Institutional Review Boards

Rush University Medical Center has two institutional review boards (IRBs). For an IRB membership list or additional information, contact the Office of Research Affairs. Below are some frequently asked questions and answers about the boards and the study review process.

Q: What is the difference between full, expedited and exempt review?

A: Below is a description of each type of review.

Full committee review: Studies that involve greater than minimal risk or vulnerable populations are reviewed by a fully convened IRB committee. The committee discusses the study and decides whether to approve the study. The IRB approval time for a study determined to require full board review is approximately 21 business days. Please note that this is an estimation and does not include studies that the IRB determines to contain controverted issues or other unforeseen delays. Studies that have contingencies identified will take an additional amount of time depending on how fast these contingencies are met.

Expedited review: This type of review is carried out for studies that involve minimal risk to subjects. Studies are reviewed by a qualified member of the IRB committee designated by the IRB chair. This member reviews the appropriate materials and consults with the principal investigator, if necessary, to decide whether to approve the study. The approval time for expedited review is approximately seven to 10 business days. Please note that this is an estimation and does not include studies that the IRB determines to contain controverted issues or other unforeseen delays. Studies that are assigned contingencies will take an additional amount of time depending on how fast these contingencies are met. The designated reviewer has the responsibility to refer the study for full committee review if warranted.

Exempt review: The human subjects’ protection division screens studies for exemptions from the requirement of 45 CFR 46. Studies that are exempt involve a low risk to subjects and, in many cases, record data so that subjects cannot be identified directly or by an identifier linked to the subject. If the study does not meet the exemption criteria, it will need to go through expedited or full committee review. The review time for the issuance of an exemption is approximately three to five business days. Please note that this is an estimation and does not include projects that contain controverted issues or other unforeseen delays. Studies that are assigned contingencies will take an additional amount of time depending on how fast these contingencies are met.

Q: Do I need to submit a study that I believe qualifies for exemption to the IRB?

A: Yes, only a Rush IRB chair or designee can declare an exemption for your study. If you believe your study qualifies for exemption, you must complete an IRB application in the Rush research portal. You cannot initiate any study activities until you have received written notice that the IRB has granted an exemption.

Q: How often does the IRB meet?

A: Rush University Medical Center has two IRBs. Each board meets once a week.

Q: How long will it take my study to be scheduled for IRB review, and what are the deadlines for submission?

A: Studies determined to require full board review are generally assigned to an IRB within one to two days of submission. Studies are scheduled at least a week, but not more than two weeks, prior to an IRB meeting. The meeting date and time are posted in the Rush research portal once the study has been scheduled.

Q: When will I hear from the IRB about my study?

A: You can expect to receive communication about study reviews within approximately two business days after completion of the review. You can expect to receive expedited and exempt review queries within three to five business days from the date of submission.

Q: How do I answer an IRB query?

A: The IRB provides written documentation of their concerns or questions, as well as informed consent recommendations. To address a specific IRB concern or question, you will need to provide a written response or explanation and a revised IRB application, when appropriate. To address an informed consent recommendation, provide two versions of the informed consent: one version with tracked changes, and one version with changes accepted.

Q: How do I change an IRB approved study?

A: 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. The amendment process involves completing the amendment application and revising the IRB application accordingly.

Q: How does the IRB determine the termination date for approval?

A: The initial expiration or termination date for a study can be no more than one year from the initial approval date. For example, if a study was initially approved on April 1, 2008, then its expiration or termination date can be no later than April 1, 2009. This includes studies that are approved pending contingencies.

Q: When is data de-identified?

A: Data is considered de-identified under the Health Insurance Portability and Accountability Act (HIPAA) when none of the following elements are present:

  1. Name
  2. All ages over 89 or dates indicating such an age
  3. All elements of dates, except year, for dates directly related to the individual, including date of birth, admission date, discharge date and date of death
  4. All geographic subdivisions smaller than a state, including street address, city, county and precinct (zip code or equivalents must be removed but can retain the first three digits if the geographic unit to which the zip code applies contains more than 20,000 people)
  5. Telephone number
  6. Fax number
  7. Email address
  8. Social security number
  9. Medical record number
  10. Health plan number
  11. Account numbers
  12. Certificate or license numbers
  13. Vehicle identification or serial numbers, including license plate numbers
  14. Device identification or serial numbers
  15. Universal Resource Locators (URLs)
  16. Internet Protocol (IP) addresses
  17. Biometric identifiers
  18. Full face photographs and comparable images
  19. Any other unique identifying number, characteristic or code