University of Illinois at Rockford - College of Medicine

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IRB Required Documents

Levels of Review:
Step 1
Administrative Review: New investigators should start with filling out the form entitled Determination of Whether an Activity Represents Human Subjects Research. This form will help guide you through the fundamental stages that will help to accurately define your activity. By using this form you will be able to document your activity and be referred to other possibly required documents.  If you are not prompted to use another form (driven by the answers you provide) then submit this form to the IRB Chair on IRB Net for an administrative review. This action will prompt a formal decision and response letter that you may use as proof that IRB review was not required.
 
Step 2
Human Subjects’ Research Educational Training: If you were prompted (by your responses to the “Determination” form) in step 1 to use the Claim of Exemption form OR Initial Application Social Science OR Initial Application Biomedical Science form then you MUST completed the required online training before your application can be reviewed by any member of the IRB. Please complete the CITI Training modules AND the HIPAA for Research online training before submitting your documents on IRB Net.
 
Step 3
Three levels of IRB Review: There are three separate possible forms that are available for your initial application review. The 1) Claim of Exemption, 2) Initial Application Social & Behavioral Science, OR 3) Initial Application Biomedical Science applications have different legal criteria that determine which form is appropriate for your research. The Determination form and other instructional documents are available for guidance.
Exempt Review:  Please refer to the instructions and checklist for more details on this application for Exempt Review. Please use any recruitment templates and/or consent templates that apply to your research.
Expedited Review:  There are two application forms to choose from, Initial Application Social and Behavioral Science OR Initial Application Biomedical Science. Both forms have checklists that can be used to insure all accompanying support documents are submitted with the application. Please note that both of these forms detail the research activities that dictate whether your study qualifies for expedited review. Please check the box(s) for all categories that apply to your research activity. If no boxes are checked OR your target subject pool is federally protected as a protected population then your application will go to the next level of review. NOTE: A representative of the IRB can recommend a higher level of review if the protocol would indicate that a greater than minimal risk may be present for the research subject.
Convened Board Review: This level of review is determined by two main issues: 
1) does the research activity focus on a protected population, OR
2) does the activity have a greater than minimal risk?
 
Step 4
What other types of approval may be required for my IRB submission?
Student PI:  If you are a student your faculty advisor MUST “sign” your application packet on IRB Net. Please grant your advisor full access to your submission packet. He/she will be copied on all communications.
Faculty PI:  Please grant IRB Net access to your department head. The department head will need to “sign” your study packet and may be copied on communications concerning your protocol. 
Department Head PI: Please grant the Dean of your College access to your IRB Net study packet. The Dean will need to “sign” your study and may be copied on communications concerning your protocol. The Dean will sign in place of the Department Head when the Department Head is signing as the PI.
 
Note:
Institutional Biosafety Committee review: If you are using rDNA or infectious agent you will need to apply to the IBC before completing the IRB process.
UIC Cancer Center: If you are conducting research in conjunction with the UIC Cancer Center please complete the required application process prior to applying for IRB approval. NOTE: OPRS on UIC campus MAY be the IRB of record. Before submitting any documents for IRB review please contact RSS.
 
Center for Clinical and Translational Sciences: UIC offers the Center for Clinical and Translational Sciences for assistance on bringing basic science into clinical research.  While this department is on the Chicago Campus, they do offer services to the Rockford Campus.