IRB Review Types
Human subjects research must be reviewed and approved by the CSU 福利小视频 Institutional Review Board (IRB) prior to the start of any study involving data collection. The level of review—Exempt, Expedited, or Full Board—depends on the level of risk to participants and the nature of the research procedures.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during routine physical or psychological tests (45 CFR 46.102(j)).
Investigators are asked to select the review category they believe best applies to their study when submitting a protocol; however, final determinations are made by the IRB office during the review process.
Use the sections below to learn more about each review type.
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Non Human-Subjects Research
To be categorized as human subjects research, the proposed research much meet the definition of research and involve human subjects. These definitions come from the US Department of Human and Health Services (HHS).
- Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subjects: A living individual about whom an investigator will obtain either information or biospecimens through intervention or interaction; or identifiable private information or biospecimens.
If you have questions about whether an activity is Human Research, contact the IRB at CSUP. If your project is not human-subject research and you wish to have a written determination, please submit a Not Human Subjects Research (NHSR) Kuali protocol application.
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Exempt Research
Summary of Exempt Research. See for detailed descriptions of these exemption categories.
The 2018 Common Rule allows some types of human subjects research to be “exempt” from regulatory requirements. This does not mean that the research is exempt from IRB review, only that the research is exempt from the full set of federal oversight, for example full board and continuing review, along with some other modifications. There are eight categories of exempt review. It is important that the IRB reviewer consider all of the proposed research activities and documents, because the proposed research would not be eligible for exempt review if any single research activity were to fall outside of the exemption categories [45 CFR 46.104(a)]
Summary of Exemption Categories:
- Research conducted in established or commonly accepted educational settings that involves normal educational practices not likely to adversely impact students’ opportunity to learn required educational content.
- Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior when the data obtained are either (i) anonymous; (ii) confidential and not sensitive; or (iii) not anonymous AND the IRB conducts a limited IRB review to make the necessary determination §46.111(a)(7).
- Research involving benign behavioral interventions in conjunction with data collection from an adult participant through written or verbal responses or audiovisual recording when the participant prospectively agrees to participate. Deception is not allowed under this category unless the participant prospectively agrees to be unaware of or misled regarding the nature or purposes of the research. If your study involves deception, please speak with an IRB representative before submitting.
- Secondary research for which consent is not required.
- Public benefit or service programs, for example internal studies by federal employees and studies under contracts or consulting arrangements.
- Taste and food quality evaluation and consumer acceptance studies.
- Storage or maintenance for secondary research for which broad consent is required.
- Secondary research for which broad consent is required.
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Expedited Research
Expedited review is a type of review wherein the IRB chair or a designated member of the IRB with sufficient experience reviews proposed research in lieu of a review by the convened board. Expedited review must be minimal risk and must fit within one of the 9 designated categories. Below is a summary of each category. For more information, please visit
Category 1: Clinical studies of drugs and medical devices only when certain conditions are met.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture when certain conditions are met.
Category 3: Prospective collection of biological specimens for research purposes by non-invasive means.
Category 4: Collection of data through noninvasive procedures routinely employed in clinical practice excluding x-rays or other procedures involving microwaves.
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes.
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 7: Research on individual or group characteristics or behaviors, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Category 8: Continuing review of research previously approved by the convened IRB when the protocol meets certain criteria, including that the research is closed to new participants.
Category 9: Continuing review of research where certain criteria apply.
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Full Committee Review
According to federal regulations, all nonexempt research must be reviewed by the convened IRB unless the research is eligible for expedited review under one of the eight categories listed above. Research may be designated as Full Board Review because it does not meet one of the regulatory definitions of minimal risk; it does not fall into a category for expedited review; because the reviewer does not believe that all criteria for approval are met; or because local policies require full board review and approval.
