Institutional Review Board: Types of Review
The IRB uses the following 3 types of review when evaluating research proposals:
If the research project involves any of the following, the project will receive a full review by the IRB Board
- Support from non-university sources (e.g., government agencies) that require full IRB approval before they will release funds.
- The likelihood of risk or substantial stress or discomfort to the subject.
- Personality tests, inventories or questionnaires of a personal and sensitive nature where subjects' identities will not be anonymous to the researcher.
- Sensitive aspects of a subject's behavior that could reasonably place a subject at risk of criminal/civil liability or be damaging to a subject's financial standing or employability.
- Sensitive aspects of a subject's behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
- Health care procedures that are not conducted for the primary benefit of the subject.
- Diagnostic or therapeutic assessments, interventions, or measures that are not standard, generally acceptable, or common practice.
- Deception or procedures that are not known to the subject (e.g., the subject will not be fully informed about study objectives.)
- Special populations (e.g., children, prisoners, pregnant women, or individuals who are mentally or psychologically ill, or incompetent) unless otherwise exempt from full review per Federal statute.
- Greater than minimal risk to subjects.
If none of the above descriptors apply to the research proposal, the project may require a less rigorous, expedited review:
Here are the criteria that determine whether a project will receive expedited review:
- Involve minimal risk (If more than minimal, it needs full review.)
- Involve recording data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice
- Involve analysis of voice recordings made for research purposes
- Involve moderate exercise by healthy volunteers
- Involve research on individual or group behavior, or characteristics of individuals, without manipulation of a subject's behavior and in a manner that does not cause stress to subjects.
- Involve collection of biological samples from non-invasive procedures or venous blood samples in healthy subjects not to exceed 550 ml in 8 weeks and no more frequently than twice weekly
If none of the preceding descriptors for full or expedited review apply to the project, the research proposal falls under the category of exempt review.
Such proposals still require the submission of a Request for Review form and IRB review. Exempt review means that the proposal only requires a review by one single IRB member to confirm that the proposal does not warrant a more in-depth review by the IRB, usually your school or college representative on the IRB.
It may be helpful to see a list of some types of research proposals that may qualify for exempt review:
- Investigations of commonly accepted educational practices in established or commonly accepted settings (e.g., a faculty member or teacher is examining a new method of teaching instruction to determine educational effectiveness.)
- Analysis of information from educational tests that will be recorded in such a manner that subjects cannot be identified.
- Surveys or interviews in which responses will be recorded in such a manner that a subject cannot be identified directly or through identifiers linked to a subject. To qualify for exempt status, the surveys would not involve vulnerable populations (e.g., juveniles) or ask questions about sensitive aspects of a subject's behavior (e.g., criminal behavior.)
- Observations of public behavior (participant observation.)
- Collection or study of publicly available existing data, documents, records or specimens.
- Collection or study of existing data, documents, records or specimens in which information will be recorded or reported in such a manner that a subject cannot be identified directly or through identifiers linked to a subject.