- What is the SRC? What is the IRB?
- Do I need SRC approval BEFORE I can begin my project? What are the SRC guidelines and rules?
- Are there special rules for Software Engineering projects where software apps diagnose a human condition or disease?
- Are there special rules for Model Rockets?
- Which additional forms are required for projects?
- Where can I get the additional forms required for SRC/IRB projects?
- How will I know when my project has been approved?
- What if I need to make a significant change in my project after I have received SRC approval to begin?
- Why are we so strict about the forms and SRC approval?
- I plan to use a laser in my experiment. Do I need pre-approval?
- When was the field of study for Behavioral Science removed?
What is the SRC? What is the IRB?
The term SRC is actually used two ways. The acronym SRC stands for Scientific Review Committee. One meaning refers to the group of people who form a committee that reviews each project application to ensure that all safety and legal requirements will be met and that the appropriate forms have been completed. The committee also reviews the completed project displays during check-in at the Synopsys Championship. A Scientific Review Committee is composed of at least three people: a biomedical scientist, a physical scientist, and a science teacher.
SRC also refers to the process of a project being reviewed. You may ask if a project “requires SRC approval” or if it has “met SRC requirements.” Projects involving humans are reviewed by a subcommittee of the SRC called the Institutional Review Board (IRB). This ensures the project will not present an excessive amount of risk to the human subjects involved in the study. An IRB is composed of at least three people: a science teacher, a school administrator and a psychologist, doctor (M.D.) or nurse (R.N.).
The SCVSEFA SRC/IRB consists of about 15 people with expertise/credentials in various subjects who work together to review each of the project applications for the Synopsys Championship. SSP (The Society for Science and the Public) requires that those signing off on application paperwork do not have a conflict of interest.
Do I need SRC approval BEFORE I can begin my project? What are the SRC guidelines and rules?
The Synopsys Championship follows the rules of the International Science and Engineering Fair with one change: the Synopsys Championship would like to pre-approve ALL projects in the Hazardous Agents, Activities and Devices category. These projects require that you submit a Form 3 with your application.
There is a diagram to help determine if a project needs SRC pre-approval. This will be true for most projects involving human participants, vertebrate animals, biological materials, living organisms, and potentially hazardous biological agents. Note: If a project involves the testing of a student designed invention, prototype or concept by a human, an IRB review and approval may be required prior to experimentation. Please be aware when doing any project that involves physical or mental disease that projects that are not completed under the direction of a qualified medically certified supervisor may not claim to diagnose or treat a medical or mental health condition. Apps designed for this purpose may not be tested by volunteers or family members. Judges may not use such an app that is connected to the internet. Projects, products, apps may claim to have the “POTENTIAL” for therapeutic effectiveness or clinical diagnostics only. The Claim to cure or definitively diagnose a medical condition can ONLY be made after completing clinical studies, using protocols approved by government agencies such as the FDA. The ISEF Rules Wizard can help you determine which forms to complete. Forms may be downloaded from the Additional Forms page.
Are there special rules for Software Engineering projects where software apps diagnose a human condition or disease?
ISEF has tightened the rules regarding the development of diagnostic apps. Because these inventions are governed by the FDA, we have made it a requirement that these apps must be tested at an RRI under the supervision of a medical professional. If a student tests the device on his/her parents or other students, they will fail to qualify for competition at ISEF in 2023. If they were to review the projects from
2022, s/he will find that we have greatly reduced the development and testing of diagnostic apps for use by the general public. Software Engineering projects need a flow chart, must use publicly available and de-identified databases and have a good bibliography.
Are there special rules for Model Rockets?
Yes. Rockets are hazardous devices. You will need to follow the Model Rocket Safety Code and submit the Model Rocket Launch Certificate that it contains. LUNAR, the Livermore chapter of the National Association of Rocketry, posts their launch schedule on their web site and is willing to help students launch their rockets safely. Population density in the Bay Area makes it difficult to find safe rocket launch sites. Contact the three local NAR chapters in the Model Rocket Safety Code before you launch your rocket for a Synopsys Championship experiment. Do not launch a rocket yourself.
Which additional forms are required for projects?
The ISEF Rules Wizard can help you determine which additional forms to complete.
| Form (1C) | Regulated Research Institutional / Industrial Setting | To be completed by the Supervising Adult AFTER an RRI project is complete. |
| Form (2) | Qualified Scientist | Required for any project involving humans, vertebrate animals, potentially hazardous biological agents (BSL2 level projects) and controlled substances. Submit BEFORE experimentation begins. |
| Form (3) | Risk Assessment | Required for any project using hazardous chemicals, activities or devices, and microorganisms that are exempt from pre-approval. Submit BEFORE experimentation begins. |
| Form (4) | Human Participants | Required for SRC/IRB pre-approval of any project involving human participants. Submit BEFORE experimentation begins. |
| Sample | Human Informed Consent | Sample consent form is required for ANY project involving humans |
| Form (5A) | Vertebrate Animal (For research at school, home, or at a field site) | Required for SRC pre-approval of any project involving animals with bones. Supervisor must sign before experimentation. Submit BEFORE experimentation begins. |
| Form (5B) | Vertebrate Animal (For research at a Regulated Research Institution) | Required for SRC pre-approval of any project involving animals with bones. Obtain IACUC approval document before experimentation and supervisor signature afterwards. |
| Form (6A) | Potentially Hazardous Biological Agents Risk Assessment | Required for SRC pre-approval of any project involving microorganisms, rDNA, tissue, blood, or body fluids; submit BEFORE experimentation begins. |
| Form (6B) | Human and Vertebrate Animal Tissue | Required for SRC pre-approval of any project involving tissue, blood, or body fluids; submit BEFORE experimentation begins. |
| Form (7) | Continuation/Research Progression Projects | Required for SRC pre-approval of any project that continues in the same field of study as a previous project. |
Where can I get the additional forms required for SRC/IRB projects?
The ISEF forms are linked above and on the page for Additional Forms.
How will I know when my project has been approved?
Check the Project Status link on this web site. Select your school and teacher and then look up your name. If your project needs SRC pre-approval you may begin experimentation only after your project status is listed as Project Approved.
What if I need to make a change in my project after I have received SRC approval to begin?
STOP!! Contact the Scientific Review Committee and explain what you need to change. Do not proceed with your project until you have received further approval from the SRC. Approval is usually given in less than 24 hours.
Why are we so strict about the forms and SRC approval?
- Student safety
- Compliance with federal and state laws
- Compliance with the ISEF rules. Adherence to the ISEF Rules allows selected winners from the Synopsys Championship to compete in: the International Science & Engineering Fair (grades 9–12), the California Science & Engineering Fair (Grades 6-12) and the Thermo Fisher Scientific Junior Innovators Challenge (formerly Broadcom MASTERS) (Grades 6–8)
- Avoidance of legal/litigation issues
I plan to use a laser in my experiment. Do I need pre-approval?
Yes, all projects that use lasers, of any power, require SRC pre-approval. No lasers are permitted in the judging area at the fair.
When was the Field of Study for Behavioral Science removed?
In 2020 the SCVSEFA Board decided to remove Behavioral Science as a field of study (projects that looked at the effects of various things on human participants). Reasons are that they were often of poor quality, typically had insufficient participants to see an effect, and they required enormous amounts of time for the IRB and administrative personnel to review and manage. We also have problems recruiting judges with expertise to review these projects. We apologize for any inconvenience.
Students who develop an app or have an engineering project that builds a device that needs to be tested may still do so if they follow the rules for human participants. These projects need SRC pre-approval by the SRC.
