nancing, and outcomes of health care services to increase knowledge and understanding of the structure, processes, and effects of health services for individuals and populations” (IOM, 1995). HSR includes studies of the effectiveness of health care interventions in real-world settings, as contrasted with studies of the efficacy1 of interventions (e.g., new drugs) under controlled settings such as a clinical trial.

As an applied field of study, HSR is closely related to nonresearch investigations that are directed toward assessing and improving the quality of operations in healthcare organizations. Indeed, HSR and health care operations form two ends of a continuous spectrum. Some HSR projects are clear examples of research; applying scientific methods to test hypotheses and produce new, genera-

BOX 1 Who Is the Intended Audience of this Report?

This report is for all types of professionals and organizations that use or disclose data on health services. Although the Department of Health and Human Services is highlighted, the report should apply as well to other federal departments and agencies that are involved in human subjects research.

For organizations that have institutional review boards (IRBs) and whose research is subject to federal regulation:

  • The practices and recommendations highlight some practices already in place in some IRBs and suggest additional support for IRB activities.

For organizations that use or disclose data but do not have an IRB or whose work is not subject to federal regulation:

  • The practices and recommendations emphasize that the protection of human subjects from risks, including nonphysical risks from use of data, are of concern to anyone who uses or discloses data.

Although not all organizations have IRBs, all human subjects should be treated with the same high standards. The committee urges organizations that do not have IRBs to adopt practices of reviewing proposed investigations to assure that data confidentiality will be maintained. The committee likewise urges organizations that have, as well as those that do not have, IRBs to adopt system-wide confidentiality procedures and policies to protect nonresearch and research data.


The term “efficacy” refers to how reliably an intervention brings about a given result under ideal, controlled conditions. The term “effectiveness” refers to how an intervention performs in the complex and variable context of real-world use and practice.

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