What is an SRC/IRB Mercer Science and Engineering Club 3 Creek Rim Drive Titusville, NJ

The Terms Scientific Review Committee (SRC) – Approves projects dealing with human subjects, vertebrate animals, pathogenic agents, controlled substances or recombinant DNA Institutional Review Board (IRB) – a committee that, according to federal regulations (45-CFR-46), must evaluate the potential physical and/or psychological risk of research involving human subjects.

Overview Why do we need SRC/IRBs Is an SRC/IRB required for all projects What is the sequence of affairs How do I know what is required What forms are involved Who has the final say

Why do we need SRC/IRBs Rules – all participants must follow the rules or their project will be rejected Supervision – to make sure researchers are supervised by trained personel Safety – to make sure researchers are performing experiments properly. Subjects must be treated properly and substances must be handled in a safe fashion Informed Consent – required if human subjects are part of an experiment Restricted Experiments – its in the rules. Not all experiments will be permitted

Is an SRC/IRB required for all projects Yes, SRC reviews are done for all project submissions to the fair And no, SRC and/or IRB reviews are required only for projects that perform research on restricted areas (discussed later). These reviews MUST occur BEFORE experimentation is started

What is the sequence of affairs 1. Choose a project topic 2. Determine what forms are needed 3. Fill out forms and submit for SRC/IRB approval (depends on form) 4. Begin experimentation 5. Complete project 6. Submit forms when entering the fair

How do I know what is required 1. Check out the rules and forms 2. Submit an SRC/IRB precheck from the club’s website 3. Use the ISEF Rules Wizard on the Science Service website 4. Contact the Mercer Science and Engineering Club

What forms are involved Form 1C: Regulated Research Institutional/Industrial Setting Form 2: Qualified Scientist Form 3: Designated Supervisor Form 4: Human Subjects Forms 5A, 5B: Vertebrate Animal Form 6: Human and Vertebrate Animal Tissue

Forms 1C and 2 Form 1C: Regulated Research Institutional/Industrial Setting – Must be completed by the scientist supervising the student research conducted in a regulated research institution (e.g., universities, medical centers, NIH, etc.) or industrial setting. Form 2: Qualified Scientist – Required for research involving pathogens; may be required for research involving rDNA, vertebrate animals, controlled substances and humans.

Forms 3 and 4 Form 3: Designated Supervisor – Required for projects using hazardous materials or devices, tissue studies or if a required Qualified Scientist is unable to supervise the experimentation. Form 4: Human Subjects – Required for all research involving humans. IRB approval required before experimentation.

Forms 5A, 5B and 6 Form 5A, 5B: Designated Supervisor – All research involving vertebrate animals that is conducted in a Non-Regulated (A) or Regulated (B) Research Site. Form 6: Human Subjects – Required for all projects using fresh tissue, organs, primary cell cultures, established cell and tissue cultures, meat or meat by-products, human or animal parts, including blood, blood products, teeth and body fluids.

Who has the final say For the Mercer Science and Engineering Fair the final review is done by the Mercer Science and Engineering Fair’s SRC For the Intel International Science and Engineering Fair the final review is done by the Intel International Science and Engineering Fair’s SRC

Summary MSEC’s SRC checks all entries Projects that require IRB/SRC approval must have the appropriate forms before starting experiments The grand prize winner’s entry will be check by ISEF’s IRB/SRC Projects that require and do not have proper approval will be rejected