Quality Improvement vs Research

Frequent Issues Related to QI:
  • What is QI and what distinguishes it from research?
  • When is IRB approval needed (i.e., when is QI human subjects research)?
  • Can QI studies be published even without IRB approval?
  • What ethical oversight is appropriate for QI activities that aren't research?

Quality improvement activities are an important component of hospital operations. Because QI activities are data-driven and involve human participants, it is not surprising that there can be overlap with research methodologies common to human subjects research. Where there overlap exists between QI and research methodologies, the federal regulations that protect human research participants may apply. Whether the QI activity is human subjects research or not, it is vital that it be executed in a manner that is ethical and respects the rights and welfare of the human participants.

What is Quality Improvement (QI)?

Definitions

Quality Improvement (QI):
A working group from the Hastings Center "...defined QI as systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings." Improving the quality of care of patients is a fundamental obligation of health care providers. The QI process involves evaluating and learning from experience.

PDSA Cycle

Research:
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. More information regarding the definition of research and who is a human subject is available elsewhere on this website.

Systematic Investigation:
An activity that is planned in advance and that uses data collection and analysis to answer a question. Although research must include systematic investigation, many non-research activities also include systematic investigation. Systematic investigation does not, in and of itself, define research.

Operations Activities:
Certain administrative, financial, legal, quality assurance, quality improvement, and public health endeavors that are necessary to support an institutions missions of delivering health care to its patients, conducting research and development, performing medical education, and contributing to national emergency response. CHOP hospital operations activities include (but are not limited to):

  1. Conducting quality assessment and improvement activities; systems redesign activities; population-based activities relating to improving health, ensuring safety, or reducing health care costs; and case management and care coordination.
  2. Reviewing the competence or qualifications of health care professionals; evaluating provider and health plan performance; training health care and non-health care professionals; and accreditation, certification, licensing, or credentialing activities.
  3. Underwriting and other activities relating to the creation, renewal, or replacement of a contract of health insurance or health benefits and ceding, securing, or placing a contract for reinsurance of risk relating to health care claims.
  4. Conducting or arranging for medical review, legal analyses, or auditing services, including fraud and abuse detection and compliance programs.
  5. Business planning and development, such as conducting cost-management and planning analyses related to managing and operating an entity.
  6. Business management and general administrative activities.

To learn more go to the Resources for How to Improve on the Institute for Healthcare Improvement website.

How does QI differ from research?

Both research and quality improvement are systematic investigations that may involve human participants but they differ in important ways. The table below is based on information adapted from The Ethics of Using QI Methods to Improve Health Care Quality and Safety

Human Subjects Research Quality Improvement
Purpose designed to develop or contribute to generalizable knowledge designed to implement knowledge, assess a process or program as judged by established/accepted standards
Starting Point knowledge-seeking is independent of routine care and intended to answer a question or test a hypothesis knowledge-seeking is integral to ongoing management system for delivering health care
Design follows a rigid protocol that remains unchanged throughout the research adaptive, iterative design
Benefits might or might not benefit current subjects; intended to benefit future patients directly benefits a process, system or program; might or might not benefit patients
Risks may put subjects at risk does not increase risk to patients, with exception of possible patients' privacy or confidentialty of data
Participant Obligation no obligation of individuals to participate responsibility to participate as component of care
Endpoint answer a research question improve a program, process or system
Analysis statistically prove or disprove hypothesis compare program, process or system to established standards
Adoption of Results little urgency to disseminate results quickly results rapidly adopted into local care delivery
Publication/Presentation investigator obliged to share results QI practitioners encouraged to share systematic reporting of insights

When is IRB approval needed for QI activities?

IRB approval may be required when the activity involves some of the following characteristics:

  • seeks to develop new knowledge or validate new treatments rather than to assess the implementation of existing knowledge;
  • when the methodology employs a standard research design, such as randomization;
  • when the protocol is fixed with a rigid goal, methodology, population, time period, etc.;
  • when the funding for the activity comes from the outside organizations such as the NIH or those with a commercial interest in the results;
  • when there will be a delay in the implementation of results;
  • when the risks from the intervention to participants are greater than minimal

Worksheet for Assessing Whether a QI Activity is Also Research

The attached worksheet is (developed by Rachel Nosowsky, Esq.) based on The Hastings Center Report The Ethics of Using QI Methods to Improve Health Care Quality and Safety . The worksheet should help QI investigators to ascertain whether or not the IRB needs to be consulted or not. Download the Worksheet.

Why doesn't the IRB review all QI activities?

The IRB system was designed to provide oversight for human subjects. The system is costly and can take weeks to months to obtain approval. By its very nature, QI is an iterative, adaptive process that often requires rapid action. To force all QI activities into the IRB system would impose such a heavy overhead that many worthwhile projects wouldn't be feasible.


Worksheet

Can QI studies be published without prior IRB approval?

Publication is only one of many criteria for determining whether a QI activity is also research, by itself, intent to publish is not sufficient to require IRB review and approval.

Even though most QI activities aren't research, there is much to be learned from sharing descriptions of these non-research activities. For example, Case Reports are generally not considered to be research but provide a valuable addition to the medical literature. By analogy, lessons learned from a QI activity should be shared with others.

Standards for reporting QI initiatives have been developed and published by the SQUIRE Development Group. Individuals intending to publish the results of a QI project should consult this Guideline.

What ethical oversight is appropriate for QI activities that aren't research?

The IRB provides ethical oversight for human subjects research but there isn't at present, a system for ethical oversight of QI activities. At a minimum, hospital departments and divisions should review all proposed QI activities to ensure that the risks to participants are not greater than minimal and that there are appropriate protections for individual's privacy and confidentiality of their identifiable data.

Resources for Questions Related to QI and Research:

Access to web links is limited to those on the CHOP intranet.

Office for Patient Safety and Quality

Anna Spraycar
Director
267-426-7367
spraycar [at] email.chop.edu
CHOP Office of Patient Safety and Quality

IRB Office

Amy Schwarzhoff
Director
267-426-2346
schwarzhoffa [at] email.chop.edu

Barbara Engel, MD, PhD
Chair
267-426-6857
engelbc [at] email.chop.edu

Mark Schreiner, MD
Executive Vice-Chair
215-590-1857
schreiner [at] email.chop.edu

 

CHOP Privacy Office

Beth Thornton
Manager, Privacy Operations
267-426-6036
thorntonb [at] email.chop.edu
CHOP Office of Patient Privacy

The Office of Research Compliance

Matthew Hodgson
AVP, Research Compliance and Regulatory Affairs
267-426-8723
HodgsonM [at] email.chop.edu
The Office of Research Compliance

Key References

  1. The Ethics of Using Quality Improvements in Health Care contains a detailed discussion of the differences between QI and research
  2. The Common Rule and Continuous Improvement in Health Care a discussion paper sponsored by the Institute of Medicine discusses the interactions and overlap between QI and research.
  3. Vogelsang J. Quantitative research versus quality assurance, quality improvement, total quality management, and continuous quality improvement.
  4. Casarett et al. Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.
  5. Baily et al. Special Report: The Ethics of Using QI Methods to Improve Health Care Quality and Safety
  6. Lynn et al. The ethics of using quality improvement methods in health care.
  7. Grady C. Quality improvement and ethical oversight.
  8. Davidoff et al. Publication guidelines for improvement studies in health care: evolution of the SQUIRE Project.
  9. Baily MA. Harming through protection?
  10. Miller and Emanuel. Quality-improvement research and informed consent
  1. Do the regulations governing research involving human subjects apply to all QI activities within CHOP?

    Not all QI activities meet the definition of research as defined in "the regulations" (45 CFR 46).

    Examples of QI that are not research:

    • A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.

    • A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.

    • A clinic implements a widely accepted assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit medical charts to see if the assessments are performed for the appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the assessment if it finds that the assessments are not being administered routinely to appropriate patients.

  2. Can I analyze data provided to me by the owner of a database, that are not individually identifiable, such as medication databases stripped of individual patient identifiers, for research purposes without having to apply the human research subjects protections regulations?

    Depending on how these data were stripped of individual patient identifiers, the resulting dataset would not meet the definition of human subject as found in the regulations. Thus if the research project includes the analysis of data for which the investigators cannot readily ascertain the identity of the subjects and the investigators did not obtain the data through an interaction or intervention with living individuals for the purposes of the research, this project does not meet the definition of human subjects research and does not require IRB review.

  3. Are there types of QI activities that are considered to be research that would require IRB review?

    If a project involves introducing an untested clinical intervention then this is considered research. When the purpose goes beyond simple QI and also involves collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, the project will likely meet the definition of human subjects research and will require IRB review. If even a small component of the QI activity is research, then the project must be reviewed by the IRB.

  4. I intend to publish the results of my QI activity; does this mean I am required to submit to the IRB for approval?

    The intent to publish is not a sufficient criterion for determining whether a QI activity involves research requiring IRB review. Planning to publish an account of a QI project does not necessarily mean that the project fits the definition of research. Download the worksheet on this page and if necessary, consult with one or more of the resources listed to determine if IRB review is necessary. Those intending to publish should consult the SQUIRE Website for checklists, explanations, resources and advice about publication standards for QI initiatives.

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