Full Member Review Applications

This page is expected to provide a description on how a resercher can obtain approval under the Full Member Review mechanism.  Be advised that several of the procedures, requirements, documentation and formatlities between the Expedited and a Full Review process are very similar.  The most important difference between the expeidted and the full member review mechanism is that the application and the associated documents will be reviewed by the entire committee.  In addition, the decision to approve, deny or to suggest modifications would be made at a convened IRB meeting where proper quorom is met.  Once the review is completed, all communications will be made by the Chair of the IRB.  Moreover, the researchers may be invited to the IRB meeting to directly address the Committee. 

  • 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
  • The IRB needs the completed applications at least 2 weeks prior to the convened meeting
  • There are no scheduled IRB meetings during the summer months (June-August) and winter break (December) - visit the Meeting Schedule page to know the upcoming meeting date(s)

 

 

NEW FULL REVIEW APPLICATION

 

Mandatory Forms and Attachments

Other Essential Documents to be submitted with the application

  • Permission letter(s) if the study is conducted at a non-MTSU facility
    • Studies that would take place outside MTSU will require appropriate permission letters from the facility
    • For instance, researchers conducting studies with school children would require a letter of support from the school's administration
  • Mutual agreemts and approvals
    • This is similar to the permission letter described above, but the difference being the research is not only conducted by MTSU representative(s) but also include workers from other Institution.  
  • ADVERSE EVENT NOTIFICATION
  • Other study-specific documents

The IRB and the Office of Compliance may require other types of documents not mentioned above.

All mandatory and other essential documents must be emailed to irb_submissions@mtsu.edu with a suitable subject line.

 

DOCUMENT SUBMISSION

The Office of Compliance now follows an updated process by which documents are received for IRB review.  The following two email accounts are designited to correspond with the researchers:

Please click here for an overview the most recent document submission process

 

REVIEW PROCESS

Administrative Actions (PRE-REVIEW):

The application and the supporting documents will be administratively pre-reviewed for completeness.  Incomplete applications will be sent back to the researcher(s) without any administrative action.  Complete applications will be assigned a new IRB ID which will resemble ##-3###.  The researchers will be corresponded by email if further information is needed.  

Full Committee Review:

Subsequently to the administrative actions, the application materials will be forwarded to two IRB reviewers as appointed by the Chair of the Committee.  After their preliminary review, the comments and concerns raised by these two committee members will be forwarded to the entire committee along with the application materials.  Additional concerns from the full committee will be collated by the Office of Compliance and they will be forwarded to the Chair.  Then, the Chair will correspond with the researchers and notify them if they should address any concerns that would help the Committee to make a determination in their upcoming convened meeting.

Investigator Options:

The IRB Chair in cooperation with the Office of Compliance will make every effort to designate the two primary reviewers such that they have the necessary working knowledge on the subject matter of the application.  If needed and when necessary, the IRB will also consult outside experts should there be no expertise within the Committee to review a certain protocol.  The researchers should nonetheless prepare their application in simple language such that any reviewer with a different field of expertise would also be able to make a meaningful judgement.  Once the researchers receive the initial concerns from the IRB Chair, they can either address the concerns, or they can wait to discuss the reviewer comments directly with the Committee at the upcoming convened meeting.  The investigators may decide to do both; they can address the concerns and elect to be present at the meeting.  The Office of Compliance encourages the researchers to directly address the Committee to open a free line of conversation and demonstrate their committment to compliance. 

Convened Meeting:

  • Quorum - A minimum of  1+ half of the total voting MTSU IRB members must be present in order to conduct IRB business. 
  • Members - The MTSU IRB is currently comprised of 13 voting members.  Therefore, at least 7 members should be present. None of the members who would be voting on the protocol should have any conflict of interest with the study.  The quorum will recounf if there should be a member with confluct and the condition for quorum defined above should still be satisified.
  • Mandatory member(s) - The "non-scientist" member of the IRB has to be present at every convened meeting in order for the IRB to be properly constituted.  In addition to the non-scientist, other members need to be present depending on the study type.  For instance, a study that uses prisoners as subjects cannot be reviewed without the member who specializes in such studies.
  • Investigators (optional) - The research team including the PI and the faculty advisor if the PI is a student will be invited to attend the convened meetings.  Although the IRB encourages the investigators to attend the meeting so they can directly address the reviewer concerns, the investigators can decide not to attend. 
  • IRB action and Vote - After the discussion period, the Chair will call for a motion and he/she would open the dicussion if the motion is seconded by a different member.  The Chair will then open the motion for discussion.  Subseuquent to the vote, the Chair will then call for a vote.  The vote by majority of the members will carry.  Depending on the outcome, there may be other motions and voting.  
  • Correspondences - In most cases, the Office of Compliance will directly correspond with the researchers and may request more information needed for the convened meeting.  After the review process, the study will be entered into the agenda of the upcoming IRB meeting.  The Chair of the IRB will then correspond with the researchers instructing them on the IRB action and what are the necessary steps they need to perform in order to receive an approval.  

Potential Outcomes and Possible Actions:

  •  More information is required
  • Protocol is approved
  • Protocol is approved pending to modification
  • Protocol will be tabled for a different convened meeting
  • The protocol request is denied
  • The study has been deferred

 

PROTOCOL APPROVAL

The researchers will receive an Expedited Approval Notice from the Reviewer or the Office of Compliance.  It is important that the researchers store the document in a safe location along with their study-related documents.  The approval notice should be sent to appropriate funding agency by the researcher.  Each protocol approved under the expedited mechanism can be kept active for up to three (3) years.  However, the PI or the faculty advisor (if the PI is a student) has to submit a Continuing Review three (3) weeks prior to the annual expiration date noted in the approval notice.  Expired protocols cannot be renewed or continued.  Therefore it is vital that the researchers obtain approval for continuation prior to the expiration date.  A protocol can be continued twice and after the third year a new application needs to be submitted.  

 

POST APPROVAL PROCEDURES & OBLIGATIONS

The applicant of the protocol or the faculty advisor (if the applicant is a student) must assume full responsibility that the study will be conducted in the guidelines listed by the research team in the protocol.  Any alteration to the protocol can be done only after obtaining written approval from the IRb or the Office of Compliance.  Starting from August, 2015, major changes to the procedures and the instruments will not be allowed and the researchers will be directed to complete a new application.  The following are a few procedures and obligations for the researchers in order to keep the protocol active.  

Data Storage

The PI or the faculty advisor (if the PI is a student) has to take responsibility of the data collected during the study.  All confidential materials need to be secured as proposed in their application.  The researchers have to notify the Office of Compliance if there are any breaches or any change of storage location is anticipated.  A suitable course of action would be determined upon the researchers' notification.  It is mandatory that the researchers store the data in a secure place for up to three (3) years after the study has ended.  After this storage time, the investigators MAY destroy the data such that the confidentiality will not be lost.  

Ammendments to Existing Expedited Protocols

Currently the "Addenda policy" is being revised and the proposal under review. Please contact the office of compliance (irb_information@mtsu.edu) for additional information on creating addendum requests.

1. Minor Ammendments

Policy in preparation - Addition/removal of investigators, small extensions of participant number and correcting typographical errors to the previously approved documents.  

2. Major Ammendments

Policy in preparation - addition of a new location for conducting the research activity, minor changes to the instruments, amendments to the informed consent, procedural changes and etc. 

Closing a Protocol

An existing protocol reviewed by the full committee can be closed at any time by filing a final report.  The investigators however should remember that the data collected during the protocol period must be stored in a secure location for up to three (3) years after the final report has been approved.  The data and the location may be subject to OHRP audit any time during this period.  

>> Adverse Event Notification <<

All adverse events, such as study-related injuries to the participants and other types of harms that may have happened to the human subjects need to be reported to the Offfice of Compliance within 48 hours by emailing compliance@mtsu.edu.  Other adverse events could include compliance breaches or inadvertant/intentional deviations in the protocol should also be reported. Any event that could potentially place the participant at risk will be deemed as "adverse" and MUST be reported. Subsequent to notifying compliance@mtsu.edu by email,, the researcher MUST submit an Adverse Event Form by providing specifics on the event and what course of action was taken to mitigate the risk(s).  The "Adverse Event Form" needs to be completed and submitted within seven (7) days of the event to irb_submissions@mtsu.edu.  

Investigator Change Notification

All addition and removal of investigators should be reported to the Office of Compliance prior to commencing research.  The PI or the faculty advisor (if the PI is a student) should submit an Addendum Request to initiate the addition/removal of investigators.   Additionally, the new investigator who will be added to the protocol should have completed proper CITI training at the time of the request.  Data collected by an individual who is not included in the protocol would not be permissible and may lead to the cancellation of the protocol.  

Progress Report and Continuing Review Request

Typically, IRB approvals for expedited and full member review mechanisms are given for up to one year.  At the end of the first year, the investigators can either opt to close the study or to continue the protocol for an additional year.  If they choose to close the study, then they will follow the process described above on how to submit a final report.  If they wish to continue the study, then they have to submit a request for Continuing Review.  The application for a continuing review should be received by the Office of Compliance at least three (3) weeks before the date of initial expiration in order to process the extension in a timely fashion.  A continuing review request may be submitted twice for the life of a protocol.  After three years, the protocol will automatically expire and a new application needs to be filed.

A PROTOCOL WILL NOT BE EXTENDED ONCE IT EXPIRES.  

 

 

OTHER ACTIONS

Denial of Approval - A protocol may be denied approval due to either noncompliance or the proposed study may not qualify to be reviewed under the expedited mechanism.  In both cases, the IRB in cooperation with the Office of Compliance will make every effort to help the researchers to address the compliance concerns and possibly resubmit the proposal.

Deferral - A protocol deferred by the MTSU IRB cannot be resubmitted or be approved for human participation.  The IRB has determined that the study is non-compliant and it poses high risk that it cannot be approved.  Be advised that the protocols deferred by the IRB cannot be overturned by any other agencies or individuals within MTSU.  Be aware that involving MTSU Administration or ranking officials to influence an IRB approval process is a violation of University's Federal-Wide Assurance and PHS policies governing human subject research.  By law, the OHRP mandates that Instituions and Universities to allow the IRB to act independent and the MTSU offers its fullest support to the Committee.  Under no circumstances will an MTSU official interfere with the review or approval process of a protocol.  Moreover, it also needs to be emphasized that the MTSU Institutional Officials reserve the right to cancel a protocol that has been approved by the IRB.  

 

 

 

 

The following process is currently under review

AMMENDMENTS TO AN EXISTING EXEMPT PROTOCOL

 Starting from August 2015 (Protocols starting with 16 or later), ammendments to exempt protocols will be restricted to only minor changes.  The changes include minor typographical changes to the protocol/instrument/informed consent.  Other allowed changes would be addition or removal of investigators.  The Office of Compliance will no longer be able to complete major changes in the instruments or the protocol that have originally been approved as exempt.

Completed amendment request forms should be sent to irb_submissions@mtsu.edu.