IRB Action Request Forms

2022 SUMMER SCHEDULE FOR IRB and IACUC

The IRB and IACUC will at a reduced capacity during June and July of 2022.  Please refer to the summer schedule page for important informaiton (Click here)

 

 

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). 

 

 

 All of these IRB forms are supported by Microsoft Office Word on Mac as well as PC.  However, the forms are not compatible with Chromebook or other operating systems or apps.  Please use Microsoft Word to fill these forms; IRB forms edited using other apps, such as Googledocs, will block the embedded features which makes those forms not suitable for review.  

 

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 if the principal investigator is a student.  The 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 - Please 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

 

* 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

For Researching with Adults

  • Expedited/Full Informed Consent Forms: 

The following templates are for conducting research with ADULTS; please scroll down for informed consent templates for minor participants.

    • In person Expedited & Full Informed ConsentTemplate (03.25.2021) This template contains disclosure on COVID-19.  There is an additional page for obtaining participant details for contact tracing.  This form also has options to administer the content of this informed consent via Zoom as weel as Qualtrics if in person informed consent cannot be administered. 
    • ZOOM Expedited and Full Informed Consent (10.01.2020) Use this only if administered via Zoom
    •  Qualtrics Survey: Expedited and Full Informed Consent: Use these only for surveys and not for other types of interactions

For Research with Minors

The following templates are used in obtaining parental permission and child assent when enrolling minor participants.

  • Parental Consent through Qualtrics (All AGES) 
    • This option is being tested.  Click for more information

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.

Language to be inserted into Informed Consent for Special Cases

Additional Information Pages

 

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

Refer to the Recruitment information page for more information - Click here

For EXEMPT protocols
  • Exempt Flyer Template - Use this for making a flyer/poster with or without tear sheets
  • Online/Email Template - Use this for inviting participants through an online script or by initiating email recruitment
  • Telephone Recruitment - Submit a text that complies with the general outline of the flyer or email templates
  • Word of Mouth - Provide a transcript to cover topics from the flyer or email templates
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.
  • Online/Email Template - Use this for inviting participants through an online script or by initiating email recruitment
  • Telephone Recruitment - Submit a text that complies with the general outline of the flyer or email templates
  • Word of Mouth - Provide a transcript to cover topics from the flyer or email templates

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 - Under Construction - Use Minor Amendment Form (Limit 2 Requests per year)

 * Alterations such as addition/removal of investigators and minor procedural changes can be done administratively by the Office of Research 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 Research Compliance

Progress Report (for Continuation) and Final Report

Biological Specimens, Data Use, or DNA