HRPP Manual Section 12-1

Quality Assurance, Quality Improvement, or Program Evaluation

The federal regulations for the protection of human research subjects define “research” as a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 45 CFR 46.102(d).

Quality assurance (QA), quality improvement (QI), and program evaluation (PE) are activities that may collect data about living individuals to measure the effectiveness of a practice, program or service or to identify ways to improve them. If these activities are not designed to develop or contribute to generalizable knowledge they do not fit the definition of research in 45 CFR 46, and they do not need IRB approval. This is true even when the findings may contribute to generalizable knowledge “after the fact”, if the activity was not designed to be generalizable.

Public health surveillance is defined as ongoing systematic activities, including collection, analysis, and interpretation of health-related data essential to planning, implementing and evaluating public health practice.The majority of public health practices (e.g., public health surveillance, implementation and evaluation of disease prevention and control projects) are based on scientific evidence, data collection and analytic methods similar to those used in research. They are not, however, designed to contribute to generalizable knowledge. Their primary purpose is to protect the health of the population through such activities as disease surveillance, prevention, or control. For those public health surveillance activities that do not meet the federal definition of “research,” Institutional Review Board review is not required.

When a planned activity meets the definition of “research” involving “human subjects,” the activity must be reviewed and approved by the Institutional Review Board (IRB) prior to initiation of the activity. See Human Research Protection Program Manual 4-3 “Determination of Human Subject Research” for definitions and requirements.

This document has been developed to provide guidance on the difference between research activities and QI, QA, and PE activities. To determine whether QA, QI, or PE activity must have IRB approval, consider if the activity is designed to develop or contribute to generalizable knowledge.  The following list differentiates between research related activities, QI, QA, and PE. If the activity does not constitute research, the activities do not require IRB review and approval. Investigators should seek IRB guidance if they have any questions or if they are unsure as to whether or not the activities constitute research.

	Research	QI / QA/PE
Purpose	Develop or contribute to generalizable knowledge (e.g., testing hypotheses)	Improve a program or service or ensure it conforms with expected norms. These activities focus on a specific institution, activity or program rather than being designed to apply to populations beyond that which is studied.
Design	Develop or contribute to generalizable knowledge	Activities are designed to measure if/how the activity is working and perhaps, as a result, identify ways to improve it.
Mandate	Activities not mandated by institution or program	Activity mandated by institution or department/clinic or program as part of its operations
Findings	Findings are not expected to directly affect institutional or programmatic practice	Findings are expected to directly affect institutional practice conduct of the program and may identify improvements and/or needed corrective actions
Population	Usually involves a subset of individuals; generally, statistical justification for sample size is used to ensure endpoints are met	May include a broad population or  all or a sample of participants within or affected by receiving a particular treatment or undergoing a particular practice or process
Benefits	Subjects may or may not directly benefit	Participants may benefit directly from activities; If there are no benefits the evaluation concentrates on program improvements or whether the program should continue and/or provides benefits to future clients.
Dissemination	Dissemination of information usually occurs in research/scientific publications; results expected to develop or contribute to generalizable knowledge by filling a gap in scientific knowledge, developing hypotheses or supporting, refining or refuting results from other research studies	Publication in peer-reviewed literature as original research is not an expectation. Dissemination of information does not necessarily occur beyond the institution evaluated; dissemination of information may occur in quality improvement publications; 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

This guidance document supersedes those previously drafted.

Version Date: 12-10-2015

Related HRPP Manual Sections

• 4-3, Determination of Human Subject Research