Welcome to the researcher portal!
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.
You can also find options to submit requests for a protocol approval letter, institutional authorization agreement (aka reliance agreement), or individual investigator agreement. Additionally, you will be able to report any issues that arise such as an unanticipated problem, adverse event, or possible noncompliance.
Please note, 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.
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 non-compliance 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.
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. 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. 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 an NC State IRB policy and guidance document about minors participating in research. This guidance should be used in conjunction with the templates below. For research with minors who are not enrolled in a post-secondary setting, 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.
- NC State’s Policy Statement on Adult Consent, Minor Assent, and Parental Permission
- Adult Consent Form Template: This is the informed consent template to be used for all NC State IRB-approved research with adults. This NC State IRB consent template is appropriate for in-person research and, with modifications to the template, for obtaining consent online, creating opt-out forms, and for research information sheets.
- Parental Permission and Minor Assent Templates: This document includes 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 in-person research and, with modifications to the templates, for obtaining consent online, creating opt-out forms, and for research information sheets.
- Broad Consent Addendum Template: 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.
- Inclusion of Minors Attending Post Secondary Institutions in Research
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 working directly with human subjects during the course of research will want to access the “Things to consider” section. This section has guidance for different research methods for the proposed study.
Those of you utilizing secondary information for your proposed study, that is, accessing data (such as FERPA or HIPAA records or creating repositories) should read the secondary research button for a definition of such and the repository button if relevant.
Those of you interested in completed survey research or using the Survey tool Qualtrics, please use the Qualtrics button to find guidance regarding online recruitment, consents, and surveys.
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.
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.
CITI is a comprehensive ethics training program for researchers conducting research with human subjects.
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.
We would love to meet with you in person. Our office regularly schedules group learning sessions at Hill Library and you can access their 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.
- NC State Library
- Request an In-Person Group Education Event Form
- Request a 1:1 meeting
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 or to complete a data management plan and upload the plan into your eIRB’s supporting documentation. 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. We have included a copy of the NC State IRB office’s data management plan and security guidance for your use and reference. As you contemplate your study design and integrate data management throughout your project, we encourage you to review the guidance below on risks and benefits, identifiable data, and data security.
- Data Management and Security Guidance from the IRB
- Primary Data Access and Security Plan
- Secondary Data Access and Security Plan
- Risks and Benefits What to Consider
- Identifiable Data FAQ
- Data Security FAQ
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.
Federal 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.
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 with the IRB where the primary PI or the research activities are occurring.
For investigators that are not affiliated with an IRB, NC State may choose to create an individual investigator agreement. The NC State researcher would file their research protocol application to the NC State IRB office for review and indicate that an unaffiliated investigator is involved in the project. Either while in process or once 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.
If you are interested in an institutional authorization or individual investigator agreement, please follow the directions below.
- Collaborative Research, Reliance Agreements, and Single IRB: NC State’s Policy
- Reliance Agreement Request Form
- Reliance Agreement Conflict of Interest (COI) Attestation Form
- Site Context Worksheet
Request a Letter
Please complete this form to request an approval letter for either an already approved protocol, an in-process filed eIRB protocol, or for a protocol for which you need a “.118 determination letter” to satisfy a federal sponsor’s funding requirements. A .118 determination letter is a letter from the IRB that you receive. It 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 eIRB application to receive a .118 determination letter; you must, however, have initiated the application, uploaded the 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 eIRB application may remain blank.
Report Unanticipated or Adverse Events
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.