Navigating Sponsored Programs During the COVID-19 Response

General Announcements

• 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). 

 

MTSU Human Research Protection Program

The Institutional Review Board (IRB) at MTSU is an appointed  committee which oversee any research projects that involve human participants. The aim of the IRB is to protect the rights and welfare of the research subjects.  No research study that involves collection of data through interaction or intervention with living individuals may begin at MTSU without the consent of its IRB.  The links on this page are designed to guide researchers through the process of seeking approval for protocols that involve the collection of data by enrolling living human subjects. Please refer to the FAQ for general IRB-related questions.

Watch an OHRP video on the IRB Membership.

Federal Wide Assurance (FWA)

• FWA number - 00005331 
• IRB Registration number - IRB00003571 
• IORG number - 0002962
• OBM number - 0990-0279
• ORI* number - 1274605

*ORI - Office of Research Integrity (Not part of OHRP) oversees misconduct in research but not human subjects protocols.

Visit the Decision Guide for answers to questions such as:

• What is "research" as defined by OHRP?
• Does my research involve Human Subjects?
• Should I apply for Exempt, Expedited or Full committee review?
  • Please note that "exempt" does not refer to an exemption from IRB oversight; it merely designates certain types of activities and interventions considered to pose less than minimal risk to the participants as exempt from continuing IRB review.  But, all of the regulatory requirements are same.
  • Also note that "expedited" does not refer to a swifter review process; it merely designates certain types of activities or interventions as minimal risk and they can be reviewed and approved through a member review process that does not require a full committee decision.  

The Online Training page will link researchers to a site where they can undergo training to obtain certification for conducting research involving human subjects. The IRB Forms page allows access to download the most current applications, final/progress reports, templates for consent forms, and other important documents.

Inquiring General Information

• The best way to contact us is by email.  Send your questions and inquiries to irb_information@mtsu.edu

Sending Documents to the IRB

• The Office of Compliance accepts only electronically filled documents
• An MTSU Faculty member MUST email the application documents to irb_submissions@mtsu.edu
• The Office of Compliance will no longer receive applications from students. Student researchers must have their faculty advisor or class coordinator email the application documents.
• Ensure all necessary boxes are completed as accurately as possible.  Incomplete applications will be sent back to the investigators and will not be reviewed until the application documents are complete.  
• Those who qualify for full review must check the committee schedule and should allow more time for  the approval process. The committee requires at least 2 weeks to review the application before bringing the study for a vote at a convened meeting.  

Review Questions

The MTSU IRB uses the following questions in evaluating if a proposed study meets the oversight standards.  

1. Is the purpose of the proposed activity/project/study clear?
2. Is the recruitment of subjects proper with adequate disclosures?
3. Is the inducement of participants reasonable?
4. Are the researchers' expertise and training adequate?
5. Are the subjects adequately informed on the potential risks/discomforts and other information?
6. Is the informed consent documentation proper?
7. Are the risks minimized if risks are necessary to complete the study?
8. Are there any benefits?
9. Is the confidentiality plan proper?
10. Is the data use and storage clearly explained?

Informative Videos

• Module 1 - (22:13 min)
• Module 2 - (27:37 min)
• Module 3 - (35:19 min)

Report Compliance Breach and Adverse Events Immediately

If you need to report a study related injury, or if you have concerns about a research project, please contact the Office of Compliance by emailing to  compliance@mtsu.edu or call 615 898 2400. ALL COMMUNICATIONS TO THE OFFICE OF COMPLIANCE WILL BE KEPT STRICTLY CONFIDENTIAL.

Email questions to:                                 Send applications and documents to:

irb_information@mtsu.edu                      irb_submissions@mtsu.edu

 

 

Office of Compliance                                                              QUICK LINKS
2269 Middle TN Blvd                                                                           IACUC Home
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Tel: 615 898 2400 | FAX: 615 898 5028                                              Review guidelines
Email: irb_information@mtsu.edu