IRB Review Process

Research activities that meet the federal definition of Human Subjects Research (HSR) must be reviewed by Research Integrity & Compliance (RIC) and/or the Institutional Review Board (IRB).

If a project does not meet the federal definition of HSR, formal IRB review and approval may not be required. For assistance with this determination, researchers should submit their proposed study in Cayuse Human Ethics and select Activities that may not meet the federal definition of “Human Subjects Research” as the “Project Type” in the Basic Information section of the application form. For additional self-determination guidance, refer to our Examples of Activities That May or May Not Require IRB Review.

Review Types

There are three types of IRB review: Exempt, Expedited, and Full Board.

The appropriate review type will be determined by RIC and/or the IRB at the time of initial submission and may be reassessed in subsequent submissions, such as for modifications or continuing reviews (if required). The review type determination is based on the level of risk associated with the study, as defined by federal regulations.

Exempt research studies involve no greater than minimal risk and must fall within one or more exemption categories as defined by federal regulations. Following IRB review, Exempt studies will receive an Exempt Verification Letter, rather than an Approval Letter.

  • In order to ensure the study continues to qualify for exemption, certain proposed changes to exempt studies must be submitted as a modification for IRB review prior to implementation. For more information on which changes require modification submission, refer to Modifications to Exempt Research.
  • Exempt studies do not require Continuing Review (Renewals); however, RIC maintains institutional oversight and requires an Administrative Check-In every two years.
  • Researchers are expected to submit a study closure when the exempt project is no longer active. Additional details are available on the After IRB Approval page.

Although classified as “exempt,” these studies still require IRB review and must meet specific regulatory criteria for exemption. This designation does not reduce the investigator’s ethical responsibilities to participants as articulated in the Belmont Report and disciplinary codes of professional conduct.

Expedited research studies involve no greater than minimal risk and must fall within one or more of the expedited review categories as defined in federal regulations. These studies are reviewed and approved by designated IRB member reviewer(s), rather than the full board.

  • Any proposed change to previously approved research must be submitted as a modification for IRB review prior to implementation.
  • Under the Revised Common Rule, certain Expedited studies may require Continuing Reviews, while others may not. RIC maintains institutional oversight and requires an Administrative Check-In every two years.
    • For studies requiring Continuing Review, a Renewal submission must be completed in Cayuse Human Ethics at least 45 days prior to the IRB-issued expiration date. Additional details are available on the After IRB Approval page.
  • Researchers are expected to submit a study closure when the project is no longer active.

Research that involves greater than minimal risk, or does not qualify for Exempt or Expedited review, must be reviewed by the IRB members during a fully convened board meeting.

  • Any proposed change to previously approved research must be submitted as a modification for IRB review prior to implementation. In some cases, minor changes may qualify for review by designated IRB member(s) rather than the full board.
  • Studies that undergo Full Board review require Continuing Review (Renewal) prior to the IRB-issued expiration date. A Renewal submission must be completed in Cayuse Human Ethics at least 45 days prior to expiration. Additional details are available on the After IRB Approval page.
  • Researchers are expected to submit a study closure when the project is no longer active.

The IRB Review Process

All human subject research studies must be submitted through Cayuse Human Ethics and follow a structured review process:

1. Administrative Pre-Review

RIC reviews the submission for completeness and may request administrative revisions or additional information before assigning the study for IRB review.

2. IRB Review

The study is reviewed by the IRB, based on its appropriate review type (Exempt, Expedited, or Full Board). The review is performed by either a designated IRB member reviewer and/or the full board, as applicable.

3. Determination Issued

A formal study determination is issued by the IRB. which may include:

  • Approved
  • Approved with Stipulations (minor changes or clarifications are required before research begins)
  • Deferred (additional information or revisions are required)
  • Not Approved

It is common for studies to go through one or more rounds of revision during the IRB review process. Investigators will be notified via email when revisions are requested, and all comments must be addressed before resubmitting for IRB review. Timely responses to these requests will help facilitate review.

Review Timelines

Study submissions are reviewed in the order they are received. The time from submission to approval depends on several factors, including the completeness of the application, the need for revisions, and current submission volume.

Typical review timelines for initial study submissions are:

  • Exempt: approximately 1–2 weeks
  • Expedited: approximately 1–2 weeks
  • Full Board: approximately 4–6 weeks

Modifications and Renewals are typically reviewed within 1–2 weeks.

Investigators are strongly encouraged to submit well in advance of their anticipated start date to allow sufficient time for review and approval.