If your project has…

Due to the risks and safety rules associated with culturing microorganisms, the NCSEF SRC restricts most microbiology projects to the Junior and Senior levels, with a few exceptions (described below). Please note: these exceptions do not and are not intended to supersede the ISEF rules, as outlined in the ISEF International Rules and Guidelines. All experiments at all grade levels should still conform to ISEF regulations.

Experiments using baker’s/brewer’s yeast (bread/beer yeast) can be performed at home (cultures can be grown at home) by all grade levels.

Experiments using yogurt/cheese/buttermilk/kefir culture starters or probiotic cultures from commercially available probiotic supplements can be performed at home (cultures can be grown at home) by all grade levels. However, if you are culturing specific strains of these types of microorganisms (i.e., if you buy pure culture slants from Carolina Biological), these cultures cannot be grown at home; the experiment must be conducted at school or an alternative facility with dedicated lab space.

Experiments using Eschericha coli ( coli) K-12 strain bacteria can be performed by all grade levels (you must be able to provide documentation verifying that your organism is the K-12 strain if requested to do so). However, this organism cannot be grown at home; the experiment must be conducted at school or an alternative facility with dedicated lab space.

Experiments involving composting or decomposition of foods can be performed at home by all grade levels as long as no samples are cultured and as long as all projects in these categories are terminated at the first visible signs of microbial growth. If microbial growth is allowed to occur at the

Elementary level, the experiment will not qualify for competition; if microbial growth is allowed to occur at the Junior and Senior levels, the experiment must be conducted at school or an alternative facility with dedicated lab space to qualify for competition.

All other types of experiments involving the culturing or other manipulation of microorganisms are not permitted at the Elementary level.

All other types of experiments involving the culturing of microorganisms (permitted at the Junior and Senior levels) cannot be performed at home; the experiments must be conducted at school or an alternative facility with dedicated lab space.

Culturing of unknown microorganisms (such as those swabbed from skin surfaces, mouths, animals, flora/fauna, and inanimate objects such as doorknobs and remote controls) must be performed at a school or alternative facility with dedicated lab space.

Experiments involving the culturing of any unknown microorganisms are not allowed at the Elementary level.

Microorganisms include, but are not limited to: bacteria, fungi (including molds), yeasts, viruses, viroids, prions, rickettsia, and parasites.

ALL projects involving microorganisms must follow the ISEF Rules regarding culturing, handling, and disposal. These procedures must be detailed in the student’s Research Plan and on their Form 3 and/or Form 6A.

Experiments involving protists are generally allowed at all grade levels as long as the organism does not cause human or animal disease or is not an environmental hazard. Experiments involving Plasmodium are NOT allowed unless they are conducted at a Regulated Research Institution with proper prior approvals in place (Junior and Senior levels only).

Any additional questions regarding the use of a microorganism in a project at any grade level should be emailed to the SRC.

Does your project involve working with:

• Microorganisms (bacteria, viruses, viroids, prions, rickettsia, fungi, mold, parasites)
• Recombinant DNA (rDNA – this is usually in the form of DNA expressed in bacteria or yeast that the microorganism does not normally express,
• such as E. coli expressing human insulin; these are also known as genetically modified microorganisms)
• Human or animal tissues (fresh or frozen, including blood and body fluids)

If you answered YES to any of these questions, please read the guidelines below for details about each topic, allowable projects, and any additional forms you may need to complete.

Also check out the Potentially Hazardous Biological Agents Biosafety Chart from ISEF

Microorganisms

Potentially hazardous microorganisms are defined by ISEF as bacteria, viruses, viroids, prions, rickettsia, fungi, and parasites. Protists such as dinoflagellates, algae, and amoeba are not included in the ISEF potentially hazardous microorganism list and thus do not require PHBA forms or pre-approval. The NCSEF and regional fairs follow ISEF rules for projects involving PHBA.

ELEMENTARY LEVEL STUDENTS ARE NOT PERMITTED to perform projects involving ISEF-defined microorganisms for North Carolina fairs. Elementary students, can, however, perform projects involving protists.

Projects that involve culturing microorganisms MAY NOT BE DONE AT HOME. This includes BSL1 organisms (defined below). These must be done in school laboratories or other approved institutions (hospital or clinic labs, university labs) in the presence of an approved supervisor (see below for definition). Culturing a microorganism involves placing it in an environmental situation in which you expect it to reproduce (grow).

Examples of culturing projects:

• Swabbing doorknobs, skin, etc., and then streaking (rubbing) the swab on an agar plate or swirling it in a broth.
• Infecting plants with mold spores and allowing the mold to grow
• Approved supervisors may include (but are not limited to)
  • A parent (for non-culturing experiments done at home)
  • The student’s science teacher (for experiments conducted at school)
  • A person who has earned a MD, DDS, DMD, RN, NP degree or other appropriate training to work in a hospital or other clinical setting
  • A person possessing or working towards a PhD or possessing the appropriate training to work in a university, commercial, or industrial laboratory
• A trained professional working at a water or sewer treatment facility

Microorganism specimens meant to be cultured can be COLLECTED at home as long as they are immediately sealed and transported to an approved experimental location.

Plant pathogens that are naturally occurring can be studied at home (e.g., viruses that cause leaf mottling), but these cannot be introduced to the plants by the student in a home environment.

Studies involving MRSA (Methicillin-resistant Staphylococcus aureus) and VRE (Vancomycin-resistant Enterococcus spp.) are strictly prohibited

Additional Forms Required for Microorganism Studies

Studies involving the following are exempt from prior SRC review and require no additional forms:

• Brewer’s or baker’s yeast, unless they are used in a rDNA study (see below).
• Lactobacillus spp., Bacillus thuringiensis, nitrogen-fixing and oil-eating bacteria, and slime mold and algae-eating bacteria introduced into their natural environments. Note that projects involving cultured forms of these bacteria are not exempt and must have prior SRC review.
• Mold growth studies on food, as long as the experiment is terminated at the first visual evidence of mold.

Studies involving the following are exempt from prior SRC review but do require a completed Risk Assessment Form 3:

• Studies involving protists, archaebacteria, and other organisms not explicitly classified by ISEF as PHBA microorganisms
• Research using manure for composting, fuel production, or other experiments that do not culture microorganisms
• Water testing experiments using commercially available test kits that remain sealed and are properly disposed.

Any other studies require prior SRC review and completed Risk Assessment Form 3 and PHBA Risk Form 6A BEFORE any experimentation takes place).

Students performing studies in a Regulated Research Institution setting (e.g., a university research laboratory or hospital laboratory), must complete Regulated Research Institution Form 1C.

Projects requiring supervision by a Qualified Scientist, you must complete a Qualified Scientist Form 2.

Biosafety Level Classifications for Microorganism Studies

Biosafety levels define the potential risk of harm, injury, or disease to plants, animals, and humans that may occur when working with microorganisms. This is important both to ensure that proper safety precautions are put in place and that the research is performed at the correct location with proper equipment and safeguards.

• Biosafety Level 1 (BSL-1): Low risk to personnel and environment. These organisms are unlikely to cause disease.
  • Examples: Escherichia coli K12, Agrobacterium tumefaciens (aka Rhizobium radiobacter), Micrococcus luteus, Neurospora crassa, Bacillus subtilis
  • BSL-1 containment is found in most high school laboratories, water-testing facilities, and college microbiology class laboratories. Work can be done on the open bench.
  • The supervisor can have general training in microbiology or a related science.
• Biosafety Level 2 (BSL-2): Moderate risk to personnel and environment. Disease, if it occurs, is mild and limited in spread. Effective treatments for disease are readily available.
  • Examples: Mycobacterium spp., Streptococcus pneumonia, Salmonella choleraesuis, most viral species that cause colds (Rhinoviruses, some human Coronaviruses), and some species of Influenza.
  • Studies involving Klebsiella pneumonia must be performed in BSL-2 settings.
  • Experiments involving human and animal waste, including sewage sludge. This does not include composted animal manure.
  • BSL-2 containment is generally found in laboratories in hospitals, clinics, and universities. Access to the laboratory is generally restricted. Biological safety cabinets (Class 2, type A) must be available. Work should be supervised by a qualified scientist who understands the risks of working with the microorganisms involved.
  • Experiments involving the culture of unknown microorganisms (e.g., swabbing doorknobs or skin and streaking agar plates) should be evaluated by your local SRC for biosafety level, but will most likely be considered BSL-2.
  • BSL-2 experiments may not be conducted in a BSL-1 laboratory.
• Biosafety Level 3 & 4 (BSL-3/4) High risk to personnel and environment. These infectious agents or toxins may be transmitted through the air which may caue serious, untreatable disease and possibly fatal.
  • Studies involving these organisms are STRICTLY PROHIBITED

Biosafety levels for unknown organisms:

• Biosafety Level 1 (BSL-1):
  • The organism is cultured on SEALED plates (sealing can be done with Parafilm or by placing the plates in TWO 2-ply heavy-duty sealed plastic bags)
  • Plates remain sealed throughout the entire experiment once inoculated
  • Sealed plates are disposed of properly under the supervision of the Designated Supervisor
• Biosafety Level 2 (BSL-2)
  • Experiments involving the culture of unknown microorganisms (e.g., swabbing doorknobs or skin and streaking agar plates) should be evaluated by your local SRC for biosafety level, but will most likely be considered BSL-2.

Safety Equipment and Disposal Procedures

All PHBA must be disposed of properly at the end of experimentation in accordance with their biosafety level. Approved disposal methods include any of the following:

• Autoclaving at 121 °C for 20 minutes
• 10% bleach solution (ISEF does not specify a time, but 10 minutes of immersion/soaking in this solution is generally sufficient to disinfect)
• Incineration
• Alkaline hydrolysis
• Pickup by an approved biosafety removal group
• Other manufacturer-approved recommendations (e.g., for commercial water-testing kits)12/12/23, 1:12 PM Potentially Hazardous Biological Agents (PHBA)
• Other disposal methods must have been approved by the Institutional Review Board of the regulated research institution where the experimentation is performed. You may be required to submit documentation in this case.

For BSL-1 studies, the following safety equipment and practices are required:

• Standard microbiological procedures, including aseptic technique.
• Lab coats are required, and disposable gloves are recommended.

3. For BSL-2 studies, the following safety equipment and practices are required:

• An autoclave should be available for decontamination.
• Lab coats, disposable gloves, and face protection are required

Recombinant DNA (rDNA)

Note: All rDNA studies are subject to the same biosafety level rules and equipment and disposal procedures as were outlined in the Microorganisms section and require the completion of a Risk Assessment Form 3 and PHBA Risk Form 6A BEFORE any experimentation takes place). They may also require a Regulated Research Institution Form 1C and/or Qualified Scientist Form 2 as outlined in the microorganisms section above.

• All rDNA studies must be pre-approved by the SRC.
• Forms required for rDNA studies must take into account the microorganism used as well as the DNA being introduced into the organism.
• No rDNA projects can be conducted at home.
• There are a few rDNA studies that can be performed in a BSL-1 environment. These include:
  • BSL-1 microorganisms (E. coli and Saccharomyces cerevisiae) and BSL-1 vector systems (these should be evaluated by the SRC).
  • BSL-1 rDNA studies must be supervised by a Qualified Scientist or trained Designated Supervisor.
• rDNA projects that involve the introduction of a BSL-2 gene (e.g., a disease factor from a BSL-2 organism) into a BSL-1 host microorganism must be conducted at BSL-2.
• BSL-2 studies must be conducted at regulated research institutions.
• The following rDNA studies are expressly PROHIBITED:
  • rDNA studies involving the introduction of oncogenes (cancer-causing genes) or other human, plant, or animal toxins.
  • Studies intended to genetically engineer bacteria with multiple antibiotic resistance genes. Note: some commercial plasmid subcloning and expression vectors code for more than one antibiotic resistance gene, so care must be taken in planning a student’s experiment.

Tissue, Body Fluid, and Blood Studies

All studies involving the use of tissue, body fluid, or blood samples are subject to the Biosafety guidelines outlined in the Microorganisms section above. If the work was performed at a regulated research institution and/or in the presence of a Qualified Scientist, a Regulated Research Institution Form 1C and/or Qualified Scientist Form 2 as outlined in the microorganisms section above.

• Most types of studies involving these materials are treated as PHBAs and require the completion of a Risk Assessment Form 3 and a Human and Vertebrate Animal Tissue Form 6B. along with PHBA Risk Assessment Form 6A except:
  • Plant tissue
  • Established cell and tissue cultures. The source of the cultures should be included in the research plan.
  • Meat, meat by-products, pasteurized milk, or eggs obtained from commercial stores, restaurants, or packing houses.
  • Hair
  • Teeth that have been sterilized via chemical disinfection or autoclaving at 121°C for 20 minutes
  • Fossilized tissue or archaeological specimens
  • Prepared, fixed tissue
• BSL-1 studies involve the collection of tissue and body fluids, not including blood or blood products, when the source has little risk of microorganism contamination.
• Self-sampling of capillary blood for analysis (e.g. for a glucometer reading) can be conducted in a home (BSL-1) setting.
• BSL-2 studies involve the collection of tissue and body fluids that may be contaminated with microorganisms, regardless of whether the microorganisms are classified as BSL-1 or BSL-2.
• Studies involving blood or blood products from:
  • domestic animals that have little risk of microorganism contamination can be considered BSL-1
  • humans or wild animals or domestic animals that have a risk of microorganism contamination are also classified as BSL-2.
• Study of tissues from animals believed to be contaminated with BSL-3 or BSL-4 organisms is PROHIBITED.
• human breast milk (unless it is certified free of Hepatitis C and HIV) and unpasteurized animal milk are classified as BSL-2.
• Studies involving human samples, WHEN THE SAMPLES CAN BE IDENTIFIED WITH A SPECIFIC PERSON, must have Institutional Review Board (IRB) review and informed consent. They must also include a completed Human Participants Form 4 and Consent Forms or all human participates. These rules do not apply if the samples come solely from the student performing the study.
• Studies involving embryonic human stem cells must be conducted at a regulated research institution, and the project must be reviewed and approved by the ESCRO (Embryonic Stem Cell Research Oversight Committee). Contact the SRC for more information

Does your project involve the use of any of the following?

• Live nonhuman vertebrate mammalian embryos or fetuses at any age (note zebrafish exception below)
• Tadpoles
• Birds and reptile eggs within 3 days (72 hours) of hatching
• Zebrafish embryos that are at least 7 days (168 hours) post fertilization
• All other nonhuman vertebrates (including fish) at hatching or birth

If you answered YES, your project must comply with the ISEF rules for VERTEBRATE ANIMALS. Please read the guidelines below for detailsabout each topic, allowable projects, and any additional forms you may need to complete.

Students performing vertebrate animal research must also comply with local, state, county, and U.S. federal laws and regulations in the jurisdiction in which the research is performed.

ALL projects involving Vertebrate Animals must adhere to the rules rules in Sections I-VI below. In addition, projects must adhere to additional rules based on the nature of the study and the research site:

• Projects conducted at a school, at home, or at a field site (Section VII)
• Projects conducted at a regulated research institution (Section VIII)

Requirement for Review and Pre-Approval PRIOR to Beginning Experimentation

Section I: The Research Plan of all vertebrate animal studies must be reviewed and approved prior to experimentation. The committee that grants this preapproval depends upon the nature of the study and the research site:

• For vertebrate animal studies performed at school/home/field, the affiliated fair Scientific Review Committee (SRC) serves as the review and approval committee (see Section VII below).
• For projects to be performed at a federally-regulated research institution, the regulated research institution’s Institutional Animal Care and Use Committee (IACUC) serves as the review and approval committee (see Section VIII below).
• After initial SRC and/or IACUC approval, a student with any proposed changes in the Research Plan must repeat the approval process before experimentation/data collection can resume.
• Certain studies involving behavioral observations of animals may be exempt from prior SRC review provided that ALL of the following apply:
  • There is no interaction with animals being observed,
  • There is no manipulation of the environment in any way, AND
  • The study meets all federal or state fish, game, and wildlife laws

Section II. Requirements for the Research Plan for Vertebrate Animal Projects

For projects involving Vertebrate Animals, the Research Plan must contain ALL elements requested in the Vertebrate Animals portion of the Research Plan Instructions, #1, including the following detailed information:

• Justification of animal use, including choice of species and number of animals to be used
• Description of alternatives to animal use considered and why they were unacceptable. Alternatives that should be included are the following “4R’s”:
  • Replace vertebrate animals with lower life form, tissue/cell cultures, or computer simulations
  • Reduce number of animals without compromising statistical validity
  • Refine experimental design to reduce animal pain or distress
  • Respect animals and their contribution to research
• Explanation of potential benefit of study to broad fields of biology or medicine
• Description of how animals will be used (methods and procedures, such as experimental design and data analysis)
• Description of procedures to be used to minimize pain and distress
• Description of species, strain, sex, age, weight, source, and number of animals proposed for use

Section III. Requirement for Supervision by a Qualified Scientist or Designated Supervisor

All research involving vertebrate animals must be directly supervised by a Qualified Scientist or a Designated Supervisor, except for projects that consist strictly of behavioral observations. The specific type of supervisor required depends upon the nature of the study and the research site (see Sections VII and VIII below).

Section IV. Areas of Vertebrate Animal Study that are Prohibited

Certain types of projects are inappropriate for pre-college students and are prohibited:

•  Projects causing more than momentary pain or suffering are prohibited
• Projects that are designed to cause the death of an animal are prohibited
• Students are prohibited from designing or direct involvement in the following types of studies on vertebrate animals:
  • Inducted toxicity studies involving a substance that could impair health or destroy life (including, but not limited to, alcohol, acid rain, insecticides, herbicides, heavy metals)
  • Behavioral studies involving conditioning with adverse stimuli, mother/infant separation, or induced helplessness
• Studies of pain
• Predator/vertebrate prey experiment

Special exceptions:

• A student may perform a tissue study involving the above types of research if the animal was euthanized for a purpose other than the student’s project and if the animal study was conducted by a Qualified Scientist at a regulated research institution with appropriate IACUC review and approval.
• Humane euthanasia (termination of life) is permitted under only certain conditions when the research is conducted at a federally regulated research institution (see Section VIII below).

Section V. Requirements for Monitoring Vertebrate Animals for Signs of Pain and Distress

All animals must be monitored for signs of distress:

• Signs of distress include: weight loss, diarrhea, progressive dermatitis (skin inflammation), rough hair coat, hunched posture, lethargy, coughing, labored breathing, nasal discharge, jaundice (yellowing of skin and/or eyes), anemia (low red blood cell count), neurological signs, bleeding, self-induced trauma, inability to eat or drink, self-isolation, etc.
• Any illness, unexplained weight loss, or death in either the control or experimental groups must be investigated, and a veterinarian must be consulted to oversee any necessary medical care. This applies both to Projects Conducted at School/Home/Field (Section VII) and at Regulated Research Institutions (Section VIII). This veterinary review must be documented.
• If illness or distress is caused by the study, experiment must be stopped immediately.
• Projects that exceed specific humane endpoints are excluded from competition:
  • Weight loss or growth retardation >15% in any experimental or control animal
  • Death rate ≥ 30% in any group or subgroup

VI. Additional Rules for Specific Types of Research

Vertebrate animal studies may be conducted at a home, school, farm, ranch, in the field, etc. This category includes studies involving:

• Animals in their natural environment
• Animals in zoos
• Livestock (used in standard agricultural practices)

These projects require completion of a Vertebrate Animals Form (5A) and may require a Qualified Scientist Form 2 (see below).

Type of Projects Allowed to be Conducted at School/Home/Field

Projects in this category must meet both of the guidelines below:

• The research must involve agricultural, behavioral, observational, and/or supplemental nutritional studies on animals, AND
• The research must involve only non-invasive and non-intrusive methods that not adversely affect animal’s health or well-being.

Note: Any project not meeting both of the above criteria must be conducted at a Regulated Research Institution (see Section VIII below). Termination of life (euthanasia) for tissue removal and/or pathological analysis is prohibited for a project conducted in a school/home/field.

Requirement for Scientific Review Committee Review and Prior Approval

• Prior to experimentation, the Research Plan must be reviewed and approved by the affiliated fair’s Scientific Review Committee (SRC), which must include a veterinarian or an animal care provider with training and/or experience in the species being studied.
• The SRC will determine if a veterinarian is required to certify that the research plan and animal husbandry are appropriate. If so, a Qualified Scientist Form 2 must be completed
• A veterinarian must be consulted in experiments involving supplemental nutrition, administration of prescription drugs, and/or activities that would be ordinarily be encountered in the animal’s daily life.

Requirements for Animal Husbandry at School/Home/Field research sites

• Animals must be housed in clean, ventilated housing appropriate for the species.
• Animals must be provided with continuous, clean (uncontaminated) water and food supply.
• Cages, pens, and tanks must be cleaned frequently.
• Care must be provided at all times, including weekends, holidays, and vacations.
• Animals must be observed daily to assess their health and well-being.
• A Designated Supervisor is required to oversee the daily animal husbandry.
• The final disposition of animals must be explained on Vertebrate Animals Form (5A)
• Required Procedure in the Case of Animal Illness or Emergency

The following procedure must be followed in the case of animal illness or emergency:

• The affected animals must receive proper medical and nursing care that is directed by a veterinarian.
• The student researcher must stop experimentation if there is unexplained weight loss or death in an experimental subject.
• The experiment may only be resumed if the cause of illness or death if not related to the experimental procedure and if appropriate steps are taken to eliminate the causal factors.

Section VIII. Additional Rules for Projects Conducted in a Regulated Research Institution

All studies not meeting the criteria in Section VII above must be conducted in a Regulated Research Institution. These projects require completion of a Regulated Research Institution Form (1C), a Vertebrate Animal Form (5B), and a Qualified Scientist Form (2).

A regulated research institution is defined as a professional research/teaching institution that is regularly inspected by the USDA and is licensed to use animals in research under U.S. federal law. Also included are federal laboratories [e.g., the National Institutes of Health (NIH), Veteran’s Affairs Medical Centers, the Centers for Disease Control (CDC)]. Additionally, pharmaceutical and biotechnology companies and research institutions that have an operational Institutional Animal Care and Use Committee (IACUC) and a program compliant with U.S. federal laws are also included.

• Requirement for Institutional Animal Care and Use Committee (IACUC) Review and Preapproval
  • The IACUC must approve all student research projects BEFORE experimentation begins.
  • Research projects at regulated research institutions must be conducted under the responsibility of a Principal Investigator.
  • The Scientific Review Committee (SRC) must all review the project to certify that the project complies with NCSEF rules; this review should occur before experimentation begins if possible.
• Rules for Specific Types of Projects Conducted at Regulated Research Institutions
  • Euthanasia (deliberate termination of life) for tissue removal and/or pathological analysis permitted, but must be performed by the Qualified Scientist or an institutional representative under current American Veterinarian Medical Association (AVMA) Guidelines. Students are prohibited from performing euthanasia.
  • Research projects that cause more than momentary or slight pain or distress to vertebrate animals is prohibited unless approved anesthetics, analgesics, and/or tranquilizers are used.
• Research in nutritional deficiency or research involving substances or drugs of unknown effects is permitted but must be stopped when first sign of clinical distress is noted. The deficiency or drug effect should then be corrected, if feasible; otherwise, the animal(s) must be euthanized.

Does your project involve either:

• Data or samples obtained through intervention or interaction with a living person(s)?
• Identifiable private information obtained about a living person(s)?

If you answered YES to either of these questions, your project must comply with the ISEF rules for HUMAN PARTICIPANTS. Please read the guidelines below for details about each topic, allowable projects, and any additional forms you may need to complete.

Requirement for Risk Assessment

When conducting research with human participants, the rights and welfare of the participants must be protected. Therefore, prior to conducting research involving human participants, the risks to study participants must be evaluated and minimized.

Project risk levels:

• No more than minimal risk: The probability and magnitude of harm or discomfort anticipated are not greater than those encountered in daily life or while performing routine physical or psychological exams or tests.
• More than minimal risk: The possibility of harm is greater than what is typically encountered in daily life. This type of research requires documented informed consent/minor assent/parental permission.

Risk Types

• Physical Risks
  • Exercise other than ordinarily encountered in daily life
  • Ingestion, tasting, smelling, or application of a substance.
  • Exposure to any potentially hazardous material
• Psychological Risks: have potential to result in emotional stress
  • Answering questions about personal experiences (sexual, physical/child abuse, divorce, mental health, etc.)
  • Answering questions that could result in feelings of depression, anxiety or low self esteem
  • Viewing violent or distressing videos

Negative Consequences Caused by Invasion of Privacy/Breech of Confidentiality

Proceedures must be followed to prevent invasion of privacy for the human participants

• Measures must be taken to ensure that identifiable research data are not disclosed to the public or unauthorized individuals
• Information that identifies the participants directly or through identifiers linked to the participants (including photos) may not be published displayed without written consent
• Projects involving medical information must comply with privacy laws & HIPAA laws
• Data collection should be truly anonymous data whenever possible

Risk Groups: Certain groups of human participants are particularly vulnerable and may require additional protection from risks:

• Any member of a group that is “naturally at-risk” (individuals who are pregnant, mentally disabled, economically or educationally disadvantaged, and physically or mentally ill)
• Special groups covered by federal regulations (children/minors, prisoners, pregnant women, and students receiving services on the Individuals with Disabilities Education Act)

Requirement for Informed Consent/Assent

Before enrolling any human participants in a study, including friends or family members, the researcher must inform the participants (and where applicable, their parents/guardians) about risks and benefits associated with study participation. This allows the participants, parents, or guardians to make an educated decision about whether or not to participate. Potential participants must also be informed that their participation is voluntary and they may leave the study at any time. This process of educating the potential participant is termed Informed Consent/Assent.

• Consent is given by adult (≥ 18 yrs old) research participants
• Assent is given by participants under 18 yrs old or individuals unable to give consent (e.g. mentally disabled) with parent/guardian permission
• Depending on the risks of the study, the local Institutional Review Board will determine if the informed consent process must be documented in writing. If so, a Human Participants Informed Consent Form must be completed for each human participant (see below).

Requirement for Institutional Review Board (IRB) Pre-review and Preapproval:

An Institutional Review Board (IRB) is a committee that evaluates the potential physical and/or psychological risks of research involving humans. An IRB at the school or ISEF Affiliated Fair level must consist of a minimum of three members, which must include:

• an educator
• a school administrator (preferably, a principal or vice principal),
• and at leaset 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, psychiatrist, psychologist, licensed social worker, or licensed clinical professional counselor.

NOTE: To eliminate conflict of interest, the Adult Sponsor, parents, Qualified Scientist, and Designated Supervisor who oversee any part of the project may serve on the IRB reviewing that project.

An IRB must review and approve all research involving humans BEFORE experimentation begins. Based on the level of risk associated with the project, the IRB will determine if documentation of written informed consent/assent/parental permission is required.

Before the student begins recruiting and/or interacting with participants, the student must submit ALL of the following to the IRB for review and pre-approval:

• A Human Participants Form (4) with the top section completed
• Research Plan (with ALL elements of the Human Participants portion of the Research Plan Instructions, #1, completed)
• a sample of the Human Participants Informed Consent Form will be presented to the human participants who are considering participating in the study
• any surveys to be administered to human participants

During the pre-review process, the IRB will determine whether written documentation of consent/assent/parental permission is required. If so, a Human Participants Informed Consent Form must be completed for each human participant. The IRB will also determine whether a Qualified Scientist is required to oversee the project (if so, the Qualified Scientist Form (2) must be completed).

If the IRB determines that the project involves minimal risks and meets specific criteria, the IRB may determine that written documentation of informed consent/assent/parental permission is not required. This is termed an “IRB Waiver of Written Informed Consent.”

Only after IRB pre-approval has been obtained, and any proposed changes to the Research Plan are approved by the IRB, the experiment can begin.

What type of studies require IRB Review and Preapproval?

Examples of studies that are considered “human participant research” and require IRB Review and Preapproval include (but are not limited to) the following:

• Subjects participating in physical activities (physical exertion, ingestion of any substance, medical procedures)
• Psychological, educational, and opinion studies (e.g. surveys, questionnaires, tests)
• Studies in which the student researcher is the subject of the research
• Behavioral observations that
  • involve any interaction with the observed individual(s) or where the researcher has modified the environment (e.g. posted a sign, placed an object)
  • occur in non-public or restricted-access settings (e.g. day care center, doctor’s office)
  • involve the recording of personally identifiable information
  • Data/record review projects that include data that are not de-identified/anonymous (e.g. data set that includes name, birth date, phone number, or other identifiable information)

Requirements for Projects Involving Human Participants Conducted at a Federally Regulated Research Institution

Institutional Review Boards (IRBs) exist at federally regulated institutions (e.g., universities, the National Institutes of Health (NIH), correctional facilities). If the project is conducted at regulated research institution, the institution’s IRB must review and approve the project BEFORE experimentation. For these types of projects, a Regulated Research Institution Form (1C) and a Qualified Scientist Form (2) must be completed. In addition, one of thefollowing must be submitted:

• A copy of the research institution’s IRB approval for the entire project (which must include the procedures used in the student’s project)
• An official letter from the IRB attesting to this approval (a letter from mentor is NOT sufficient).

Additional Rules for Specific Types of Research

• Analysis of medical procedures and administration of medications:
  • Must be performed under direct supervision of a qualified professional (who must be named in the IRB-approved protocol).
  • Students may NOT administer medications or perform invasive medical procedures
• Standardized tests not in the public domain
  • Must be administered, scored, and interpreted by a Qualified Scientist
  • Copies of the test instrument must be obtained legally
• Collection of data via the Internet is allowed but must be done in a manner that ensures
  • Data collection is anonymous
  • Informed consent is obtained
  • Participants are of appropriate age to give informed consent

Requirement for Final Scientific Review Committee (SRC) Approval

After completion of project, the local Scientific Review Committee (SRC) must review and approve previously approved projects to ensure students followed the approved Research Plan.

Exempt Studies

Some studies involving humans may be exempt from IRB pre-approval or human participants paperwork provided that the project fulfills the specific criteria outlined below. However, if the project was performed at a regulated research institution and/or in the presence of a Qualified Scientist, the Regulated Research Institution Form 1C and/or the Qualified Scientist Form 2 must still be completed.

If there is any uncertainty regarding whether the project meets the criteria for an Exempt Study, the project should be submitted to the local IRB prior to experimentation. The local IRB will then determine if the study meets the criteria for an IRB-exempt study.

Examples of Exempt Studies include the following:

• Testing of a student designed invention, concept, etc. only if ALL THREE of the following apply:
  • Feedback received is a direct reference to the product
  • Personal data is not be collected
  • Testing does not pose a health hazard
  • Completion of a Risk Assessment Form (3) is still recommended.
• Data/record review studies conducted with pre-existing data sets only if BOTH of the following apply:
  • The data set is publically available or published (e.g. baseball statistics)
  • There is no interaction with individuals or collection of data from individuals for the purpose of the student’s project
• Behavioral observations of unrestricted, public settings (e.g. mall, park) only if ALL THREE of the following apply:
  • The researchers does not interact with the individuals being observed
  • The researchers does not manipulate the environment
  • The researchers does not record any personally identifiable data
• Projects involving data received in a de-identified/anonymous format only if BOTH of the following apply:
  • The professional providing the data must certify in writing that (a) data have been appropriately de-identified and (b) are in compliance with all privacy/HIPAA laws, AND
  • After experimentation, the Scientific Review Committee ensures that the data were appropriately de-identified by review of the written documentation provided by the supervising professional.