How to Navigate IRB Paperwork.

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Presentation transcript:

How to Navigate IRB Paperwork

What is the IRB? An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.

Which projects require IRB? Project needing prior approval from the IRB include projects involving... Bacteria Chemicals Fire/Explosives/Weapons Human Participants/Consumption Rockets Vertebrates/Invertebrates

Elementary/Junior High "Rarely, if ever approved" list Mold/Bacteria Blood Vertebrates Projectiles Lab grade chemicals

Where is the paperwork? Begin at the main CUSD web page. In the gold bar, click on the CURRICULUM tab and select science.

Where is the paperwork? Once on the main science page, choose the science fair paperwork link in red.

Where is the paperwork? On this page, choose the category the project needing approval falls into. As an example, Human Participants will be modeled.

Where is the paperwork? This page has links to every form that would be needed for a project involving human participants.

Research Plan When completing the research plan, complete parts a-d that can be done prior to beginning and the section below that corresponds with the project.

Form 1 Form 1 can be typed into online and printed out. Boxes are check enabled. If the forms are not typed, then they must be completed in ink. Don't forget to read and check off #1-5 and the appropriate section of #6. This page requires a signature.

Form 1A Form 1A can also be typed into online. In most cases, the classroom teacher is the adult sponsor. Choose an "actual start date" well past the IRB meeting date; it can always be changed later. Do not forget to provide addresses of all non-school locations.

Form 1B This is the only form that must be filled out by all students working on the project. This page requires 2 signatures. Do not fill out boxes #2 & #3.

Form 2 Qualified Scientist This is form is not always needed. Only complete this form if the students are working with an expert in the field. This page requires 2 signatures.

Form 3 Risk Assessment Make sure to answer all of the questions completely. Even if there is no risk involved with the project itself, make sure it is stated that there are no risks associated with this project. If a qualified scientist is required, a signature is needed.

Form 4 Human Consent & Human Participation There are two parts to form 4. The top box of human participant must be completed by the student. This page requires 3 signatures. 1) School nurse/psychologist 2) Educator other than self 3) School administrator

Form 4 Human Consent & Human Participation This form is the permission slip that participants need to get signed prior to completing a survey type of project. Only participants fill this out. It must be returned to students conducting the experiment.

Risk Matrix For the Risk Matrix, make sure both pages are used. On this Page... Fill out the description. Check off any potential hazards. Check off level of risk. Check off probability.

Risk Matrix On this page... Check off the risk level. Describe how hazards will be controlled. If there are no hazards, state that here. This page requires 2 signatures.

IRB Checklist The last thing to do as paperwork is collected, is to use this checklist to make sure everything that needs to be submitted is complete. Once the classroom teacher signs off, it is given to the site coordinator for a final review. This page requires 2 signatures.

Paperwork Process for Students Step 1: Research the topic and write a research plan. (one per group) Step 2: Get approval from your classroom teacher for the research plan. Step 3: Fill out one set of the forms for the project. Only form 1B must be filled out by each member when working in groups.

Teacher's Responsibility Provide feedback on the student's research plan. Make sure that procedures are clear and that everything required from the instructions is included. Once the student is finished filling out the forms, in pen or typed, get the necessary signatures from the administration, teacher, and school nurse/psychologist.

Teacher's Responsibility Make a copy of the student's paperwork before submitting it. The paperwork will not be returned. Turn in the paperwork to the site coordinator for final approval. Remember that the coordinators must have the paperwork in to the IRB one week prior to the meeting.

IRB dates Although dates listed below are for scheduled IRB meetings, paperwork should be submitted by the site coordinator one week prior to the meeting dates. September 14, 2016 October 25, 2016 November 14, 2016 December 6, 2016 January 17, 2017 February 7, 2017

Checklist Adult Sponsor 1

Signature portion of Checklist for Adult Sponsor form 1 Click to add text