Quality Improvement Projects vs  Quality Improvement Research Activities

In general, a quality improvement (QI) project does not need to be submitted to the IRB. The comparison chart below is intended to help you determine whether an activity is a "Project or "Research"

EQUIP TIPS Additional Guidance:

QI Project vs. QI Research 

 

Definitions

Definitition

QI Project

An activity that is specifically initiated with a goal of improving the performance of institutional practices in relationship to an established standard

However, if a project was originally initiated as a local QI project but the findings are of interest and the project investigator chooses to expand the findings into a research study, IRB review would be required at that time

QI Research

An activity that is initiated with a goal of improving the performance of institutional practices in relationship to an established standard, with the intent to contribute to generalizable knowledge (“widely applicable”)

Meets the definition of Human Subjects Research:

Core Elements

Core  Elements

HIPAA Rule:  the following activities are considered “healthcare operations” (they are not considered “research”):

  • Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, if the obtaining of generalizable knowledge is not the primary purpose of studies resulting from the activities
  • Population-based activities relating to improving health or reducing healthcare costs
  • [Clinical] protocol development, case management and care coordination

 

Authorization: 

  • HIPAA Rule does not require a covered entity to secure individual authorization (nor a waiver) for use or disclosure of PHI for these activities, as long as the covered entity describes the activities in its Notice of Privacy Practices
  • HIPAA Authorization is required if there is disclosure of PHI outside of the covered entity
    • “Release to” section:  UCI faculty/resident name
    • “Purpose” section:  QI activity publication
    • the signed authorization should be uploaded and maintained in the patient’s record; note, the patient has the right to ask for a copy of the signed authorization form
    • translated HIPAA Authorizations

Privacy and confidentiality:  A QI activity retains the standard for ensuring the privacy and confidentiality of the population and data being accessed and studied; also, review the above note regarding HIPAA Authorization

Intent:  generate generalizable results

Additional risk or burden:  the project includes risks or burdens beyond the standard of practice to make the results generalizable

Design:  involves randomization or an element that may be considered less (or more) than standard of care

HIPAA Rule:  requirements for waiving informed consent and/or waiving the requirements for documentation of informed consent must be met

 

Documentation

DOCUMENTATIAON

Documentation:

  • -  journals and conference platforms typically ask whether your project received an IRB review
  • -  recommendation: submission of a NHSR determination request and maintain the IRB email determination for the life of the project
  • - Submit a non-human subject research (NHSR) determination request via Kuali Research (KR) Protocols.

 

Publication: 

  • -  publications must describe the activity as a “project” ; also, review the above note regarding HIPAA Authorization

IRB review:  activities that meet the definition of Human Subjects Research require IRB review

Additonal Resources