Guidance

Quality Assurance and Quality Improvement (QA/QI) Projects

IRBMED
May 13, 2022 11:00 am
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According to U-M Human Research Protection Program (HRPP) and federal (OHRP) guidance, IRB review and approval is not required for activities that are limited to Quality Assurance and Quality Improvement (QA/QI) activities. However, IRB approval is required when QA/QI activities are designed such that they meet the definition of research (below) in addition to improving the quality of care for patients. As there are several common features between QA/QI and human subject research, QA/QI determinations are not always straightforward. The purpose of this document is to provide guidance on this topic for IRB regulatory staff and the U-M research community.

  • Definitions

    HHS 45 CFR 46.102 (Common Rule)

    Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

    Human subject [aka human participant] means means a living individual about whom an investigator (whether professional or student) conducting research:

    1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
      [and/]or
    2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    U-M HRPP Operations Manual (OM)

    A “systematic investigation” is an activity conducted in pursuit of answering a specific research question or to permit conclusions to be drawn. The research is described in a formal protocol that sets forth an objective and a set of procedures to reach that objective, and results in the formulation of generalizable knowledge based on conclusions drawn. In turn, “generalizable knowledge” is knowledge based on the findings of a particular research study (or studies) that may be applied more broadly with the expectation of predictable outcomes.

    QA/QI Clinical: “Systematic, data-guided activities designed to implement promising ways to improve clinical care, patient safety and health care operations. The activity is designed to bring about immediate positive changes in the delivery of healthcare, programs, or business practices in the local setting.” 

    QA/QI Non-Clinical: “Data collected with the limited intent of evaluating and improving existing services and programs or for developing new services or programs. Examples include teaching evaluations or customer service surveys.”
     

    ⇨ If an activity DOES NOT meet the definition of research, human subject, or human subject research, IRB review is mostly NOT required. The U-M HRPP Operations Manual (table 5, page 43) outlines the scenarios when an IRB application is required and when an IRB application is NOT required for Not Regulated projects.

  • IRB Applications: General Scenarios

    Note: Obtaining a self-determination letter in eResearch is currently not available.

    An IRB application is not required for QA/QI projects where the project does not meet the definition of research or where there is no research component. However, for various reasons, researchers may seek IRB review and confirmation that their project is a QA/QI effort not subject to human subject research regulations at 45 CFR 46. IRBMED strongly recommends that researchers provide the following information when submitting an IRB application for a QA/QI determination:

    1. Create a “Human Subject Research” application in eResearch and complete it with the general information about the project. Provide the following as part of the application:
      1. Provide standard information in Section 01.
      2. Select the “Not Regulated” category in Section 01-1 Application Type.
      3. Select the “QA/QI…” category in Section 04. 
    2. In Section 01.8 Project Summary: Provide adequate details about the project
      Provide details like background, methodology, and specific goals (both long-term and short-term as applicable). If there is a project plan or other similar document that includes these details, upload it in Section 44 of the IRB application.
    3. In Section 01.8 Project Summary: Provide adequate details to support the QA/QI nature of the project 
      1. Explain how generalizability is limited. Simply stating generalizability is limited is not adequate. See Section II. Definitions listed above for additional info. 
      2. Describe the use of analysis/results generated in the project 
        1. Will it be used to develop/update/refine current guidelines for practice? 
        2. Are any improvements planned at the local level (department, unit) or larger (multiple institutions)? 
    4. For QA/QI projects with interventions: When implementing an intervention or a program for QA/QI purposes, it is important to know the full intent and scope of the intervention.
      1. Review and address the points covered above from #1 to #3
      2. In addition, clearly state in Section 01.8 Project Summary whether the study team is implementing the proposed intervention as a research intervention to evaluate its safety or effectiveness or whether it is being implemented solely to improve the quality of care. NOTE: Projects with both research and QA/QI intents that include human participants are likely not eligible for a Not Regulated determination. For these scenarios, the application type in Section 01-1 should be changed from “Not Regulated” to the most appropriate option. The OHRP 2008 letter (reference linked below #6) provides additional insight regarding QA/QI projects with research aspects.
      3. Complete and upload the QA/QI checklist (linked below in reference #5) in Section 44 of the IRB application.

  • Special Scenarios

    Complex QA/QI projects

     IRBMED strongly encourages researchers to consult with IRBMED regulatory staff on complex QA/QI projects before submitting the Not Regulated application for IRB review. Contact IRBMED at the general email address ([email protected]) to be connected with a regulatory staff member. Complex QA/QI projects include:

    1. Projects with multiple phases or cohorts where one particular cohort or phase may be eligible for a QA/QI determination.
    2. Collaborative QA/QI (CQI) projects carried out at multiple institutions. Collaborative projects must have adequate justification for how the generalizability of the study results is limited to QA/QI. For additional information, review reference #1 below.

    Publication as an indication of QA or Research

    As outlined in the references #1 and #2 below, the intent to publish (share descriptions/results with interested others) is not a criterion for determining whether an activity is research or QI.

    HIPAA

    HIPAA requirements regarding patient privacy apply whether an activity is research or quality improvement. QA/QI activities involving patient information must follow HIPAA requirements. Any presentations or publications need to maintain the privacy of individual patients involved in the project. HIPAA Privacy Board review is usually NOT conducted as part of the QA/QI determinations by IRBMED.

  • Resources
    1. Presenting/Publishing QI – guidance from the Michigan Medicine Program for Quality Improvement (QI) 
    2. OHRP FAQs on Quality Improvement Activities 
    3. U-M HRPP Operations Manual 
    4. OHRP Decision Chart: Chart 01: Is an Activity Human Subjects Research Covered by 45 CFR Part 46?  
    5. Checklist for QA/QI projects with interventions 
    6. OHRP 2008 letter to Dr. Peter Pronovost on complex QA/QI projects
Tags: Regulatory Study Teams
Units: Institutional Review Boards (IRBMED)
Topic: eResearch Regulatory Management (eRRM) HIPAA & Protected Health Information Investigator & Study Team Responsibilities Regulations & Policies (Federal, State & Local)
Questions?

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Edited By: [email protected]
Last Updated: May 13, 2022 11:00 AM