Information for MTSU Faculty who work with Human Subjects

General Announcements:

  • Protocols are prescreened within 4 days of submission.  You will receive an email at the completion of this process.  If you do not receive an email, please contact us.

  • It generally takes two weeks for protocols to be reviewed after the IRB office has prescreened them and confirmed the application packet to be complete.

  •  The MTSU IRB receives a higher number of applications during September-October and February-March.  We request your patience during these months.  The MTSU IRB continues to receive IRB applications during the summer break (June-August). 

 

This page is intended to assist MTSU faculty members who may be required to obtain IRB approval or sponsor a student for IRB approval. Faculty research could be relevant to one or more of these categories:

  1. Faculty serving as sponsor - the faculty member may either be an academic advisor or research supervisor of a student whose research involves humans.  The faculty member may not be the primary beneficiary of the research outcomes.  
  2. Faculty responsible for class projects - the faculty member is a course director of an MTSU educational program that requires the collection of data from human subjects.
  3. Faculty conducting independent study - the faculty member is either a PI or an active co-investigator in a study involving human participants. Faculty members who fall under this category are usually familiar with the IRB processes and may need very minor assistance.  The faculty member may have students or postdocs conduct several tasks within the study, but the faculty member is the chief beneficiary of the research outcome.

Training 

Regardless of which of the above categories the faculty member is associated with, he/she must complete CITI training in order to be eligible for the designated role.  Since students do not have the institutional authority, they cannot take on responsibilities that may potentially cause irreversible challenges to their academic status.  Hence, the IRB requires that the faculty in charge be adequately trained in human subject research and be familiar with various IRB procedures.  As a first step, we encourage faculty to view the following informative videos available through the Office for Human Research Protections (ORHP) to understand the history and role of the IRB in human subjects research:

The above videos provide an overall understanding, but merely watching them does not meet MTSU's human subject training requirement.  Once you have watched these video clips, please visit  CITI program www.citiprogram.org to complete your training.

  • First-time users must register for an account using your official name (Ensure that the first and last names you provide to CITI match your MTSU records and your IRB applications).
  • You will be asked a series of questions by the CITI portal to automatically determine which training module would most fit your needs.
  • Faculty and staff must complete the "Social and Behavioral Research" course AND applicable "optional" modules depending on the type of research and group of participants. 
  • In most instances, the Office of Research Compliance will be able to access your course completion information.  However, be prepared to provide proof of certification if directed by the IRB or the Office of Research Compliance.  

1. Faculty Serving as a Sponsor 

The faculty member may either serve as an academic advisor or as a thesis mentor to a student who conducts research that involves data collection from living human subjects.  In some instances, you may be an MTSU staff member who has been assigned to mentor student research projects.  We have encountered several scenarios where the faculty mentor's primary field of interest may not entail human subjects.  There may be a secondary interest that connects the student research project and the faculty member.  In some cases, the faculty advisor was assigned to a student by Academic Affairs and the student decides to work with human subjects.  Regardless of the reason, the faculty sponsor is granted the institutional authority and the consequent regulatory responsibility.   The main responsibility is to ensure that the student is compliant.  Therefore, it is essential that the study sponsor is familiar with IRB steps and the regulatory responsibilities before accepting mentorship of a student.  
 

1.1 Application Procedure

Depending on the type of research the student plans to conduct, there may be different sets of paperwork he/she would be required to submit.  If this is your first time sponsoring a student, the Office of Research Compliance encourages you to email irb_information@mtsu.edu and request a meeting for advice on how to proceed.  In most instances, please be aware that the student you sponsor must provide the following mandatory items for your review before you can forward the application packet to the IRB:
  • Fully completed application form for your endorsement or signature. (Please note that a physical "ink" signature is not necessary.  Entering your name in the signature field using MS Word is sufficient.)  Submit the original Word document to allow MTSU IRB to capture your signature and other embedded macros. 
    • Exempt form - READ
    • Expedited form - READ
    • Full Committee Review form - READ
  • Informed Consent document - READ
    • If working with minors the researchers must provide a template for parental consent and child assent - Click here to visit the Working with Minors page.  
    • In rare cases, a waiver to consent may be granted. The researcher must submit a consent waiver form - READ

    • Click here to watch an OHRP video on General Informed Consent Requirements

  • Recruitment material, such as flyers, email transcript, etc - VIEW.
  • Proof that the student has completed CITI training.
  • Applicable permission letters if the study is conducted outside MTSU.
  • Study instruments, such as surveys.  The student should ensure that all of the modules are operational before sending for IRB review if he/she will conduct the study through an online site.
Please review the application and the supporting documents for completeness and submit the application packet via a single email to irb_submissions@mtsu.edu after you have indicated your approval by entering your name and date.  Please DO NOT combine the files, but instead attach them separately.   Enclose a note in the email  to clearly indicate that you will be supporting the student and you will be responsible for the post-approval regulatory processes (READ).  It may speed the process to also copy the research team, including the student PI, when you email the packet.  This will also enable the student to respond to any reviewer questions.  Always use your MTSU email ID when applicable.  
 

1.2 Sponsor Responsibilities

Please be aware that if a student is required to either generate an expedited application or attend a full committee review, it is critical that the student receive guidance from an advisor who has working experience with IRB matters.  Therefore, you may request the student to invite a faculty co-investigator who is specialized in human subject research.   It is essential that you are aware of the research activities and ensure that the protocol is followed without any deviation.  In the event there are deviations, immediately report non-compliance to the compliance hotline compliance@mtsu.edu.   Also, familiarize yourself with the responsibilities of the Principal Investigator (PI) (READ) and the post-approval responsibilities (READ) of the research team.   Even accidental violations of the approved protocol may result in the withdrawal of the data, leading to serious consequences to the student's academic status.  
 
In addition to the critical role during the approval process, the sponsor is also charged with additional post-approval responsibilities.  Since the PI is a student, all of the responsibilities are shared between the sponsor and the PI (READ).  Moreover, the sponsor must ensure that the research-related records and documents are stored properly in accordance with the approved protocol for at least three (3) years after the data collection has ceased.  Therefore, it is important that the sponsor is familiar with the post-approval tasks (READ). 
 
Please visit the IRB's FAQ page for specific information. Click
 
 

2. Faculty Responsible for Class Projects

In this scenario, the faculty member is most likely a course director or someone who is responsible for a class which involves conducting a small human subject study as part of the curriculum.  The responsible individual could be full time faculty, temporary faculty, part-time faculty, staff or even an adjunct faculty member.  Regardless of rank and affiliation with MTSU, their compliance role is the same as that described under "Sponsor" in the previous section.  The faculty member in this case has two options to consider: (1) an IRB approval can be requested by the faculty member for the entire class project - also known as a "standing protocol;" or (2) the students can apply for individual IRB approval - referred to as a "student-initiated protocol."  There are a few factors that need to be considered before a choice is made.  
 

2.1 Standing Protocols 

This process is useful in instances where the IRB experience is not the focus of the curriculum, but the students would conduct a short study to meet their academic requirements.  The course director designs the methods of the study and takes ownership of the research.  Once the research framework is constructed, the faculty member would apply for an IRB approval as a principal investigator (PI) through a workflow described in the "Application Procedure" described above.  Student researchers will not be added at the application stage.  Depending on the type of research design, the application needs to be furnished in the appropriate format and will be reviewed accordingly.  Since the class requirements are unique, it is essential that the faculty member consults with the Office of Research Compliance for clear guidance on what supporting documents will be required.   Once the protocol is approved, the faculty member can request amendments to include student researchers AFTER the students have successfully completed their CITI training.  
 
Please note that this protocol set-up may be a one-time time commitment for the faculty member.  If the class project involves minimal risk and it qualifies for exemption, the IRB approval for the class is valid for several years.  If the class project is reviewed under the expedited or full committee review mechanism, then it is valid for 3 years with a few requirements.  The protocol can be extended beyond 3 years in most cases.  The Office of Research Compliance recommends that course directors consider this mechanism if the student research segment of the course is short and is not a major component of the curriculum.  The responsibilities of the students who would like to register through this option are provided on the student information page.  
 
The MTSU IRB has issued standing protocols for a few a classes as a test.  Based on the limited data, the students will likely experience the following advantages and disadvantages when class project research is conducted through this mechanism:
 
Advantages:
  1. The "standing protocol" has preassigned procedures so the students have few tasks other than completing their appropriate CITI training.
  2. The class coordinator handles all of the compliance-related issues.
  3. For the faculty, record keeping is limited to just one protocol.  As described later, the course director is responsible for all research activities carried out through the class, which includes record keeping.  By using this mechanism, the course director does not have to initiate multiple protocols for each class.  
Disadvantages:
  1. This mechanism allows less flexibility for the students to customize their research design.
  2. The student cannot continue the project for higher studies.
  3. The student will miss out on the education experience of developing a human subject research protocol and participating in the IRB review process.
  4. For the faculty member, the initial IRB approval process may be time consuming.

2.2 Student-initiated Protocols  

The students MUST complete CITI training before the class semester starts and they must inform the class coordinator that the student will be requesting an individual protocol.  This option is expected to have the following implications for students:
 
Advantages:
  1. The student receives first-hand experience of the IRB process.
  2. The student has more independence in research design, but the faculty member must ensure that the design is compliant.
  3. There is a possibility for publication.
  4. There is a provision to utilize the study as part of future research ventures (e.g., thesis, dissertation, funding request).
Disadvantages:
  1. May be very challenging and for both the student and the faculty member.
  2. May be time-consuming if not dealt with properly - IRB approval may take anywhere from 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 protocol application must be carried out as described above in the "Application Procedure" subsection.  Within this provision, the course director will have the same responsibility as a Sponsor.  

2.3 Course Director's Responsibilities

Regardless of whether the course director used a "standing protocol" mechanism or he/she allowed a student-initiated application, the course director is charged with record keeping responsibilities and communication with the Office of Research Compliance for pre- and post-approval processes. While the "standing protocol" mechanism allows a reduced workload for the course director, it is essential that he/she make a choice such that the academic goals are met adequately.  
 
If the course director is not familiar with IRB procedures, he/she must be aware that students should receive proper guidance in the event a student is required to either generate an expedited application or asked to attend a full committee review.  Therefore, the course director must consider inviting, or allowing to student to request, a different faculty member who is specialized in human subject research to be a co-mentor in the study.  It is also important to note that the course director must be aware of all of the activities of the research and ensure that the protocol is followed without deviation.  In the event there are deviations, immediately report non-compliance to the compliance hotline compliance@mtsu.edu.  Also, familiarize yourself with the responsibilities of the Principal Investigator (PI) (READ) and the post-approval responsibilities (READ) of the research team.  Even accidental violations of the approved protocol may result in the withdrawal of the data, leading to serious consequences to the students' academic status.  
 
In addition to the critical role during the approval process, the faculty sponsor is also charged with additional post-approval responsibilities.  Since the PI is a student, all of the responsibilities are shared between the sponsor and the PI (READ).  Moreover, the sponsor to ensure that the research-related records and documents are stored properly in accordance with the approved protocol for at least three (3) years after the data collection has ceased.  Therefore it is important that the sponsor is familiar with the post-approval tasks (READ). 
 
Please visit the FAQ page for specific information. Click
 
 

3. Faculty Conducting Independent Study

The faculty member may either serve as a PI or a specialist co-investigator in a study.  If the faculty member is also the PI, then he/she is charged with all of the regulatory responsibilities.  Please note that the faculty member will be allowed to have students or postdocs work in the proposed research, and "independent" does not mean that the faculty member would conduct the study alone.  
 

3.1 Application Procedure

Depending on the type of research,  there may be different sets of paperwork that the faculty member would be required to submit.  In general, the PI must provide the following mandatory documents:
  • Fully completed application form
    • Exempt form - READ
    • Expedited form - READ
    • Full Review form - READ
  • Informed consent document - READ
    • If working with minors, the researchers must provide a template for parental consent and child assent.
    • In rare cases, a waiver to consent may be granted. The researcher must submit a consent waiver form. READ
  • Recruitment material, such as flyers, email transcript, etc. VIEW
  • Applicable permission letters if the study is conducted outside MTSU.
  • Study instruments, such as surveys.  The PI should ensure that all of the modules are operational before sending them for IRB review if the study will be conducted online.

Once you are confident that the application is complete, submit the application packet via email to irb_submissions@mtsu.edu.  DO NOT COMBINE all of the files together -- attach the files separately in the same email.  It may speed the process if you would also copy the research team, including any student researchers, when you email the packet.  This will also enable the students to respond to any reviewer questions.  Always use an MTSU email ID when applicable.  Incomplete applications that lack the necessary documentation will not be reviewed.  The Office of Research Compliance will return incomplete applications without any administrative action.

3.2 Responsibilities

If a faculty PI has student co-investigators, the faculty menber is required to provide adequate guidance to the students and interns.  In the event there are deviations, immediately report non-compliance to the compliance hotline compliance@mtsu.edu.  In addition, familiarize yourself with the responsibilities of the PI (READ) and the post-approval responsibilities (READ) of the research team.  Please be aware that even accidental violations of the approved protocol may result in the withdrawal of the data.  
 
Please visit the FAQ page for specific information. Click
 
 
 

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Send your questions to irb_information@mtsu.edu
New Faculty members who have recently accepted a position at MTSU can also call 615-494-8918.