Information to MTSU Faculty who work with Human Subjects

General Announcments:

  • 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, then 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 expected to help MTSU faculty community who may be required to obtain IRB approval or sponsor a student for IRB approval. Faculty research could come under one or more of these categories:
  1. Class project - the faculty is a course director of an MTSU educational program that requires the collection of data from human subjects
  2. 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.  
  3. Independent - faculty is either a PI or an active co-investigator in a study involving human participants - faculty members who come under this category are usually familiar with the IRB processes and may need very minor assistance.  The faculty member can have students or postdocs to conduct several tasks within the study but the faculy member is the chief beneficiary of the research outcome.

Training 

Regardless of which of the above category the faculty comes under, he/she must complete CITI training in order to be eligible for the designated role.  Since students do not have the Institutional authority, it is unfair to delegate them with responsibilities that may potentially cause irreversible challenges to their academic status.  Hence, the IRB requires that the faculty in charge to 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 OHRP to understand the history and role of IRB in human subject research:

The above videos are expected to provide an overall understanding, but merely watching them does not meet the 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 your first and last names you provide to CITI matches your MTSU records and your IRB applications)
  • A series of questions by the CITI portal to automatically determine which training module would most fit your need.
  • Faculty and staff must complete the "Social and Behavioral Research" course AND applicable "optional" modules depending the type of research and kind of participants. 
  • In mst 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 IRB or the Office of Research Compliance.  
  •  

1. Faculty Serving as a Sponsor 

The faculty 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 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.  Or in some cases, the faculty advisor was designated to a student by the academic affairs and the student decides to work with humans.  But regardless of the reason, the faculty sponsor is assigned with 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 to mentor a student.  
 

1.1 Application Procedure

Depending on the type of research the student plans to conduct, there may be different sets of paper work 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 to advise you 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 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 allowMTSU IRB to capture your signature and other embedded macros. 
    • Exempt form - READ
    • Expedited form - READ
    • Full Review form - READ
  • Informed consent document - READ
    • Working with minors the researchers have to 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 has to 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 work 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 once you have indicated your approval by entering your name and date.  Please DO NOT collate the files together 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 make the process swifter if you would 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 making the process swifter.  Always use MTSU email ID when applicable.  
 

1.2 Sponsors' Responsibilities

Please be aware that if a student is required to either generate an expedited application or asked to attend a full committee review, it is very critical that the student gets guidance from an advisor who has working experience with IRB matters.  Therefore, you may request the student in such instances to invite a faculty co-investigator who is specialized in human subject research.   It is essential that you are aware of the activities of the research and ensure 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 students' 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 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 IRB's FAQ page for specific information. Click
 
 

2. Faculty Responsible for Class Projects

The faculty 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.  Regardless of their rank and affiliation with MTSU, their compliance role is the same as that of what is described under "Sponsor" in the previous section.  The faculty now has two options to consider from: (1) an IRB approval can be requested for the entire class project, by the faculty - also called as "standing protocol;" or (2) have the students apply for individual IRB approval - referred to as "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 then 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 work flow 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 appropriate format and it 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 a clear guidance on what supporting documents will be required.   Once the protocol is approved, the faculty, can request for 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.  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 course directors to consider this mechanism if the student research part 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 in the student information page (READ).  
 
This MTSU IRB has issued standing protocols for a few a classes as a test.  Based on the limited data, the students are expected to face the following advantages and disadvantages when the research of a class project is conducted through this mechanism:
 
Advantages:
  1. The "standing protocol" has preassigned procedures so the students do not have to do much other than completing their appropriate CITI training
  2. The class coordinator handles all of the compliance-related issues and the students just concentrate on completing their project
  3. For the faculty, records keeping is limited to just one protocol.  As described later, the course director is responsible for all of the research activities carried out through the class which includes records keeping.  By using this mechanism, the course director does not have to worry about 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 also miss out on the education experience of developing a human subject research protocol and participating in the IRB review process
  4. For the faculty, the initial IRB approval process may be time consuming and stressful

2.2 Student-initiated Protocols  

The students MUST complete CITI training before the class semester starts and they have to inform the class coordinator that the student will be requesting an individual protocol.  This stream is expected to have the following implications to the students:
 
Advantages:
  1. The student receives a first hand experience of the IRB process
  2. Independence in research design for the student, but the faculty has to ensure that the design is compliant
  3. Possibility for publication
  4. Provision to carry the study to be part of future research ventures - like thesis, dissertation, request funding, etc.
Disadvantages:
  • May be very challenging and sometimes very stressful for both student as well as the faculty
  • Time consuming if not dealt with properly - IRB approval may take anywhere between 2-4 weeks leaving very little time for completing the project.  
  • 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 whether the course director used a "standing protocol" mechanism or he/she allowed a student-initiated application, the records keeping responsibilities and communicating with the Office of Research Compliance for pre- and post-approval processes are charged to the course director. However, the "standing protocol" mechanism will allow reduced work load for the course director.  But it is essential that the course director makes his/her choice such that the academic goals are met adequately.  
 
If the course director is not familiar with the IRB procedures, it is essential to be aware that the students must 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 allow 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 course director must be aware of all of the activities of the research and ensure 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 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 may either serve as a PI or a specialist co-investigator in a study.  If the faculty 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 to work in the proposed research and "independent" does not mean the faculty member would conduct the study alone.  
 

3.1 Application Procedure

Depending on the type of research,  there may be different sets of paper work he/she would be required to submit.  In general, the PI must provide the following mandatory documents:
  • Fully filled application form
    • Exempt form - READ
    • Expedited form - READ
    • Full Review form - READ
  • Informed consent document - READ
    • Working with minors the researchers have to provide a template for parental consent and child assent
    • In rare cases, a waiver to consent may be granted. The researcher has to 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 work before sending for IRB review if study will be conducted online

Once you are assured that the application is complete, submit the application packet via email to irb_submissions@mtsu.edu.  DO NOT COLLATE all the files together.  Attach the files separately in the same email.  It may make the process swifter 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 making the process swifter.  Always use MTSU email ID when applicable.  Incomplete applications that lack all the necessary documentation will not be reviewed.  The Office of Research Compliance will return incomplete applications without any administrative action(s).  

3.2 Responsibilities

If you have student co-investigators, as a faculty PI, you are 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.   Also, 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.