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Institutional Review Board (IRB)

Welcome to the UTHSC IRB! The website is being re-designed to make it easier for you to work with the IRB and locate the information you need. We are streamlining the navigation, posting popular items where you can find them quickly, and adding new features. Check back frequently for updates!

What’s New?

The 2012 IRB Submission and Review Schedule is now posted. Just click the Meeting Schedules tab on the left side of your screen to access the updated schedule.

Educational/Training Opportunities

The UTHSC IRB is now offering quarterly training sessions, IRB Insights. These will be opportunities for researchers to learn more about human research protections and how to use the IRB electronic system, iMedRIS.

Mark your calendars for these future IRB Insights opportunities:

  • Wednesday, 29 February: Potluck – Bring your questions to the IRB
  • Wednesday, 30 May: Creating revised study documents within iMedRIS, including hidden text instructions in the consent form templates
  • Wednesday, 29 August: Adverse Events, Unanticipated Problems, and other Reportable Information and which Form 4 to Use
  • Wednesday, 31 October: iMedRIS: Initial Project Submission

    Complete the IRB Insights Registration Form to reserve a seat!

For information on other iMedRIS training opportunities and the CITI program, please visit the Training tab on the left.

IRB Tip

Quality Improvement (QI) Projects and IRB Review

QI activities oftentimes occupy an uncertain territory between clinical care and research.  Although most QI activities involve a systematic investigation of some question of interest, many do not involve research as defined in the federal regulations for the protection of human subjects (45 CFR 46).  In other cases, QI activities are designed to accomplish both a research purpose as well as a non-research purpose and IRB review is required.  The following chart formulates some criteria that may be helpful in determining whether a QI project involves a research component and must be reviewed under the regulations for the protection of human subjects:

QI projects may include a research component if:

QI projects do not include a research component if:
  • One purpose of the project is to develop generalizable results by testing a hypothesis OR by establishing a clinical practice standard where none exists
  • Study procedures involve applying a new intervention that is beyond current standard practice
  • Study procedures involve randomizing subjects into different intervention groups
  • The project imposes risks or burdens to patients beyond those associated with the standard of practice
  • One outcome sought is to generate an analysis that can be applied to other programs, processes or systems
  • The only purpose of the project is to assess or improve a process, program, or system OR improve performance as judged by established/accepted standards
  • The only procedures involve standard practices, interventions or treatments
  • The only study procedures involve observing or comparing interventions that are already being done
  • The project does not impose additional risks on patients, with the exception of privacy/confidentiality concerns
  • The only outcome sought is an improvement in a program, process, or system

IRB Tip Archive

 


 

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UTHSC IRB office
910 Madison
Suite 600
Memphis, TN 38163

Phone: (901) 448-4824
Fax: (901) 448-5103
Email: irb@uthsc.edu