EXEMPT Procedures

  • 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.
  • Expect longer processing time during the months of September-October and February-March.

 

SUMMARY

This page will provide the researchers with an outline of the necessary documents and paperwork to be completed in conjunction with EXEMPT procedures for obtaining IRB approval 

Exemption Definition

"Exempt" does not mean that the study is excluded from IRB oversight; it only means that the proposed activities meet lower levels of oversight requirement.  Moreover, research activities are exempt from "full-length" regulations for the protection of human research subjects when they are considered minimal risk (the probability or magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [as defined by 45 CFR 46.102(i)]) and the ONLY involvement of human subjects falls within one or more of the exemption categories listed on the checklist.

The IRB will not consider any research exempt that involves prisoners, that involves a test article regulated by the FDA, unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6) and 21 CFR 56.104(d). Additionally, the research must fulfill MTSU's ethical standards to be considered exempt.

Before you fill your application

First determine if your research qualifies for exemption.  This would lead you to a different set of forms. Follow this simple decision chart to decide if you qualify for an exemption:

Screening Questions to Determine Exemption Qualification Response
1. Are the subjects from a vulnerable group (prisoners, seriously ill or cognitively impaired)? Yes No
2. Do you plan to collect behavior information that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the individual's financial standing, employability or reputation? Yes No
 3. Will you collect sensitive information or personal aspects of the subject's behavior (drug/alcohol use, illegal conduct, sexual behavior, mental health, etc)? Yes  No
 4. Except for researching normal education practices, will this study involve minors (under 18)? Refer to below for clarification on "education practices"  Yes No
 5. Will this research expose the subjects to discomfort or stress beyond the levels encountered in daily life? Yes No
6. Do you plan to videotape the participants (in some qualifying cases audiotaping may qualify for exemption when no other means of data collection is available, like speech studies)? Yes No
 
If you answered Yes to any of the above questions, then you WILL NOT qualify for an exemption.  You  have to file a petition through either the EXPEDITED or the FULL REVIEW process.
 
Additional questions on projects that involve minors and other protected individuals for determining exemption:
  • Will the study involve the participation of protected individuals?
    • Minors (less than 18 years of age) - Click here to know more about research with minors
    • Pregnant women
    • Prisoners
    • Protected minority races
    • Subjects who are incapable of providing consent
If you answered "YES" to "minor children" go to the next question, and if you answer "YES" to any of the remaining questions, then you will have to fill out an expedited or a full review form.
  1. Other than non-identifiable demographics, will the data collection involve name(s), addresses and other types of personal information, including health data of the minors or their relatives?
    1. YES – the study is NOT exempt
    2. NO – go to question 2
  2. Will the study involve the delivery of education?
    1. NO – the study is NOT exempt
    2. YES – go to question 3
  3. Does the education delivery entail typical curriculum and activities involving testing?
    1. NO – the study is NOT exempt
    2. YES go to 4
  4. Will the data collection involve videotaping or recording the voices of the minors?
    1. YES – the study is NOT exempt
    2. NO – go to 5
  5. Will an evaluation assessment be conducted to address a “research” question? (Refer to the FAQ page on OHRP’s definition of “research”)
    1. YES – the study is NOT exempt
    2. NO – the testing is done to evaluate an education method or technique – go to question 6
  6. Will the students in class do the same activity/activities?
    1. NO – the study MAY NOT BE exempt AND go to question 7
    2. YES – go to question 7
  7. Regardless of your response to question 6, Will you be recruiting participants randomly or through purposeful selection
    1. YES – the participants will be selected randomly through a clear acceptable inclusion criteria
    2. NO – the participants will be selected purposefully – you will need parental consent and child assent
 

 

MAKING  NEW  EXEMPTION  REQUESTS

 

Essential Forms and Attachments

Other Documents

  • Recruitment details (flyer, email transcript, etc.)
  • 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 on "official letter heads" signed by an individual who has the authorization to do so. 
    • For instance, researchers conducting studies in a church or a library would a letter of support on official stationary from a representative who is entitled to approve your activity provided - Send scan of the letter for IRB review and keep the original for your records
  • Mutualagreemts 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

 

Be advised that the necessary documents are not restricted to the above list but IRB and the Office of Compliance may require other types of documents depending on your study.  

INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED.  The timeline for review starts only after the application is complete

All essential and optional materials should be emailed to irb_submissions@mtsu.edu.  

 

AMENDMENTS to an EXISTING EXEMPT PROTOCOL

 Starting from August 2015 (Protocols starting with 16 or later), amendments 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.

 

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 designated to correspond IRB matters with the researchers:

The applications MUST be submitted by a faculty member.  Students cannot request for a protocol.  Please click here for an overview the most recent document submission process

 

REVIEW PROCESS

The application and the supporting documents will be administratively reviewed for completeness.  Incomplete applications will be sent back to the researcher(s) without any administrative action.  Those applications that are considered to be "complete"will be assigned a new IRB ID which will resemble the pattern ##-1###.  The researchers will be corresponded by email if further information is needed to make a determination.  In the event that the reviewer determines that the protocol may not qualify for exempt status, the application may be sent for a consultation.  The researcher will be directed to submit an expedited or a full member application once the Office of Compliance confirms nonexemption decision.  

Researchers please be aware that all IRB decisions are final and may not retracted.   The researcher can appeal a decision by making a written request to the Chair of IRB (Please visit the IRB Membership page).  The decision of the IRB Chair is final and cannot be appealed.  Moreover, under no circumstances the research team can involve MTSU Administration or ranking officials in a review process.  The University's Federal-Wide Assurance and the PHS policies preclude the involvement of administrative members to influence the approval process.  However, the Institutional Officials reserve the right to cancel an approved IRB protocol.  

 

PROTOCOL APPROVAL

The researchers will receive an Exempt Approval Notice from 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.  At the present, there is no date of expiration for exempt protocols.  The researchers are required to follow the methods listed by them in the protocol application.  Any deviation will have to be reported immediately.

 

POST APPROVAL OBLIGATIONS

Reporting Adverse Events:

Depending on how serious the information is, the researchers are advised to send an initial email to compliance@mtsu.edu describing the nature of the event.  Any study-related injuries or other types of events that could have resulted in compromising the safety of the participants qualify as "adverse events."   The initial notification should reach the Office of Compliance within 48 (FORTY EIGHT) hours after the event took place.  Subsequently, the researcher will submit an Adverse Event Form by providing specifics on the event and what course of action was taken to mitigate the risk(s).

Investigator change notification(s):

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.  

Study Complete Notification and Protocol Cancellation:

The researcher is required to notify the Office of Compliance once a study has been completed and data collection will no longer be conducted.  The researchers should bear in mind that they are responsible for all of the study-related documents for up to three (3) years once the data collection has ended.  For Exempt protocols, the researcher can simply send an email to request the cancellation of a protocol.  

Other Important Conditions:

The applicant of the protocol or the faculty advisor (if the applicant is a student) take 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.

 

OTHER ACTIONS

Denial of Exemption:

A protocol may be denied approval due to either noncompliance or the proposed study may not qualify the exemption status.  In both cases, the Office of Compliance will make every effort to help the researchers to address the compliance concerns.  In rare instances, where the proposed study could not be achieved under the exemption criteria, the researcher will be asked to resubmit a fresh application to be reviewed under either expedited or full committee mechanism. 

Refer to Expedited:

As explained above, a study may not qualify for IRB exemption and it will have to be reviewed by one of the more stringent classifications.  

Appeal Process:

All IRB decisions are final and may not be changed under most circumstances.   A researcher may nonetheless appeal a decision by making a written request with proper justification to the Chair of IRB (Click here for a list of current IRB members).  The decision of the IRB Chair is final and cannot be appealed and there are no exceptions.  The researchers MUST NOT INVOLVE OTHER UNIVERSITY OFFICIALS.  Be advised 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.  In contrast however, an authorized Institutional Official reserves the right to cancel a protocol that has been previously approved by the IRB.