Rush University’s Office of Research Affairs has two institutional review boards (IRBs) as part of its human research protections program (HRPP).
Each IRB is equally constituted and reviews the same types and levels of research.
Each IRB meets once a week, every week throughout the calendar year.
All research studies, including those that may qualify for exemption, must be submitted to the Rush University IRB for approval through the Rush Research Portal.
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.
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.