IRB Determination Checklist

Step 1: Identify the Type of Project

Is this a course/class project?

• Yes — Class/Course Project

  An assignment completed as part of a course for educational purposes.

• No — Research/Other Project

  An independent faculty, staff, thesis, dissertation, or other project conducted outside the requirements of a specific course.

Important: A class/course project may still require IRB review if it involves human subjects research.

Step 2: Is This Human Subjects Research?

Does the project involve a systematic investigation designed to develop or contribute to generalizable knowledge?

• No → Continue to Step 3: Not Human Subjects Research
• Yes → Continue to Step 4: Determine the Appropriate Level of IRB Review

Examples of projects that may contribute to generalizable knowledge:

• ER dental visit study intended to inform broader trends or practices
• Simulation training study intended to inform educational practices beyond the course
• Student perception study intended to inform interventions or practices beyond the immediate classroom

Step 3: Not Human Subjects Research — Start Here

• No interaction or intervention with individuals
• No identifiable private information
• Fully de-identified data with no codes or links
• Internal program evaluation or quality improvement only
• Literature review or meta-analysis

If ALL applicable criteria are met → Not Human Subjects Research

NOTE: Submit for administrative determination/review.

* May require additional review as determined by the advisor, sponsor, or IRB.

Step 4: Exempt Review — Lowest Risk

• Anonymous surveys/interviews
• No identifiers collected or linked
• Observation of public behavior
• Publicly available data
• De-identified existing data
• Normal educational practices in standard educational settings

If applicable and no higher-risk elements are present → Exempt Review

NOTE: Submit for review and determination by the IRB Chair.

What is Exempt?

Research that meets one or more specific federal exemption categories and involves no more than minimal risk. Exempt research still requires an IRB determination before the research begins and may require informed consent or an information statement when appropriate. Once determined exempt, it is generally not subject to continuing IRB review.

Step 5: Expedited Review — Minimal Risk

• Minimal risk only (no greater than the risks encountered in daily life or during routine examinations)
• Noninvasive procedures involving adults
• Audio/voice recordings
• Moderate exercise involving healthy adults
• Existing data, records, or specimens that may be identifiable
• Behavioral research without significant stress, manipulation, or deception

If ANY apply and no Full Board triggers are present → Expedited Review

NOTE: Submit for review by the IRB Chair or an IRB-designated reviewer.

What is Expedited Review?

Research involving no more than minimal risk that falls within federally established expedited review categories. Some research involving vulnerable populations may qualify when appropriate protections are in place.

Step 6: Full Board Review — Greater Than Minimal Risk

• Greater than minimal risk
• Psychological stress, significant discomfort, or harm is possible
• Sensitive topics that could create additional risk (e.g., illegal activity, drug/alcohol use, or sexual behavior)
• Identifiable sensitive information
• Potential risk to employment, reputation, legal standing, or other important interests
• Vulnerable populations requiring additional protections (e.g., children or prisoners)
• Deception or incomplete disclosure that requires IRB consideration
• Non-standard clinical procedures or interventions
• Collection of blood or biological specimens not part of routine clinical care
• External sponsor requires Full Board review

If ANY apply → Full Board Review

NOTE: The full IRB committee will review the research at a convened meeting.

Quick Logic

Class/Course Project or Research/Other Project?

Systematic investigation designed to develop or contribute to generalizable knowledge?

• No → Not Human Subjects Research → Administrative determination
• Yes → Human Subjects Research → Determine level of IRB review

Meets an Exempt Category?

→ Exempt Review → IRB Chair determination

Minimal Risk + Meets Expedited Criteria?

→ Expedited Review → IRB Chair or designated reviewer

Greater than Minimal Risk or Full Board Trigger?

→ Full Board Review → Entire IRB Committee