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:

  1. 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
  2. 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 ElementHuman Subjects ResearchQuality Improvement
IntentContribute to generalizable knowledgeImprove a program, practice, process, or service of a specific institution
DesignDevelop or contribute to generalizable knowledge; may involve randomization of individuals to different treatment regimens, programs or processesNot 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 EvaluatedIt is not the specific intent that findings of the activity will directly affect institutional or programmatic practice; however they may influence future policiesFindings of the activity are expected to directly affect institutional practice and may identify corrective action(s) needed
PopulationUsually involves a subset of individuals; generally, statistical justification for sample size is used to ensure endpoints are metIncludes 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
BenefitsParticipants may or may not benefit directly; benefit, if any, to individuals or practice is incidental or delayedParticipants or practices are expected to benefit directly from the activities, although those benefits may not be immediately realized
Dissemination of ResultsThe 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 knowledgeThe 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 ConsiderHuman Subjects ResearchQuality 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.