IRB Policy 230 Exempt Research

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Last Updated: Apr 13, 2026, 12:46 PM

Effective date: April 10, 2026 (revised version; originally adopted on October 8, 2021)

I. Policy Purpose

This policy establishes the requirements and procedures for the IRB's review and determination of whether research involving human participants qualifies for exempt status. This policy ensures compliance with applicable federal regulations and the ethical principles of the Belmont Report. This policy 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. For exempt research not requiring limited IRB review, a trained staff member within the Office of Research Compliance may carry out the review; for exempt research requiring limited review the designated reviewer or IRB Chair shall conduct. 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.

Exempt Research refers to research involving human subjects which fall within one or more exemption categories defined by federal regulations (45 CFR 46.104) and meet all required ethical criteria.

Limited Review refers to the review required for certain exempt research categories under 45 CFR 46.104(d) to evaluate provisions for protecting the privacy of participants and maintaining the confidentiality of identifiable data. The IRB Chair or a designated reviewer conducts limited reviews.

Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not 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

Investigators may not independently determine that their study qualifies for exempt status. They must obtain an official exemption from the IRB before initiating any research activities involving human subjects. Exempt research must meet applicable federal criteria, any other applicable laws, regulations, or codes, adhere to the Belmont principles, and implement safeguards to protect privacy and confidentiality.

IV.    General Procedures

A. Submission and Initial Review

Investigators must submit a complete application to the IRB along with all study materials (e.g., survey instruments, interview guides, recruitment scripts, consent scripts). The ORC documents all submissions and forwards the IRB application and materials to the designated reviewer or IRB Chair for determination.

The reviewer assesses whether the study meets exemption criteria, determines whether limited IRB review is required, and may request clarifications or revisions from the investigator. The designated reviewer or IRB Chair issues the official determination and may determine that the research qualifies for exemptions but cannot disapprove the research. If the reviewer cannot determine that the research qualifies for exemption, they must refer the submission for review under the appropriate expedited or full board review category.

B. Ethical and Regulatory Elements

To qualify for a determination, the proposed research must fall within one or more of the exemption categories established under 45 CFR 46.104(d), the principles of the Belmont Report, and:

  • Presents no more than minimal risk to participants.
  • The research must implement safeguards to protect participant privacy and confidentiality.
  • When interacting with participants, investigators provide sufficient information to support an informed and voluntary decision to participate.
  • The research does not involve vulnerable populations (e.g., minors, pregnant persons, or individuals with diminished decision-making capacity) in ways that would preclude exemption under the applicable category.
    • Exempt categories do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners (45 CFR 46.104(b)(2)).
    • Exempt 2(iii) and Exempt 3 do not apply to research with minors.
    • Exempt category 2(iii), 3(i)(c) require limited review.
  • SIUC does not utilize category 7 or 8 (broad consent).
  • FDA regulated research is generally not eligible for exemption, except where explicitly allowed by federal guidance (e.g., certain taste and food evaluation studies).
  • When required under the applicable exemption category, the IRB will conduct a limited review to ensure adequate provisions are in place to protect the privacy of participants and to maintain the confidentiality of identifiable data. Research that does not satisfy the criteria for limited review cannot be determined exempt and requires expedited or full board review.

C. Modifications to Approved Exempt Research

Investigators must submit proposed changes that could affect the study’s exemption status prior to implementation. Minor administrative changes (e.g., typographical edits) do not require IRB approval before implementation but must be documented by the investigator and included in any subsequent progress report or modification. Changes that affect the initial exemption determination may require additional review or referral to expedited or full board review.

D. Progress Reports (Continuing Review) and Study Close-Out

Exempt research does not require ongoing (continuing) IRB review; however, investigators must submit a progress report every three (3) years confirming that the study remains active and continues to be conducted in compliance with institutional policies and the original exemption determination. The ORC documents all progress reports and informs the IRB accordingly. Investigators must notify the IRB when the study is complete and submit a study close-out report.

E. Reporting and Records

Exempt research remains subject to institutional reporting requirements. 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.

F. Documentation and Recordkeeping

The ORC maintains records of all exempt determinations and progress reports. Investigators are responsible for retaining research records in accordance with institutional policies, any applicable granting or sponsor agency requirements, and federal regulations.