IRB Requirements for Student Research Projects

 

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

The answer is "YES" in most parts.   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 expected to provide brief answers 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/FRCAC
 
When the project is not intended to contribute to generalizable knowledge, and is just intended to be an education 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 on sensitive topics or the ones that involve vulnerable populations will need IRB approval regarless of their research status.
 
The Office of Compliance will conduct special lectures and work shops 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 Compliance is committed to advancing the Universities 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. Click
 

What should I do for my class project?  

The 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 apply for an IRB application.  the MTSU IRB has standing protocols for some of the University classes where the students will be added to the study as co-investigators through an amendment.  The students MUST complete CITI training before the class coordinator could 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 completing 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 studies
  3. The student will also miss out on the education 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 stream is expected to have the following advantages and a few disadvantages as listed below:
 
Advantages:
  1. The student receives a first hand experience of the IRB process
  2. Independence
  3. Possibility for publication
  4. Provision to carry the study to be part of future research ventures - like thesis, dissertation, request funding, etc.
Disadvantages:
  1. May be very challenging and sometimes very stressful
  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 Compliance recognizes that is very challenging and stressful, especially for new students, to navigate through all the rules and regulations to determine what type of application one is required to fill.  The subsequent sections are expected to assist the students who wish to submit their own IRB proposals by describing a work flow that has successfully helped many researchers to turn in clear research protocols.  
 
Please visit the FAQ page for specific information. Click

 

Where do I start with my IRB application process?  

As mentioned earlier, the IRB process could be very stressful and overwhelming, even for a very seasoned IRB user.  Many young researchers have expressed their frustration noting the lack of clarity in the regulatory process.  The following work flow is expected to give a frame work for a new IRB application.  Corresponding weblinks are provided for convenience, however, there may be subtle or drastic 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 "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.  Click here to visit the MTSU IRB's online training site - watch the videos listed above
  3. Work on your informed consent - although the informed consent is a document, it is essential to note that the consent process is a conversation.  Once the researcher determines what activities & procedures require informed consent, then it will be much more clearer what can be done and what 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 from them needs to be disclosed up front. Click here to know more about informed consent.  Click here to 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. Now determine what type of survey or research instrument you will use that would comply with the consent process and answer your research questions
  7. Look for what the IRB reviewers may be looking for in your application - click here to know more
  8. Develop a research protocol - a step by step flow of various procedures and practices - to comply with all of the above.  During this process, you will gain better clarity on what type of review mechanism to request. Click here to read general information about the various IRB review processes.
    1. Exempt click here
    2. Expedited click here
    3. Full Committee Review click here
  9. In situations you need assistance or help, recruit or invite co-investigators to work with you - ensure they have CITI training
  10. If your study is conducted at the physical location of a place other than MTSU, then provide letters of permission
  11. Request a faculty advisor who best suits your research goal to be your sponsor - please note that the students cannot apply for a protocol.
    1. This is not done 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 what are the responsibilities of a researcher once a protocol has been approved.  Non-compliance to the approved protocol may lead to strict penalties and sanctions. Click here to know more about post-approval responsibilities so you can be prepared even before you request for an 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 all the files together - However, request your faculty advisor to send the filled IRB forms and supporting documents in a single email unless there are memory overflows.  The faculty advisor also has to include a note of support and a statement of commitment to the study - Click here to know how to send your application to the IRB
  15. Your application will initially be pre-reviewed by the Office of 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 subject research program.
  17. Set up a meeting with the compliance staff to go over your research plan and what type 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

  • The IRB approval needs to be obtained prior to initiating the data collection;  but you can plan your research can be designed before approaching the Office of Compliance.

  • The MTSU-sponsored scholars' program officers collaborate with the Office of Compliance to check if the 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/FRCAC projects that involve human subject research MUST have an approved IRB protocol prior to the funding date.  The Graduate Office will hold funding for studies that do not have an IRB approval if the appropriate research committee granted the scholarship.  

 

Please visit the FAQ page for specific information. Click
 
Visit the following sites to know more about the MTSU-sponsored student research programs
Undergraduate Research Center (URC)
URECA

 

 

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