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)?
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.
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.
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.
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):
- 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.
- 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.
- 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.
- Conducting or arranging for medical review, legal analyses, or auditing services, including fraud and abuse detection and compliance programs.
- Business planning and development, such as conducting cost-management and planning analyses related to managing and operating an entity.
- 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.
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.
- The SQUIRE Website has numerous useful tools and guidelines for those doing Quality Improvement work.
- Publication Guidelines for Quality Improvement Studies in Health Care: The Evolution of the Squire Project Annals of Internal Medicine, 2008
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
Sr. Director, Clinical Operations & Enterprise Improvement
spraycar [at] email.chop.edu
CHOP Office of Patient Safety and Quality
schwarzhoffa [at] email.chop.edu
Barbara Engel, MD, PhD
engelbc [at] email.chop.edu
Mark Schreiner, MD
schreiner [at] email.chop.edu
CHOP Privacy Office
Manager, Privacy Operations
thorntonb [at] email.chop.edu
CHOP Office of Patient Privacy
The Office of Research Compliance
AVP, Research Compliance and Regulatory Affairs
HodgsonM [at] email.chop.edu
The Office of Research Compliance
- The Ethics of Using Quality Improvements in Health Care contains a detailed discussion of the differences between QI and research
- 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.
- Vogelsang J. Quantitative research versus quality assurance, quality improvement, total quality management, and continuous quality improvement.
- Casarett et al. Determining when quality improvement initiatives should be considered research: proposed criteria and potential implications.
- Finkelstein et al. Oversight on the borderline: quality improvement and pragmatic research
- Baily et al. Special Report: The Ethics of Using QI Methods to Improve Health Care Quality and Safety
- Lynn et al. The ethics of using quality improvement methods in health care.
- Grady C. Quality improvement and ethical oversight.
- Davidoff et al. Publication guidelines for improvement studies in health care: evolution of the SQUIRE Project.
- Baily MA. Harming through protection?
- Miller and Emanuel. Quality-improvement research and informed consent