International Rules & Guidelines 2019 Intel International Science and Engineering Fair

Navigating the Approval Process:  International Rules for Pre-college Research  Who? What? Where? Why? What’s next?

Consultant: Dr. Erin Rumpke Who? Society for Science & the Public Michele Glidden, Chief Program Officer Lisa Icenroad, ISEF Program Manager Diane Rashid, Rules Coordinator Email: SRC@societyforscience.org ISEF Scientific Review Committee Ms. Susan Appel Mr. Henry Disston Dr. Jennifer Green Dr. Paula Johnson Dr. Timothy Martin Mrs. Evelyn Montalvo Mr. Joseph Scott Dr. Jason Shuffitt Mrs. Andrea Spencer Consultant: Dr. Erin Rumpke

Who? Roles & Responsibilities Involved in the Project: Student Researcher Student Researcher Parents The Adult Sponsor The Qualified Scientist The Designated Supervisor Review Committees: The Institutional Review Board (IRB) The Scientific Review Committee (SRC) The Institutional Animal Care and Use Committee (IACUC) Institutional Biosafety Committee (IBC)

What? The International Rules for Pre-college Science Research: Guidelines for Science and Engineering Fairs is published annually to support students doing independent research safely. They are the official rules of the Intel ISEF and for students competing at a Society-affiliated science fair.  

What? The International Rules are currently organized into 5 key sections: Rules for All Projects Human Participant Rules Vertebrate Animal Rules Potentially Hazardous Biological Agents (PHBA) Rules Hazardous Chemicals, Activities or Devices Rules

Where? Where the research is conducted is a major factor in the approval process: Home School Farm, ranch, in the field, etc. Industrial Setting Registered Research Institution (RRI)

Why? The purpose of the International Rules is to: protect the rights and welfare of the student researcher protect the rights and welfare of the human participant ensure adherence to federal regulations ensure use of safe laboratory practices protect the environment determine eligibility for competition in the Intel ISEF 2019

HUMAN PARTICIPANTS

Human Participant Projects Any medical procedure Psychological, educational and opinion studies (e.g., surveys, questionnaires, tests) Studies in which the researcher is the subject of the research Testing of student designed invention, prototype or computer application by human participants other than student researcher Data/record review projects that include data that are not de- identified/anonymous This is an overview of the review processes when humans are involved in a project in any way. We will come back to this and discuss each of these in detail. For now, we will transition to a type of project that often falls into the Exempt or Expedited category that are not traditional human subjects research.

School IRB Conducted at school, at home or in the community that are not affiliated with a Regulated Research Institution (RRI) must be reviewed and approved by the School IRB before the student may begin recruiting and/or interacting with human participants. The School IRB must assess the risk and document its determination of risk on Form 4.

RRI IRB Projects that are conducted at a Regulated Research Institution (RRI) (e.g., university, hospital, medical center, government lab) must have IRB approval from the RRI. A copy of the IRB approval for the entire project must be obtained. A letter from an adult mentor and/or Qualified Scientist is not sufficient documentation of the RRI IRB review and approval process.

Types of Human Participants Approval FULL IRB Student invention tested by anyone other than the student researcher Medical device inventions and prototypes must be conducted in an RRI EXEMPT Student researcher is the only person testing the invention and does not pose a safety hazard Review page 8 Exempt studies

Exempt Human Studies Student-designed Invention, Prototype, Computer Applications or Engineering/Design Project in which the student researcher is the only person testing the invention, prototype or computer application and the testing does not pose a health or safety hazard. It is recommended that a Risk Assessment Form (3) be completed.

Student-designed Invention, Prototype, Computer Application & Engineering/Design Projects Full IRB review and pre-approval is necessary when the student- designed invention, prototype, application, etc. is tested by human participants other than the student researcher(s). This includes surveys conducted regarding potential use, review of the product and/or opinions regarding the project. Projects in which the invention, prototype or project involves a medical diagnosis or intervention (as defined by the FDA or Medical Practices Act) and is tested on human participants must be conducted at a Regulated Research Institution (RRI) with a Qualified Scientist and receive IRB Approval from the Institution. A Risk Assessment Form 3 is recommended for all student- designed inventions or prototypes.

VERTEBRATE ANIMALS

Vertebrate Animals Defined Vertebrate animals, as covered by these rules, are defined as: Live, nonhuman vertebrate mammalian embryos or fetuses Tadpoles Bird and reptile eggs within three days (72 hours) of hatching All other nonhuman vertebrates (including fish) at hatching or birth. Exception: Because of their delayed cognitive neural development, zebrafish embryos are not considered vertebrate animals until 7 days (168 hours) post- fertilization.

Guiding Principles: The guiding principles for the use of animals in research include the following “Four R’s”: Replace vertebrate animals with invertebrates, lower life forms, tissue/cell cultures and/or computer simulations where possible. Reduce the number of animals without compromising statistical validity. Refine the experimental protocol to minimize pain or distress to the animals. Respect animals and their contribution to research. If the use of vertebrate animals is necessary, students must consider additional alternatives to reduce and refine the use of animals.

Vertebrate Animal Rules Rules for All Vertebrate Animal Projects Additional Rules for Projects Conducted at School/Home/Field Additional Rules for Projects Conducted in a Regulated Research Setting Exempt Studies (do not require Pre-Approval)

What’s Next? The ISEF SRC is considering a re-organization of the International Rules: New Code of Ethics Separating Rules from Guidance from Process Incorporating Engineering Design & Invention

Most Common SRC Challenges

Frequent SRC Issues Missing Forms Form 1C – Regulated Research Institute/Industrial Setting Form 3 – Risk Assessment Human Informed Consent Form Forms 6A & 6B – Potentially Hazardous Biological Agents Form 7 – Continuation Projects Form RRI letters of approval from IRB and/or IACUC

Frequent SRC Issues Improperly Completed Forms Form 4 – Human Participants Form

Frequent SRC Issues Missing Signatures Qualified Scientist Form 1C – Regulated Research Institute/Industrial Setting Form 6A – Potentially Hazardous Biological Agents IRB or SRC Chair/Members Form 1B – Approval Form Form 4 – Human Participants Form Form 5A – Vertebrate Animal Form Forms 6A – Potentially Hazardous Biological Agents Risk Assessment Form

Frequent SRC Issues Missing Information Research Plan/Project Summary Project Start and End Dates Source of Cell Cultures ATCC vs fresh tissue Strain of Bacteria, esp. E. coli Source of public available Data

Frequent SRC Issues Too Much Information Previous Years Work described in Abstract Description of Mentor’s work versus Student’s experiment Signed Human Consent Forms References to Patents or Copyrights MSDS Sheets

Top Reasons for FTQ Study conducted prior to January 2018 Genetically engineering organisms with multiple drug resistance traits. Toxicity study utilizing vertebrate animals Behavioral experiment using conditioning with aversive stimuli