Institutional Review Board (IRB)

 

Navigating Sponsored Programs During the COVID-19 Response

 

At this time, ORSP, Grants Accounting, and other business units are conducting business as usual for research administration.

 There is not yet any federal-wide or state-wide guidance published regarding the effects of the evolving COVID-19 response on recipients’ ability to fulfill our programmatic and administrative obligations.

 As such we are relying on individual sponsors’ websites and list serves for updates on the agency-specific responses/plans regarding submission deadlines, reporting deadlines, work stoppages or slow-downs, and possible project period extensions. 

 Do not hesitate to contact your Pre-Award Specialist or Award Manager with any questions about your awards or proposals.

 MTSU’s response plan at this time does not impose any limits on the conduct of research and other sponsored work other than the 1) out-of-state travel cancellation, and 2) unavailability of undergraduate student workers.  Please know that MTSU’s generous continuation of wages for undergraduate students who are unable to report for work is not an allowable expense for sponsored projects, and will not be charged to your grants.

 While individual agencies may ultimately allow compensation paid during work stoppages, we do not expect that to be a state-wide or federal-wide response.  Additionally, in those cases where the compensation is allowed, we have no indication that additional funding will be available to pay for the effort necessary to fulfill the project once work resumes.  If grant-funded student workers do report for work, their time should be reported and charged to the grant.  Also, pursuant to the message from Human Resources on the matter, graduate student assistants must to report to work in order to receive compensation, in the form of wages or stipend, and to continue to qualify for tuition assistance.

 ORSP recommends that faculty with active or planned work with federal agencies periodically visit the Council on Government Relations’ (COGR) comprehensive directory to federal agency guidance during the public health emergency:  Institutional and Agency Responses to COVID-19 and Additional Resources.

 

IMPORTANT: The IRB forms are supported by Microsoft Office Word on Mac as well as PC.  However, the forms are not compatible with Chromebook.  Ensure that the forms are edited using Microsoft Office; Forms edited using other apps, such as Googledocs, will not be accepted.

IMPORTANT: Research with minors involving online surveys:

The MTSU IRB is currently accepts online studies only involving adult participants; nonetheless, surveying minors via online means will be dealt with on a case-by-case manner through the full committee review mechanism. 

 

General Announcments:

  • Allow a minimum of 4 business days BEFORE you call us regarding the status of your petition
  • Please allow at least 2 weeks for protocols to be reviewed AFTER your application is complete.  Applications found to be incomplete during the prescreening process would be sent back to the investigators.
  • Expect additional processing time during the months of September-October and February-March.  The MTSU IRB continues to accept and review protocols during the summer months (June-August).

 

IRB Seal2 

 

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.

 

Click here to watch an OHRP video on the IRB Membership

 

Federal Wide Assurance (FWA)

The FWA is a contract or agreement that establishes standards for human subjects research as approved by the Office for Human Research Protections ("OHRP"). It is the policy of the Institutional Review Board ("IRB") of Middle Tennessee State University to uphold its Assurance as filed with the OHRP.
  • FWA number - 00005331 (Expiration 01/12/2022)
  • IRB Registration number - IRB00003571 (Expiration 02.08.2020)
  • IORG number - 0002962
  • OBM number - 0990-0279 (Expiration 10/31/2018)
  • 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

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. Check out the Students page. 
  • 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 (TWO) 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

The following links are videos from the OHRP to further educate researchers on the necessity of ethics in human subject research specifically pertaining to the protection of human subjects.:

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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Murfreesboro, TN 37132                                                                     Types of IRB reviews
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Email: irb_information@mtsu.edu