IRB Forms

 

  • Allow at least 2 weeks for protocols to be reviewed.
  • During the months of August-September and February-March, expect longer processing time.

 

Instructions

  • Complete all necessary training before submitting your application - Researchers will be asked to resubmit if training modules are not completed.
  • Respond to all the questions in the application appropriately - incomplete applications will NOT be reviewed.
  • Applications are to be submitted via email attachment to irb_submissions@mtsu.edu.
  • The applications MUST be emailed by the faculty advisor or research mentor.  Students can no longer submit applications directly to the IRB. .
  • Send the filled application documents provided in this page in the original format - DO NOT convert to PDF.
  • DO NOT collate individual forms into a single file - Send each of the forms and components as a separate file.

Applications for New Research

  • Expedited and Full - IRB application for Full or Expedited Review
  • Exempt - 
    • OLD Form - Accepted till July 31st of 2017 - ***not recommended***
      • Please note that the old form does not include all the features that are required to make a streamlined exemption determination.
      • The old form lacks tracking capability making compliance oversight more complex.
    • New FormIRB Application for Exempt Reviews  (Updated 08.08.2016) - ***RECOMMENDED***
      • Please use the new form if possible.
      • Although longer than the old form, the new form addresses all the necessary questions needed to complete the review process.
      • The new form also contains space to record the review process in a single document.
      • Importantly, the entire review process can be better tracked using the new form, especially all future amendments could be recorded in a single file.  

* Not sure whether your study qualifies for exemption? See the Decision Chart or FAQ for information on whether your research will qualify for Exempt, Expedited of Full Review. 

Consent Form for EXEMPT protocols

For researching with adults
  • OLD FORM - a copy of the informed consent template is included in the old exemption request form. 
  • NEW FORM - Exempt Informed Consent Template (Updated on 08.08.2016)
  • Under certain circumstances, researching with minors may be exempt.  Contact irb_information@mtsu.edu to find out how to prepare parental consent for such studies.  

Consent and Assent Forms for EXPEDITED protocols

For researching with adults
For researching with minors
  • For children 0-12 years
  • For participants between 12-18 years
    • Combined Parental consent - Child assent form - IRBF010d
    • Parental consent only - IRBF010e - Contact irb_information@mtsu.edu
    • Child assent only - IRBF010f - contact irb_information@mtsu.edu

Research with Minors - Please note that the parents have to provide active consent for allowing their children to participate in most of the studies unless determined otherwise by the IRB.  An "opt-out" clause for consent will no longer be accepted by MTSU IRB.

For requesting changes/alterations or waiver of the informed consent
  • (Please note to alter or waive consent, you must provide justification to do so. Fill out the appropriate portion of the Request for Waiver or Alteration of Consent and submit with your IRB application).

Recruitment and Advertising your Research

 

For EXEMPT protocols
  • Exempt Flyer Template
  • Telephone Recruitment - Submit a text that complies with the general outline of the flyer template
  • Online Recruitment - Use the flyer template to prepare your advertisement through social media and etc. 
  • Email Recruitment - Submit the proposed email transcript.  Use the flyer template as an outline
  • Word of Mouth - Provide a transcript
For EXPEDITED/FULL protocols
  • Expedited/Full - Flyer Template
    • The IRB will consider other types of recruitment flyers that closely resemble the template given here. Click here for examples.
  • Telephone Recruitment - Submit a text that complies with the general outline of the flyer template
  • Online Recruitment - Use the flyer template to prepare your advertisement for blog posts etc. 
  • Email Recruitment - Submit the proposed email transcript.  Use the flyer template as an outline
  • Word of Mouth - Provide a transcript

Making Changes to an Active Protocol

 * Alterations such as addition/removal of investigators and minor procedural changes can be done administratively by the Office of Compliance.  However, major changes to the protocol will have to be approved by the IRB and the investigators should allow enough time
*CAUTION - The investigators are not allowed to implement the changes unless a written notice of approval has been issued by the Office of Compliance
 

 

Progress Report (for Continuation) and Final Report

Biological Specimens, Data Use, or DNA

Language to be inserted into Informed Consent for Special Cases