Quality Improvement/Quality Assurance Projects – When Do They Require IRB Review?

June 2021 Issue

(Note: this article is an update of an article with the same name published in November 2016)

Authors:

  • Fanny K. Ennever, PhD, CIP
    Previously: Manager, Regulatory Policy Development
    Human Subject Protection Program
    Boston Medical Center and Boston University Medical Campus
  • James Moses, MD, MPH
    Previously: Associate Chief Quality Officer
    Boston Medical Center
  • Matthew Ogrodnik, MS, CIP
    Director, Office of Human Research Affairs
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Introduction

IRB review is required when an activity constitutes human subjects research. Quality Improvement (QI) and Quality Assurance (QA) projects always involve human subjects, but only have to be submitted to the IRB for review if they meet the Common Rule definition of research. The IRB, in partnership with Boston Medical Center quality and patient safety leadership, adopted official guidelines to distinguish when QI/QA projects do and do not require review, and established an exempt category for QI/QA projects without external funding that do require IRB review.

 

Quality Improvement/Quality Assurance Activities

Traditional QI/QA projects are typically designed, or intended, to:

  • improve patient care;
  • compare a program/process/system to an established set of standards such as standard of care, recommended practice guidelines, or other benchmarks;
  • improve the performance of institutional practice or local systems;
  • bring about improvements in health care delivery.
From a patient’s point of view, a significant feature of QI/QA activities is that the intervention that is undertaken has already been proven to be beneficial in other settings. In contrast, clinical trials are designed to test drugs, devices, procedures, or process changes that are not known to be better than standard care; and, therefore, it is ethical to randomly assign individuals to the new intervention or to standard care.

 

The Common Rule Definition of Research

The Common Rule definition of research is, “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”This definition is important, because activities that do not meet this definition do not have to be submitted to the IRB for review.

A key term in the above definition is “generalizable.” This is not the same as “publishable.” Thus, investigators on a QI/QA project can plan for the results to be published without triggering a requirement for IRB review, as long as the publication will not describe the project as research. Standards for QUality Improvement Reporting Excellence (SQUIRE) is a source for guidelines on publishing QI/QA projects.

Certain features that indicate that a QI/QA project might be research (designed to create “generalizable” knowledge) include randomization, deception, an unproven intervention, and altering or withholding standard treatment.

 

Criteria for QI/QA Projects that Do NOT Require IRB review

The IRB has established the following criteria for when Quality Improvement and Quality Assurance activities are not considered to meet the definition of research and do not require IRB review. All criteria must be met:

  • When the intervention involves patients, all patients who get the intervention are expected to benefit.
  • The purpose of measurement related to the QI/QA project is to determine the effect of process change, measure performance, or for submission to an authorized national or state registry and/or database that has the intent to improve the delivery of clinical care.
  • The purpose of the QI/QA project is to improve institutional processes or delivery of care consistent with established quality standards.
  • When the initiative involves patients, all patients involved in the initiative will receive standard of care at a minimum.
  • The project involves systemic data collection to monitor and compare performance to defined standards.
  • The project will be described as “quality improvement” in public presentations, academic curriculum vitae, publications, and/or other representations to any third party audience, with a planned statement similar to: “This project was undertaken as a Quality Improvement Initiative at Boston Medical Center, and as such was not formally supervised by the Institutional Review Board per their policies.”
  • There is an agreement with the clinical practice unit (hospital, clinic, division, or care group) that this is a QI/QA project that will be implemented to improve institutional processes or delivery of care.
  • The project will be conducted by clinicians and staff where the project will take place, and involves staff and/or patients of Boston Medical Center or the Boston University Dental Clinic.
  • The intent of the project is NOT to test a novel hypothesis, answer a research question or replicate another researcher’s original study.
  • The project does NOT seek to test interventions, treatments or practices that are not currently considered standard of care in any existing practice (neither consensus-based, nor evidence-based).
  • The project does NOT involve withholding any aspect of standard of care.
  • The intent of the project is NOT to design or develop a new standard of care or benchmark.
  • No physician or staff member will be blinded to any aspect of the patient’s care.
  • No persons (including patients and investigators) will be exposed to risks beyond those involved in clinical care that are greater than minimal risk.
  • The project does NOT involve a research design (e.g., randomization) or practice that overrides clinical decision-making.
  • The project does NOT involve using a medication or medical device or procedure outside of usual medical practice.
  • The project does NOT involve funding from a research grant or other research procedure.
  • The project will NOT be described as research in representations such as publications, presentations, or academic dossier.
  • Chart reviews are NOT the only activities of the entire QI/QA project.

 

Responsibilities to Assess Whether QA/QI Projects Require IRB Review

Ultimately, it is the responsibility of the investigator to submit for IRB review if a project meets the definition of human subjects research. To assist investigators, a checklist with the above criteria is available on the IRB website. This checklist is also embedded into the electronic QI Hub application through the BU Barry M. Manuel Office of Continuing Medical Education for tracking patient safety QI/QA projects throughout Boston Medical Center and Boston University. The mission of QI Hub is to create and support a culture of healthcare quality improvement (QI) engagement for BMC, the Boston HealthNet Community Health Centers, and Boston University through accredited education, mentorship and administrative oversight.

 

Protected Health Information

All Protected Health Information (PHI) involved in the QI/QA project must be transmitted, stored, analyzed, or otherwise exist only on HIPAA-compliant electronic systems that meet the security standards for protection of PHI established by Boston Medical Center or the Boston University Dental Clinic.

 

Examples

The following table gives examples of QI/QA projects in different categories, including changes that would make the project not qualify as QI/QA:

Basic QI/QA Project

QI/QA that is not research

QI/QA that is research

Research that is not QI/QA

Add a medical record alert for patients ≥60 not vaccinated for pneumococcus

Track provider utilization of alerts and vaccination rates

Randomize alert to go to provider or medical assistant

Limit the alert to patients ≥70 to see if more efficient use of resources

Deliver a training program to radiologists on minimizing radiation dose

Assess radiologist satisfaction with training and comprehension

Compare radiation doses for patients of radiologists who got trained in-person vs. electronically

Develop a novel “gamified” training program

Implement a more user-friendly standard checklist for fall-risk screening

Track checklist usage and assessment outcomes

Randomize floors to repeat assessment every 24 vs. every 48 hours

Implement fall-risk screening checklist in Emergency Department

 

New Exempt Category for QI/QA Activities that Do Require IRB Review

Even if a QI/QA project qualifies as human subjects research, if it does not have external funding, then it can qualify for an exempt determination. Review of exempt research is somewhat less burdensome on the investigator because the application is shorter.

A QI/QA research project qualifies for the exempt category if:

  • All patients who get an intervention are expected to benefit.
  • All measurements that are collected are to determine the effect of the process change.
  • All patients involved in the intervention receive standard care at a minimum.
  • The intervention meets evidence-based or consensus-based quality standards.
  • Confidentiality protections are appropriate to the sensitivity of the data collected.
  • Obtaining consent from the patients is not practicable because the change or intervention will be carried out in a clinical setting where there is no meaningful way for patients to opt out of receiving the intervention.

Consent from the patients who experience the intervention is not required. However, if any subjects, including healthcare professionals, participate in surveys, interviews, focus groups, or training, they must provide abbreviated consent (a shorter consent process that does not require a signature unless PHI is collected; see the “Exempt Information Sheet Template” on the IRB website).

This exempt category is listed as Exempt category (11) in the Exemption Categories section of the INSPIR application.

 

Summary

The IRB has specific questions and a BMC QI Checklist to determine when a Quality Improvement/Quality Assurance (QI/QA) project requires submission to the IRB; and an exempt category for some QI/QA projects that do require submission because they also meet the definition of research.