IRB: Ethics & Human Research

Health Care Operations Activities That May Constitute Research: The Department of Veterans Affairs’s Perspective

This article describes a set of procedures that the Veterans Health Administration (VHA) of the U.S. Department of Veterans Affairs established to help investigators, administrators, and institutional review boards at VHA institutions determine whether an operations activity constitutes research. Health care operations activities such as quality assurance and quality improvement differ from research in that health care operations activities are specifically designed to support the operations of a health care institution, while research, as defined by the Common Rule, is specifically designed to contribute to generalizable knowledge. The VHA further defines generalizable knowledge as information that expands the knowledge base of a scientific discipline or other scholarly field of study. Both health care operations activity and research utilize systematic investigation to achieve their objectives. As with research, the results of health care operations activity may be published in scientific journals and ultimately expand scientific knowledge. Thus, neither systematic investigation nor publication effectively distinguishes health care operations activity from research. However, when a health care operations activity goes beyond its purpose of supporting the operations of a health care institution by adding elements specifically designed to expand the knowledge base of a scientific discipline or other scholarly field of study, the activity constitutes research.

Tsan M-F, Puglisi T. Health care operations activities that may constitute research: The Department of Veterans Affairs’s perspective. IRB: Ethics & Human Research 2014;36(1):9-11.

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