Quality improvement & quality assurance

Defining research vs. quality improvement/quality assurance

This information is intended as guidance in making a preliminary determination regarding the need for IRB oversight. Whenever there is uncertainty as to whether a project is considered Research or QI/QA, the investigator should request guidance from the Human Subjects Office (HSO).

Purpose

To establish the definition of Research versus Quality Improvement (QI) or Quality Assurance (QA)—referred to collectively in this guidance as ‘QI/QA.’

Research projects must comply with specific policies and regulations designed to protect human subjects and privacy rights. QI/QA projects are not required to be carried out in accordance with research policies and regulations; however, it may be difficult for an investigator to determine if the project is Research or QI/QA. Since this determination may have a significant impact on the project design, procedures, and regulatory compliance, the investigator should not hesitate to ask the HSO for guidance. There are serious consequences for not following Indiana University policies and Federal regulations when conducting research.

The first section provides definitions for Research and QI/QA. The second section provides certain characteristics typically associated with Research and QI/QA projects. Once you review the definitions and characteristics, you should be able to determine the appropriate category for your project. If you determine that the project is similar to both definitions, then the project is Research.

Section 1: Definitions

What is research? The Common Rule defines research as “a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge”. [Source: Code of Federal Regulations 45CFR46.102]]

Please be aware the intent to publish is an insufficient criterion for determining whether a project involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results. [Source: OHRP FAQs]

What is Quality Improvement / Quality Assurance (QI/QA)? The human subjects regulations offer no formal definition of Quality Improvement or Quality Assurance. The IU Human Research Protection Program considers QI/QA to involve:

Data collection and analysis for an institution’s own internal operation monitoring and program improvement purposes, that is, only if:
1. the data collection and analysis is limited to the use of data originally collected for any purpose other than the currently proposed activity, or
2. is obtained through oral or written communications with individuals
Implementation of an accepted practice to improve the delivery or quality of care or services (including but not limited to education, training, procedures related to care or services) provided by a specific institution, that is, only if the purposes are limited to:
1. altering the utilization of the accepted practice; and
2. collecting data to evaluate the effects on the utilization of the practice

NOTE: QI/QA activities are not designed to contribute to generalizable knowledge.

VA researchers should refer to additional definitions and guidance in VHA Handbook 1058.05—VHA Operations Activities that may Constitute Research.

Section 2: Distinction between Human Subjects Research and Quality Improvement

Distinctions between assessed elements in Human Subjects Research and QI/QA
Assessed Element	Human Subjects Research	Quality Improvement
Intent	Contribute to generalizable knowledge	Improve a program, practice, process, or service of a specific institution
Design	Develop or contribute to generalizable knowledge; may involve randomization of individuals to different treatment regimens, programs or processes	Not intended to develop or contribute to generalizable knowledge, does not involve randomization of individuals (although random sampling could be part of the design), but may involve comparison of variations in programs
Effect on Program or Practice Evaluated	It is not the specific intent that findings of the activity will directly affect institutional or programmatic practice; however they may influence future policies	Findings of the activity are expected to directly affect institutional practice and may identify corrective action(s) needed
Population	Usually involves a subset of individuals; generally, statistical justification for sample size is used to ensure endpoints are met	Includes all or most receiving a particular treatment, program, or process (although random sampling could be part of the design); exclusion of information from some individuals significantly affects conclusions
Benefits	Participants may or may not benefit directly; benefit, if any, to individuals or practice is incidental or delayed	Participants or practices are expected to benefit directly from the activities, although those benefits may not be immediately realized
Dissemination of Results	The intent to publish or present the findings is generally presumed at the outset; dissemination of information usually occurs in research/scientific publications or other research/scientific forums; results expected to develop or contribute to generalizable knowledge or to advance a scientific body of knowledge	The intent to publish or present is generally NOT presumed at the outset; dissemination of information may occur in quality improvement publications or presentations; when published or presented to a wider audience, the intent is to suggest potentially effective models, strategies, assessment tools or provide benchmarks or base rates rather than to develop or contribute to generalizable knowledge

Section 3: Similarities and Differences between Human Subjects Research and QI/QA

Similarities and differences between Human Subjects Research and QI/QA
Point to Consider	Human Subjects Research	Quality Improvement
Purpose	To test a hypothesis, advance a scientific body of knowledge, OR establish practice standards where none are accepted	To assess or promptly improve a program, or system OR improve performance as judged by accepted/established standards
Starting Point	To answer a question or test a hypothesis	To improve performance
Benefits	Designed to contribute to generalizable knowledge and may or may not benefit subjects	Designed to promptly benefit a process, program, or system and may or may not benefit participants
Risks/Burdens	May place subjects at risk and stated as such	By design, does not increase participant risk more than negligibly, with exception of possible privacy/confidentiality concerns
Data Collection	Systematic data collection	Systematic data collection
End Point	Answer a research question	Promptly improve a program/process/system
Testing/Analysis	Statistically prove or disprove a hypothesis or in the case of qualitative research, establish scientific evidence to support an understanding of reasons, opinions, and motivations which supports the construction of a hypothesis	Compare a program/process/system to an established set of standards
Requirements and Oversight	Research projects must meet IRB requirements for protection of human subjects Researchers conducting research must also meet HIPAA requirements regarding authorization to use or disclose protected health information Researchers conducting research must also meet FERPA requirements regarding access and use of student records	Quality Improvement projects are not covered by IRB requirements. IU physicians are allowed by HIPAA to use protected health information for Quality Improvement projects without patient authorization
Characteristics	One of the main goals of the project is to advance general knowledge in the academic, scientific, or professional community The project will have a specific hypothesis or research question The project involves an organized review of relevant literature The project will be conducted using a research design that will lead to scientifically valid findings. Elements of a research design include control groups, random selection of subjects, statistical tests, sample design, etc. Most of the participants are not expected to derive a personal benefit from the knowledge gained One goal of the project is to generate, evaluate or confirm an explanatory theory or conclusion and invite critical appraisal of that conclusion by peers through presentation and debate in public forums	The project identifies specific services, protocols, practices, or processes or outcomes within a department, program or facility for improvement The project team may review available literature and comparative data, or programs, practices or protocols at other institutions in order to design improvement plan, but may not plan a full scientific literature review The project design uses established quality improvement methods (such as PDSA cycle) aimed at producing change within a program The project design does not include sufficient research design elements to support a scientifically valid finding Most of the participants in the project are expected to benefit from the knowledge gained The project does not impose any risk or burden on the participants The main goal of the project is to improve patient care, a program or service

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes [purposes are limited to (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes] include:

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

Section 4: IRB Oversight

Retroactive approval: The IRB cannot retroactively approve research. If a project commenced without IRB approval and was later determined to constitute research with human subjects, please review the Guidance on Reporting Unanticipated Problems and Noncompliance.

Publication considerations: Some academic journals require documentation of IRB oversight, or in lieu of IRB oversight, a determination that IRB oversight is not required of a project that does not represent human subjects research. In these cases, the HSO recommends investigators complete and submit an Application for Not-Human Subjects Research via KC IRB prior to commencing the project.

Funding considerations: If a project is funded as ‘human subjects research’, please submit the appropriate human subjects research application for IRB review. If a funder requires documentation of IRB oversight or determination that oversight is not required for a project which does not represent human subjects research, please follow the instructions in ‘Publication considerations’ above.

Projects utilizing data collected for a QI/QA project: Some projects propose to utilize data that are already in existence and that were collected as part of a QI/QA endeavor. Depending on the design of the project, this may represent research with human subjects. Please contact the HSO for assistance in making this determination.