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QI Project vs QI Research

Comparing a QI Project vs a QI-Research Activity

DEFINITION

DEFINITION QI PROJECT QI RESEARCH

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

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 QI PROJECT QI RESEARCH

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 he standard for ensuring the privacy and confidentiality of the population anddata 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 QI PROJECT QI RESEARCH

Documentation:

  • -  journals and conference platforms typically ask whether your project received an IRB review
  • -  recommendation: submission of a NHSR form (return to the IRB, and the IRB will complete this form and return to you), and maintain the final signed form for the life of the project

 

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

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