ISEF Rules 2024-2025 PDF

INTERNATIONAL RULES FOR PRE-COLLEGE SCIENCE RESEARCH GUIDELINES FOR SCIENCE AND ENGINEERING FAIRS 2024–2025 INTERNATIONAL RULES FOR PRE-COLLEGE SCIENCE RESEARCH: GUIDELINES FOR SCIENCE AND ENGINEERING FAIRS 2024–2025 TABLE OF CONTENTS General Requirements for All Projects 1. ISEF Ethics Statement.......................................................................................................................................................................................... 3 2. ISEF Eligibility/Limitations................................................................................................................................................................................... 3 3. ISEF Requirements............................................................................................................................................................................................... 3 4. Continuation/Research Progression of Projects................................................................................................................................................ 4 5. Team Projects....................................................................................................................................................................................................... 4 Roles and Responsibilities of Students and Adults 1. The Student Researcher(s).................................................................................................................................................................................. 5 2. The Adult Sponsor............................................................................................................................................................................................... 5 3. The Qualified Scientist......................................................................................................................................................................................... 5 4. The Direct Supervisor.......................................................................................................................................................................................... 5 5. The Affiliated Fair Scientific Review Committees (SRC).................................................................................................................................... 6 6. The Institutional Review Board (IRB)................................................................................................................................................................... 6 7. Regulated Research Institution/Industrial Settings Review Committees..........................................................................................................7 8. ISEF Scientific Review Committee.......................................................................................................................................................................7 Human Participants Rules 1. Rules...................................................................................................................................................................................................................... 8 2. Exempt Studies...................................................................................................................................................................................................10 3. Human Participant & IRB Resources...................................................................................................................................................................11 Vertebrate Animals Rules 1. Rules for ALL Vertebrate Animal Studies.......................................................................................................................................................... 12 2. Additional Rules for Projects Conducted at School/Home/Field...................................................................................................................13 3. Additional Rules for Projects Conducted in a Regulated Research Institution..............................................................................................13 Potentially Hazardous Biological Agents Rules 1. Rules for ALL Projects Involving Potentially Hazardous Biological Agents.....................................................................................................15 2. Additional Rules for Projects Involving Unknown Microorganisms.................................................................................................................16 3. Additional Rules for Projects Involving Recombinant DNA (rDNA) Technologies..........................................................................................16 4. Additional Rules for Projects Involving Tissues and Body Fluids, Including Blood and Blood Products......................................................16 5. Potentially Hazardous Biological Agents Risk Assessment.............................................................................................................................18 Hazardous Chemicals, Activities or Devices Rules 1. Rules for ALL Projects Involving Hazardous Chemicals, Activities or Devices...............................................................................................19 2. Additional Rules for Specific Regulated Areas................................................................................................................................................19 3. Hazardous Chemicals, Activities or Devices Risk Assessment........................................................................................................................ 21 Engineering & Inventions Projects Guide............................................................................................................................................ 22 Sources of Information............................................................................................................................................................................. 23 ISEF Display & Safety Regulations......................................................................................................................................................... 26 Categories & Sub-Categories.................................................................................................................................................................. 29 Information on Required Abstract.........................................................................................................................................................30 Forms..............................................................................................................................................................................................................31 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 1 INTERNATIONAL RULES AND GUIDELINES The full text of the International Rules and forms in html and as a downloadable pdf. ISEF RULES WIZARD An interactive tool which asks questions about your intended project and provides a list of forms required. ISEF RULES FAQS Answers to questions that are commonly received in the email account [email protected]. We encourage you to submit suggestions. THESE RULES ARE APPLICABLE FOR Society for Science affiliated science fairs and the Regeneron International Science and Engineering Fair 2025. The purpose of these rules is to: protect the rights and welfare of the student researcher protect the rights and welfare of human participants protect the health and welfare of vertebrate animal subjects protect and promote good stewardship of the environment ensure adherence to federal regulations ensure use of safe laboratory practices determine eligibility for competition in ISEF For pre-review and approval of your project, find your fair at: https://findafair.societyforscience.org For rules questions, contact the ISEF Scientific Review Committee: [email protected] For general questions, contact: Society for Science Science Education Programs 1719 N Street, NW, Washington, DC 20036 office: 202-785-2255, fax: 202-785-1243 email: [email protected] Page 2 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF ALL PROJECTS The International Rules and Guidelines for Science Fairs is Scientific fraud and misconduct are not condoned at any level available at societyforscience.org/ISEF in multiple formats. of research or competition. This includes plagiarism, forgery, Familiarity with the rules is critical for students, parents, teachers, use or presentation of other researcher’s work as one’s own mentors, fair directors and local and affiliated fair Scientific and fabrication of data. Fraudulent projects will fail to qualify Review Committees (SRC) and Institutional Review Boards (IRB). for competition in affiliated fairs and ISEF. Society for Science reserves the right to revoke recognition of a project subsequently ETHICS STATEMENT found to have been fraudulent. Student researchers, as well as adults who have a role in their projects, are expected to maintain the highest ethical standards. ELIGIBILITY/LIMITATIONS These standards include, but are not limited to: 1. Each ISEF-affiliated fair may send to ISEF the number of projects allocated and committed to within their affiliation Integrity. Honesty, objectivity, and avoidance of conflicts agreement. of interest are expected during every phase of the project. The project should reflect independent research done by 2. A student must be selected by an ISEF-affiliated fair, and meet the student(s) and presented in their own words with proper both of the following: citation, most particularly if artificial intelligence is used. a. be in grades 9–12 or equivalent; and The project may only represent one year of work and must b. not have reached age 20 on or before May 1 preceding not include fraudulent data, plagiarism or inappropriate use ISEF. of AI in presenting work that is not their own. 3. English is the official language of ISEF. Student project boards Legality. Compliance with all federal, state and local laws and and abstracts must be in English. regulations is essential. In addition, projects conducted outside the U.S. must also adhere to the laws of the country and 4. Each student is only allowed to enter one project. That project jurisdiction in which the project was performed. All projects may include no more than 12 months of continuous research must be approved by a Scientific Review Committee (SRC), and may not include research performed before January 2024. and when necessary must also be approved by an Institutional 5. Team projects must have no more than three members. Review Board (IRB), Institutional Animal Care and Use Teams competing at ISEF must be composed of the original Committee (IACUC), and/or Institutional Biosafety Committee members who competed at the ISEF-affiliated fair and must (IBC). It is recommended that students reference their local, all meet ISEF eligibility. state or national laws and regulations. 6. Students may compete in only one ISEF affiliated fair, except Respect for Confidentiality and Intellectual Property. when proceeding to a state/national fair affiliated with ISEF Confidential communications, as well as patents, copyrights, from an affiliated regional fair. and other forms of intellectual property must be honored. Unpublished data, methods, or results may not be used 7. Projects that are demonstrations, ‘library’ research or without permission, and credit must be given for all informational projects, and/or ‘explanation’ models are not contributions to the research. recommended or appropriate for ISEF. Stewardship of the Environment. It is the responsibility 8. All sciences and engineering disciplines are represented at of the researcher and the adults involved to protect the ISEF and projects compete in one of the 22 categories. environment from harm. Introduction or disposal of native, Review a complete list of categories and sub-categories genetically-altered, and/or invasive species, (e.g. insects, with definitions. plants, invertebrates, vertebrates), pathogens, toxic chemicals 9. A research project may be a part of a larger study performed or foreign substances into the environment is prohibited. It by professional scientists, but the project presented by the is recommended that students reference their local, state or student must be only their own portion of the complete study. national regulations and quarantine lists. Acknowledgment of Risks. All projects involve some amount REQUIREMENTS of risk. Everyone is expected to recognize the hazards, assess the risks, minimize the risks, and prepare for emergencies. GENERAL Animal Care. Proper care and respect must be given to 1. All domestic and international students competing in an vertebrate animals. The use of non-animal research methods ISEF-affiliated fair must adhere to all rules as set forth in this and alternatives to animal research are strongly encouraged document. and must be explored before conducting a vertebrate animal 2. All projects must adhere to all of the tenets of the Ethics project. The guiding principles for the use of animals in Statement. research includes the following “Four R’s:’ Replace, Reduce, Refine, Respect. 3. It is the responsibility of the student and the Adult Sponsor to evaluate the study to determine which forms are required and Human Participant Protection. The highest priority is the whether approval by a committee must be obtained prior to health and well-being of the student researcher(s) and experimentation. human participants. 4. Projects competing at ISEF must have an exhibit that adheres Potentially Hazardous Biological Agents (PHBAs). It is the to ISEF Display & Safety requirements and is visible during responsibility of the student and adults involved in the project all operable hours of the exhibit hall without reliance on to conduct and document a risk assessment, and to safely electricity or internet connections. handle and dispose of organisms and materials. International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 3 5. All projects must adhere to the requirements of the affiliated participate. This review must occur after experimentation fair(s) in which it competes to qualify for participation in and before competition. ISEF. Affiliated fairs may have additional restrictions or requirements. Knowledge of these requirements is the DIGITAL PAPERWORK AND SIGNATURES responsibility of the student and Adult Sponsor. Submission of forms generated by a digital system are allowable under the following conditions: APPROVAL AND DOCUMENTATION 1. The forms must have the same content and order as ISEF forms. 1. Project documentation should begin before experimentation with the current forms available. Projects involving human 2. Digital signatures must have a verification system via login and participants, vertebrate animals, and potentially hazardous have a time and date stamp to indicate this authentication. biological agents must be reviewed and approved by a local 3. Paperwork submitted to Society for Science for ISEF must be or regional Institutional Review Board (IRB) or Scientific scanned and submitted via the online portal. Review Committee (SRC) prior to the start of experimentation. Note: If a project involves the testing of a student designed CONTINUATION/RESEARCH PROGRESSION OF PROJECTS invention, prototype or concept by a human, an IRB review and approval may be required prior to experimentation. See 1. As in the professional world, research projects may build Human Participants Rules for details. on work performed previously. A valid continuation project is a sound scientific endeavor. Students will be judged only on 2. Every student must complete the Student Checklist (1A), a laboratory experiment/data collection performed over Research Plan/Project Summary and Approval Form (1B) and 12 continuous months beginning no earlier than January 2024 review the project with the Adult Sponsor in coordination with and ending May 2025. completion by the Adult Sponsor of the Checklist for Adult Sponsor (1). 2. Any project based on the student’s prior research could be considered a continuation/research progression project. 3. A Qualified Scientist is required for all studies involving These projects must document that the additional research Biosafety Level 2 (BSL-2) potentially hazardous biological is a substantive expansion from prior work (e.g. testing a new agents and DEA-controlled substances and is also required variable or new line of investigation). Repetition of previous for many human participant studies and many vertebrate experimentation with the same methodology and research animal studies. question, even with an increased sample size, is an example of 4. After initial IRB/SRC approval (if required), any proposed an unacceptable continuation. changes in the Student Checklist (1A) and Research Plan/ 3. The display board and abstract must reflect the current year’s Project Summary must be re-approved before laboratory work only. The project title displayed in the finalist’s booth may experimentation/data collection resumes. mention years (for example, “Year Two of an Ongoing Study”). 5. After competing in an Affiliated Fair, projects may not be Previous year’s databooks, research papers and supporting changed or amended. However, additional data may be documents may be at the booth if properly labeled as such. collected using the same methodology that was previously 4. Longitudinal studies are permitted as acceptable approved for the affiliated fair. continuations under the following conditions: 6. Projects which are continuations of a previous year’s work a. The study is a multi-year study testing or documenting and which require IRB/SRC approval must undergo the the same variables in which time is a critical variable. review process with the current year Research Plan/Project (Examples: Effect of high rain or drought on soil in a Summary prior to experimentation/data collection for the given basin, return of flora and fauna in a burned area current year. over time.) 7. Any continuing project must document that the additional b. Each consecutive year must demonstrate time-based research is new and different by completing Continuation/ change. Research Progression Projects Form (7). This form must be c. The display board must be based on collective past displayed at the project booth. conclusionary data and its comparison to the current 8. If work was conducted either virtually or on site at a regulated year data set. No raw data from previous years may be research institution, industrial setting, or any work site other displayed. than home, school or field at any time during the current ISEF 5. All projects must be reviewed and approved each year project year, the Regulated Research Institutional/Industrial and forms must be completed for the new year. Setting Form (1C) must be completed and displayed at the project booth. TEAM PROJECTS 9. After experimentation, each student or team must submit a (maximum) 250-word, one-page abstract which summarizes 1. Team projects compete and are judged in the category of their the current year’s work. The abstract must describe research research at ISEF. All team members must meet the eligibility conducted by the student, not by the supervising adult(s). requirements for ISEF. 10. A project data book and research paper are not required, 2. Teams must have no more than three members. A team with but are strongly recommended for judging purposes. members from different geographic regions may compete at Regional or local fairs may require a project data book and/ an affiliated fair of one of its members, but not at multiple fairs. or a research paper. However, each affiliated fair holds the authority to determine whether teams with members outside of a fair’s geographic 11. All signed forms, certifications, and permits must be territory are eligible to compete, understanding that if available for review by all regional, state, national and the team wins the right to attend ISEF, all team members’ international affiliated fair SRCs in which the student(s) expenses must be supported by the fair. Page 4 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF that apply to the student project, particularly when involving a. Team membership cannot be changed during a given human participants, vertebrate animals, potentially hazardous research year unless there are extenuating circumstances biological agents or hazardous chemicals, devices or activities. and the local SRC reviews and approves the change, Should have close contact with the student throughout the including converting a team project to an individual timeline of the project. project or vice versa. Such conversions must address rationale for the change and include a clear delineation Responsibilities: between research preceding the change and that which The Adult Sponsor is responsible for: will follow. A memorandum documenting this review and Working with the student to evaluate any possible risks approval should be attached to Form 1A. involved in order to ensure the health and safety of the student b. Once a project has competed in a science fair at any level, conducting the research and the humans and/or animals team membership cannot change and the project cannot involved in the study. be converted from an individual project to a team project Reviewing the student’s Student Checklist (1A) and Research or vice versa. Plan/Project Summary to ensure that: c. In a future research year, any project may be converted experimentation follows local, state, and federal laws and from an individual to a team project, from a team to ISEF rules an individual project and/or have a change in team forms are completed by other required adults membership. any required Qualified Scientist meets the criteria as set 3. Each team is encouraged to appoint a team leader to forth in the ISEF Rules and Guidelines coordinate the work and act as spokesperson. However, each the student’s research is eligible for entry in ISEF member of the team should be able to serve as spokesperson, be fully involved with the project, and be familiar with all THE QUALIFIED SCIENTIST (QS) aspects of the project. The final work should reflect the Qualifications: coordinated efforts of all team members and will be evaluated Earned a doctoral/professional degree in a scientific discipline using the same judging criteria as individual projects. related to student’s area of research 4. Each team member must submit an Approval Form (1B). Team AND/OR members must jointly submit the Checklist for Adult Sponsor (1), one abstract, a Student Checklist (1A), a Research Plan/ Individual with extensive experience and expertise in the Project Summary and other required forms. student’s area of research 5. Full names of all team members must appear on the abstract Must be thoroughly familiar with the following regulations that and forms. govern the student’s area of research including all local, state, Federal and if applicable, non-U.S. national regulations and laws. ROLES AND RESPONSIBILITIES OF STUDENTS AND ADULTS Can also serve as the Adult Sponsor, if that person meets both sets of qualifications THE STUDENT RESEARCHER(S) May live elsewhere and not be local to the student, in which The student researcher is responsible for all aspects of the case, a Direct Supervisor must be appointed and trained research project: to serve as the onsite supervision as necessary for the specific Enlisting the aid of any required supervisory adults (Adult student project. Sponsor, Qualified Scientist, etc.) Responsibilities: Following the International Rules & Guidelines, obtaining The Qualified Scientist is responsible for: all necessary approvals (SRC, IRB, etc.) and completing all Reviewing the ISEF rules relevant to the project and approving appropriate documentation the student’s research plan or engineering design prior to the Performing the project (which may include, but is not limited start of experimentation to) experimentation, data collection, engineering, data Providing direct supervision throughout the timeline of the analysis, and any other process or procedures related to project or coordinating with a Direct Supervisor to serve the project in this capacity Understanding and abiding by the Ethics Statement and Ensuring the proper training of the Student Researcher and/or attesting to this understanding on Approval Form 1B. Direct Supervisor in the necessary procedures To avoid conflict of interest, no Adult Sponsor, parent or Completing the required documentation which may include other relative of the student, the Qualified Scientist, or Direct the Regulated Research Institutional Setting Form (1C), the Supervisor who oversees the project, may serve on the SRC Qualified Scientist Form (2) and the Risk Assessment Form (3), or IRB reviewing that project. when applicable. The Adult Sponsor THE DIRECT SUPERVISOR (DS) Qualifications: Qualifications: An Adult Sponsor may be a teacher, parent, professor, and/or other professional scientist Does not need an advanced degree Should be knowledgeable in the area of student research, be Must be familiar with the student’s project and agree to any familiar with the regulations around procedures and materials training necessary International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 5 May also serve as the Adult Sponsor for the project A Scientific Review Committee (SRC) examines projects for the following: If the project involves the use of Vertebrate Animals (where behavior/habitat is influenced by humans), must be Evidence of proper supervision knowledgeable about the humane care and handling Completed forms, signatures, research dates, and preapproval of the animals dates (when required) Responsibilities: Evidence of proper team composition Providing direct supervision of the student experimentation Compliance with rules and laws governing human and/or Completing the required documentation — the Direct animal research and research involving potentially hazardous Supervisor box on the Qualified Scientist Form (2) when biological agents and/or hazardous chemicals, activities or applicable devices Reviewing and completing the Risk Assessment Form (3) when needed Compliance with ISEF ethics statement Use of accepted and appropriate research techniques REVIEW COMMITTEES Evidence that risks have been properly assessed To avoid conflict of interest, no Adult Sponsor, parent or Evidence of search for alternatives to animal use other relative of the student, the Qualified Scientist, or Direct Supervisor who oversees the project, may serve on the IRB, SRC, Humane treatment of animals IACUC or any other committee reviewing that project. A project Documentation of substantial expansion for continuation reviewed by a committee with a conflict of interest may fail to projects qualify. Additional members are recommended to help avoid a potential conflict of interest and to increase the expertise of Evidence of appropriate literature search and attribution the committee. FOR HUMAN PARTICIPANT PROJECTS REVIEW — THE INSTITUTIONAL AFFILIATED FAIR SCIENTIFIC REVIEW COMMITTEE (SRC) REVIEW BOARD (IRB) A Scientific Review Committee (SRC) is a group of qualified An Institutional Review Board (IRB), is a committee that, according individuals that is responsible for evaluation of student research, to federal regulations (45-CFR-46), must evaluate the potential certifications, research plans and exhibits for compliance with physical and/or psychological risk of research involving humans. the rules, applicable laws and regulations at each level of science All proposed human research must be reviewed and approved by fair competition. Affiliated Fairs may authorize local SRCs to serve an IRB before experimentation begins. This includes review of any in this prior review capacity. The operation and composition surveys or questionnaires to be used in a project. of the local and Affiliated Fair SRCs must fully comply with the Federal regulations require local community involvement. International Rules. Directions for obtaining preapproval are Therefore, it is advisable that an IRB be established at the school available from the affiliated fair. A list of fairs can be found at level to evaluate human research projects. If necessary, the local https://findafair.societyforscience.org. or ISEF-affiliated SRC can serve as an IRB as long as it has the Most proposed research projects involving vertebrate animals required membership. An IRB must consist of a minimum of three and/or potentially hazardous biological agents must be reviewed members including the following: and approved BEFORE experimentation. Local or regional SRC An educator (not the teacher that is serving as the Adult prior review is not required for human studies previously reviewed Sponsor) and approved by a properly constituted IRB. A school administrator (preferably principal or vice principal) ALL projects, including those previously reviewed and approved by an IRB must be reviewed and approved by the SRC after A medical or mental health professional. The medical or experimentation and before competition in an Affiliated Fair. mental health professional may be a medical doctor, nurse Projects which were conducted at a Regulated Research practitioner, physician’s assistant, doctor of pharmacy, registered Institution, industrial setting or any work site other than home, nurse, psychologist, licensed social worker or licensed school or field and which were reviewed and approved by the clinical professional counselor. The medical or mental health proper institutional board before experimentation, must also be professional on the IRB may change depending on the nature approved by the Affiliated Fair SRC. of the study. This person must be knowledgeable about and capable of evaluating the physical and/or psychological risk An SRC must consist of a minimum of three persons, including involved in a given study. the following: Additional Expertise: If an expert is not available in the a biomedical scientist with an earned graduate degree immediate area, documented contact with an external expert an educator is recommended. A copy of all correspondence with the expert at least one additional member (e.g. emails) must be attached to Form 4 and can be used in lieu of the signature of that expert. Additional Expertise: Many project evaluations require additional expertise (e.g., on biosafety and/or of human risk groups). If the IRBs exist at federally Regulated Research Institutions (e.g., SRC needs an expert as one of its members and one is not in universities, medical centers, NIH, correctional facilities). the immediate area, all documented contact with an external Prisoner advocates must be included on the IRB when research expert must be submitted. If animal research is involved, at participants are incarcerated. The institutional IRB must initially least one member must be familiar with proper animal care review and approve all proposed research conducted at or procedures. Depending on the nature of the study, this person sponsored by that institution. The Adult Sponsor and the local IRB can be a veterinarian or animal care provider with training and/or are responsible for ensuring that the project is appropriate for a experience in the species being studied. pre-college student and adheres to ISEF rules. Page 6 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF It is the responsibility of the members of the IRB to thoroughly to confirm that applicable ISEF rules have been followed. ISEF review the Research Plan and collectively decide whether to SRC may request additional information from students prior to approve the project, request revisions to the methodology/ ISEF or may interview potential ISEF participants at the fair to require more oversight (e.g., QS) to reduce risk to participants, ensure that they qualify to compete. or to determine that the project is not appropriate for student ISEF SRC, like an Affiliated Fair SRC, is made up of adults research. An IRB documents the determination of risk level on knowledgeable about research regulations. In addition to the review Human Participant Form 4. of all projects at ISEF, committee members answer questions about In reviewing projects just prior to a fair, if the SRC serving at that the rules throughout the year from students and teachers. The ISEF level of competition judges an IRB’s decision as inappropriate, SRC can be contacted at [email protected]. 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 Members of ISEF Scientific Review Committee 2024 affiliated fair SRCs and/or with ISEF SRC in questionable cases. Ms. Susan Appel COMBINED SRC/IRB COMMITTEE Mr. Henry Disston A combined committee is allowed as long as the membership Dr. Jennifer Green meets both the SRC and IRB requirements listed previously. Dr. Paula Johnson REGULATED RESEARCH INSTITUTIONS/ (RRI) REVIEW COMMITTEES Dr. Timothy Martin Regulated Research Institution: A Regulated Research Mrs. Evelyn Montalvo Institution within the U.S. is defined as a professional research/ teaching institution that is regularly inspected by the USDA and Mr. Joseph Scott is licensed to use animals covered by the Animal Welfare Act Mrs. Lisa Scott and may also be subject to U.S. Public Health Service Policy. Dr. Jason Shuffitt Also included are all federal laboratories such as National Institutes of Health, Veteran’s Affairs Medical Centers and the Mrs. Andrea Spencer Centers for Disease Control. In addition, pharmaceutical and Mrs. Jeanne Waggener 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 may complete the Regulated Research Institution/Industrial Setting Form 1C to address the adult supervision and conditions of research. THE ISEF SCIENTIFIC REVIEW COMMITTEE (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 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 7 HUMAN PARTICIPANT RULES Rules involving human participants The following rules were developed to help pre-college student b. Projects that are conducted at a Regulated Research researchers adhere to the federal regulations governing Institution (RRI) (e.g., university, hospital, medical center, professional scientists and to protect the welfare of both human government lab) must have IRB approval from the RRI. A participants and the student researcher. Health and well-being copy of the IRB approval for the project must be obtained. is of the highest priority when students conduct research with A letter from an adult mentor and/or Qualified Scientist human participants. is not sufficient documentation of the RRI IRB review and According to Code of Federal Regulation 45, CFR 46, a human approval process. participant is a living individual about whom an investigator conducting research obtains (1) data or samples through 3. The student must comply with all determinations made by the intervention or interaction with individuals(s) or (2) identifiable School or RRI IRB before beginning any interaction with human private information. participants (e.g., recruitment, data collection). a. If the IRB requires a Qualified Scientist (QS), Form 2 Examples of projects that are considered “human participant research” include: must be completed by the QS before any interaction with human participants. The School IRB will review this Participants in physical activities (e.g., physical exertion, completed form before approving the project. ingestion of any substance, any medical procedure) b. If the IRB requires a Direct Supervisor (DS), Form 3 Psychological, educational and opinion studies (e.g., surveys, must be completed before any interaction with human questionnaires, tests) participants. The School IRB will review this completed Studies in which the researcher is the subject of the research form before approving the project. Testing of student designed invention, prototype or computer c. See rule #4 below regarding required procedures for application by human participants other than student obtaining informed consent/assent and/or researcher parental permission. Data/record review projects that include data that are not de- 4. Participation in research may begin only after research identified/anonymous (e.g., data set that includes name, birth participants have voluntarily given informed consent/assent date, phone number or other identifying variables) (in some cases with parental permission). Adult research participants may give their own consent. Research participants Behavioral observations that under 18 years of age and/or individuals not able to give a. involve any interaction with the observed individual(s) or consent (e.g. developmentally disabled individuals) give their where the researcher has modified the environment (e.g., assent, with the parent/guardian providing permission. post a sign, place an object). The School IRB will determine whether the consent/assent/ b. occur in non-public or restricted access settings (e.g., day parental permission may be a) verbal or implicit or b) must be care setting, doctor’s office) written. See the Risk Assessment information on page 11 and c. involve the recording of personally identifiable the online Risk Assessment Guide for further explanation of information. informed consent. a. Informed consent requires that the researcher provides RULES complete information to the participant (and where 1. Student researchers must complete ALL elements of the applicable, parents or guardians) about the risks and Human Participants portion of the Research Plan/Project benefits associated with participation in the research Summary Instructions and evaluate and minimize the physical, study, which then allows the participants and parents or psychological and privacy risks to their human participants. guardians to make an informed decision about whether or See Risk Assessment information on page 11 and the online not to participate. Risk Assessment Guide (https://sspcdn.blob.core.windows. b. Participants must be informed that their participation net/files/Documents/SEP/ISEF/Resources/Risk-Assessment- is voluntary and that they are free to stop participating Guide.pdf) for additional guidance. at any time (i.e., they may participate or decline to 2. Student research involving human participants must be participate, with no adverse consequences of non- reviewed and approved by an Institutional Review Board participation or aborted participation). (IRB) (See page 6) before any interaction (e.g., recruitment, c. Informed consent may not involve coercion. data collection) with human participants may begin. It is the d. When written parental permission is required and the responsibility of the IRB to evaluate potential physical and/or study includes a survey, the survey must be attached to psychological risks of the project and make a determination the consent form. about whether the project is appropriate for student research and safe for the student researcher and participants. e. The student researcher may request that the IRB waive the requirement for written informed consent/parental a. Projects that are conducted at school, at home or in permission in his/her research plan if the project meets the community that are not affiliated with a Regulated specific requirements. See section on IRB waivers for Research Institution (RRI) must be reviewed and approved more information about situations in which written by the School IRB before the student may begin recruiting parental permission and/or written informed consent can and/or interacting with human participants. The School be waived by the IRB. IRB must assess the risk and document its determination of risk on Form 4. Page 8 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF 5. The research study must be in compliance with all privacy laws 12. The following forms are required for studies involving human (e.g., U.S. Family Educational Rights and Privacy Act (FERPA) participants: and the U.S. Health Insurance Portability and Accountability a. Checklist for Adult Sponsor (1), Student Checklist (1A), Act (HIPAA)) when they apply to the project (e.g. the project Research Plan/Project Summary, and Approval Form (1B) involves medical information). b. Human Participants Form (4) for projects reviewed by 6. Students are prohibited from independently diagnosing school IRB or IRB approval documentation from an RRI disease, administering medication, and/or performing medical and all applicable informed consents and survey(s) procedures on human participants. c. Regulated Research Institution Form (1C), when applicable a. A student may observe and collect data for analysis of d. Qualified Scientist Form (2), when applicable medical procedures, medication/treatment efficacy, and e. Risk Assessment (3) when applicable diagnosis of illness, only under the direct supervision of a licensed health care provider/professional. Students are IRB WAIVER OF WRITTEN INFORMED CONSENT/PARENTAL PERMISSION prohibited from drawing blood or conducting any other The IRB may waive the requirement for documentation of written medical procedures on anyone except themselves. informed consent/assent/parental permission if the research b. This Healthcare provider/professional must be named in involves only minimal risk and anonymous data collection and if it the research plan/ protocol approved by the IRB. The IRB is one of the following: must also confirm that the student is not violating the 1. Research involving normal educational practices appropriate practice act (medical, nursing, pharmacy, etc) of the state or country in which he/she is conducting 2. Research on individual or group behavior or characteristics the research. of individuals where the researcher does not manipulate the c. Students are prohibited from providing advice, diagnostic participants’ behavior and the study does not involve more than minimal risk. or medical information to participants without direct supervision and involvement of a medical professional. 3. Surveys, questionnaires, or activities that are determined This includes publishing diagnostic apps on public by the IRB to involve perception, cognition, or game theory, websites or app stores without appropriate FDA approvals. etc. and that do NOT involve gathering personal information, invasion of privacy or potential for emotional distress. 7. Student researchers may NOT publish or display information in a report that identifies the human participants directly 4. Studies involving physical activity where the IRB determines or through identifiers linked to the participants (including that no more than minimal risk exists and where the probability photographs) without the written consent of the participant(s) and magnitude of harm or discomfort anticipated in the (Public Health Service Act, 42, USC 241 (d)). research are not greater than those ordinarily encountered in DAILY LIFE or during performance of routine physical activities. 8. All published instruments that are not in the public domain must be administered, scored and interpreted by a Qualified If there is any uncertainty regarding the appropriateness of Scientist as required by the instrument publisher. Any and all waiving written informed consent/assent/parental permission, it is use and distribution of the test must be in accordance with strongly recommended that documentation of written informed the publisher’s requirements, including procurement of legal consent/assent/parental permission be obtained. copies of the instrument. HUMAN PARTICIPANT INVOLVEMENT IN STUDENT-DESIGNED INVENTION, 9. Studies that involve the collection of data via use of the internet (e.g., email, web-based surveys) are allowed, but PROTOTYPE, COMPUTER APPLICATION, ENGINEERING/DESIGN CONSUMER researchers should be aware that they can pose challenges in PROJECTS & PRODUCT TESTING collecting anonymous data, obtaining informed consent, and Student-designed invention, prototype, computer application, ensuring that participants are of the appropriate age to give engineering/design projects and product testing that involve informed consent. testing of the invention or consumer product by any human a. Studies that involve the use of minors in conducting participant require attention to the potential risks to the online surveys must have Informed Consent and the individual(s) testing or trying out the invention/prototype. parent/guardian of the minor must provide written 1. IRB review and pre-approval is required when the student- parental permission before the survey may be given to the designed invention, prototype, application, etc. is tested by minor. The procedures used to obtain parental permission human participants other than the student researcher(s) or must be described in the Research Plan. single adult guardian/adult sponsor/QS/DS when the testing requires an adult tester. This includes surveys conducted b. In order to protect the confidentiality of the participants, regarding potential use or opinions of the invention or it is extremely important that IP addresses, as well as consumer product by the general public. This is not intended to the data provided, be safeguarded. Precautions must be apply to professional feedback from experts in the field of study. delineated in the Research Plan. 2. Human participants testing of an invention, prototype or project that involves a medical diagnosis or intervention For suggestions as to how to comply with 9a and 9b above (as defined by the FDA or Medical Practices Act) must adhere please see the Online Survey Consent Procedures. to Rule 6 of the Human Participant Rules regarding prohibition 10. After initial IRB approval, a student with any proposed changes of medical procedures and be supervised by a health care in the Research Plan must repeat the approval process and professional with appropriate credentials and specialization regain approval before resuming interaction (recruitment, data in the area of medical diagnosis or intervention being studied. collection) with human participants. 3. A Risk Assessment Form 3 is required for all projects that 11. After experimentation and before competition, the Affiliated involve human participant testing of any project involving Fair SRC will review for compliance with all rules. student- designed inventions, prototypes or consumer products. International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 9 EXEMPT STUDIES (DO NOT REQUIRE IRB PREAPPROVAL OR HUMAN PARTICIPANTS PAPERWORK) Some studies involving humans are exempt from IRB pre-approval or additional human participant forms. Exempt projects for ISEF and affiliated fairs are: 1. Student-designed Invention, Prototype, Computer Applications, Engineering/Design Project or Consumer Product Testing in which the student researcher is the only person testing the invention, prototype, computer application or consumer product and the testing does not pose a health or safety hazard. a. The exemption can also apply when the human participant testing is a single adult guardian or Adult Sponsor/QS/DS when the testing requires an adult tester. b. It is required that a Risk Assessment Form (3) be completed for all such projects. c. IRB review and pre-approval is required if the project involves more than the student researcher or any introduction of a human variable or factor in the testing of a consumer product/invention/prototype/application (e.g., amount of sleep, strength or endurance of tester, etc.). 2. Data/record review studies (e.g., baseball statistics, crime statistics) in which the data are taken from preexisting data sets that are publicly available and/or published and do not involve any interaction with humans or the collection of any data from a human participant for the purpose of the student’s research project. 3. Behavioral observations of unrestricted, public settings (e.g., shopping mall, public park) in which all of the following apply: a. the researcher has no interaction with the individuals being observed b. the researcher does not manipulate the environment in any way and c. the researcher does not record any personally identifiable data. 4. Projects in which the student receives pre-existing/ retrospective data in a de-identified/anonymous format which complies with both of the following conditions: a. the professional providing the data certifies in writing that the data have been appropriately de-identified before being given to the student researcher and are in compliance with all privacy and HIPAA laws, and b. the affiliated fair SRC ensures that the data were appropriately de-identified by review of the written documentation provided by the supervising adult(s). Page 10 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF HUMAN PARTICIPANT & IRB RESOURCES Use this information to help determine the level of risk involved in a study involving human participants. All human participant projects are considered to have some level of risk. No more than minimal risk exists when the probability and magnitude of harm or discomfort anticipated in the research are not greater (in and of themselves) than those ordinarily encountered by a potential participant in everyday life or during performance of routine physical or psychological examinations or tests. More than minimal risk exists when the possibility of physical or psychological harm or harm related to breach of confidentiality or invasion of privacy is greater than what is typically encountered in everyday life. Most of these studies require documented informed consent or minor assent with the permission of parent or guardian (as applicable). 1. Examples of Greater than Minimal Physical Risk a. Exercise other than ordinarily encountered in everyday life. b. Ingestion, tasting, smelling, or application of a substance. However, ingestion or tasting projects that involve commonly available food or drink will be evaluated by the IRB which determines risk level based upon the nature of the study and local norms. c. Exposure to any potentially hazardous material. 2. Examples of Greater than Minimal Psychological Risk A research activity (e.g. survey, questionnaire, viewing of stimuli) or experimental condition that could potentially result in emotional stress. Some examples include: answering questions related to personal experiences such as sexual or physical abuse, divorce, depression, anxiety; answering questions that could result in feelings of depression, anxiety, or low self esteem; or viewing violent or distressing visual images. 3. Privacy Concerns a. The student researcher and IRB must consider whether an activity could potentially result in negative consequences for the participant due to invasion of privacy or breach of confidentiality. Protecting confidentiality requires measures to ensure that identifiable research data are not disclosed to the public or unauthorized individuals. b. Risk level can be reduced by protecting confidentiality or collecting data that is strictly anonymous. This requires the collection of research in such a way that it is impossible to connect research data with the individual who provided the data. 4. Risk Groups If the research study includes participants from any of the following groups, the IRB and student research must consider whether the nature of the study requires special protections or accommodations: a. Any member of a group that is naturally at-risk (e.g. pregnant women, developmentally disabled persons, economically or educationally disadvantaged persons, individuals with diseases such as cancer, asthma, diabetes, AIDS, dyslexia, cardiac disorders, psychiatric disorders, learning disorders, etc.) b. Special groups that are protected by federal regulations or guidelines (e.g. children/minors, prisoners, pregnant women, students receiving services under the Individuals with Disabilities Education Act (IDEA). See the online Risk Assessment Guide and Online Survey Consent Procedures for more detailed information on risk assessment. If the risk is more than minimal, a Risk Assessment Form 3 is required. International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 11 VERTEBRATE ANIMAL RULES Rules involving vertebrate animals The following rules were developed to help pre-college student that were considered, and the reasons these alternatives researchers adhere to the federal regulations governing were unacceptable; explanation of the potential impact or professional scientists and to protect the welfare of both animal contribution this research may have on the broad fields of subjects and the student researcher. Health and well-being is biology or medicine. of high priority when students conduct research with animal b. Description of how the animals will be used. Include subjects. methods and procedures, such as experimental design The Society for Science strongly endorses the use of non-animal and data analysis; description of the procedures that research methods and encourages students to use alternatives will minimize the potential for discomfort, distress, to animal research, which must be explored and discussed in the pain and injury to the animals during the course of research plan. The guiding principles for the use of animals in experimentation; identification of the species, strain, research include the following “Four R’s”: sex, age, weight, source and number of animals proposed Replace vertebrate animals with invertebrates, lower life for use. forms, tissue/cell cultures and/or computer simulations where possible. 2. All vertebrate animal studies must be reviewed and approved before experimentation begins. An Institutional Animal Care Reduce the number of animals without compromising and Use Committee, known as an IACUC, is the institutional statistical validity. animal oversight review and approval body for all animal Refine the experimental protocol to minimize pain or distress studies at a Regulated Research Institution. The local or to the animals. affiliated fair SRC serves in this capacity for vertebrate animals studies performed in a school, home or field. Any SRC serving Respect animals and their contribution to research. in this capacity must include a veterinarian or an animal care If the use of vertebrate animals is necessary, students must provider with training and/or experience in the species consider additional alternatives to reduce and refine the use of being studied. animals. 3. Students performing vertebrate animal research must satisfy All projects involving vertebrate animals must adhere to the US federal law as well as local, state, and country laws and rules for all vertebrate animal studies AND to either Section A or regulations of the jurisdiction in which research is performed. Section B rules, depending on the nature of the study and the 4. Research projects which cause more than momentary or slight research site. pain or distress are prohibited. Any illness or unexpected A project is considered a tissue study and not a vertebrate animal weight loss must be investigated and a veterinarian consulted study if tissue is obtained from an animal that was euthanized to receive required medical care. This investigation must be for a purpose other than the student’s project. (Use of tissues documented by the Qualified Scientist or Direct Supervisor, obtained from research conducted at a Regulated Research who is qualified to determine the illness, or by a veterinarian. Institution requires a copy of an IACUC certification with the If the illness or distress is caused by the study, the experiment name of the research institution, the title of the study, the must be terminated immediately. IACUC approval number and date of IACUC approval.) In tissue 5. No vertebrate animal deaths due to the experimental studies, a student may observe the vertebrate study, but may procedures are permitted in any group or subgroup. not manipulate or have any direct involvement in the vertebrate a. Studies that are designed or anticipated to cause animal experimental procedures. vertebrate animal death are prohibited. Vertebrate animals, as covered by these rules, are defined as: b. Any death that occurs must be investigated by 1. All nonhuman vertebrates (including fish) at hatching or birth. a veterinarian, the Qualified Scientist or the Direct 2. Live nonhuman vertebrate mammalian embryos or fetuses Supervisor who is qualified to determine if the cause of death was incidental or due to the experimental 3. Tadpoles procedures. The project must be suspended until the 4. Bird and reptile eggs starting three days (72 hours) prior to cause is determined and then the results must be hatching documented in writing. Exception: Because of their delayed cognitive neural c. If death was the result of the experimental procedure, the development, zebrafish embryos may be used up to seven days study must be terminated, and the study will not qualify (168 hours) post-fertilization and not be considered a vertebrate. for competition. However, regardless of time of treatment, survival past the 7 days 6. All animals must be monitored for signs of distress. Because must be considered a vertebrate animal and the entire study is significant weight loss is one sign of stress, weight must subject to all of the rules below. be recorded at least weekly with 15% being the maximum permissible weight loss or growth retardation (compared to RULES FOR ALL VERTEBRATE ANIMAL STUDIES controls) of any experimental or control animal. If weighing 1. All vertebrate animal studies must have a research plan that of animals cannot be done in a fashion that is safe for both the includes: researcher and the animal, then an explanation and approval a. Justification why animals must be used, including the by an SRC or IACUC needs to be included in the research plan, as well as an alternative method(s) to address signs of distress. reasons for the choice of species, the source of animals Additionally, body conditioning scoring (BCS) systems are and the number of animals to be used; description, available for most species of animals utilized in research and explanation, or identification of alternatives to animal use Page 12 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF agriculture and are an objective method for assessing the All vertebrate animal studies that do not meet the criteria overall health status of the research subject, with or without in Section A. must be conducted in a Regulated Research weight loss. A BCS system should be included in the design of Institution (see Section B). any study utilizing live vertebrate animals and results regularly 2. Animals must be treated kindly and cared for properly. recorded. Animals must be housed in a clean, ventilated, comfortable 7. Students are prohibited from designing or participating in an environment appropriate for the species. They must be given experiment associated with the following types of studies on a continuous, clean (uncontaminated) water and food supply. vertebrate animals: Cages, pens and fish tanks must be cleaned frequently. Proper a. Induced toxicity studies with known toxic substances that care must be provided at all times, including weekends, could cause pain, distress, or death, including but not holidays, and vacation periods. Animals must be observed limited to alcohol, acid rain, pesticides, or heavy metals or daily to assess their health and well-being. A Direct Supervisor studies with the intent to study toxic effects of a substance is required to oversee the daily husbandry of the animals. Any of the following U.S. documents provide further guidance for on a vertebrate animal. animal husbandry: b. Behavioral experiments using conditioning with aversive stimuli, mother/infant separation or induced helplessness. Federal Animal Welfare Regulation c. Studies of pain. Guide for the Care and Use of Laboratory Animals d. Predator/vertebrate prey experiments. Guide for the Care and Use of Agricultural Animals in 8. Justification is required for an experimental design that Agricultural Research and Teaching (Ag-Guide) involves food or fluid restriction and must be appropriate to Quality Assurance Manuals (for the appropriate species) the species. If the restriction exceeds 18 hours, the project must be reviewed and approved by an IACUC and conducted 3. The local or affiliated fair Scientific Review Committee must at a Regulated Research Institution (RRI). determine if a veterinarian’s certification of the research and animal husbandry plan is required. This certification, as well 9. Animals may not be captured from or released into the wild as SRC approval, is required before experimentation and is without approval of authorized wildlife or other regulatory documented on Vertebrate Animal Form 5A. A veterinarian officials. All appropriate methods and precautions must be must certify experiments that involve supplemental nutrition, used to decrease stress. Fish may be obtained from the wild administration of prescription drugs and/or activities that only if the researcher releases the fish unharmed, has the would not be ordinarily encountered in the animal’s daily life. proper license, and adheres to state, local and national fishing laws and regulations. The use of electrofishing is permissible 4. If an illness or emergency occurs, the affected animal(s) must only if conducted by a trained supervisor; students are receive proper medical or nursing care that is directed by prohibited from performing electrofishing. a veterinarian. A student researcher must stop experimentation if there is unexpected weight loss or death in the experimental 10. A Qualified Scientist or Direct Supervisor must directly subjects. The experiment can only be resumed if the cause of supervise all research involving vertebrate animals, except illness or death is not related to the experimental procedures for observational studies. and if appropriate steps are taken to eliminate the causal 11. After initial SRC approval, a student with any proposed factors. If death is the result of the experimental procedure, changes in the Research Plan/Project Summary of the the study must be terminated, and the study will not qualify project must repeat the approval process before laboratory for competition. experimentation/data collection resumes. 5. The final disposition of the animals must be conducted in a responsible and ethical manner, and must be described on A. Additional Rules for Projects Conducted at School/ Vertebrate Animal Form 5A. Home/Field 6. Euthanasia for tissue removal and/or pathological analysis is Vertebrate animal studies may be conducted at a home, not permitted for a project conducted in a school/home/field school, farm, ranch, in the field, etc. This includes: site. 1. Studies of animals in their natural environment. 7. Livestock or fish raised for food using standard agricultural/ 2. Studies of animals in zoological parks. aquacultural production practices may be euthanized by 3. Studies of livestock that use standard agricultural a qualified adult for carcass evaluation. practices. 4. Studies of fish that use standard aquaculture practices. 8. The following forms are required: a. Checklist for Adult Sponsor (1), Student Checklist (1A), These projects must be reviewed and approved by an SRC in Research Plan/Project Summary, and Approval Form (1B) which one member is either a veterinarian and/or an animal care provider/expert with training and/or experience in the species b. Vertebrate Animal Form (5A) being studied. c. Qualified Scientist Form (2), when applicable 1. These projects must adhere to BOTH of the following B. Additional Rules for Projects Conducted in a guidelines: Regulated Research Institution a. The research involves only agricultural, behavioral, All studies not meeting the criteria in Section A that are observational or supplemental nutritional studies on otherwise permissible under ISEF rules must be conducted in animals. a Regulated Research Institution (RRI). A Regulated Research AND Institution within the U.S. is defined as a professional b. The research involves only non-invasive and non- intrusive research/teaching institution that is regularly inspected methods that do not negatively affect an animal’s health or by the USDA and is licensed to use animals covered by well-being. the Animal Welfare Act and may also be subject to U.S. International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF Page 13 Public Health Service Policy. Also included are all federal EXEMPT STUDIES (DO NOT REQUIRE SRC PREAPPROVAL) laboratories such as National Institutes of Health, Veteran’s 1. Studies involving behavioral observations of animals are Affairs Medical Centers and the Centers for Disease Control. exempt from prior SRC review if ALL of the following apply: In addition, pharmaceutical and biotechnology companies and research institutions that utilize research animals that are a. There is no interaction with the animals being observed, not covered by the Animal Welfare Act but have an operational b. There is no manipulation of the animal environment in any Institutional Animal Care and Use Committee (IACUC) and way, and are in compliance with U.S. federal laws are included in this c. The study meets all federal and state agriculture, fish, definition. For projects conducted outside of the United game and wildlife laws and regulations. States, a Regulated Research Institution would be a comparable research institution that adheres to country laws governing the care and use of vertebrate animals. Some protocols permitted in a Regulated Research Institution are not permitted for participation in ISEF; adherence to RRI rules is necessary but may not be sufficient. 1. The Institutional Animal Care and Use Committee (IACUC) or the comparable animal oversight committee must approve all student research projects before experimentation begins. Such research projects must be conducted under the responsibility of a principal investigator. The local and affiliated fair SRCs must also review the project to certify that the research project complies with ISEF Rules. This local and regional SRC review should occur before experimentation begins, if possible. 2. Student researchers are prohibited from performing euthanasia. Euthanasia at the end of experimentation for tissue removal and/or pathological analysis is permitted. All methods of euthanasia must adhere to current American Veterinary Medical Association (AVMA) Guidelines. 3. Research projects that cause more than momentary or slight pain or distress to vertebrate animals are prohibited unless mitigated by IACUC-approved anesthetics, analgesics and/or tranquilizers. 4. Research in nutritional deficiency or research involving substances or drugs of unknown effect is permitted to the point that any clinical sign of distress is noted. In the case that distress is observed, the project must be suspended and measures must be taken to correct the deficiency or drug effect. A project can only be resumed if appropriate steps are taken to correct the causal factors. 5. The following forms are required: a. Checklist for Adult Sponsor (1), Student Checklist (1A), Research Plan/Project Summary, and Approval Form (1B) b. Regulated Research Institution Form (1C) c. Qualified Scientist Form (2) d. Vertebrate Animal Form (5B) e. PHBA Risk Assessment Form (6A) – for all studies involving tissues and body fluids. f. Human and Vertebrate Animal Tissue Form (6B) – for all studies involving tissues and body fluids. Sources of Information are available as a separate section at the end of the document. Page 14 International Rules: Guidelines for Science and Engineering Fairs 2024–2025, societyforscience.org/ISEF POTENTIALLY HAZARDOUS BIOLOGICAL AGENTS (PHBA) RULES Potentially Hazardous Biological Agents Rules for use of microorganisms (including bacteria, viruses, viroids, rickettsia, fungi and parasites), recombinant DNA technologies or human or animal fresh/frozen tissues, blood, or body fluids. Students are permitted to do research projects with potentially a Regulated Research Institution laboratory with a minimum hazardous biological agents meeting the conditions and rules of BSL-2 containment and documented IBC review and described below which were designed to protect students approval. Representative examples include, but are not and to ensure adherence to federal and international biosafety limited to the following known agents: MRSA (Methicillin- regulations and guidelines. Resistant Staphylococcus aureus), VISA/VRSA (Vancomycin Intermediate or Resistant Staphylococcus aureus), VRE When dealing with potentially hazardous biological agents, it is (Vancomycin-Resistant Enterococci), CRE (Carbapenem the responsibility of the student and all of the adults involved in Resistant Enterobacteriacae), ESBLs (Extended Spectrum a research project to conduct and document a risk assessment on Beta-Lactamase producing gram negative organisms), and Form (6A) to define the potential level of harm, injury or disease fungi (yeasts or molds) with known resistance to antifungal to plants, animals and humans that may occur when working with agents. biological agents. The risk assessment determines a biosafety level which in turn determines if the project can proceed, and if 8. Insertion of antibiotic resistance markers for the clonal so, the proposed laboratory facility i

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