IRB Levels of Review
Human subjects research proposals are reviews via one of three processes: "exempt," "expedited," or "full review."
“Exempt” and “Expedited” Review
Possible with certain categories of research (as specified in the federal regulations) and may be reviewed outside of the full IRB committee by one or more experienced IRB members.
- Expedited and Exempt protocols are reviewed in the order received; there are no deadlines for these protocols. However, this does not guarantee a fast approval process. Submit your IRB applications as early as possible before the anticipated start date.
"Full Review"
Protocols that do not qualify for exempt or expedited review must be reviewed by the full IRB committee at a convened meeting.
Exempt
- Exempt DOES NOT mean the study is exempt from review.
- Exempt level review requires a determination through submission of an IRB application. The determination is made at the administrative level by a reviewer in the Office of Research Compliance. The review will remain at this level through determination, after which a determination letter will be provided.
- If your study involves prisoners or other institutionalized persons, it does not qualify for exemption unless the research is aimed at involving a broader subject population that only incidentally includes prisoners or institutionalized persons (i.e., they become incarcerated or institutionalized during the course of the research).
- To qualify for Exempt level review, the research study must fall into any of the eight categories delineated in the federal regulations (see below).
Eight categories represent studies that present minimal risk to subjects.
Research involving normal educational practice in an established or educational setting
May apply to research involving children, pregnant women, human fetuses, and neonates. Examples:
- Evaluating the use of accepted or revised standardized tests
- Testing or comparing a curriculum or lesson
- A program evaluation of pharmacy continuing education
- Tests, surveys, interviews, observations
Research involving educational tests, survey procedures, interview procedures, or observation of public behavior (may include anonymous data, identifiable non-sensitive data; or identifiable and sensitive data for which an IRB conducts a limited IRB review to make the determination)
May apply to research involving pregnant women, human fetuses, and neonates.
May only apply to research involving children if the research is limited to educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed AND the information obtained is not identifiable and sensitive in nature.
Examples:
- Surveying teachers, nurses or doctors about a technique or an outcome
- Conducting an audio recorded interview about an experience or an opinion of a community program
Research involving benign behavioral interventions (may include anonymous data, identifiable non-sensitive data; or identifiable and sensitive data for which an IRB conducts a limited IRB review to make the determination)
May apply to research involving children, pregnant women, human fetuses, and neonates.
Note: If your study involves deception or incomplete disclosure to subjects, it does not qualify for this exemption unless the subject is informed prior to agreeing to participate that they will be unaware of or misled regarding the nature of the research or purpose of the research.
- Subjects will play an online game
- Subjects will solve puzzles under various noise conditions
- Subjects will decide how to allocate a nominal amount of received cash between themselves and someone else
Research involving existing data, documents, and specimens (may include publicly available identifiable data or specimens, unidentifiable data or specimens with no contact or re-identification, receipt/use of private health information, or research conducted by or on behalf of a federal entity)
May apply to research involving children, pregnant women, human fetuses, and neonates.
Examples:
- Retrospective chart review study with no identifiers recorded or linked (no coding)
- Analyzing existing tissue samples or a dataset with no identifiers recorded or linked (no coding)
Research involving evaluation of public programs or procedures to obtain benefits.
May apply to research involving children, pregnant women, human fetuses, and neonates.
Research involving taste and food quality evaluation, and consumer tests
May apply to research involving children, pregnant women, human fetuses, and neonates.
Research involving storage or maintenance of identifiable private information or biospecimens (broad consent and limited IRB review is required)
Does not apply to research with children.
Secondary research involving use of identifiable private information or biospecimens (broad consent and limited IRB review is required)
Does not apply to research with children.
Expedited
- Expedited categories involves collection of data or biological specimens in a manner that is not anonymous and that involves no more than minimal risk to subjects.
- Expedited level review is conducted by the IRB Chair, Vice Chair or a designated IRB member.
To qualify for expedited level review, the research must fall into any of the nine regulated categories listed below.
- Clinical studies of drugs and medical devices
- Collection of blood samples
- Prospective noninvasive collection of biological specimens (e.g., urine, saliva, feces, etc.)
- Non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
- Data, documents, records, or specimens that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
- Voice, video, digital, or image recordings made for research purposes.
- Individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
- Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Full Board Review
- Studies requiring full board review present more than minimal risk to subjects, and/or involve vulnerable populations such as prisoners or other institutionalized persons, pregnant women, fetuses, neonates, persons with diminished capacity to consent, and in some cases children.
- Proposed research studies involving human subjects that do not qualify for Exempt or Expedited review must be reviewed by the IRB at a convened meeting (full committee review). The IRB meets once a month to review full board applications. In order for your full board application to be reviewed by the board you must submit by the monthly deadline. The deadline to submit is approximately 3 weeks prior to the scheduled meeting.