Tips for Forms & Projects:

The following should be completed in the order presented:

The Student Checklist (1A) should be completed in conjunction with the Research Plan.

• The school address (#3) should include the PHYSICAL address along with the mailing address if they are different. Remember, research cannot be conducted in a PO Box!
• The Actual Start Date (#6) must be the date that the student began his/her laboratory and/or data collection work - not when the background or library research began. The actual start date and the projected start date can be the same, or the actual start date can be months after the projected start date, just so long as all approvals have been acquired BEFORE the ACTUAL research start date.
• The Actual End Date (#6) must be the date that the student stopped his/her laboratory and/or data collection work - not when data analysis or work on the board was completed.
• If a student wishes to continue collecting data between competitions (i.e.: after the Regional Science Fair and before the CSEF), then an amendment to this form should be done stating that the student will be collecting more data and give the newly anticipated end date AS LONG AS THE PROCEDURES DO NOT CHANGE!!
• Field Research (#7) refers to data collection that is done away from the school, home and/or research institution (i.e.: collection of data at different stream sites around the state, collection of surveys at sites such as businesses and/or schools other than the student researcher's, observations done in public places, etc.). If there is field work done, we need a list of all of those sites and addresses if possible (general locations if not), please attach to this form if the list is long.

The Research Plan MUST be TYPED and should be completed in conjunction with the Student Checklist (1A).

• When writing the research plan, please have students clearly identify each of the four points needed in the plan: Question Being Addressed; Hypothesis/Problem/Engineering Goal(s); Procedures & Data Analysis; and Bibliography. This will aid in the review of the research plans and cut down on the need for clarification in many cases.
• Human Subjects Research must also include who the subjects will be; how the subjects will be recruited; what the subjects will be asked to do (IN DETAIL!); what the potential risks or discomforts might be to the subjects; what the potential benefits to society and/or each subject might be; how privacy will be protected; and how informed consent will be obtained.
• Vertebrate Animal Research must also include potential alternatives and a justification to the use of vertebrate animals; the potential impact or contribution this study may have; how discomfort, pain and injury to the animals will be minimized; detailed chemical concentrations and drug dosages (if applicable); exactly how many animals will be used and what type; exactly what the housing and oversight will be for each type of animal; and exactly what will be done with the animals once the study is over.
• Potentially Hazardous Biological Agent Research must also include how the Biosafety Level was determined; exactly where the agent, cell line, etc. is being obtained; exactly what the safety precautions being taken are; and exactly how and where the biological agents will be disposed of when the study is over.
• Projects that include Hazardous Chemicals, Activities & Devices must also include how the Risk Assessment was done and the results; exactly what the chemical concentrations and drug dosages might be; exactly what the safety precautions are and procedures will be to minimize potential risk; and exactly what the methods of disposal will be if applicable.

The Checklist for Adult Sponsors (1) should be done once the Student Checklist (1A) and Research Plan are near completion.

• The Checklist for Adult Sponsors form is to be used by the Adult Sponsor when reviewing students' research plans and seeing that the proper approvals are acquired BEFORE research on the project begins. This means it should be signed and dated BEFORE research begins - attesting to the fact that the Adult Sponsor has indeed done his/her job in guiding the student researcher in getting the proper approvals.
• If the Adult Sponsor feels that more detail is needed in the Research Plan, he/she should not sign this form until it is corrected.
• The Adult Sponsor should make sure that question #4 matches question #6.
• Please note that the Adult Sponsor should sign and date it according to the date of REVIEW and not the date of signature. This is useful if the students have research notebooks and the teacher reviews and initials those before transferring everything to the ISEF forms.

The Approval Form (1B) should be completed once their Student Checklist (1A), the Research Plan and the Checklist for Adult Sponsors are all complete.

• The student should review the research plan with his/her parents/guardian and sign this form together. This must be done BEFORE the student can begin laboratory/data collection work.
• If prior Scientific Review Committee (SRC) approvoal for use of vertebrate animals and/or potentially hazardous biological agents and/or Institutional Review Board (IRB) approval for use human subjects is required, then all paperwork must be sent to the appropriate SRC/IRB for review and approval (#2a) BEFORE the student can begin laboratory/data collection work.
• If prior SRC/IRB approval is required and the student is working at a REGULATED Research Institution like a university AND they obtained the necessary approvals from that institution, then the local SRC/IRB can give approval (#2b) AFTER the project is complete, but PRIOR to competition. The student must have a Form 1C and any required institutional approvals in hand.
• Just prior to the student's Regional Science Fair, their SRC will review the paperwork and will approve (#3) the project for competition.
• If a student is selected to attend the CSEF, just prior to that competition, the CSEF SRC will review all paperwork and will approve (#3) the project for competition.
• Please note that even though a local school SRC/IRB may have approved a project prior to experimentation, a regional and state SRC can deem that the local review body made a mistake and refuse to allow a project for competition for not following the rules and guidelines.

An Abstract must be completed once the project is completed and all analysis and conclusions are done.

• CSEF Finalists MUST use the CSEF Abstract form and NOT the ISEF Official Abstract Form.
• Abstracts should be written in past tense and should include the objective(s) of the study, the general procedure(s) used, the result(s) of the study and the significance of the result(s). The abstract should not include acknowledgements (such as referencing mentors or laboratories involved in the project).
• Read more information on writing abstracts.

A Regulated Research Institutional/Industrial Setting Form (1C) is completed AFTER experimentation is completed at a research institution or industrial setting.

• If only part of a student's research is completed at the research institution, then this form can be completed at any time after the research start date and does not have to wait until all experimentation is completed, but this might be noted on the form somewhere for clarification.
• Please pay particular attention to the signature box- if the student did the research at the institution, then that institution must have given their approval if it involves human subjects, vertebrate animals or potentially hazardous biological agents. For example, Colorado State University has its own Regulatory Compliance Board and if a student were to go there to do a research project with a professor (or anyone else), the student's research must be approved by this board and the CSU board overrides any decision a school IRB may have made regarding the study, as the school has no jurisdiction at CSU.

• Subjects - Describe who will participate in your study (age range, gender, racial/ethnic composition). Identify any vulnerable populations (minors, pregnant women, prisoners, mentally disabled or economically disadvantaged).
• Recruitment - Where will you find your subjects? How will they be invited to participate?
• 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?
• Risks - What are the risks or potential discomforts (physical, psychological, time involved, social, legal, etc) to participants? How will you minimize the risks?
• Benefits - List any benefits to society or each participant.
• Protection of Privacy - Will any identifiable information (e.g. names, phone numbers, birth dates, email addresses) be collected? Will data be confidential or anonymous (Confidential means that the information collected will only be accessible to those authorized to have access like the Student Researcher and the Adult Sponsor. Anonymous means that there is absolutely no way that anyone could link a person's participation in the project to the data gathered.)? If anonymous, describe how the data will be collected anonymously. If not anonymous, what procedures are in place for safeguarding confidentiality? Where will the data be stored? Who will have access to the data? What will you do with the data at the end of the study?
• 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.

• Live, non-human vertebrate mammalian embryos for fetuses,
• Bird and reptile eggs within three days (72 hours) of hatching; and
• All other non-human vertebrates (including fish) at hatching or birth.

A project that involves behavioral observations and where:

• there is no interaction with the animals being observed;
• there is no manipulation of the environment in any way; AND
• all federal or state fish, game and wildlife laws and regulations are followed

does NOT need to be reviewed by an SRC prior to experimentation.

The Research Plan for a project that uses Vertebrate Animals must include the following:

• A discussion of potential alternatives to the use of vertebrate animals and detailed justification as to why vertebrate animals must be used.
• An explanation of the potential impact or contribution this research may have.
• Detail all procedures to be used, including methods used to minimize potential discomfort, distress, pain and injury to the animals during the course of experimentation and detailed chemical concentrations and drug dosages if applicable.
• Detail the number of animals being used, the species, strain, sex, age, etc. including justification for the number of animals planned for the research.
• Describe housing and oversight of daily care.
• Discuss disposition of the animals at the termination of the study.

Vertebrate Animal research projects are categorized into two categories, those that can be done at a non-regulated site and those that must be done at a regulated research institution. Vertebrate Animal studies may be conducted at a non-regulated research site (home, school, farm, ranch, in the field, etc.) ONLY if each of the following applies:

• The research involves agricultural, behavioral, observational or supplemental nutritional studies on animals AND
• The research involves only non-invasive and non-intrusive methods that do not negatively affect an animal's health or well-being.

All other studies using vertebrate animals must be conducted at a regulated research institution.

If there are unexpected deaths in either the experimental or control groups, the cause of the death must be investigated. If the experimental procedure is responsible for the deaths, the experiment must be immediately terminated. A death rate of 30% or greater in any group or subgroup is not permitted and the project will fail to qualify for competition.

Research Projects at Non-Regulated Sites

The SRC must decide what type of supervision the project requires:

• A Designated Supervisor is not required for a Vertebrate Animal study when it involves animals in their natural environment where there is no interaction between the Student Researcher and the subject animals. Otherwise, a Designated Supervisor is required to be responsible for the quality of care and handling of the animals in the project.
• A Veterinarian is not required for all Vertebrate Animal studies, but is recommended for experiments that involve supplemental nutrition and/or activities that would not be ordinarily encountered in the animal's daily life.
• A Qualified Scientist is not required for all Vertebrate Animal studies, but may be suggested by the SRC.

Form 5A must be filled out by the researcher for each different type of animal being used and include the number of animals being used in the study, the housing and husbandry to be provided, and what will happen to the animals after experimentation.

Research Projects at Regulated Research Institutes

Form 5B must be filled out by the Qualified Scientist or the Principal Investigator at the regulated research institution. A copy of the regulated research institution IACUC approval letter must be attached to this form. The Qualified Scientist must describe the USDA Pain Category that the research falls under. The local SRC must also review the project to certify that the research complies with ISEF rules. This review should happen before experimentation begins.

Proper euthanasia at the end of experimentation for tissue removal and/or pathological analysis is permitted. Only the Qualified Scientist or an institutional representative may perform the euthanasia.

The following types of studies on vertebrate animals are prohibited:

• All induced toxicity studies, such as those using alcohol, acid rain, insecticide, herbicide, heavy metal, etc.;
• Behavioral experiments involving operant conditioning with adverse stimuli, mother/infant separation or induced helplessness;
• Studies of pain; and
• Predator/prey experiments.

• Organism is cultured in a plastic Petri dish and sealed.
• Experiment involves only procedures in which the Petri dish remains sealed throughout the experiment.
• The sealed Petri dish is disposed of in the appropriate manner under the supervision of the Designated Supervisor.

If a culture is opened for identification, sub-culturing or isolation, it must be treated as a Biosafety Level-2 (BSL-2) study and involve BSL-2 laboratory procedures and equipment. A high school laboratory is not typically considered a BSL-2 lab, however, there can be exceptions and self-certification. See the ISEF Rules and Guidelines on BSL-2 self-certification for more information.

The following types of tissue do not need to be treated as potentially hazardous biological agents:

• Plant tissue
• Established cell and tissue cultures (i.e.: those obtained from the American Type Culture Collection); the source and catalog number of the cultures should be identified in the Research Plan Attachment
• Meat or meat by-products obtained from food stores, restaurants, or packing houses
• Hair
• Teeth that have been sterilized to kill any blood borne pathogen that may be present
• Fossilized tissue or archeological specimens
• Prepared fixed tissue slides

There are additional rules that apply to projects that involve tissues and body fluids, including blood and blood products. These types of projects must ALSO complete a Human and Vertebrate Animal Tissue Form 6B.

• If tissue is obtained from an animal that was sacrificed for a purpose other than the student's project, then it does not need to be considered a Vertebrate Animal project and Form 5B does not need to be completed. Documentation of the Institutional Animal Care and Use Committee (IACUC) approval for the original animal study from which the tissue was obtain is required however.
• If the animal was euthanized solely for the student's project, the study must be considered a Vertebrate Animal project and Form 5B must also be completed.
• All studies involving human or wild animal blood or blood products must be considered a BSL-2 study and involve BSL-2 laboratory procedures and equipment.
• All studies involving domestic animals may be considered a BSL-1 study and be handled in accordance with standards and guidelines set forth in the OSHA, 29CFR, Subpart Z.
• Human breast milk of unknown origin, unless certified free of HIV and Hepatitis C and domestic unpasteurized animal milk must be considered BSL-2 agents.
• Pasteurized domestic animal milk may be considered BSL-1 agents.
• Studies of human body fluids, where the sample can be identified with a specific person, must ALSO be considered a Human Subjects project and have IRB review and informed consent. Students may use their own body fluid without review and consent.

Any study involving agents belong to the BSL-3 or BSL-4 groups ARE NOT ALLOWED AT ALL!!! BSL-3 contains agents that usually cause serious disease or that can result in serious economic consequences (i.e.: West Nile virus, equine encephalitis virus, Riskettsia riskettsii, SARS coronavirus, etc.). BSL-4 contains agents that usually produce disease that is often untreatable (i.e.: hemorrhagic fevers, Ebola virus, etc.).