Institutional Review Boards

There are three levels of IRB review. The levels are based on risks (perceived or actual).

Exempt review

• Human subject research that involves little to no risk at all (e.g., retrospective data collection from the medical record, survey/questionnaire style research).
• Generally reviewed and approved by IRB administrative staff, often in 3-5 business days.

Expedited review

• Performed by one IRB member.  
• Study must be minimal risk.  
• Often reviewed within 3-5 business days but may vary.

Full review

• Greater than minimal risk; must be reviewed by a full IRB committee. 
• Typically requires continuing review at least every 12 months.  
• Often reviewed within 21-25 business days but may vary. 

Once you submit your study to the IRB by your departmental approver, the status of your study changes from “Departmental Review” to “IRB Assignment”. The process works as follows:  

• Status will change periodically during the review process.
• Status can be tracked within the Rush research portal. 
• Studies are generally assigned to an IRB within three to five days.  
• Studies that require full board review will be scheduled for review after pre-screening by IRB administration.  
• After securing pre-screening requirements, a study may be scheduled for the next available IRB review date.  
• Studies are scheduled at least a week prior to an IRB meeting.  
• The meeting date and time are posted in the Rush research portal once the study has been scheduled. 

The IRB provides written documentation of concerns, questions or recommendations. 

• To address a specific IRB concern or question, you must provide a written response or explanation and a revised IRB application.
• To address an informed consent recommendation, provide two versions of the informed consent: one version with tracked changes and one version with accepted changes. 

If you want to alter or revise IRB-approved research, you must submit an amendment application to the IRB via the Rush research portal and obtain approval prior to implementing the changes.

Fees for IRB review vary, but a 30% overhead fee is applied to each submission. Each fee below includes the overhead fee.

• Initial IRB Review: $4,000
• External IRB Initial Review: $4,000
• Continuing Review: $1,500 
• Sponsor Amendment: $800 
• Study Closeout: $550
• Serious Adverse Event (SAE): $250

Each rate includes overhead fee.

• CTMS Startup: $650
• CTMS Maintenance: $450