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 to 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 expiration date. For instance, if a PI plans to collect data for three years, 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 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 expiration date. Failure to submit a final report will lead to penalties that include denial of future protocols and reporting to the 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 expiration date. The approval conditions and schedule for requesting the continuing review, along with the expiration date, 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 expiration date.
  • 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 approval to implement any changes to the protocol.
• Final Report: The investigator must close the protocol by submitting a final report prior to the expiration date. Failure to submit a final report will lead to penalties that include denial of future protocols and reporting to the 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 approval to implement any changes to the protocol.
• Final Report: The investigator must close the protocol by submitting a final report prior to the expiration date. Failure to submit a final report will lead to penalties that include denial of future protocols and reporting to the 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 expiration date would be considered null and void, and the researcher may not be able to use them. Funding received during the lapse period would be returned to the concerned agency. Other penalties, such as denial of future protocols and reporting to concerned academic divisions, will be enforced.

Deadline Reminders:

The researcher must make appropriate arrangements to request continuing review in a timely manner. No reminders will be sent. The same is true for submitting final reports (closeout). The dates and deadlines for each protocol will be clearly displayed in the approval notice, and the PI/FA are expected to take appropriate action in accordance with their PI/FA responsibilities.