Researchers are required to submit a Request for Protocol Review to the IRB if their research involves human participants or their data. The IRB will determine if the research meets the requirements for oversight, according to federal regulations (45 CFR 46).

The request must be reviewed by the IRB prior to collecting data or contacting participants. For continuing or modifying a current protocol, use the appropriate form located on the IRB Forms page.

Protocol Review Process

Step One: Protocol Completion

Complete the Request for Review, Continuation, or Modification form. The current request forms are up-to-date.

Attach Human Research and Responsible Conduct of Research (RCR) CITI course completion reports (not CITI certificates) along with any other supporting documentation such as consent/assent forms, site letter of support or permission, recruiting materials, questionnaire/survey (provide screenshots), flyers, email or phone scripts, etc.

Step Two: Submit Protocol to IRB

Submit one digital PDF attachment of your completed protocol to [email protected]. Do not submit your protocol directly to the IRB Chair.

Please do not submit:

  • Multiple attachments
  • A Word Document file
  • Scanned copies of your protocol
  • An outdated protocol review form

When your protocol has been forwarded for review, you should receive an email confirmation. The email will contain your protocol number and an estimated decision date (EDD). If you do not receive a response within 1 business day, please contact [email protected].

Step Three: Estimated Decision Date

The IRB should provide feedback or a protocol decision within 10 business days. If you do not receive feedback within 10 business days, please contact [email protected].

Please be aware that EDD dates may need to be altered due to high protocol volumes or the holiday break.

Step Four: Decisions

Decisions are based on the definition provided by 45 CFR 46 (2018 Common Rule).

The possible decisions reached could be:

  • Approved
    • You may begin your research.
  • NHPR
    • Your research is deemed not human protection research based on 45 CFR 46. Even though your research is considered NHPR, it is your responsibility as a researcher to notify the IRB if any changes in your protocol occur.
  • Further Review
    • You will need to provide clarification or corrections to your submitted materials. Once these requests are completed and highlighted in yellow, you will resubmit the updated version to [email protected]. Your protocol will receive a new decision in 10 business days.
  • Full Board Review
    • Your protocol will be placed on the agenda for the next IRB meeting. You will be notified via email, and if necessary, invited to discuss your research in greater detail with the IRB committee. Please note that not all protocols come full board.

If you have any questions or concerns about the protocol review process, please contact us at [email protected].