1. International Rules & Guidelines 2019
Intel International Science and Engineering Fair

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

3. Consultant: Dr. Erin Rumpke
Who?
Society for Science & the Public
Michele Glidden, Chief Program Officer
Lisa Icenroad, ISEF Program Manager
Diane Rashid, Rules Coordinator
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

4. 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)

5. 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.  

6. 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

7. 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)

8. 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

9. HUMAN PARTICIPANTS

10. 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.

11. 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.

12. 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.

13. 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

14. 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.

15. 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.

16. VERTEBRATE ANIMALS

17. 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.

18. 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.

19. 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)

20. 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

21. Most Common SRC Challenges

22. 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

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

24. 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

25. 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

26. 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

27. 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