Institutional Review Board: Types of Review
The IRB employs two types of review: review by a single member of the IRB and a full-board review by a quorum of the IRB. Each proposal is reviewed by a single member of the IRB who determines which of the following responses is appropriate:
If the research project involves any of the following, the IRB member will determine that the project will be reviewed by the full board and will be designated as such the response.
- 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 IRB member may determine that the project's approval will be expedited. Following are the factors that determine that decision:
- Involve minimal risk (If more than minimal, the full board will evaluate the proposal.)
- 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 apply to the project, the research proposal will be designated as exempt. However, such proposals still require the submission of a Request for Review form and IRB review. Determining whether a project is exempt is the purview of the IRB, not the individual researcher. At the University of Portland, all research involving human subjects must go through the IRB.
Following are examples of research projects that are typically deemed exempt:
- 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.