Dates and Deadlines

 

There are specific deadlines and dates of expiration for each protocol.  Please refer to the protocol approval notice for these dates.  In general, the following applies for all of the protocols approved by the MTSU IRB:

Exempt Studies:

  • Approval/Expiration date: The PI will be allowed to choose the date by which the study is expected to end.  This will be done at the application stage.  The protocol approval notice will display this chosen date although the study can be extended by making a written request prior to the date of expiration.    For instance, a PI plans to collect data for 3 years, then the protocol will be assigned an expiration date according to the chosen last date of the study.  The PI will be able to extend the previously anticipated end date by merely making a written request before the three-year approval period ends.  .  
  • Post-Approval Procedures/Actions: Although exempt studies are excluded from continuing review, the protocol will still be overseen by the IRB.  The investigator is expected to report any changes.
  • Final Report: The investigator must close the protocol by submitting a final report prior to the date of expiration.  Failure to submit a final report will lead to penalties  that include denial of future protocols and reporting to Office of Research Integrity for misconduct. Academic Affairs will be notified if student PIs fail to close their protocols.  

Expedited Studies:

  • Approval/Expiration date: The protocols are approved for one year by default.  The protocol can be continued for three years by requesting a continuing review before the date of expiration.  The approval conditions and schedule for requesting the continuing review along with the date of expiration will be displayed in the approval notice.  The following are specific scenarios:
    • The PI will be allowed to choose the date by which the study is expected to end at the application stage.  If the PI requests an early termination (less than one year), then the study will be scheduled to expire on the first anniversary of the initial approval. However, the protocol can be extended by requesting a continuing review prior to the date of expiration.   
    • If the PI proposes to collect data longer than one year, then a schedule for continuing review will be displayed in the approval notice along with dates of approval and expiration. The investigator must submit a project report before the mentioned deadline to request a continuing review  to extend the protocol beyond the one-year approval period.  The protocol can be continued for up to three years.  
  • Post-Approval Procedures/Actions:  In addition to the continuing review, the investigator must seek IRB's approval to implement any changes to the protocol.  
  • Final Report: The investigator must close the protocol by submitting a final report prior to the date of expiration.  Failure to submit a final report will lead to penalties  that include denial of future protocols and reporting to Office of Research Integrity for misconduct. Academic Affairs will be notified if student PIs fail to close their protocols.  

Full Committee Review Studies:

  • Approval/Expiration date: The dates of expiration and the frequency of continuing reviews are determined by the IRB at a convened meeting.  The approval notice will display all of these dates clearly.   The PI/FA would not be able to make changes to these dates.
  • Post-Approval Procedures/Actions:  In addition to the continuing review, the investigator must seek IRB's approval to implement any changes to the protocol.  
  • Final Report: The investigator must close the protocol by submitting a final report prior to the date of expiration.  Failure to submit a final report will lead to penalties  that include denial of future protocols and reporting to Office of Research Integrity for misconduct. Academic Affairs will be notified if student PIs fail to close their protocols.  

Penalties for Non-Compliance

Data collected beyond the date of expiration would be considered as null-and-void and the researcher may not be able to use them.  Funding received during the lapse