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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?

Estimated Review Timeframe

  • Convened Full Board Approval – 6-7 weeks
  • Expedited Approval – 4-5 weeks
  • Exempt Approval – 1-2 weeks
  • Amendments to Existing Protocols – 2-6 weeks (depending on if convened full board approval is needed)
Note: These timeframes are for planning purposes only. The timeline begins when the application is submitted to the IRB office for review and assumes that the protocol submission is complete with all required supplemental documentation uploaded. Factors such as when the protocol is submitted, the quality of the application and materials, the study’s complexity, the IRB review level required as well as any ancillary reviews will result in a protocol’s approval possibly being completed sooner or taking longer than what is listed above. Students should work with their faculty point-of-contact for their research protocol to set appropriate IRB review and approval expectations, as the above timelines are not applicable.

There are three levels of IRB approval: convened full board, expedited, and administrative review leading to an exemption determination. The IRB office determines which level of approval is needed for a research protocol and facilitates those review processes to ensure that all NC State University research protocols meet applicable standards for compliance, ethics, and participant protections.

If a study is about to be federally funded by the National Science Foundation (NSF) or National Institutes of Health (NIH) but there are no immediate plans to conduct research with human subjects, principal investigators can apply to the IRB for a “.118 Determination” or “Just-in-Time” request respectively. Unlike the exempt, expedited, or convened full board IRB approval levels, .118 determinations and most Just-in-Time approvals are preliminary determinations for phased research that require a future protocol amendment to receive IRB approval.

For research not subject to IRB review because it does not meet the federal definition of research or human subjects research, a researcher can request a “Not Human Subjects Research” determination from the IRB office. Projects that are determined to be NHSR do not receive an IRB approval level. 

Researchers cannot request a specific IRB review level for their project due to the NC State University regulation governing human subjects research and the required expertise needed to make such determinations in context of the changing landscape of current laws, regulations, policies, standards, socio-political climates at all levels from local to international contexts as well as the specific research design, sponsorship, contracts, and agreements that inform the IRB review level required.

Sometimes a research funder or sponsor (e.g., government agency, private foundation or company) will set specific requirements related to human subjects research that they are involved with. They might ask that a study be reviewed more stringently by the IRB to meet the funder’s/sponsor’s own standards or legal requirements. While the NC State IRB decides the minimum review needed, a funder/sponsor can require more. This also sometimes occurs with contracts or other agreements related to human subjects research where, to be a good partner, the NC State University IRB will facilitate that higher level of review if requested by the appropriate agency.

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 focus 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

Convened Full Board Review and Approval

An IRB office staff member helps the researcher prepare their application before sending a study for final review and approval by the convened full board. Studies reviewed by the IRB convened full board are either more than minimal risk to participants or 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 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. 

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). 

Expedited Review and Approval

An IRB office staff member and an IRB full board member with appropriate expertise carry out this type of review and approval. An IRB office staff member helps an investigator prepare their protocol application for final review by a full board member. When the application is ready for final review, the IRB staff member will refer the study to the full board member with appropriate expertise for final 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. 

Please note: Expedited review does not equate to “rushed review”; it is simply the established name of “mid-level” IRB review that is not as stringent as convened full board review nor exempt from regulatory requirements as studies that receive an exemption determination from the IRB office.

Administrative Review and Approval

Administrative review and approval, which includes studies that are exempt, exempt with a limited review, and FLEX exempt are completed by IRB office staff. 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 a study is minimal risk and the research design fits into the categories of exemption outlined in 45 CFR 46.104. Examples of exempt research include minimal risk surveys with adults, interviews and focus groups with adults, benign behavioral interventions, taste tests with commercially available or GRAS ingredients, or interventions that can be considered “normal educational practices.” Research studies determined to be exempt from the regulations are still considered research with human subjects but they are not subject to the regulations in 45 CFR 46. The NC State IRB office can choose whether or not to apply some of the regulatory standards to an exempt study.

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. IRB staff can review and approve exempt with a limited review studies.

The NC State IRB office exemption unit standard established a “FLEX exemption” category. FLEX exempt studies are minimal risk studies that would normally be reviewed at the expedited level but NC State chooses to review them at the exempt level. IRB staff can review and approve FLEX exempt studies.

Studies that do not qualify for a FLEX exemption include, but are not limited to, those that are:

  • More than minimal risk research
  • Funded from any source, including NC State University
  • Cooperative research
  • Clinical trial research studying a health-related outcome (biological or behavioral)
  • Subject to additional oversight from any U.S. federal agency (e.g., Food and Drug Administration, Department of Defense, etc.)
  • Using a drug, biologic, medical device, invasive research procedure, blood draw, or
  • Introducing energy into the body (e.g., x-ray)

Not Human Subjects Research Determination

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 research or 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.  

If you need a “Not Human Subjects Research Determination” please complete the “NHSR Request Form.” Once the form is received by the IRB, the IRB staff will respond to your request within 2-3 business days. After the determination is issued, if you need an official letter with the determination, please request an official NHSR letter.

Just-In-Time Approval for NIH Funded Studies

Some organizations that sponsor research require IRB approval or pending approval before accepting new grant proposals. Grant proposals applying for NIH funding can seek a type of IRB approval called the “Just-In-Time Approval” or “JIT.” Please refer to the guidance “NIH Grants and the IRB” for Just-In-Time guidance for NIH grants. 

Applying for Just-In-Time Approval (NIH studies only)

To seek Just-In-Time approval, researchers must complete the following steps:

  1. Open a new IRB application in the eIRB system.
  2. On the Title tab, write “[Just-In-Time Request]:” in the protocol’s title box along with the protocol title if the grant proposal. The protocol title should match your grant title.
  3. List the funding source as “NIH” for Just-In-Time approval.
  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 Just-In-Time approval, 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, including the upload of all supporting documentation materials.
  6. Click the “Save” button above the narrative boxes you entered text into.
  7. Navigate to the Routing and Status tab of the eIRB application and click the “Submit to IRB office” button. The IRB office cannot process a Just-In-Time approval without a submitted protocol.
  8. Complete the letter request form on the NC State IRB website for a Just-In-Time approval letter. No requests submitted over email can be honored.

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 before requesting Just-In-Time approval.

.118 Determinations for NSF Funded Studies

Some organizations that sponsor research require IRB approval or pending approval before accepting new grant proposals. For NSF studies, the NC State IRB can provide researchers with a “.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. 

.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.

Applying for a .118 Determination (NSF studies only)

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. On the Title tab, write “[.118 Determination Request]:” in the protocol’s title box along with the protocol title. The protocol title should match your grant title.
  3. List the funding source as “NSF” for .118 determinations.
  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. 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.”
  6. Click the “Save” button above the narrative box 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 without a submitted protocol.
  8. Complete the letter request form on the NC State IRB website for a .118 determination letter. No requests submitted over email can be honored.

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 before requesting a .118 determination.

IRB Lifecycle

  1. Determining Approval
  2. Preparing and Submitting
  3. Application Review Process
  4. Responsibilities After Initial Approval
  5. Close a Study

View full lifecycle
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