IRB Action Request Forms

 

  • Allow at least 2 weeks for new protocols to be reviewed after the application is complete.
  • 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 may not 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.
  • Use Microsoft Office to fill the documents and DO NOT use online utilities - embedded macros will be lost if edited using apps like GoogleDocs

Applications for New Research Protocols

  • Protocol Application form for Expedited and Full Review -
  • Exemption Request Form- 
    • OLD Form - Accepted till July 31st of 2017 - ***NOT ACCEPTED ANY MORE***
      • 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 FormExempt Review Form  (Updated 08.08.2016) - ***RECOMMENDED***
      • The new form contains space to record the review process in a single document.
      • The entire review process is documented in the new exemption form.

* 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. 

Informed Consent Form

For researching with adults
For researching with minors
  • Research involving children 0-12 years
  • Research involving minor 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).

Language to be inserted into Informed Consent for Special Cases

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 Amendments to an Active Protocol

  • New Minor Amendments Form - Revised on 07.25.2018
    • unlimited changes to add/remove co-investigators, fix errors or omissions in the protocol documents and templates, extend participant sample size and other non-procedural changes. 
    • These amendments can be made rapidly with minimal turn-around time when this new form is used.  
  • Significant Amendments - Addendum/Amendment Request Form - Limit 2 submissions per year

 * 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