General Announcements

Is IRB Approval Required for Student Research Projects that Involve Human Subjects?

The answer is "YES" most of the time.  Student research, such as class projects and poster presentations, have the same requirements as any other studies that involve human participation. If your class is conducting a systematic investigation intended to contribute to generalizable knowledge (aka research), and is contacting human subjects or using archival data that could be connected to humans, then this would require IRB review. Also, all students, faculty, and research advisors or colleagues who are involved in data collection or analysis will need to complete the appropriate training before they can begin working on data collection or analysis.

 This page is intended to provide brief answers as to whether IRB oversight is required for the following types of student research programs:

• Class Projects
• Thesis/Dissertation
• Honors project
• Scholars Week Posters and Talks
• URECA / MT-IGO

When the project is not intended to contribute to generalizable knowledge, and is just intended to be an educational experience for the students, IRB approval would not be required.  However, neither the student nor the faculty/staff would be able to publish or present any of the findings.  In addition, such studies cannot be used in a Thesis or Dissertation as they no longer meet the definition of "research" projects.   Moreover, projects involving sensitive topics or vulnerable populations will need IRB approval regarless of their research status.

The Office of Research Compliance will conduct special lectures and workshops for students who are interested in knowing more about the IRB approval process.   Preparation for the IRB approval process is a very worthwhile educational experience and the Office of Research Compliance is committed to advancing the University's research and education mission.

Before starting the IRB training, it may be a good practice for students to watch the following video clips to gain more insight into the process of human research and its regulatory component:

• Module 1 - (22:13 min)
• Module 2 - (27:37 min)
• Module 3 - (35:19 min)
• Everything Investigators Want to Know but are Afraid to Ask - (40:20 min)

Please visit the FAQ page for specific information.

How should I handle the IRB requirement for my class project?  

Students can either apply for their own student-initiated IRB application through a faculty advisor or register through a "standing protocol" that has been specifically issued for the class.  

Standing Protocols: Check with your course director if you need to make an IRB application. The MTSU IRB has standing protocols for some University classes where students will be added to a study as co-investigators through an amendment.  The students MUST complete CITI training before the class coordinator can add the students to the protocol.  Registering through a "standing protocol" has several advantages and a few disadvantages as listed below:

Advantages:

1. The "standing protocol" has preassigned procedures so the students do not have to do much other than complete the CITI training
2. The class coordinator handles all of the compliance-related issues and the students just concentrate on completing their project

Disadvantages:

1. This mechanism allows less flexibility when designing the research
2. The student cannot continue the project for higher-level studies
3. The student will also miss out on the educational experience of developing a human subject research protocol and participating in the review process

Student-initiated Protocols:   The students MUST complete CITI training before the class semester starts.  Inform the class coordinator that you will be filing your own protocol.  This option is expected to have the following advantages and a few disadvantages as listed below:

Advantages:

1. The student receives first-hand experience regarding the IRB process
2. Independence
3. Possibility of publication
4. Provision for further utilization of the study as a part of future research ventures (e.g., thesis, dissertation, request funding)

Disadvantages:

1. May be very challenging 
2. Time consuming if not dealt with properly - IRB approval may take anywhere between 2-4 weeks leaving very little time for completing the project  
3. A clear direction may not be available - the regulatory conditions can often be study-specific

The Office of Research Compliance recognizes that it can be very challenging, especially for new students, to navigate through the rules and regulations to determine what type of application one is required to complete.  The following sections are intended to assist students who wish to submit their own IRB proposals by detailing a workflow that has successfully helped many researchers to submit clear research protocols.  

Please visit the FAQ page for specific information.

Where do I start with my IRB application process?  

As noted earlier, the IRB process can be complex, even for a very seasoned IRB user.  Many young researchers have expressed frustration at the lack of clarity in the regulatory process.  The following workflow provides a framework for a new IRB application.  Corresponding weblinks are provided for convenience, however, there may be subtle or major differences in the actual requirements depending on the nature of the study.

1. Read this weblink thoroughly.
2. Complete your CITI training:
   1. All students must complete the "Social and Behavioral Research (SBR)" course
   2. AND complete "Students in Research" under SBR (offered by the CITI Program)
   3. AND complete other modules depending on your study. Visit the MTSU IRB's online training site - watch the videos listed above.
3. Work on Informed Consent - Although Informed Consent is a document, it is essential to note that the consent process is a conversation. Once the researcher determines which activities and procedures require informed consent, it will be much more clear what can and cannot be done.  Assess the risks and discomforts to be experienced by the participants and disclose that in your Informed Consent.  Any additional information, such as demographics, personal behavior and other types of information you plan to collect needs to be disclosed up front. Learn more about informed consent.  Watch an OHRP video on General Informed Consent Requirements.
4. Determine if the data collected through the informed consent process is sufficient to answer the research question without placing the participants in potential risk.
5. Also determine your participant pool - who they are and how you plan to recruit/enroll them.
6. Decide what type of survey or research instrument you will use that would comply with the consent process and answer your research questions.
7. Consider what the IRB reviewers may be looking for in your application.
8. Develop a research protocol - a step by step outline of various procedures and practices - to comply with all of the above.  During this process, you will gain clarity regarding what type of review mechanism to request. Read general information about the various IRB review processes.
   • Exempt
   • Expedited
   • Full Committee Review
9. If you need assistance, recruit or invite co-investigators to work with you - ensure that they have CITI training.
10. If your study is conducted at a physical location other than MTSU, provide letters of permission.
11. Request a faculty advisor who best suits your research goal to be your sponsor - please note that students cannot apply for a protocol.
    1. This is not to prevent students from applying, but to protect them from institutional liabilities in case the protocol is non-compliant.  
    2. If a protocol is found non-compliant, all or a portion of the data could become invalid, thereby affecting the students' academic status.
    3. You are not required to keep your academic advisor as your research advisor; sometimes, the academic advisor may have limited knowledge in human subject research and may not be able to guide you with the research and regulatory challenges.
12. Be aware of the responsibilities of a researcher once a protocol has been approved.  Non-compliance with the approved protocol may lead to strict penalties and sanctions. Click here to find out more about post-approval responsibilities so you can be prepared before you request approval.
13. Start filling out your forms - Click here to visit the MTSU IRB Forms page.
14. Submit your application form through your faculty advisor. DO NOT collate the files together - however, request your faculty advisor to send the completed IRB forms and supporting documents in a single email if possible.  The faculty advisor must also include a note of support and a statement of commitment to the study - Click here to learn how to send your application to the IRB.
15. Your application will initially be pre-reviewed by the Office of Research Compliance.  An associate will contact you within 4 (four) business days with further instructions.  Subsequently, your protocol will be reviewed in accordance with your review mechanism and a determination will be sent to you.
16. Speak to other students and faculty who have a successful human subjects research program.
17. Set up a meeting with the compliance staff to review your research plan and the types of regulatory challenges you are likely to face.  Email your request to irb_information@mtsu.edu.

• Students MUST complete all necessary training before seeking IRB approval.

• IRB approval must be obtained prior to initiating the data collection, but your research can be designed before approaching the Office of Research Compliance.

• The MTSU-sponsored Scholars' Program officers collaborate with the Office of Research Compliance to ensure that student presentations have prior IRB/IACUC approval.  The posters that do not meet this criteria will be recalled by the respective poster selection committee.

• URECA / MT-IGO projects that involve human subjects research MUST have an approved IRB protocol prior to the funding date.  The College of Graduate Studies will hold funding for studies that do not have an IRB approval if the appropriate research committee granted the scholarship.  

 

• Undergraduate Research Center (URC)
• URECA

 

 

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