Student Research Guidance

Background

The purpose of an IRB is to review research conducted using human subjects. For the purposes of UNT’s IRB, human subjects research is defined as:

  • Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to create generalizable knowledge. Generalizable knowledge means new information that has relevance beyond the population or program from which it was collected, or information that is added to the scientific literature. (45CFR46.102(l))
     
  • Human Subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens or (2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.” (45CFR46.102(e))

Research projects conducted by students, such as theses, dissertations, honors projects, capstone projects, and independent study projects, that meet the definitions of Human Subject and Research must be submitted for review and approval by the IRB.

The Office of Human Research Protections (OHRP) recommends that institutions ensure knowledgeable individuals assist investigators in making the appropriate decision about the status of their project and ensure that an IRB reviews all studies that are determined to be human subjects research. Determinations must be made by Research Integrity and Compliance staff and not individual researchers. Student Researchers and Principal Investigators must reach out to the untirb@unt.edu to assist with these determinations. This process ensures that the requirement of obtaining IRB review and approval for applicable projects is satisfied as required by federal regulations.

Students should expect the IRB process to take at least one month. However, review times vary based on complexity of the research. Graduate students are encouraged to begin their discussions with their faculty advisor about the nature of their intended research and its potential IRB review as soon as possible.

Please reach out to untirb@unt.edu with any questions.

Tips for Student Researchers

Submission

For help submitting a new study to the UNT IRB, consult this guidance document.

The guidance document will take you through each question of the application, explain the questions in more detail, as well as provide tips on how to answer the questions effectively. Additionally, if you are a new researcher, consider watching a recent training video to help get you started. 

All sections of the application (Core info through Section 9) must be completed before you are able to submit in Cayuse. Within Cayuse, look for a blue check mark on the left side of the screen next to each section once the section has been completed. Once the submission is marked complete, the study will be routed within the IRB submission portal to the PI. The PI must log in and select “certify” for the submission to be routed to the IRB for review. Your study will not be routed to the IRB office for review until the submission is certified by the PI. Communication with your PI is key.

Review and Response
All IRB submissions are reviewed in the order that they are received. You can check on the status of your protocol in the Cayuse system. Please plan ahead to allow a sufficient amount of time for submission, review, and approval of your study. The current review timeline is posted in a message within the Cayuse system and will depend on the volume of submissions received by the IRB office. Protocols of greater complexity or risk will take more time to review. Additionally, protocols that are incomplete or lack details will be returned, further delaying the review and approval processes. 

Please review all of the website resources and the application thoroughly to assess the readiness of your study documents for review. If you have any questions, you would like a status update, or if the current review timeline will place undue burden on your research, please contact untirb@unt.edu or call at 940-565-4643. 

Once the Regulatory Analyst has conducted an initial review of your study, if clarification or revisions are needed, the study will be returned to you in the Cayuse system for edits. The PI and Primary Contact listed within the application will receive an email from the Cayuse system, which will let you know your protocol has been returned. We request that you complete the revisions in their entirety as soon as possible and resubmit the revised documents within the Cayuse system.

Read through the application before submission to ensure that all information is accurate and consistent. Any information that is not clear or that is contradictory can delay the IRB review timeline.
Approval
There are 3 categories of review including Full Board, Expedited, and Exempt Review. In all cases, all human subjects research studies must undergo a review and approval by IRB before any initiation of research begins. Full Board studies are reviewed at monthly board meetings and must be submitted prior to the first of the month to be reviewed at that month’s meeting; Approvals are issued following the meeting. Expedited reviews are conducted by the Research Integrity and Compliance staff and a single member of the IRB committee; Approvals are issued following the review. Exempt reviews are conducted typically by only one reviewer within the Research Integrity and Compliance Office; Approvals are issued following the review.
Communication
The Primary Contact and PI will receive all study communication. As a student, you can list yourself as the Primary contact if you would like, but the PI must be a full-time faculty or staff member who is PI eligible.

Please call (940) 565-4643 or email untirb@unt.edu with any questions.

Frequently Asked Questions

FAQs
  • Does my class assignment need IRB approval?
  • What type of training do I need to complete to work on a human subjects research study?
  • Can I, as a Student, serve as the Principal Investigator (PI)?
  • Do I need to route my application to the PI for review?
  • How can I request assistance with the forms, IRB process, or my study submission?
  • How much time should I allow to obtain an IRB approval of my research?
  • How do I know what I need to Submit?
  • What if I want to make changes to my study after I have IRB approval?
  • What does the study expiration date mean?
  • When can I close my study with the IRB?
     
  • Does my class assignment need IRB approval?

    • In general, if a project is meant to complete an assignment for a class and has no/will never have relevance beyond the class, it does not require IRB review. If students or faculty think the data may be used for research purposes beyond the classroom assignment, then an IRB application should be filled out prior to research-related activities. Data procured for the purposes of ‘course work’ may not under any circumstances be used for research without consulting and obtaining approval from the IRB. Students who publish their research projects via any vehicle, e.g. blogs, must have submitted an IRB application for review prior to conducting the research. No retroactive determination is available.
       
  • What type of training do I need to complete to work on a human subjects research study?

    • All IRB applicants are required to complete mandatory online training via CITI Program prior to submitting their applications. Research will not be approved until the training requirements are met.
       
    • All CITI training requirements can be found on our Training and Education webpage. CITI courses can be accessed by following these steps.
       
  • Can I, as a Student, serve as the Principal Investigator (PI)?

    • Students may not serve as the Principal Investigator (PI) of any human subjects research study. Students may serve in the “Student Investigator” and “Key Personnel” roles. The PI must be a full-time faculty or staff member who is PI eligible. All human subjects research must be approved by the student’s Principal Investigator before coming to the IRB. Ultimately, the IRB holds the Principal Investigator responsible for the oversight of an approved research protocol in conjunction with the student.  Oversight of the research encompasses the ethical, administrative, fiscal, and conduct of research study activity.
       
  • Do I need to route my application to the PI for review?

    • Your IRB submission must be submitted to review by the PI. Your study will not be routed to the IRB office for review until the submission is reviewed and certified by the Principal Investigator. Once the submission is marked complete, the study will be routed within the IRB submission portal to the PI. The PI must log in and select “certify” for the submission to be routed to the IRB for review. Your study will not be routed to the IRB office for review until the submission is certified by the PI. If the Principal Investigator is completing the submission, they must mark both “Complete Submission” as well as click “Certify” for routing to be initiated.
       
  • How can I request assistance with the forms, IRB process, or my study submission?

    • Please reach out to untirb@unt.edu or call 940-565-4643. We are available to schedule one-on-one meetings to walk through the application submission and review process with you, or to answer any IRB related questions you may have.
       
  • How much time should I allow to obtain an IRB approval of my research?

    • Students should expect the IRB process to take at least one month. However, review times vary based on complexity of the research. Graduate students are encouraged to begin their discussions with their faculty advisor about the nature of their intended research and its potential IRB review as soon as possible.
       
  • How do I know what I need to Submit?

    • For help submitting a new study to the UNT IRB, consult this guidance document. With your study submission, you must include any supplemental forms and documents related to your study (Informed Consent documents, data collection tools, recruitment materials, permission letters from external sites, etc.). If you are a new researcher, consider watching a recent training video to help get you started.
       
    • If you are unsure which documents may be needed for your protocol, please review the IRB Forms and Templates page and read each application question thoroughly. All requested items must be attached in the appropriate locations within your IRB Submission. If you have any questions, please contact untirb@unt.edu.
       
  • What if I want to make changes to my study after I have IRB approval?

    • After your protocol is approved by the IRB, you must submit a modification request in Cayuse and obtain IRB approval for ANY changes prior to the implementation of the changes. To submit a modification to an approved study, you must log into Cayuse and click on the study you would like to modify. In the upper right-hand corner, click the blue button "+New Submission” and select "Modification" and then “Edit.” Complete the modification page, explaining all of the changes you would like to make to your approved study and then navigate to the affected sections of your study and complete the updates. Once complete, mark the routing button as “Complete Submission” and have the PI “Certify” the submission. Once the PI certifies, the submission will be received by the UNT IRB and will undergo review.
       
  • What does the study expiration date mean?

    • The expiration date is the date the study must be renewed by in order for study activity to continue. If approval for continuation is not granted prior to the expiration date of the protocol, all recruitment, subject enrollment, and other research related activities (e.g. study visits, chart reviews, data analysis using subject identifiable data, manuscript development, etc.) must stop.
       
    • Failure to submit timely requests for renewal of a study demonstrates non‐compliance with federal regulations and institutional policy.
       
  • When can I close my study with the IRB?

    • Projects should only be closed if they are no longer interacting with subjects and all data has been collected, the data has been “cleaned,” analysis of identifiable data is complete, and all identifiers have been removed from data sets. When a study ends, is closed, canceled for any reason, or is prematurely completed you must complete a closure form in Cayuse. A closure form serves as notification to the IRB that study activity is no longer being performed.
       
    • DO NOT CLOSE THE PROJECT TOO SOON! Once a Closure Form is processed, no further research related activity can occur and any contact with subjects or access to data for research purposes will no longer be allowed.
       
    • The PI and Student Investigator is responsible for submitting a closure report, indicating any research findings and/or outcome of the project. All protocols are approved for the time period as stated in the IRB approval letters. Prior to the end of the last year of the protocol, the researchers are required to submit a closure report and attach the IRB Final Report form from the IRB Forms and Templates page.