Types of Research Review
The IRB categorizes research proposals into three review levels based on the potential risk to human subjects:
1. Exempt Research
Applies to studies presenting no more than minimal risk to non-vulnerable participants. The IRB Chair or Coordinator determines exemption status.
- Research on instructional strategies, curricula, or classroom management techniques
- Research using cognitive tests or public observation (provided data is anonymous and non-damaging)
- Research involving publicly available or fully de-identified diagnostic specimens and data
- Evaluation of public service or benefit programs
- Taste and food quality studies involving wholesome, additive-free foods or safe agricultural limits
2. Expedited Review
Applies to studies involving no more than minimal risk (including certain studies involving minors or minor protocol adjustments):
- Participating in observational studies or interviews with children
- Minimal-risk blood draws (e.g., finger sticks or limited venipuncture under 50 ml) or non-invasive specimen collection (hair, saliva, dental plaque)
- Non-invasive clinical measurements (e.g., MRI, ECG, EEG, Doppler blood flow, moderate exercise testing) using market-cleared devices.
3. Full Board Review
Reserved for research that involves potential risk to human subjects. Requires review by the complete IRB panel:
- Administration of new investigational drugs or substances
- Research involving pregnant women, fetuses in utero, or subjects with life-threatening conditions
- Physically intrusive procedures or studies causing significant physical/psychological stress
- Research involving vulnerable or protected populations (e.g., prisoners, children, individuals with mental impairments)
- Research involving sensitive/illegal behaviors where disclosure could trigger legal or civil liabilities
Continuing Review
- Protocols are approved for a maximum duration of 12 months
- Continuing review must be requested at least once per year
- Expedited process applies for continuations if no changes have been made to the protocol and no adverse events have occurred; otherwise, a full board review is required
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