What are the Types of IRB Reviews?

 

The IRB uses THREE types of review mechanisms

Exempt

Expedited

Full Member Review

 

A short descriptio of each of the mechanism is described below.  You can view the specific requirements for each of the review type by clicking the appropriate links.  Please bear in mind that the examples given on this page are listed only as a starting point to help you decide what kind of review you may request. You should thoroughly read and understand the requirements which are detailed in the PDFs linked to each review type before making a final decision. 

Exempt Review

Research qualifying for Exempt Review must present no more than minimal risk to participants. Most research qualifying as Exempt at MTSU will fall into one of the following categories below. Surveys or interviews on sensitive topics will not qualify for Exempt review. Additionally, research involving videotaping subjects will not qualify for exempt review (in some cases audiotaping may qualify). Download the PDF  for a complete description on how to qualify for the Exempt Review mechanism and for other rarely used categories. You will need to indicate what category you believe your research meets on your Exempt Review Application.Exempt reviews are conducted by staff in the Research Compliance Office.

  • Evaluation or Comparison of Commonly Accepted Instructional Strategies/Curricula
  • Educational Tests, Surveys, Interviews, or Observations
  • Collection or Study of Existing Data

Use this checklist to determine if your study qualifies for exemption:

 

Screening Questions to Determine Exemption Status Response
1. Are the subjects from a vulnerable group (prisoners, seriously ill or cognitively imparied)? 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)?  Yes No
 5. Will this research expose the subjects to dicomfort or stress beyond the levels encountered in daily life? Yes No
6. Do you plan to videotape the participants (in some cases audiotaping may qualify for exemption)? 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.

Click here for more information on the Exempt review process and documentation required to apply for MTSU IRB approval under this scheme

Expedited Review

Research qualifying for Expedited Review must present no more than minimal risk. Most research qualifying for Expedited review at MTSU will meet one of the following categories. View the PDF for a description on how to qualify for the Expedited Review mechanism. Under this mechanism, the protocols are reviewed typically by ONE member of the IRB committee.  Please note that the current practice is such that the reviewer will communicate directly with you about any necessary revisions or additional information needed before granting approval.   In rare instances, additional reviewers will be designated for studies that require more than one expertise to determine compliance.  

  • Research involving exercise studies or studies using physical devices. 
  • Collection of data from voice, video, digital or image recordings made for research purposes
  • Research on group or individual characteristics of behavior (when not meeting Exempt Requirements)
  • Collection of blood samples
  • Collection of biological specimens for research purposes collected by noninvasive means.
  • Collection of data through noninvasive procedures.
  • Clinical studies of drugs and medical devices.
  • Research involving materials that have been collected for non-research purposes (when not meeting Exempt Requirements)

Click here for more information on the Expedited review process and documentation required to apply for MTSU IRB approval under this scheme

Full Review

If your research presents more than minimal risk or does not meet the qualifications for Exempt or Expedited review you will need to apply for Full Review. Read the PDF above carefully and follow all directions including strict adherence to time requirements. Examples of research that would require full review are listed below.The Full IRB committee will review your protocol at a convened meeting.  After the meeting the IRB Chair will contact you with the IRB's decision along with any additional questions and revisions needed.

  • Research that might put subjects at risk
  • Research involving deception that might have adverse effects on the subjects
  • Research involving vulnerable populations (e.g. individuals with cognitive impairments)

Click here for more information on the Full Member review process and documentation required to apply for MTSU IRB approval under this scheme

Be aware that the practice of direct correspondence between the reviewers and the investigators may change when the Office of Compliance upgrades its application submission mechanism.  Presently all applications are entertained through emails and it has posed several challenges in turn-around times, especially during peak submission months.  Therefore, the Office of COmpliance is working towards an automated review system that would involve online submission of applications.   The direct communication with the IRB members was instituted to make the review process more swift, but it exposes unfrotunately exposes the identity of the reviewer.  The Office of Compliance is working with the VIce Provost's office to bring changes to this procedure such that the reviewer identity can be protected and the process will be more efficient.  

 

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