IRB Policy 220 Levels of Review

Effective Date: April 10, 2026 (revised version; originally adopted on September 10, 2021).

I. Policy Purpose

This policy establishes the categories of IRB review for research involving human participants and describes how the IRB determines the appropriate level of review. This policy applies to all SIUC faculty, staff, and students conducting human subjects research.

II. Policy Definitions

Research means a systematic investigation, including research development, testing, and evaluation, that is designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)).

Human subject means an individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction, and uses, studies, or analyzes the information or biospecimens; or obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)).

III. Policy Statement

SIUC faculty, staff, and students conducting human subjects research must obtain an official IRB determination or approval before initiating human subjects research activities. The IRB, not the investigator, assigns the level of review in accordance with federal regulatory categories.

IV. General Procedures

A. IRB Determinations and Level of Review

The IRB conducts an initial administrative screening and review of all submitted projects to determine whether the project constitutes human subjects research and, if so, to assign the appropriate determination or level of review.

When investigators submit an IRB application and all required study materials (e.g., survey instruments, interview guides, recruitment scripts, consent scripts, etc.), the IRB Chair or designated reviewer determines the appropriate level of review based on the nature of the research, the degree of risk to participants, and applicable federal regulations. Some submissions result in a determination that the activity does not constitute human subjects research and does not require IRB review.

The IRB assigns the following levels of reviews and issues determinations/approvals as applicable:

IRB Levels of Review
Determination/Review Level	Description	See Policy
Exempt	Research involving human participants that fall within one or more federally established exemption categories at 45 CFR 46.104, presents no more than minimal risk, and meets exemption criteria of any other applicable laws, regulations, or codes. Requires an official IRB exemption determination before the research begins. The IRB Chair or a designated reviewer reviews the submission and issues the exemption determination. Note: some exempt categories require limited review.	Policy 230
Expedited	Research involving human participants which presents no more than minimal risk, falls within one or more federally established expedited review categories published in accordance with 45 CFR 46.110, and meets the criteria of any other applicable laws, regulations, or codes to be approved under an expedited review process. Requires an official IRB approval before research begins. The IRB Chair or a designated reviewer reviews and approves the research.	Policy 240
Full Board	Research involving human participants that presents more than minimal risk or does not qualify for exempt or expedited review, and meets the criteria of any other applicable laws, regulations, or codes for the approval of human subjects research. Requires an official IRB approval before research begins. The IRB reviews and approves the research at a convened meeting with a quorum present.	Policy 250
Not Human Subjects Research (NHSR)	The activity does not meet the federal definition of research involving human subjects found at 45 CFR 46. The IRB encourages iinvestigators to request a formal determination letter before beginning the activity. Investigators who do not request a determination are responsible for ensuring the activity does not meet the definition of human subjects research. The IRB cannot issue determinations after activities have begun.	Section IV.C

B. General Review Process

For information on the IRB review process, the ethical principles governing human subjects research at SIUC, and investigator responsibilities, see policies 200 and 210.

C. Activities Not Requiring Review

Some activities do not require IRB review because they do not meet the federal definition of human subjects research, as defined by federal regulations. Common examples include:

Oral history and journalistic activities.
Course-based activities designed to teach research methods where investigators do not intend to generalize or distribute findings. For guidance on course-based activities, see Guidance for Class Projects.
Quality improvement or program evaluation activities conducted solely to improve internal institutional programs where findings will not be generalized.

Upon request, the IRB will review a submitted project and, when appropriate, issue a Not Human Subjects Research (NHSR) determination. The IRB will not issue an NHSR determination for activities that an investigator has already initiated. Investigators must contact the IRB before beginning an activity if they are unsure whether it requires review.