In healthcare, both Quality Improvement (QI) and Human Subjects Research (HSR) play pivotal roles in advancing patient care and clinical practices. However, confusion often arises regarding the differences between these two methodologies. This blog post aims to clarify the distinctions and commonalities between QI and HSR, based on insights from the paper by Gregory E. Gilbert and colleagues.¹

Quality Improvement (QI) is primarily concerned with enhancing processes within a specific healthcare setting. The main objective is to identify and rectify inefficiencies or problems in clinical procedures to improve patient care. QI projects are typically localized, meaning their findings are relevant only to the institution where they were conducted. The focus is on immediate application and ongoing assessment to foster continual improvement.

Human Subjects Research (HSR), on the other hand, aims to generate new, generalizable knowledge that can be applied beyond the initial study setting. HSR follows a structured methodology to test hypotheses and produce findings that contribute to the broader scientific community. This type of research often involves rigorous protocols and is designed to answer specific questions with the intent of publication and dissemination.

1. Intent and Outcome:
   • QI: Seeks to improve specific clinical processes and outcomes within a single institution. The results are usually not intended to be generalized outside the facility performing the project
   • HSR: Aims to create new knowledge that can be generalized to other settings and contribute to the scientific literature.
2. Scope and Methodology:
   • QI: Employs flexible and iterative methods such as the Plan-Do-Study-Act (PDSA) cycle, focusing on rapid-cycle testing and implementation.
   • HSR: Utilizes more rigid and predefined protocols, with a strong emphasis on hypothesis testing and controlled study designs.
3. Regulatory Oversight:
   • QI: Although QI projects may not always require Institutional Review Board (IRB) approval, it is beneficial to submit proposals to ensure compliance to ethical standards.
   • HSR: Mandatory to seek IRB approval as it involves systematic investigation designed to produce generalizable knowledge, often involving human subjects.

A common misconception is that the methodologies used in QI and HSR are fundamentally different. In reality, both can utilize similar qualitative and quantitative methods. The distinction lies not in the techniques employed but in the purpose and application of the results. Misunderstanding this can lead to improper classification, which may have significant implications, such as the loss of federal funding for institutions.

Healthcare professionals must clearly understand whether their project constitutes QI or HSR. Misclassification can lead to ethical and regulatory complications. Tools like ‘Differences Distinguishing Human Subjects Research from Quality Improvement’ can aid in making this determination. Engaging with the IRB early in the project planning phase is crucial to ensure appropriate oversight and adherence to ethical standards.

Both Quality Improvement and Human Subjects Research are essential for the continuous advancement of healthcare practices. By understanding the differences and appropriately categorizing projects, healthcare professionals can contribute effectively to both local improvements and the broader scientific community.

For those involved in healthcare scholarship, it is imperative to foster clarity in the methodology and intent of their projects to ensure ethical and effective outcomes.

For further reading and detailed guidelines on conducting QI and HSR, healthcare professionals are encouraged to consult the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines and engage with their institution’s IRB.

AVA members have access to free mentorship for posters, presentations, publications, QI projects and HSR. Contact AVAFoundation@avainfo.org for more information.