive the requirement for documentation of written informed consent if the research involves only minimal risk and anonymous data collection and if it is one of the following:
   1. Research involving the observation of legal public behavior
   2. Research involving collection or study of existing publicly available data or records
   3. Research involving normal educational practices
   4. Research on individual or group behavior or characteristics of individuals where the researcher does not manipulate the subjects’ behavior and the study does not involve more than minimal risk.
   5. Surveys and questionnaires that are determined by the IRB to involve perception, cognition, or game theory and do NOT involve gathering personal information, invasion of privacy or potential for emotional distress. If there is any uncertainty regarding the appropriateness of waiving informed consent, it is strongly recommended that informed consent be obtained.
   6. 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 (in and of themselves) than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities.
4. If a research subject is under 18 years of age, it is recommended that, in all cases, informed consent be obtained. Both the parent/legal guardian and the school age research subject must sign Form 4 (Human Subjects and Informed Consent Form). However, an IRB may decide that informed consent is not required because of the allowable exceptions listed above. When the IRB waives informed consent of research subjects under the age of 18 for studies involving surveys or questionnaires, documentation justifying this waiver must accompany Form 4.

The SLVSEF Combined SRC/IRB

The SLVSEF will establish a committee, which serves as both an SRC and an IRB. This committee must include at least:

1. Biomedical scientist (e.g., Ph.D., M.D., D.V.M., D.D.S., D.O.)
2. Science teacher
3. School administrator (preferably, a principal or vice-principal)
4. one of the following who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study: a medical doctor, physician’s assistant, registered nurse, a psychiatrist, licensed psychologist, or licensed social worker.

At least one member of the committee will be familiar with proper animal care procedures when reviewing projects using non-human.