The NC State IRB office asks three sequential questions to determine if IRB approval is necessary for a project and from where the IRB approval should be sought. If the answer is \u201cyes\u201d to the first question, we then proceed to the next question, and so on. If the answer to one of the first two questions is \u201cno,\u201d then the study does not need IRB approval.If the answer to question number three is \u201cno,\u201d the project does not require IRB approval through NC State University but may require it elsewhere. If a researcher needs an official determination regarding if IRB approval is required or not required, please contact IRB-Director@ncsu.edu<\/a>.<\/p>\n\n\n\n Research<\/a> is defined as a systematic investigation designed to develop or contribute to generalizable knowledge. At NC State, regulated research is supervised by two distinct bodies. The IRB office oversees research involving living humans, whereas IACUC<\/a> oversees research involving non-human vertebrate animals. <\/p>\n\n\n\n Evaluation, assessment, and quality improvement activities<\/a> can be systematic but they generally do not aim to create generalizable knowledge. These activities only cross over into regulated research if the work will be used for any other purpose (thus contributing to generalizable knowledge) OR the work involves humans and an FDA “test article” (e.g., an AI tool, medical device, software application, wearable, biologic, drug) under 21 CFR<\/a> regardless of whether the work is systematic or the intent is to generalize.<\/p>\n\n\n\n To meet the definition of research, your project must involve both a systematic investigation and an intent to generate or contribute to generalizable knowledge unless the FDA exception above applies.<\/p>\n\n\n\n A human subject is a living individual “about whom” a researcher collects or analyzes data. <\/p>\n\n\n\n Your project involves human subjects if you, as a researcher, do any of the following:<\/p>\n\n\n\n If your project meets both definitions – it is research and human subjects research – you must submit an IRB application. Approval can never be retroactive, so you must receive it before recruiting participants, collecting\/scraping data, or accessing identifiable private records or biospecimens. <\/p>\n\n\n\n For more nuanced details, please review our guidance “Is is human subjects research? The definition of a human subject<\/a>.”<\/p>\n\n\n\n Whether you can get IRB approval through NC State University for a project that is “research” and “human subjects research” depends on your affiliation and the nature of your project.<\/p>\n\n\n\n You are considered an agent of the institution if you are currently at NC State University as a student, faculty, or staff member. If the project meets the definition of research, human subjects research, and the research will be within the scope of your role at NC State University, you should submit to the NC State University IRB for protocol approval unless the research falls into one of the special circumstances below and you’ve consulted with the NC State IRB office to confirm that the office cannot serve as the IRB of Record for your project.<\/p>\n\n\n\n If you are not affiliated with NC State University, you do not need NC State University IRB approval unless an NC State person is on your research team. However, to target NC State populations for research purposes, you must secure the following permissions:<\/p>\n\n\n\n The IRB office assigns the appropriate review level for your project to ensure it balances risks and benefits and protects participants per 45 CFR 46.111<\/a>. Because the review level depends on complex, shifting regulations, researchers cannot request a specific review level that is lower than what the IRB determines is necessary. While the IRB determines the minimum required review, funders, sponsors, or data providers may demand a stricter level of review. The NC State IRB will facilitate this higher level of review if requested.<\/p>\n\n\n\n Research studies vary in complexity and risk, which dictates the level of IRB review required under 45 CFR 46.111<\/a>. The IRB focuses on balancing risks and benefits, ensuring transparent communication with participants, and verifying sound research design that does not expose participants to unnecessary risk. <\/p>\n\n\n \n \n\n Though not all IRBs review and approve studies that can be exempted from the broader federal regulations in 45 CFR 46<\/a>, NC State University’s human subject regulation (REG 10.10.03<\/a>) requires that the IRB office make the exemption determination instead of the researcher. <\/p>\n\n\n\n IRB staff handle the pre-review, final review, and approval of all studies that qualify for an exemption determination.<\/a> <\/p>\n\n\n\n Some exempt studies are required to undergo a limited IRB review. Limited IRB review considers a study’s data management plan and, where appropriate, broad consent when determining if the study can be approved. Limited review occurs concurrently with IRB review and approval. <\/p>\n\n\n\n Minimal risk studies that would normally require expedited review can sometimes be reviewed at the exempt level if the study qualifies for a FLEX exemption per the NC State University IRB unit standard on exemption requests. Studies that do not qualify for a FLEX exemption include, but are not limited to, those that are:<\/p>\n\n\n\n \n \n\n Expedited studies are minimal risk and fit into one of the federally defined categories eligible for expedited review<\/a>. They are subject to all regulations of 45 CFR 46.111<\/a> and 45 CFR 46.116<\/a>.<\/p>\n\n\n\n An IRB office staff member conducts an expedited protocol’s pre-review but the final review and approval is done by an IRB full board member with appropriate expertise in the research methods and population(s) targeted.<\/p>\n\n\n\n Please note: <\/strong>Expedited is simply the regulatory name of \u201cmid-level\u201d IRB review; it does not mean the review is rushed.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n For studies that are more than minimal risk, or minimal risk studies that do not fit into expedited categories, an IRB office staff member pre-reviews the protocol before sending it for final review and approval by the convened full board. <\/p>\n\n\n\n The full board meets once a month (usually the first Tuesday). Additional review layers may be required depending on the study’s complexity, sponsorship, or international elements. Studies reviewed at the convened full board level must have all informed consent requirements of 45 CFR 46.116<\/a> (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111<\/a>.<\/p>\n\n\n\n Occasionally, a convened full board study will warrant additional layers of review. This can be due to the research design; the annual review requirements for an individual study; additional obligations from applicable regulations; sponsor requirements; special populations considerations; or in some cases, the study conducting international research. <\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n If your project does not meet the federal definitions of “research” and “human subjects research,” the IRB does not have jurisdiction. In these cases, complete the NHSR Request Form<\/a>. IRB staff will respond in several business days to follow-up. You can then request an official NHSR letter<\/a> if needed. <\/p>\n\n\n\n Please note: An NHSR determination is different from exemption determination. Studies that receive an exemption determination are considered human subjects research but meet certain criteria that allow for flexibility of review. A \u201cNot Human Subjects Research”(NHSR) determination means that the project is not considered human subjects research at all. <\/em> <\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n Some research sponsors require IRB approval or pending approval before accepting new grant proposals. Because these protocols are not yet fully developed, the IRB offers preliminary determinations. Grant proposals applying for NIH funding can seek a type of preliminary determination called the “Just-In-Time Approval” or “JIT.” Please refer to the guidance \u201cNIH Grants and the IRB<\/a>\u201d for Just-In-Time guidance for NIH grants. <\/p>\n\n\n\n Applying for Just-In-Time Approval (NIH studies only)<\/strong><\/p>\n\n\n\n To seek Just-In-Time approval, researchers must complete the following steps:<\/p>\n\n\n\n Please note, that a Just-In-Time approval is staged research; you should first familiarize yourself with the NC State IRB guidance on phased and staged research protocols<\/a> before requesting Just-In-Time approval. <\/p>\n\n\n <\/p>\n <\/details>\n\n\n \n \n\n Some research sponsors require IRB approval or pending approval before accepting new grant proposals. Because these protocols are not yet fully developed, the IRB offers preliminary determinations. For NSF studies, the NC State IRB can provide researchers with a \u201c.118 Determination Letter.” A .118 determination letter states that a study will involve research with human subjects but the protocol cannot be fully developed yet and lacks immediate plans for the involvement of human subjects. Researchers do not need a complete a full IRB application to receive a .118 determination letter. <\/p>\n\n\n\n .118 determination letters are valid for a period of 1 year. Within that year, researchers are expected to file a protocol amendment with the IRB office detailing their proposed research design in order to receive IRB approval to conduct human subjects research. <\/p>\n\n\n\n Applying for a .118 Determination (NSF studies only) <\/strong><\/p>\n\n\n\n Researchers do not need to have a fully complete IRB application to be granted a .118 determination or Just-In-Time request; they do, however, need to complete the following steps:<\/p>\n\n\n\n Please note, that a .118 determination is staged research; you should first familiarize yourself with the NC State IRB guidance on phased and staged research protocols<\/a> before requesting a .118 determination.<\/p>\n\n\n <\/p>\n <\/details>\n\n\n <\/div>\n <\/div>\n\n\nIs It Research?<\/h3>\n\n\n\n
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Is It Human Subjects Research?<\/h3>\n\n\n\n
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Is IRB Approval Through NC State University Needed?<\/h3>\n\n\n\n
For NC State Affiliates (Students, Staff, Faculty)<\/h4>\n\n\n\n
Special Circumstances<\/h5>\n\n\n\n
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For External Researchers <\/h4>\n\n\n\n
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Types of IRB Review and Approval<\/h2>\n\n\n\n
Review Levels and Determinations<\/h3>\n\n\n\n
IRB Review Levels<\/h4>\n\n\n\n
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Special Determinations<\/h4>\n\n\n\n
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IRB Review Processes<\/h3>\n\n\n\n
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Administrative Review Leading to an Exemption Determination<\/h2>\n <\/summary>\n
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Expedited Review and Approval<\/h2>\n <\/summary>\n
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Convened Full Board Review and Approval<\/h2>\n <\/summary>\n
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Not Human Subjects Research Determination<\/h2>\n <\/summary>\n
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Just-In-Time Approval for NIH Funded Studies<\/h2>\n <\/summary>\n
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.118 Determinations for NSF Funded Studies<\/h2>\n <\/summary>\n
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IRB Lifecycle<\/h3>\n \n