Middle/High School Science Fair Information Session GSEF/ISEF Rules and Guidelines Changes and Modifications

17 Categories Animal Sciences Behavioral and Social Sciences Biochemistry Cellular and Molecular Biology Chemistry Computer Science Earth and Planetary Science Engineering: Electrical and Mechanical Engineering: Materials and Bioengineering Energy and Transportation Environmental Management Environmental Sciences Mathematical Sciences Medicine and Health Sciences Microbiology Physics and Astronomy Plant Sciences

Preparation of Forms: Which forms do I need? DeKalb Official Registration Form (on top) Abstract Checklist for Adult Sponsor (Form 1) Student Checklist (Form 1 A) Research Plan Approval Form (Form 1B) Important Reminders: These forms are required for all projects 2 copies of the entire packet must be submitted to the county office by January –deadline date forth coming

DeKalb Official Registration Form

Forms You Might Need Regulated Research Institutional/Industrial Setting (Form 1C) Qualified Scientist (Form 2) Risk Assessment (Form 3) Human Participants – Informed Consent (Form 4) Vertebrate Animals (Forms 5A and 5B) Potentially Hazardous Biological Agents (Form 6A) Human and Vertebrate Animal Tissue (Form 6 B) Continuation Projects Form (Form 7)

Regulated Research Institutional/Industrial Setting (Form 1C) * Studies conducted at research institution/industrial setting or any setting outside of school or home require Form 1C

Required for some projects Doctoral/professional degree related to student research Completes Form 2 – QS Form Most likely if you require forms 4, 5, and 6 Qualified Scientist (Form 2)

Risk Assessment (Form 3) No more than minimal risk: probability of harm or discomfort anticipated in research is not greater than those ordinarily encountered in daily life More than minimal risk: possibility of physical or psychological harm is greater than typically encountered in everyday life. These studies required informed consent: Physical risks Psychological risks Invasion of privacy Risk groups

When more than minimal risk If IRB determines that potentially there could be emotional stress When subjects belong to risk group Informed consent required (Form 4)

IRB can waive requirement of informed consent if study with minimal risk and, anonymous data collection and, one of the following Study of normal educational practices Behavior study where no manipulation Surveys of perception, cognition, game theory Physical activity with no more than minimal risk (daily activity, routine physical activities)

IRB Committee IRB must include: An educator A School Administrator And of the following who is knowledgeable and capable of evaluating the physical and/or psychological risk involved in a given study: A medical doctor Physician’s assistant Registered nurse A psychiatrist A psychologist Licensed social worker Licensed clinical professional counselor

Vertebrate Animals (Forms 5A and 5B) Difference between forms 5A and 5B is the location of the research Vertebrate Animals (5A): If you use animals, fish, eggs, embryos, etc. at home, school or field. Vertebrate Animals (5B): If your animal research is done at a regulated research institution.

What is a vertebrate animal? Live, nonhuman vertebrate mammalian embryos or fetus Bird and reptile eggs within 3 days of hatching All other nonhuman vertebrates at hatching or birth

Studies at Regulated Research Institutions Must be approved by IACUC (Institutional Animal Care and Use Committee) Local SRC should review project before experimentation Experimentation must follow ISEF guidelines and adhere to restrictions regarding pain QS completes Form 5B which includes documentation of IACUC approval

Scientific Review Committee (SRC) Projects involving the following must be reviewed by the SRC before experimentation begins: Vertebrate animals Potentially hazardous biological agents A SRC must consist of 3 members: A biomedical scientist An educator At least one other member

Potentially Hazardous Biological Agents (Form 6A) Microorganisms (including bacteria, viruses, fungi, etc.) Recombinant DNA technologies Human or animal fresh tissues, blood or body fluids All above studies require a risk assessment

Overview: Biosafety Level Risk groups BSL 1 studies can usually be conducted in a high school or college teaching laboratory. BSL 2 studies are usually conducted in a regulated research institution BSL 3 and BSL 4 studies are prohibited for ISEF projects Form 6A (potentially biological agents form) required for all projects involving microorganisms, rDNA and fresh tissue

Biosafety risk groups BSL 1 if Organisms cultured in plastic petri dish or petrifilm Culture dish remains sealed throughout experiment Culture dish disposed of in appropriate manner BSL 2 if petri dish is opened

Human and Vertebrate Tissue (Form 6B) Required for all projects using Fresh tissue Primary cell cultures Blood and blood products Body fluids

Continuation Projects (Form 7) Studies that are a continuation from a previous year’s project require Form 7

GSEF/ISEF Rules and Guidelines Changes and Modifications See last page in your science fair handout for rule changes and modifications

Middle/High School Science Fair Information Session GSEF/ISEF Rules and Guidelines Changes and Modifications