Types of Review: Exempt, Expedited, and Full Board Review
Depending on risk and subject demographic, a proposal will fall into one of three categories: exempt, expedited, or full board review. Although investigators should request the level of review they feel is appropriate for their project, this should not be a major concern. The IRB Chair, in consultation with committee members if necessary, will determine the correct level of review.
"Exempt" means review by one IRB member, sometimes in consultation with others. A research activity may be declared exempt if it is considered low-risk and the only involvement of human subjects will be in the categories outlined in 45 CFR 46.101(b). Briefly described, these categories are:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices.
- Research using anonymous or no-risk tests, surveys, interviews, or observations.
- Most research involving pubic officials.
- Research involving the collection or study of existing data if it is publically available or if subjects cannot be identified.
- Research examining public benefit or service programs.
- Taste and food quality evaluation and consumer acceptance studies.
Although subject consent is always needed, signed consent forms are typically not recommended if they are the only identifying variable in an otherwise anonymous project. Approval for exempt projects is good for 5 years, unless the researchers decide to change the protocol.
Most exempt level reviews are completed within two weeks after being received by the IRB from the department chair.
Projects not eligible for an exempt review may be eligible for an expedited review. "Expedited" means review by the IRB chair and one or more experienced reviewers.
In general, research may qualify for expedited review if it is judged to involve only minimal risk, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate informed consent procedures. For example, the collection of physical data through non-invasive procedures is eligible for an expedited review, including:
- Height and weight
- ECG, MRI, Ultrasound
- Moderate exercise
- Blood or other bodily fluids
The full list of categories of research that may be reviewed as expedited can be found in 45 CFR 46.110.
Most expedited reviews are completed within approximately three weeks after being received by the IRB from the department chair.
A full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review. Individuals intending to conduct research that requires a full board review should allow ample time to complete the review process.
The following categories of research require full IRB approval:
- Projects for which the level of risk is determined by the IRB Chair to be greater than minimal.
- Projects that involve the intentional deception of subjects, such that misleading or untruthful information will be provided to participants.
- Projects that involve sensitive or protected populations (such as children or cognitively disabled individuals).
- Projects that plan to use procedures that are personally intrusive, stressful, or potentially traumatic (stress can be physical, psychological, social, financial, or legal).
Regularly scheduled IRB meetings are early, mid, and late semester. Applications requiring a full board review should be received by the IRB at least two weeks before a meeting in order to be reviewed. Contact ORSP for specific meeting dates.
Next: About Informed Consent