IRB Policy 240 - Expedited Research

Effective date: April 11, 2026 (revised version; originally adopted on October 8, 2021)

I. Policy Purpose 

This policy establishes the requirements and procedures for the IRB's expedited review of research involving human participants that does not qualify for exempt status. This policy ensures compliance with applicable federal regulations and the ethical principles of the Belmont Report. It applies to all SIUC faculty, staff, and students conducting human subjects research.

II. Policy Definitions 

Designated Reviewer refers to the IRB Chair or an IRB member appointed by the Chair to conduct reviews on behalf of the IRB. A designated reviewer may not disapprove research and must refer any research they cannot approve under an applicable review category to a convened meeting of the IRB. 

Expedited Review is a review procedure through which research involving no more than minimal risk and falling within one or more federally established categories may be reviewed and approved by a designated reviewer rather than the full IRB board. 

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

Vulnerable Population means groups requiring additional protections under federal regulations, including minors, pregnant persons, prisoners, and individuals with diminished decision-making capacity. 

III. Policy Statement 

Research that presents no more than minimal risk and falls within one or more of the expedited review categories established under 45 CFR 46.110 may undergo expedited review by a designated reviewer rather than full board review. 

Investigators must obtain an official determination from the IRB before initiating any research activities involving human subjects.  

To qualify for expedited review, research must fall within one or more of the categories established under 45 CFR 46.110 and satisfy all of the following criteria: 

• The research presents no more than minimal risk to participants.
• The research adheres to the ethical principles of the Belmont Report, including respect for persons, beneficence, and justice.
• The research implements appropriate safeguards to protect participant privacy and the confidentiality of identifiable information.
• Investigators provide sufficient information to support an informed and voluntary decision to participate.
• The research does not involve vulnerable populations in ways that would preclude expedited review under the applicable category. 

The U.S. Department of Health and Human Services maintains a complete listing of the federal expedited review categories under 45 CFR 46.110 on its website. Falling within a federal expedited review category does not by itself establish that all criteria are met. The designated reviewer must independently assess each submission.

IV. General Procedures

A. Submission and Initial Review 

Investigators must submit a complete application to the IRB, including copies of all study materials (e.g., survey instruments, interview guides, recruitment scripts, consent documents, etc.). The designated reviewer will evaluate submissions to determine whether the research meets expedited review criteria and may request additional information or clarification before issuing a determination.  

The designated reviewer may refer any application to the full IRB board for review at any time, including when the research raises questions beyond the scope of expedited review or when the designated reviewer determines that full board consideration is warranted. 

Investigators must receive written approval before beginning any research activities involving human subjects. The ORC will document all determinations in its records and inform the IRB of all research approved under the expedited review procedure.

B. Modifications to Approved Expedited Research 

Investigators must submit proposed changes to approved expedited research to the IRB before implementation. Modifications to previously approved expedited research may be reviewed and approved through a designated reviewer. The designated reviewer will determine whether the research continues to qualify for expedited review. Changes that affect the initial determination may require referral to full board review.  

Minor administrative changes (e.g., typographical corrections to materials that do not alter meaning or scope) do not require resubmission but should be documented by the investigator and disclosed at the time of any subsequent continuing or modification review.

C. Continuing Review 

Expedited research requires continuing review at least once per year. Investigators must submit a request for continuing review to the IRB confirming that the study remains active, that no unanticipated problems have occurred, and that the research complies with the approved protocol, applicable federal regulations, and institutional policies. A designated reviewer may conduct continuing review. The ORC will document and inform the IRB of all continuing reviews. 

If an approval expires before completion of a continuing review, investigators must immediately cease all activities involving human subjects and obtain new approval before resuming any activity involving participants, including recruitment.

D. Reporting and Records  

Investigators must promptly report any of the following to the IRB in accordance with applicable institutional policies:

• Unanticipated problems involving risks to participants or others
• Adverse events or unexpected harm to participants
• Breaches of confidentiality or data security incidents
• Instances of noncompliance with the approved protocol or institutional requirements 

The IRB evaluates all reports in accordance with applicable policies. 

Research records must be retained in accordance with all applicable institutional and federal requirements.