For Researchers

Important resources that the IRB office doesn’t want you to miss are in the grey Quick Links box on the right of your screen. Click on the bulleted text to access a resource, which will result in a PDF document opening for you or redirection to another part of the NC State IRB website.

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. Note that the Documentation to Submit with Your IRB Application link will take you to template files, including those for in-person research during COVID-19.

The red portal navigation 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 a participant’s 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 and you are a faculty/staff member, please complete the Rush Request Form. The NC State IRB Director will respond to your request within five business days with a determination of whether or not your request will be granted. The rush request form is only for faculty/staff experiencing unanticipated problems that necessitate a rush review request. Student research protocols must plan in advance as the PRP program has been discontinued. For those who qualified during the 2020-2021 academic year and did not receive a review, please review the updated information linked below.

Priority Review Process for Students
Back to Top

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 to be exempted. 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, the NC State IRB office stipulated the requirement for an annual review in your initial protocol approval letter, or your protocol was approved under the old federal regulations, 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, Limited, Expedited, Full Board, or Continuing) in studies with vulnerable or international populations or where a funder requires (e.g. NSF, etc).

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.

Back to Top

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 find below three consent files with instructional guidance and templates. The first consent template package has two consent form templates one can use with adult participants, 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 consent sought online or in person. With modification, they can be used for opt-out or research information sheets.  The third template file contains broad consent addedums for adult participants and parents/guardians of minor participants. 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 adult 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.

We have also included below the 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 consent, parental permission, minor assent, and broad consent addendum templates below.

  • NC State IRB Policy Statement on Adult Consent, Minor Assent, and Parental Permission
  • NC State IRB Policy Statement on Research Involving Minors
  • NC State IRB Policy Statement on Inclusion of Minors Attending Post Secondary Institutions in Research
  • Adult Consent Form Templates (REVISED!): This document contains instructions and two consent form templates compliant with the current federal regulations for use with adults. The first template is for minimal risk exempt online survey research generating banal, non-sensitive information about participants. The second template is more commonly used for some exempt and all mid-level (e.g. Expedited) and Full Board studies. The longer consent template is appropriate for online and in-person research. With modification, the long-form template can be used to create opt-out forms and for research information sheets if it is appropriate for your research design and your study is approved for a waiver of consent.
  • Parental Permission and Minor Assent Templates (REVISED!): This document includes instructions, a parental permission form, and three minor assent templates (for ages 7-10, 11-13, and 14-17 years old) to be used with all NC State IRB-approved research with minors. The parental permission and minor assent templates are appropriate for obtaining parental permission and assent remotely and in person. Researchers may create a research information sheet from the following templates as well as parental permission opt-out sheets, but they should only be done if your project qualifies and was approved for a full waiver of consent. Opt-out processes for research with minors are rarely granted by the NC State IRB and must be justified.
  • Broad Consent Addendum Templates (REVISED!): Broad consent allows you, the researcher, to keep a participant’s re-identifiable or identifiable information or biospecimens for future research if the participant (or parent/guardian and child, if researching minors) agrees. Broad consent can never be required of participants and carries some additional researcher responsibilities. There are two templates: one for adult participants and one for parents/guardians of a minor participant. The minor assent form templates have stock language discussing broad consent for minors aged 11 and up that a research team can use if appropriate, but it must be used in conjunction with seeking parent/guardian permission for broad consent.
  • Verification of Translation Guidance and Form
Back to Top

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, please cross reference with other portions of the For Researchers portal as well as the Documentation to Submit with Your IRB Application page.

Data Collection Guidance

Data Collection Forms – Please note: The forms listed below relate to data collection; additional forms you may need to submit with your IRB application are listed on the Documentation to Submit with Your IRB Application page.

Data Collection Templates

Clinical trials are research studies that involve living human beings that study a medical or health-related social-behavioral intervention. Participants in a clinical trial are assigned to a control group or an intervention group, of which there might be one or more interventions being studied. All clinical trials are subject to additional research requirements. See the below links for more information.

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

Back to Top

Training and Education Requirements and Opportunities

NC State University Training Requirement: Anyone on the research team that is involved in the recruitment process, consent process, implementation of interventions and other data collection processes, analysis of identifiable/re-identifiable private data, or supervising a student who will be doing these activities must provide the IRB proof of completion of human subjects training with their IRB application. Please refer to the “NC State University Training Requirements for Completing Research with Human Subjects” guidance for requirements. This requirement applies to studies reviewed and approved at all levels, including exemptions.

Asynchronous Online Learning

CITI Training: The primary mode used for IRB training is CITI asynchronous training. CITI is a comprehensive ethics training program for researchers conducting research with human subjects. CITI is a platform that hosts online human subjects research training. The NC State University IRB requires all NC State University researchers to complete CITI training before receiving IRB approval to work with people. This includes all research team members who recruit, consent, collect data from, or handle identifiable/re-identifiable data. This training helps to ensure that the research design is participant-centered and that the researchers, who are the key players in protecting participants’ rights and welfare throughout the research process, know what to expect and do. CITI training requirements can be found in the “NC State University Training Requirements for Completing Research with Human Subjects” guidance. Instructions for how to use CITI at no cost can be found in the CITI Set-Up Tutorial.  

NC State University Online Training Module: The NC State University Institutional Review Board (IRB) Overview video is brief (>15 minutes) and highlights the perspective of the NC State IRB office when reviewing research and the NC State University IRB operations. The video was created before COVID-19 and the Final Rule took effect. The video is available by accessing the following deep link: https://reporter.ncsu.edu/link/courseview?courseID=RES-COMPLI-IRB&deptName=RES. Please see the “NC State University Training Requirements for Completing Research with Human Subjects” guidance for instructions on how to access and use the NC State University Online Training Module.

Cooperative Research and Unaffiliated Investigators: When NC State researchers want to collaborate with people who are outside of NC State University and not affiliated with an IRB, along with executing an official agreement with the IRB, training requirements still apply. If  CITI access is unavailable to a researcher, the training requirements are different. Please review the training requirements for unaffiliated investigators, the PowerPoint template for lead researchers to edit appropriately, and the training completion and affirmation

NC State University IRB Detailed Guidance: The NC State IRB offers in-depth and specialized guidance on our website. These guidance documents and tutorials will help you with specific research methods, general guidance about the NC State IRB processes, and how to navigate research associated with federal regulations like the DoD and the FDA.


Synchronous Training Opportunies

Training Sessions Offered Through the Libraries: The NC State IRB office has partnered with the NC State University Libraries to offer multiple sessions for researchers working with human subjects. These sessions are live and specialized targeting areas that researchers ask most about. These sessions are offered in the Fall and Spring semesters and include sessions such as IRB Basics: Part 1, IRB Basics: Part 2, Use of Secondary Data in Research, Devices Research and the FDA, Using Apps, Software, and Wearables in Human Subjects Research, The IRB and Qualitative Research, Survey Research and the IRB, and more. A comprehensive list of offerings can be found by reviewing the list of available IRB workshops. Researchers sign up for these sessions through REPORTER.

Targeted Training for your Classes or Research Team: We provide training for your team’s specific needs should you request targeted training from our office. This request is made via the Group Education Event Form. This includes guest lectures for classes where research ethics and compliance is being addressed. 

Drop-in Virtual Office Hours: If you have specific questions about writing or revising your application, we offer drop-in virtual office hours facilitated by IRB staff. Find more information on the In the News section of the IRB website.

One-on-One Consultation: If you’d like to meet with us individually, please email the email most appropriate for your request. Request a 1:1 meeting:

Back to Top

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 develop a data access and management plan for your research protocol’s data lifecycle and can help you complete the data access and management plan form if you need one.

The data access and management plan form is required for researchers who have Full Board studies or, on a case-by-case basis, for an Expedited study where one of the following is true: a materials transfer agreement (MTA) or data use agreement (DUA) is necessary, the researcher plans to access HIPAA data set(s) with a waiver of consent, the research design will use homegrown mobile application(s) and/or devices to collect research data from participants, the researcher is collecting or accessing extremely sensitive personal data as part of the research design, the researcher plans to keep re-identifiable/identifiable data for future research, or an IRB staff member has told the research team to complete the form.

A copy of the NC State IRB office’s data management plan and security guidance and information on identifiable data sets is also provided below for your use and reference. We’ve also provided guidance on the use of applications and software for research with human subjects.

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.

Back to Top

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. You will also find the topical NC State IRB policy statements throughout the portal sections and the Quick Links at the top of the portal page helpful references.

The IRB serves as a protector of participant welfare through review of research proposals involving humans to ensure that the planned research activities are ethical in practice and compliant with the federal regulations governing research with human subjects.

Researchers submit applications to the IRB office that includes the following information:

  • what the research is about
  • why the research is important, and
  • how the researcher plans to carry out the research project, including:
    • who the participants in the study will be
    • the details about all study activities that the researcher would like to implement
    • how the research data will be analyzed, handled, and shared
    • all participant materials (e.g. recruitment message, consent form, procedural documents)
    • supplemental materials, as needed (e.g. COVID-19 documents, FERPA gatekeeper access or supervisor permission letters, CITI training certificates, PRP materials, etc.)

Once the researcher submits the application, administrators and, in later stages of review, Full Board member(s) and expert consultant(s), read through the research proposal. The review of each individual study begins with the reviewer thinking about the participants’ experience, what information participants will need in order to decide to be in the study, and how the risks and benefits of the study design will impact participants through the articulated research plan. The IRB office staff helps the researcher prepare the application for final review by making sure all materials are included, the application is consistent, and it meets all regulatory requirements.

When the application is complete, the IRB office staff sends the application for the final review. The review level 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. Depending on the level of review required, the study’s final review might be 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 federal regulations?
  • Is it research with human subjects as defined by the federal regulations?
  • Is NC State University engaged in research with human subjects as defined by the federal 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 the human’s 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 at this level may undergo a limited IRB review. Limited IRB review considers data protection and, where appropriate, 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 through application feedback to you. 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, an Expedited level of review is not a rushed 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 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 the researcher prepare their 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. Full Board studies 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 Full Board 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 Renewals

All approved studies, regardless of review level, 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 for the protocol. Renewals are for Full Board studies and, rarely, a few Expedited studies to renew their IRB approval once every 12 months. Both amendment and renewal requests can be filed on the Title tab of an approved IRB application. Please consult the eIRB screenshot tutorial for further guidance on how to file a renewal or amendment.

Local Context and Participant Context

This type of review is completed by a subject matter expert that is not an IRB Full Board member, nor a member of the research team or someone with a conflict of interest, to evaluate the risks to your participants in your proposed research. A local or participant context review is completed by an expert in the population being studied or the local culture and laws of the population being studied. The context reviewer will provide insight and information regarding culture, laws, or the participants that the IRB may need to assess risk to participants in your research design.

Local and participant context reviews are conducted during your IRB review, usually prior to the final review of the protocol. You may be asked to provide the names and contact information for at least 2 potential reviewers with the proper expertise in your IRB application for a context review. The researcher is expected to facilitate the local and participant context reviews per the NC State IRB Policy Statement on Local Context and Participant Context Reviews. An IRB application often cannot be approved without a context review 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. It is your responsibility, as the researcher, to facilitate the scientific merit review process and to submit the completed review with your IRB application. The review cannot be done by you or anyone on your research team due to conflicts of interest.

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 Rush Request Form
Back to Top

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. 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, GDPR, GINA, 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 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.

Back to Top

Cooperative Research

In order to achieve the institutional mission of “Think and Do,” the NC State University IRB office recognizes that researchers often form collaborative partnerships with their colleagues at other institutions for the purposes of research. With the implementation of NIH’s Single IRB (sIRB) and Cooperative Research as defined in the federal regulations governing research with human subjects, the federal regulations require one IRB of record for review and approval of collaborative research that involved human subjects. Institutional authorization agreements (also known as reliance agreements), individual investigator agreements, and letters of acceptance of exemption determinations allow for collaborative research with human subjects to take place with appropriate IRB oversight.

Reliance Agreement (also called institutional authorization agreement): is a contract that allows one IRB office to rely on another IRB office for protocol review and oversight. The IRB that reviews and approves the research is called the “IRB of Record.” The IRB that does not review the research and relies on another IRB for review and approval of the project is called the “Relying IRB.” Reliance agreements are typically implemented for research with human subjects that is reviewed at the expedited or Full Board level. In rare cases, these may be completed for exemptions. NC State University does not require a reliance agreement for exemptions but will enact one if a partnering IRB requires it.

Reliance agreements save research teams the trouble of undergoing protocol review and approval at multiple institutions for the same study while ensuring consistent protections for human subjects. It is expected, with an institutional authorization agreement, that all researchers use the same procedures that were reviewed and approved by the IRB of Record as noted in 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. The reviewing IRB is determined by the IRBs involved in the cooperative research and the determination is made by considering roles and responsibilities of researchers, location of research efforts, IRB expertise, and funding.

Letters of Acceptance of Exemption Determination: If an IRB determines that a study is exempt from the federal regulations, it typically does not enter into a formal reliance agreement as described above. This often leads to both IRBs reviewing and approving the same exempt project. At NC State University, to reduce burden, if all research procedures are approved by another IRB and it is clear in the approved protocol that an NC State researcher is involved with the project, then instead of the NC State IRB re-reviewing the same protocol, we will provide the NC State researcher with a letter stating that the NC State IRB accepts the exempt determination from the other institution. This is only used if all procedures that the NC State researcher completes have been reviewed and approved by the collaborating IRB and there are no differences. When the NC State IRB provides this letter, it is only considered IRB approval for the NC State researcher and is not applicable to anyone not listed on the letter. If the NC State researcher’s roles and responsibilities change, they must immediately contact the NC State IRB before doing any unapproved activities. This is considered NC State relying on another IRB’s review and approval – but it is not executed through a formal reliance agreement.

Individual Investigator Agreement: For NC State University researchers who want to involve research team members or other investigators that are not affiliated with an IRB, NC State may choose to enact an individual investigator agreement. This agreement allows NC State’s IRB to provide oversight for the unaffiliated researcher because, through this agreement, the unaffiliated researcher agrees to the rules and regulations set forth by NC State. In order for this to occur, the individual investigator must read through and sign the agreement, complete appropriate training, enact the research protocol as approved by the IRB, and follow all federal laws and NC State University regulations and policies. Please note, an individual investigator agreement is not appropriate for individuals affiliated with an institution that has an IRB with an FWA number.

How do you apply for a reliance agreement, letter of acceptance for an exemption determination, or an individual investigator agreement? You can apply for all of these options through the online eIRB system. With each online IRB submission, you will complete and submit a reliance agreement request form, training completion certificates, appropriate attestations (described below), and other applicable documents such as site context forms, ancillary reviews, and executed agreements. If NC State is not the reviewing IRB, the IRB application does not have to be completed thoroughly. 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: ” as a prefix to your project title 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.  The training requirements are outlined in the NC State University Training Requirements for Completing Research with Human Subjects document. All of the CITI certificates must be completed within the past three years of the protocol application, all modules need to be completed at 80% or greater, and the training must be appropriate to the proposed research to be accepted. Each research team member’s training certificates from CITI and NCSU IRB Overview Video must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB.
  • 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 to complete a COI management plan. You can then upload the plan you’ve developed with the COI Manager 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 NC State IRB office at 919-515-7515 or email irb-coordinator-admin@ncsu.edu.

  • Do one of the following:
    • Open a new protocol application or
    • 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 relies on the NC State University IRB review and approval of the protocol.
  • Title your protocol in the project title section “Reliance Agreement: ” as a prefix to your project title on the title tab if this is a new protocol application; otherwise, annotate this request in the amendment request form.
  • 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. Note that if this request is a part of an amendment to an already approved protocol, you must follow the directions in the eIRB screenshot tutorial for how to annotate your application appropriately for an amendment request.
  • Complete the “Reliance Agreement Request” form linked below for each site as it outlines the nature of the collaboration. Upload the completed document to your protocol’s supporting documentation section.
  • Upload proof of human subjects research training for each NC State University research team member.  The training requirements are outlined in the NC State University Training Requirements for Completing Research with Human Subjects document.
  • All of the CITI certificates must be completed within the past three years of the protocol application, all modules need to be completed at 80% or greater, and the training must be appropriate to the proposed research to be accepted. Each research team member’s training certificates from CITI and NCSU IRB Overview Video must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB.
  • 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 NC State IRB office at 919-515-7515 or email irb-coordinator-admin@ncsu.edu.

  • Open an NC State eIRB application.
  • Title your protocol in the project title section “Letter of Acceptance of Exemption Determination Request: ” as a prefix to your project title 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.
  • Fill out the rest of the application using the eIRB screenshot tutorial guidance.
  • Complete and upload the “Reliance Agreement Request” form to request a letter of acceptance for exemption determination (linked below) to the protocol’s supporting documentation.
  • Upload the approved IRB application from the other institution along with any documentation, such as an approval letter to the protocol’s supporting documentation.
  • Upload proof of human subjects research training for each NC State University research team member.  The training requirements are outlined in the NC State University Training Requirements for Completing Research with Human Subjects document. All of the CITI certificates must be completed within the past three years of the protocol application, all modules need to be completed at 80% or greater, and the training must be appropriate to the proposed research to be accepted. Each research team member’s training certificates from CITI and NCSU IRB Overview Video must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB.
  • 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 to complete a COI management plan. You can then upload the plan you’ve developed with the COI Manager or a letter she provides you to your protocol’s supporting documentation.
  • Submit your protocol to the IRB office for review.

If you need assistance, please contact the NC State 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.
  • The researcher can either:
    • Include the individual investigator agreement request as part of the initial protocol application OR
    • If the protocol is approved, the researcher must submit an amendment request to the approved NC State eIRB application to add the individual investigator(s) to the research team. Note in the amendment request that the amendment asks for the processing of an individual investigator agreement between NC State University and from.
  • 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 for all members of the research team
    • For all NC State University team members and individual investigators, all must meet the training requirements outlined in the NC State University Training Requirements for Completing Research with Human Subjects document.
    • All of the CITI certificates must be completed within the past three years of the protocol application, all modules need to be completed at 80% or greater, and the training must be appropriate to the proposed research to be accepted. Each research team member’s training certificates from CITI and NCSU IRB Overview Video must be uploaded in the protocol’s supporting documentation prior to final review and approval by the NC State IRB.
    • In the unusual circumstances where an individual investigator does not have access to the CITI and NCSU IRB Overview Video platform, the following process should be followed for the individual investigator to receive training

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

Back to Top

Request a Letter

Electronic approval letters on NC State University letterhead can be generated for protocols that are already approved or after a protocol that is currently in process is approved. To do so, please complete all sections of the below Request a Letter form, including the telephone number. Make sure what you put into the form matches the IRB application that the letter is being requested for. The approval letter on letterhead will be uploaded to your protocol’s supporting documents once approved as well as emailed to you.

Our office can also produce .118 determination letters if you need one for National Science Foundation (NSF) funding processes. A .118 letter states 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 IRB application to receive a .118 determination letter; you must, however, have initiated an IRB application, written [.118 Determination Request] in the protocol’s title box along with the protocol title, and state in the description tab’s 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 take place until after the PI has complete and full IRB approval via an amendment process,” and have submitted the protocol to the IRB office for review and .118 determination. The rest of the IRB application aside from the Title tab and the first narrative box on the Description tab should be blank when you submit the application to the IRB office for a .118 determination. Please note, a .118 determination is staged research and you should familiarize yourself with the NC State IRB guidance on phased and staged research protocols.

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

Request a Letter Form
Back to Top

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, unless it is in-person research during COVID-19. Please consult the Research in the Time of COVID-19 guidance for those reporting deadlines and processes. 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

Back to Top

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
Back to Top