For Researchers

Before submitting a protocol to the NC State IRB, please thoroughly review the Research in the time of COVID-19 document in the Quick Links box. This guidance is updated regularly.  Changes in IRB submission requirements or procedures will be noted with highlights.

The dashboard buttons below are designed to support you as you complete your research at NC State University before, during, and after your eIRB application is submitted and approved. The buttons contain information you’ll need to move successfully through the eIRB application process, including tips specific to your participant population, research methods, and funding sources.




The NC State IRB does not grant retroactive approval. If you’re planning on researching living humans, please file your eIRB application well in advance before you want to begin your research, including participant recruitment.

Planning Your IRB Application

One of the most frequently asked questions of the NC State IRB Office is, “When will my eIRB protocol application be reviewed?” Protocols are reviewed on a first-come, first-served basis year-round. It typically takes 4 – 6 weeks from submission for an initial administrative review of a protocol to occur.

Most protocol applications are not approved on their first submission due to information that is incomplete or needs clarification. In those cases, the NC State IRB office will return the protocol to the PI for revisions.  Once revisions are submitted, the protocol application is again reviewed in the order it was received. Please note that until you receive final approval from the NC State IRB Office, you cannot begin your research, including participant recruitment.

We advise that, at a minimum, you should file a complete eIRB application at least 2 months in advance of when you would like to begin your research. If you plan to conduct research internationally or with devices, drugs, external collaborators or funders, vulnerable populations, or your research contains more risk than a participant would encounter in their normal daily life, please file your eIRB application far in advance. This will allow the appropriate amount of time for IRB review, necessary revisions, and compliance with regulatory oversight.

Often a researcher contacts the NC State IRB Office to request an “expedited” review of their protocol. An expedited study is a technical term in the IRB world which means your study requires a  more thorough review by the NC State IRB Office. What the researcher means to say instead is, “Can you rush my protocol to the front of the review queue?” Unless the request will immediately affect participant well-being, the answer is usually no. It’s a matter of justice and equity to your fellow NC State researchers who are also waiting for their protocol to be reviewed.

If you still want to request a rush of your eIRB application, email the NC State IRB Office. Please include your eIRB protocol number, the request for a rushed review, and the detailed circumstances that necessitate a rushed review. The NC State IRB Office will respond to your request within five business days with a determination of whether or not your request will be granted.
Priority Review Process for Students

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Reviews, Renewals, and Amendments

There are six types of protocol reviews that the NC State IRB Office conducts: Administrative, Exempt, Limited, Expedited, Full Board, and Continuing. Regardless of the level of review, any proposed changes to an approved protocol must be submitted via an amendment and any unanticipated problems, adverse events, participant complaints, and noncompliance must be shared immediately with the NC State IRB Office.

  • Administrative reviews are the pre-reviews by the NC State IRB Office Staff or Full Board members to assess a protocol’s completeness and readiness for a status determination as an exempt, limited review, expedited, or Full Board study.
  • Exempt reviews are conducted by the NC State IRB Office Staff or Full Board members. These protocols are minimal risk to participants. Studies that are exempt do not undergo an annual review once approved.
  • Limited reviews are pre-reviewed by NC State IRB Office Staff and completed by Full Board members. These protocols are minimal risk to participants but require a more thorough review and higher data management and security procedures. Studies that undergo a limited review and are subsequently approved do not have an annual review requirement.
  • Expedited reviews are pre-reviewed by NC State IRB Office Staff and completed by Full Board members. Studies approved under Expedited Review, are minimal risk studies that subject to the regulations of 45 CFR 46. These studies do not undergo annual renewal unless specified by the IRB Office or Full Board.
  • Full Board reviews are pre-reviewed by NC State IRB Office staff and completed by the Convened Full Board. The Convened Full Board meets on the first Tuesday of each month year-round. Protocols reviewed at this level are subject to all of the regulations in 45 CFR 46. Full Board studies must undergo a continuing review each year.
  • Continuing reviews (also known as renewals): are annual reviews (and reapproval) of a protocol. Unless your study was initially approved by the convened Full Board or the NC State IRB Office stipulated the requirement for an annual review in your initial protocol approval letter, you do not have to undergo a continuing review process.
  • Context reviews (also known as local context review, participant context review, or a scientific merit review): These reviews are conducted by external experts who have intimate knowledge of the population and/or methods the protocol wishes to employ. They review the protocol application and provide feedback to the NC State IRB about the protocol. A context review occurs only in conjunction with another type of review (i.e. Exempt, Expedited, Full Board, or Continuing) in studies with vulnerable or international populations or where a funder requires (e.g. NSF).

Amendments are filed any time a principal investigator seeks to make any changes to an already approved protocol. These can range from minor modifications, such as editing the members of the research team to significant changes like manipulating an aspect of the data collection or data analysis.

If you wish further details about reviews, renewals, or amendments, check out the 45 CFR 46.

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Consent and Assent Information and Templates

Participating in research is a gift that your participants give to you, the researcher, and to those who will benefit from the research. This gift is always voluntary and can only be given in the context of a full understanding of the research’s activities, risks, benefits, and a participant’s affirmative choice. The process by which a person’s understanding, autonomy, and choice to participate in research is called informed consent for adults (i.e. those aged 18 years old or older) or parental permission and minor assent for participants younger than 18 years old. Valid informed consent is the process of letting participants know about the research, answering their questions about the research, and providing ongoing space for the participant to make the choice to participate in your research or not.  It is not simply signing a form; it begins, rather, with the information you share at recruitment through the moment the data is published and shared.

The documents linked in this section will help you with creating a consent process for your research protocol. We begin with NC State’s policy statement on adult consent, minor assent, and parental/guardian permission. In short, consent/assent is a vital part of our core values and of the federal regulations for research with human subjects. We also have added our policy statements for research with minors and a statement on including minors in research at secondary institutions. You’ll also find below three consent files with instructional guidance and templates. The first consent template package is for use with adults, whereas the second consent template package contains a parental permission form and three minor assent templates for ages 7-10, 11-13, and 14-17 years old. For research with minors, if the child does not want to be in the research, you must honor the minor’s choice even if their parent gave permission for the child to participate in research. Both template packages are appropriate for in-person consent/assent and, with modification, to obtain consent online, create an opt-out form or research information sheets. The third file concerns broad consent, which you can use with adults or parents/guardians (for research with minors). Broad consent allows the researcher to retain a participant’s re-identifiable or identifiable data for future research purposes. A broad consent addendum is only used in conjunction with one of the consent or parental permission consent templates and never by itself. Broad consent also can never be required of participants to be in your research. Read through all instructions in the file before editing the template form(s) within the parameters of the IRB prompts for use with your protocol, delete all extraneous materials and IRB prompts, and upload clean copies to your application’s supporting documentation in the eIRB application system.

If you will be obtaining consent in person, we also expect you to upload to your eIRB application a verbal script that you will use to talk with participants and, where appropriate, parent/guardian about the research. The verbal script should be written to be comprehensible to the population you’re targeting and avoid any technical language. If a technical word must be used, please refine it in lay language. We do not have a verbal script template; however, we expect at a minimum that it includes the following:

  • Purpose of research
  • Description and time duration of all research activities
  • Risks and benefits of participation
  • Compensation, if any
  • Explanation of the role of funding/sponsorship where applicable
  • Opportunity for the participant to ask questions about the research

We have also included below NC State IRB guidance about translation verifications for those of you who are conducting research with non-English speaking populations that should be used in conjunction with the templates below.

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Research Methods

We trust that you will choose the most appropriate methods for your study to answer your research question(s). Some areas of study, such as genetics and genomics, or technologies, such as devices and drugs, come with additional risks to participants or federal regulations that researchers must comply with. These are documented below.

Those of you interested in completed survey research or using the survey tool Qualtrics, please use the Qualtrics button to find guidance regarding how to use the platform. General guidance about online recruitment, consents, and surveys is contained in the document Survey Research and the IRB below.

If you plan to utilize existing information for your proposed study, that is, accessing data (such as FERPA or HIPAA records or creating repositories) should read the secondary research blurb below as well as refer to the Data Management and Security and the Federal and International Regulations and Guidance sections of this portal.

In addition to these topics below, refer to the NC State Guidance section of this site as well.

Using existing or future secondary data for research means that you want to use information or biospecimens – originally collected for nonresearch purposes – as data for your research project OR you want to use information or biospecimens – originally collected for research purposes other than the project currently proposed – as data for the research project that you are now proposing. Data and materials do not have to exist as of the IRB application you are submitting. They just need to have been/or be collected or generated for purposes other than the research you are proposing (in other words, they would exist or be created regardless of your project taking place).

Secondary Research with Biological Samples and Data video

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Education and Outreach

The thinking and doing of research ethics and integrity is complex! NC State’s IRB office is here to support you in this process through online and in-person events. We offer some generalized training online or through the libraries but we can also target training to your specific needs should you request targeted training from our team.

Online Learning

Learn about IRB history and practices any time of day or night from the comfort of your own home. CITI training is often required for federally funding research, while Research Compliance eLearning’s IRB video is specific to the philosophy of NC State’s IRB.

Collaborative Institutional Training Initiative (CITI)
CITI is a comprehensive ethics training program for researchers conducting research with human subjects.

Research Compliance eLearning
Research Compliance eLearning is a landing page where you can find multiple research compliance tutorials. Once on the page, scroll down to “Do I Need IRB Approval?” and click on Institutional Review Board for The Protection of Human Subjects.


Face-to-Face Learning

We would love to meet with you in person. Our office regularly schedules topical workshops at the NC State University Libraries. You can access the Libraries’ event calendar in the links below. If you wish to request an IRB educational event specially targeted to a particular content area for a group, please fill out the In-Person Group Education Event Form linked below. And if you’d like to meet with us individually, please email the email most appropriate for your request.

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Data Management and Security

Confidentiality and privacy are two of the major risk areas in research completed at NC State and the security around these matters is constantly evolving. As we say in the consent and assent templates, trust is the foundation of the participant/researcher relationship. Much of that trust is tied to collecting, accessing, managing, storing, and destroying participants’ data and biospecimens in a secure manner that participants agree with.

To help you clarify how you will manage participants’ data, the NC State IRB requires you to complete either put the necessary information in the eIRB application and/or to complete a data management plan and upload the plan into your eIRB’s supporting documentation depending on the nature of your study, the level of review it requires, and other factors such as funding, collaborative partnerships, and content or use of the data. We strongly advise that you work with your departmental IT support person, who will be an invaluable resource to you to accurately fill this form out. The data access and management plan form is required for researchers who plan to collect data directly from their participants and have studies that either will be reviewed by the Full Board or, on a case-by-case basis, are for an Expedited study where an IRB staff member has told the research team to complete the form. We have included a copy of the NC State IRB office’s data management plan and security guidance and information on identifiable data sets below for your use and reference.

As you contemplate your study design and integrate data management throughout your project, we encourage you to also review other relevant sections of this portal.

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NC State IRB Guidance

Below you will find guidance regarding the key questions researchers ask the IRB as well as the documents that provide the foundation for which the NC State IRB and researchers operate. These include theoretical and philosophical underpinnings that scaffold the NC State IRB operations. For specific methods, please access the research methods button on the For Researchers dashboard for targeted, granular advice.

The IRB is made up of administrators and faculty members that read through research proposals involving humans. They do this to ensure that the planned research activities are ethical in practice and compliant with the federal regulations governing research with human subjects. A researcher submits an application to the IRB office that includes details about all study activities that they would like to implement. The application entails information about what the research is, why it is important, and how the researcher plans on carrying out the research project. The application provides information regarding who the participants in the study will be, what information the researcher will share with participants, what the processes for recruiting participants are, how the researcher plans on gaining informed consent from participants, what procedures are used in order to attain information from participants to use for research purposes, and finally – how all of that information will be analyzed and handled. During the review process, the IRB looks over these protocols for issues like risks to participants, benefits to participants, and clearly articulated plans to carry out the research. The IRB reviews each individual study by thinking about the participants’ experience, what information participants will need in order to decide to be in the study, and if the study design poses risks and benefits to participants. Once the IRB receives the application, the IRB office staff helps prepare the application for final review by making sure all materials are included, the application is consistent, and it meets all regulatory requirements. Once this is completed, the IRB office staff sends the application for the final review. The final review for a study is determined by the study design (including participant type, risks to participants, methods used in the study, etc) and the regulatory requirements for that design. The final review (dependent on the level of review required) is either completed by IRB office staff, an individual IRB Full Board Member, or the convened IRB Full Board. The IRB Full Board is made up of faculty members, staff members, students, community members, scientists, and non-scientists. Each IRB Full Board member has a diverse background ranging from diversity in sex, gender expression, race, religion, culture, age, areas of expertise, and life experiences (among many other things). These diverse perspectives allow for the Full Board to thoroughly review studies engaging all people. If a study requires expertise that is not represented by the Full Board, the IRB office will identify someone appropriate to advocate for that participant group. Throughout the research process, the IRB serves as an advocate for all people in research, while also serving as the regulatory body that holds researchers accountable to ethical and compliant standards when completing research with human subjects.
  • Is it research as defined by the regulations?
  • Is it research with human subjects as defined by the regulations?
  • Which IRB needs to review the project (Is NC State University engaged in research with human subjects as defined by the regulations)?

Is it Research?

Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Is it Human Subjects Research?

Human Subject is defined as a living individual about whom an investigator conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens (this includes manipulation of environment)
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Do I need IRB approval through NC State University?

If you are affiliated with NC State University and acting as a researcher for NC State University, you are considered an agent or an employee. As a result, your research project (even if you are a student) will need IRB approval through NC State University. This can be done through submitting an application to the NC State IRB or if completing collaborative research, through requesting a Reliance Agreement (where one IRB relies on the review and approval of another IRB).

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

  • act on behalf of the institution.
  • exercise institutional authority or responsibility.
  • perform institutionally designated activities.

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

Administrative Review and Approval

This type of review and approval is carried out by an IRB Office staff member. Determinations from this type of review lead to a determination of Exemption. An Exemption determination means that your study is minimal risk and it fits into the categories of Exemption outlined in 45 CFR 46.104.

Studies reviewed in this manner may undergo a Limited IRB Review. Limited IRB Review considers data protection and broad consent.

Expedited Review and Approval

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 to prepare your application for review by the Full Board member. This type of review is for studies that are minimal risk and subject to the regulations outlined in 45 CFR 46.110 and fit into one of the “Expedited Review Categories

Studies reviewed via this type of review must have all informed consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.

Full Board Review and Approval

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 to prepare your application for final review by the convened Full Board.

Studies reviewed by the convened Full IRB 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 outlined above.

Studies reviewed via this type of review must have all Informed Consent requirements at 45 CFR 46.116 (unless appropriately waived) and meet the criteria for approval at 45 CFR 46.111.

Occasionally a study will warrant an additional layer of review. This can be due to the PI wanting to make changes, the annual review requirements for an individual study, sponsor requirements, special populations, or some international research.

Amendments and Approval Renewals

All approved studies, regardless of approval type – must submit any intended changes to the IRB for review and approval before those changes are implemented. This is called an Amendment to an approved study. Changes to a study may range from editorial to procedural. Amendment requests are reviewed at the same level the initial study was approved under. If the Amendment changes the risk profile to participants, then a new review level will be implemented.

Local Context and Participant Context

This type of review is completed by an expert that is not an IRB Full Board Member. This type of review is usually completed by someone who is an expert in the population being studied or the local culture and laws of the population being studied. This review will be requested by the IRB office. You may be asked to provide a reviewer with the proper expertise. This review consists of the reviewer providing insight and information regarding culture, laws, or the participants that the IRB may need when considering the risks to your research. This review happens at the same time as the IRB review. An IRB application cannot be approved without this for most Expedited and Full Board studies using unique populations or international populations.

Scientific Merit Review

A scientific merit review is an independent review and approval that assesses the scientific merit of a study. The NC State IRB office does not require a scientific merit review unless your study is affiliated with the DoD or there are very special circumstances surrounding your research project.

HRPO Review

This type of review is carried out by the “Human Research Protection Office” and is specifically affiliated with the Department of Defense (DoD). This type of review is required for all research subject to the DoD Regulations. This review is NOT carried out by the NC State IRB office, though you will need to submit your NC State IRB approval materials to them.

Documentation to Submit with Your IRB Application
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Federal and International Regulations and Guidance

Here at NC State, research projects with human subjects are subjected to several federal regulations. The first, and most important as it applies to all research with human subjects, is the 45 CFR 46. It has recently been updated and is colloquially known as the Final Rule or the 2018 regulations. Subpart A applies to all human participants, while subparts B, C, and D contain additional protections for targeted vulnerable populations.

There are other federal regulations that apply to studies but they are dependent on the research questions, research population, research methods, or other contexts. These include the FDA regulations and the DoD regulations. Additionally, there your study may be subjected to certain laws such as FERPA, HIPAA, GINA, GDPR, etc. If you wish to research associated with the Department of Defense, please read our DoD guidance. For health care contexts and use of HIPAA covered data, please review our HIPAA guidance. For use of student records, please read the FERPA guidance.  If your study design meets the definition for a clinical trial, please review our soon to be posted clinical trial guidance (both social-behavioral research and biomedical research can be deemed clinical trials) in the FDA open and close section.

Are you performing research with human subjects that is funded by the Department of Defense (DoD) and/or uses any DoD resources or people (including ROTC)? If so, your research is considered supported by DoD and you are subject to additional requirements from the DoD regarding human subjects research (including Exempt, Expedited, and Full Board Approvals).

DoD entities include (but may not be limited to) these groups:

  • Air Force
  • Air Force Academy
  • Army
  • Coast Guard
  • Coast Guard Academy
  • Defense Advanced Research Projects Agency (DARPA)
  • Defense Intelligence Agency
  • LAS
  • Marines
  • Military Academy (West Point)
  • Missile Defense Agency
  • National Geospatial-Intelligence Agency

  • National Guard
  • National Security Agency
  • National War College
  • Naval Academy
  • Navy
  • Office of Naval Research
  • Pentagon Force Protection Agency
  • ROTC
  • Tricare Health System
  • U.S. Army Corps of Engineers
  • U.S. Naval Observatory

Additional Requirements for DoD supported research are noted in the guidance below. These requirements include specific content to be included in study documents and procedures, an additional review process with a Human Research Protection Officer (HRPO) outside of the NCSU IRB office, and possibly a Scientific Merit review. Please read through the guidance below in order to meet all of your additional requirements.

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Reliance and Individual Investigator Agreements

In order to achieve the institutional mission of “Think and Do,” the NC State IRB Office recognizes that researchers often form collaborative partnerships with their colleagues at other institutions for the purposes of research. With the implementation of “Single IRB” (sIRB), the federal regulations now require one IRB of record for review and approval of collaborative research with human subjects. Both institutional authorization agreements (also known as reliance agreements) and individual investigator agreements allow for collaborative research with human subjects to take place with appropriate IRB oversight.

With an institutional authorization agreement, a legal contract is created that allows one institutional IRB office (e.g. relying IRB) to rely on another institutional IRB office (e.g. IRB of record) for protocol review and oversight. This saves a research team the trouble of undergoing protocol review and approval at multiple institutions for the same study. It is expected, with an institutional authorization agreement, that all PIs use the same procedures that were reviewed and approved by the IRB of record for the reliance agreement. If researchers wish to use procedures that differ from what is reviewed and approved by the IRB of record, an institutional authorization agreement is not appropriate.

Here at NC State, we expect that PIs who are affiliated with NC State to have the NC State IRB office be the IRB of record providing the protocol review and approval with any non-NC State co-PIs covered under an institutional authorization agreement. In cases where the primary PI or the research activities are occurring at another institution, NC State will consider entering into a reliance agreement where NC State is the relying IRB with another IRB functioning as the IRB record only in cases where the primary PI and the research activities are occurring outside of the NC State community.

For investigators that are not affiliated with an IRB, NC State may choose to create an individual investigator agreement. The NC State researcher files their research protocol application to the NC State IRB office for review normally but they will need to submit an amendment to add the individual investigator(s) after the protocol is approved. When the amendment to add the individual investigator to the approved protocol is approved, the individual investigator would officially agree to abide by all the rules, regulations, and authority of NC State’s IRB Office while working on the collaborative project. Please note, an individual investigator agreement is not appropriate for individuals affiliated with an institution that has an IRB.

If you are interested in an institutional authorization or individual investigator agreement for your protocol, please follow the directions below.

  • Open an NC State eIRB application.
  • Title your protocol in the project title section “Reliance Agreement: <insert name of study>” on the title tab.
  • In the description tab, answer “yes” to the question, “Will the investigators be collaborating with researchers at any institutions or organizations outside of NC State?”
  • Subsequent questions will appear on the description tab. Briefly state what the study is about and that the protocol is a reliance agreement request where NC State relies on an external IRB’s review and approval of the protocol. All investigators that will be engaged in the research will need to be named on the description tab. “Engaged” means that they are actively involved in the recruitment, consent, data collection, and/or analysis of identifiable/re-identifiable data. You will also need to articulate what your (e.g. NC State’s) role is in the research protocol as well as what the roles and responsibilities will be for the external-to-NC-State collaborators will be.
  • Complete and upload the “Reliance Agreement Request” form (linked below) to the protocol’s supporting documentation. This form outlines the nature of the collaboration amongst investigators and institutions and should match what is said in the description tab of the eIRB application.
  • Upload proof of human subjects research training for each NC State University research team member. All NC State research team members will need to complete the NC State IRB Training via the Research Compliance eLearning site. Once logged into the page, scroll down to “Do I Need IRB Approval?” and click on Institutional Review Board for The Protection of Human Subjects video. All research team members will also need to take and provide proof of CITI training, which includes an HSR Basic course (Track 1: Biomedical Researchers, Track 2: Social-Behavioral-Educational Researchers, Track 3: Administrative Data and Biospecimens), a Responsible Conduct of Research course, a Conflicts of Interest course, and (if appropriate to the protocol) a CITI GCP course (Track 1: Biomedical Researchers-Working with Devices, or Track 2: Social-Behavioral-Educational Researchers: When SBER Research is a Clinical Trial).  The CITI certificates of completion must be completed within the past three years of the protocol application. Each research team member’s Research Compliance eLearning and CITI completion certificates must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB.
  • Upload the “Site Context Worksheet” completed by the IRB of record to the protocol’s supporting documentation
  • Upload Conflict of Interest (COI) information. You can do this in one of two ways:
    • Option 1: Complete an attestation letter (form linked below) for each NC State University research team member indicating there are no conflicts of interest.
    • Option 2: If you are unsure about if there are any conflicts of interest, please work with NC State Conflicts of Interest Manager Jill Dale to complete a COI management plan. You can then upload the plan you’ve developed with Manager Dale or a letter she provides you to your protocol’s supporting documentation.
  • Upload ancillary review approval information for all applicable reviews from NC State to your application’s supporting documentation. Ancillary reviews are contextual and depend on your research design, but generally include research with chemicals, biospecimens, radiation, software licensing, or data use agreements. Consult with Carter if you have questions on what would be required for your protocol.
  • Submit your protocol to the IRB office for review.

When the application is finalized, the NC State University IRB will provide a “Site Context Approval Letter” that you can keep for your records or provide to the reviewing IRB.

If you need assistance, please contact the IRB Office at 919-515-7515 or email irb-coordinator-admin@ncsu.edu.

  • Submit an amendment request to your already approved NC State eIRB application. Note in the amendment request that you are asking for the processing of a reliance agreement where <insert other institution’s name> relies on the NC State University IRB review and approval of the protocol.
  • In the description tab, answer “yes” to the question, “Will the investigators be collaborating with researchers at any institutions or organizations outside of NC State?”
  • Subsequent questions will appear on the description tab. You will need to name all investigators that will be engaged in your research. “Engaged” means that they are actively involved in the recruitment, consent, data collection, and/or analysis of identifiable/re-identifiable data. You will also need to articulate what your (e.g. NC State’s) role is in the research protocol as well as what the roles and responsibilities will be for the external-to-NC-State collaborators will be.
  • Complete the “Reliance Agreement Request” form linked below for each site as it outlines the nature of the collaboration. Upload this document to your protocol’s supporting documentation section.
  • Upload proof of human subjects research training for all research team members at NC State and the other collaborating institution(s). All NC State research team members will need to complete the NC State IRB Training via the Research Compliance eLearning site. Once logged into the page, scroll down to “Do I Need IRB Approval?” and click on Institutional Review Board for The Protection of Human Subjects video. All research team members will also need to take and provide proof of CITI training, which includes an HSR Basic course (Track 1: Biomedical Researchers, Track 2: Social-Behavioral-Educational Researchers, Track 3: Administrative Data and Biospecimens), a Responsible Conduct of Research course, a Conflicts of Interest course, and (if appropriate to the protocol) a CITI GCP course (Track 1: Biomedical Researchers-Working with Devices, or Track 2: Social-Behavioral-Educational Researchers: When SBER Research is a Clinical Trial).  The CITI certificates of completion must be completed within the past three years of the protocol application. Each research team member’s Research Compliance eLearning and CITI completion certificates must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB. Researchers at the other collaborating institution need to provide proof of training in human subjects research that complies with their institution’s requirements, which may or may not be CITI training, but needs to be documented and in compliance with federal, funding, and NC State IRB requirements.
  • Complete the “Site Context Worksheet” listed below for each collaborating site. Upload this document to your protocol’s supporting documentation section.
  • Submit the amendment request to the IRB office for review.

If you need assistance, please contact the IRB Office at 919-515-7515 or email irb-coordinator-admin@ncsu.edu.

  • The NC State University researcher must submit an application to NC State.
  • Once the protocol is approved, the researcher submits an amendment request to the approved NC State eIRB application. Note in the amendment request that the amendment asks for the processing of an individual investigator agreement between NC State University and <insert name(s) of the unaffiliated individual investigator(s)>.
  • In the description tab, answer “yes” to the question, “Will the investigators be collaborating with researchers at any institutions or organizations outside of NC State?”
  • Subsequent questions will appear on the description tab. You will need to name all investigators that will be engaged in your research. “Engaged” means that they are actively involved in the recruitment, consent, data collection, and/or analysis of identifiable/re-identifiable data. You will also need to articulate what your (e.g. NC State’s) role is in the research protocol as well as what the roles and responsibilities will be for the individual investigator(s).
  • Complete the “Reliance Agreement Request” form linked below for each site as it outlines the nature of the collaboration. Upload this document to your protocol’s supporting documentation section.
  • Upload proof of human subjects research CITI training for all investigators, including the individual investigator(s), which includes an HSR Basic course (Track 1: Biomedical Researchers, Track 2: Social-Behavioral-Educational Researchers, Track 3: Administrative Data and Biospecimens), a Responsible Conduct of Research course, a Conflicts of Interest course, and (if appropriate to the protocol) a CITI GCP course (Track 1: Biomedical Researchers-Working with Devices, or Track 2: Social-Behavioral-Educational Researchers: When SBER Research is a Clinical Trial).  The CITI certificates of completion must be completed within the past three years of the protocol application.

If you need assistance, please contact the IRB Office at 919-515-7515 or email irb-coordinator-admin@ncsu.edu.

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Request a Letter

Letters can be generated for protocols that are already approved or after a protocol that is currently in process is approved. Our office can also produce .118 determination letters if you need one for your federal funder. The .118 letters state that your study will involve research with human subjects but the protocol cannot be fully developed yet and it lacks immediate plans for the involvement of human subjects. You do not need a fully complete eIRB application to receive a .118 determination letter; you must, however, have initiated the IRB application, write [.118 Determination Request] in the protocol’s title, uploaded your grant application to the supporting documentation, and provided a brief sketch of the scope of research, planned activities, and targeted populations by filling out the eIRB’s Title, Description, and Populations tabs. When requesting a .118 determination letter, the other parts of the IRB application may remain blank but you must submit the application for review and approval as a .118 determination.

Please complete this form to request an approval letter for an already approved protocol, an in-process filed eIRB protocol, or for a submitted protocol for which you need a .118 determination letter.

Request a Letter Form
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Report Unanticipated or Adverse Event

In the course of the research, it is statistically likely that, at some point, there will be an unanticipated problem or adverse event with human subjects.  It’s important, first, to immediately assess and triage the situation so that the participant(s) are not directly in harms’ way. As soon as that is taken care of, please fill out the confidential form below. You have up to five days to report. Not reporting at all, or reporting in an untimely manner, results in non-compliance and could impact your ability to conduct research or use the research data collected. You can also e-mail or call the IRB office at 919.515.8754 or irb-director@ncsu.edu if you need immediate help. If you call and leave a message, follow that message up with an e-mail.
Report Unanticipated or Adverse Events Form

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Report Noncompliance

Your IRB materials, once approved by the IRB, are the blueprint of your study. You are expected to follow the IRB approved research protocol, and use only IRB approved materials when conducting your research. Additionally, it is expected that you cultivate a climate of voluntariness and transparency (as appropriate) with your participants. Any unapproved departure from your approved IRB protocol, a departure from ethical practices, or implementation of research with human subjects without appropriate IRB approval is considered noncompliance.

Noncompliance has many different consequences, but can result in your being prevented from using data that were collected outside of IRB approval, or require reporting to the federal government. Most importantly, any departure from your approved IRB protocol that INCREASES RISK TO PARTICIPANTS, without IRB approval, is very serious and must be dealt with immediately. Please see our guiding information regarding noncompliance.

Noncompliance Guidance

Report Noncompliance Form
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