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Office of Research and Innovation
Research Administration and Compliance
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Step 1: Determining if IRB Approval is Required

Do I need IRB Approval? 

The NC State IRB Office asks three sequential questions to determine if IRB approval is necessary for a project and, if so, from where the IRB approval should be sought. If the answer is “yes” 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 “no,” then the study does not need IRB approval.If the answer to question number three is “no,” 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 research study is a very careful way of looking at something and collecting data in order to answer a specific question aiming to inform or solve a problem. Research can be done with or without the involvement of humans. Regulated research with living humans at NC State University is supervised by the IRB office and research with vertebrate animals that aren’t humans at NC State is supervised by the Institutional Animal Care and Use Committee (IACUC). Research is different from quality improvement and assessment/evaluation activities.

Is it Research?

Research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” There are two aspects of this definition that make a research project regulated, and both aspects must be present in a research project for it to be reviewed and approved by the IRB. These aspects include the practice of a systematic investigation and the contribution to generalizable knowledge. Note: if you are testing the safety or efficacy of a device, drug, or biologic, regardless of contributing to generalizable knowledge, you are considered to be completing research by the FDA.

  • If the answer to the question “Is It Research?” is “no,” then IRB approval is not required. Please also review the pilot study and feasibility work IRB unit standard.
  • If the answer to this question is “yes,” then IRB approval may be required. To determine the IRB’s jurisdiction, we ask “Is it Human Subjects Research?” 

Is it Human Subjects Research?

Human subject is defined as a living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and 2) uses, studies, or analyzes the information or biospecimens, including manipulation of the human’s environment. This also includes when an investigator conducting research obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. You can read more in our guidance “Is is human subjects research? The definition of a human subject.”

Is IRB Approval through NC State University Needed?

If you are affiliated with NC State University and acting as a researcher for NC State University — even if you are a student — you are considered an agent or an employee. As a result, your research project will need IRB approval through NC State University. This can only be done by submitting an application to the NC State IRB.

An institution’s employees or agents refers to individuals who either:

  • Act on behalf of the institution in the scope of their role at NC State;
  • Exercise institutional authority or responsibility in the scope of their role at NC State; or
  • Perform institutionally designated activities in the scope of their role at NC State.

Employees and agents can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

  • If you are completing cooperative research with other institutions affiliated with an IRB or with individuals unaffiliated with an IRB, please review our guidance on Cooperative Research.
  • If you are an NC State researcher and you think you qualify for the use of a private IRB due to the “more than minimal risk” nature of your biomedical study, please review our information about the use of the WCG IRB as an NC State Researcher.
  • If an investigator is engaging in outside research for another entity and there is no NC State University involvement, the NC State University IRB cannot serve as the IRB of record (reviewing IRB). This includes when an NC State person is serving as an investigator and completing human subjects work as a part of their “Start Up,” or other External Professional Activities for Pay. For faculty innovators and NC State Start-Up companies, please refer to the NC State Office of Research Commercialization for additional information.
  • If you are unaffiliated with NC State University and you would like to target NC State University populations, you must seek “gatekeeper permission” from the appropriate person at NC State. This is usually a department head, dean, or director. IRB approval is not required unless there is an NC State person on the research team implementing the project. 

What Type of Approval Do I need?

There are three levels of review: convened full board, expedited, and administrative. The IRB determines which level of review is required, and consequently, whether approval — if granted — will result in an exemption determination, or result in either expedited or convened full board review. Related to these reviews, a researcher can also request a “Not Human Subjects Research” determination or, for studies about to be funded, a “.118 Determination” “Just-in-Time” request. 

Why there are Different Types of Review Processes

Individual research studies range in type and complexity, and as a result, are governed by varying laws and regulations with different approval standards. The regulation governing research with human subjects (45 CFR 46.111) details the criteria for approval and the varying types of review/approval levels. 

The criteria for IRB approval focuses on balancing the risks and benefits of the individual research project, how the individual project transparently communicates the research and its risks and benefits to participants, and how the individual research project uses sound research design that does not expose people to unnecessary risk. 

Each Level of Review/Approval Explained

This type of review and approval is carried out by an IRB office staff member and the convened IRB full board. An IRB office staff member helps the researcher prepare their application for final review by the IRB-convened full board. Studies reviewed by the IRB convened full board are either more than minimal risk to participants or they are minimal risk to participants but do not fit into any of the expedited categories. Studies reviewed at the convened full board level must have all informed consent requirements of 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.

Occasionally, a convened full board study will warrant an additional layer 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. 

The convened full board meets once a month, usually on the first Tuesday of the month (varies due to the academic calendar, holidays, or the need for an out-of-cycle meeting). 

This type of review and approval is carried out by an IRB office staff member and an IRB full board member with appropriate expertise. An IRB office staff member helps you prepare your application for final review by the full board member. When the application is ready for final review, the IRB staff member will refer the study to the full board member for final review. Please note: expedited review does not equate to “rushed review” in this sense; it is simply the name of the “mid-level” review. 

Expedited review is for studies that are both minimal risk and fit into one of the “Expedited Review Categories.” Every expedited-level study is subject to the regulations outlined in 45 CFR 46.110. Studies reviewed at the expedited level must have all informed consent requirements of 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111. 

This type of review is completed by IRB office staff. Determinations from this type of review can only lead to a determination of exemption. Though not all IRBs review and approve studies that can be exempted from 45 CFR 46.111, NC State University’s human subject regulation (REG 10.10.03) requires that the IRB office make the exemption determination instead of the researcher. 

An exemption determination means that your study is minimal risk and it fits into the categories of exemption outlined in 45 CFR 46.104. Research studies determined exempt from the regulations are still considered research with human subjects. An exemption determination just means that not all of the regulations in 45 CFR 46 must be applied to the individual study and the NC State IRB office may instead choose whether or not to apply some standards. Studies reviewed at this level may be required to undergo a limited IRB review. Limited IRB review considers data protection and, where appropriate, broad consent — and can be completed by IRB staff. 

A “Not Human Subjects Research” determination means that the research activity is not regulated by the IRB in any way because the activity is not considered human subjects research. A study is not considered human subjects research if the answer to the questions “Is it research as defined by the federal regulations?” or “Is it human subjects research as defined by the federal regulations?” is no. 

Answering “no” to either of those questions means the IRB does not have jurisdiction to review the project and no IRB approval is necessary. Note that this determination is different from a study reviewed and determined to be exempt. Exempt studies are considered human subjects research; they merely meet certain criteria that allow for flexibility of review. A “Not Human Subjects Research”(NHSR) determination means that the project is not considered human subjects research at all.  

Email irb-director@ncsu.edu or request an official NHSR letter if you need IRB confirmation of a “Not Human Subjects” determination.

Some organizations that sponsor research require IRB approval or pending approval before accepting new grant proposals. Other sponsors, including the National Institute of Health (NIH) and the National Science Foundation (NSF), as well as some private, non-profit organizations, will accept new grant proposals with the understanding that the researcher will proceed with the IRB review process upon receiving notification of a score in the fundable range. This is called the Just-in-Time procedure. Please refer to the guidance “NIH Grants and the IRB” for Just-In-Time guidance for NIH grants. 

In addition to the “Just-In-Time” approval process, the NC State IRB also can provide researchers with a “.118 Determination Letter.” A .118 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 IRB application to receive a .118 determination letter. 

Applying for a .118 Determination or Just-In-Time Request

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:

  1. Open a new IRB application in the eIRB system.
  2. Write “[.118 Determination Request]:” in the protocol’s title box along with the protocol title if the grant proposal is for NSF or “[Just-In-Time Request]:” for NIH grant proposals. The protocol title should match your grant title.
  3. List the funding source as “NSF” for .118 determinations or, for Just-In-Time requests, list the NIH as the funding source.
  4. List the faculty point of contact for the protocol. This should be someone at NC State who is also listed on the grant application.
  5. For .118 determination requests, go to the description tab of the eIRB application. State in the first narrative box that “All procedures and supplemental documents will be submitted for IRB review and approval before it is implemented. No study procedures including recruitment, consent, data collection, or data analysis will occur until after the PI has complete and full IRB approval via an amendment process.” For Just-In-Time requests, all designed procedures, or as many designed procedures as are presently available, should be provided and the IRB application should be completed to the best of the researcher’s ability.
  6. Click the “Save” button above the narrative boxes you just pasted text into.
  7. Navigate to the routing and status tab of the eIRB application and click the “Submit to IRB office” button. Aside from the information mentioned above that you must include in the title and description tabs, the rest of an IRB application for a .118 determination should be blank. The IRB office cannot process a .118 determination request or Just-In-Time request without a submitted protocol.
  8. Complete the letter request form on the NC State IRB website for a .118 determination or Just-In-Time request letter. No requests submitted over email can be honored.

Please note, a .118 determination and Just-In-Time request is staged research; you should first familiarize yourself with the NC State IRB guidance on phased and staged research protocols before requesting a .118 determination or a Just-In-Time request.

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