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  • Responsible Conduct of Research
    MTSU Institutional Review Board

Human Subjects Research Training

 

Important Announcement

  • All researchers, whether they are students, faculty or staff, MUST complete "Social and Behavioral Research SBR)" training course through CITI
  • STUDENTS - In addition to above, the students must also complete "Students in Research" module listed under SBR
  • Depending on the type of the research topic, type of participants and the risk level, additional modules or courses have to be completed - refer to the training table shown below.

Who has to complete the training?

  • MTSU faculty, staff, and students who are engaged in research with human participants MUST complete training in human subjects protections prior to seeking IRB approval
  • Non-MTSU researchers, who are collaborators or co-investigators in a protocol that requires MTSU IRB oversight must have also completed appropriate training.  If the collaborator completed CITI training, please ensure the required modules (click here) have been completed.  
  • In addition to the investigating team, all those who would directly or indirectly intervene with the data collection in an MTSU-sponsored research activity involving humans MUST also be certified to perform human subject research
  • This requirement also applies to any individual who serve on the IRB as members or administrators or GAs and student interns who assist the IRB work flow, regardless of their specific role in the IRB
  • Although other forms of certifications can be accepted on a case-by-case manner, we STRONGLY recommend researchers to complete appropriate  training through the CITI program (explained below); most CITI training certifications are valid for up to 3 years

 

Directions to Set up a CITI Program Account

  1. Follow this link to start your CITI program training: www.citiprogram.org.
  2. First-time users must register for an account using your official name 
    1. IMPORTANT - Ensure your first and last names you provide to CITI matches your MTSU records and your IRB applications
  3. Click here for general information on how to enroll in a CITI course

Directions to Complete Your Training

  1. Once you register for your new CITI account, you will now have to add training courses to your profile so you can complete the requirements. Click here for general information on how to enroll in a CITI course.  For specific MTSU-required training course, follow these steps: 
    1. Click on "Main Menu"
    2. Click "Click here to affiliate with another Institution"
    3. You will be prompted to a search window - enter "Middle Tennessee State University" and click "Next"
    4. Once you select MTSU, then click "Add a Course or Update Learner Groups"
    5. Scroll down to Question 1 in the next window and check "Social * Behavioral Research Investigators"
    6. Respond to Question 2 if you will be collecting health information or you will be conducting clinical research
    7. Respond to Question 3 by checking the appropriate box for responsible conduct of research (RCR)
      1. If working with Biomedical data, you MUST complete Biomedical RCR
      2. If working with behavioral data, you MUST complete Social & Behavioral RCR
      3. If working with physical sciences, you MUST complete Physical Science RCR
      4. If working with humanities, you MUST complete Humanities RCR
    8. Respond to Question 4 on Conflict of Interest
    9. Skip Question 5
    10. Respond to Question 6 only if you are an IRB member or you will work with the Compliance Office
    11. Click "Submit"
    12. The selected training courses would appear in your menu
    13. Select the training by clicking on it and you will be required to complete CITI Integrity Assurance Statement.  Once you agree to the statement, you will be allowed to visit the modules.  
  2. Complete all required courses and corresponding modules as described in the subsequent sections
  3. In most instances, the Office of 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 Compliance.  

Training Requirements

The IRB requires all individuals who would be recruiting or intervening in a research study that involves humans must receive human subject training prior to seeking a protocol approval.  MTSU uses the CITI program to enforce this mandatory OHRP requirement.  The training requirement is imposed on all individuals who will be collecting data from a living individual regardless if the contact is direct or indirect.  The Principal Investigator (PI) or the faculty advisor (if the PI is a student) must enforce this requirement without any exceptions.  The PIs or the faculty advisors must also maintain proper training records for their entire research team and they should also ensure that the training dates are up to date.

Mandatory Course(s) 

One or more of the following course(s) must be completed by the researcher prior to seeking IRB approval. The courses specified as "OPTIONAL" in the CITI website may be mandatory depending on the type of study and the kind of participants.  
 
IMPORTANT - please note that the previously offered "No More than Minimal Risk" training is not accepted any longer.  This is because CITI has made a few changes from January of 2016 such that the new "Social and Behavioral Research" training replaces the old minimal risk course.  In addition, several of the modules offered within the old Social and Behavioral training are now offered as "supplemental." This new arrangement is expected to allow students and faculty members to complete only those modules that are relevant to their research.  
 
  • All students MUST complete "Social and Behavioral Research" training AND the `optional' module "Students in Research" (ID1321) AND complete additional modules depending on your study (refer the table listing provided in the bottom).  Click here for an entire list of modules under this training course.  
  • Faculty/staff must complete "Social and Behavioral Research" AND complete additional modules depending on your study (refer the table listing below).  Click here for a full list of modules under this training course.  
  • If the study is funded by a federal agency, then all of the researchers in the study must also complete "Responsible Conduct in Research" relevant to the field of study. 

Additional Mandatory Courses and Modules

In addition to the mandatory course(s) mentioned above, one or more of the following module(s) or course(s) must also be completed based on the type of study or participant pool.  Please note that CITI calls these as "optional" but they are mentioned so because  the requirement is left at the IRB's discretion.  Moreover, it is best practice for the researchers to complete these  supplemental modules.  However, the OC will not hold the review in the event the researcher is genuinely unaware of this requirement as long as the Social and Behavioral training has been successfully completed.  But, the approval will be pending to the successful completion of meeting all training requirements.  

 
Applicant Type
 
 
Research Type
 
 
Participants
 
 
 
Additional Course(s) and/or Module(s) to be Completed
 
Researchers  
Any
 
Any
 
Social and Behavioral Research training
Students
 
 Any
 
Any
 
Students in Research (ID1321)
IRB Members
 
 N/A
  N/A  
 (1) IRB Administrator's Responsibilities (ID13813) AND 
(2) IRB Member Module - What Every New IRB Member Needs to Know (ID816)
Any
 
Any
 
Prisoners
 
Research with Prisoners (SBE ID 506)
Any
 
Any
 
Children/Minors
 
Research with Children (SBE ID507)
Any 
 
Elementary and Secondary Education
 
Children/Minors
 
Research in Public Elementary and Secondary Schools (SBE ID508)
Any
 
International Matters
 
Any
 
(1) International Research (SBE ID509) AND
(2) International Studies (ID971)
Any
  Any   Workers/Employees
 
(1) Research and HIPAA Privacy Protection (ID14) AND
(2) Vulnerable Subjects - Research involving Workers/Emloyees (ID483)
Any
 
Involving Internet 
 
Any
 
Internet Based Research (SBE ID510)
Any
  Collecting health information  
Any
 
Health Information Privacy and Security (HIPS) Course
             

 

 

CLICK HERE TO VIEW THE CITI PROGRAM'S INFORMATION DOCUMENT

 

Informative Videos

The following links are videos from the OHRP to further educate researchers on the necessity of ethics in human subject research specifically pertaining to the protection of human subjects.  MTSU IRB recommends researchers to watch these videos prior to completing their training.  PLEASE BE AWARE THAT WATCHING THESE VIDEOS IS NOT A REPLACEMENT FOR CITI TRANING.  

 

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