What is an SRC/IRBWhat is an SRC/IRB

Mercer Science and Engineering Club3 Creek Rim Drive

Titusville , NJ 08560www.mercersec.org

www.mercersec.org

The TermsThe 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.

www.mercersec.org

OverviewOverviewWhy do we need SRC/IRBsIs an SRC/IRB required for all projectsWhat is the sequence of affairsHow do I know what is requiredWhat forms are involvedWho has the final say

www.mercersec.org

Why do we need SRC/IRBsWhy 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

www.mercersec.org

Is an SRC/IRB required for Is an SRC/IRB required for all projectsall 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

www.mercersec.org

What is the sequence of affairsWhat 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

www.mercersec.org

How do I know what is requiredHow do I know what is required

1. Check out the rules and forms

2. Submit an SRC/IRB precheck email from the club’s website

3. Use the ISEF Rules Wizard on the Science Service website

4. Contact the Mercer Science and Engineering Club

www.mercersec.org

What forms are involvedWhat forms are involved

Form 1C: Regulated Research Institutional/Industrial Setting

Form 2: Qualified ScientistForm 3: Designated Supervisor Form 4: Human SubjectsForms 5A, 5B: Vertebrate AnimalForm 6: Human and Vertebrate

Animal Tissue

www.mercersec.org

Forms 1C and 2Forms 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.

www.mercersec.org

Forms 3 and 4Forms 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.

www.mercersec.org

Forms 5A, 5B and 6Forms 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.

www.mercersec.org

Who has the final sayWho 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

www.mercersec.org

SummarySummaryMSEC’s SRC checks all entriesProjects that require IRB/SRC

approval must have the appropriateforms 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