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The Office of Quality Compliance conducts three types of reviews:  Best Practice, Routine, and For-Cause.  Click on the appropriate link below to use the assessment tools for your studies.

  • Best Practice Review can be by a study responsible investigator (PI or RI). They are used to provide recommendations on-site about how to improve study activities involving human participants.
  • Routine Review is an evaluation of a research study that is non-exempt involving human subjects and approved by the U of Utah’s IRB.
  • For-Cause Review is a triggered investigation of any research study involving human subjects that has been identified through the ORI&C.

 

Best Practice Review


“Best Practice Review” is a review requested by a study principal investigator (PI).  These reviews are to provide recommendations on-site about how to improve study activities involving human participants.  These reviews will provide information to the PI and study team about the how well their study is meeting federal, funder, and university regulations as well as university policies.

 

Routine Review


A “Routine Review is an evaluation of a research study that is non-exempt involving human subjects and approved by the U of Utah’s IRB. This type of review may involve studies that have federal, industry, or foundation funding.  These reviews will usually include a grant fidelity review as well.  Routine reviews will be structured using the four-tiered system described below:

  • Tier 1 = more than minimal risk studies that are federally, industry-sponsored, or foundation funded
  • Tier 2 = more than minimal risk studies that use investigational drugs and/or devices
  • Tier 3 = minimal risk studies that are federally, industry-sponsored, or foundation funded
  • Tier 4 = minimal risk studies that are not funded

 

For-Cause Review


A “For-Cause Review” is a triggered investigation of a research study that has been identified through the Assistant Vice President for Research Integrity & Compliance’s office.  Reasons for triggering an investigation are due to

  • Whistleblower Complaint
  • Research Subject Complaint
  • Employee Complaint
  • IRB request due to new information that has the potential to negatively impact the rights and welfare of research participants
Last Updated: 10/21/20