combined with research. When they are, they should undergo the same ethical and policy assessment as other research projects.
The Belmont Report relies primarily on the different goals of research and practice to distinguish the two activities. Medical and behavioral clinicians gather information or perform interventions to advance the interests of individual patients or clients. Researchers, on the other hand, collect data and perform interventions “to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:3). Like the Belmont Report, the Common Rule’s definition of research looks primarily to the intended aim of the activity. According to the Common Rule, “[r]esearch means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge” (U.S. Department of Health and Human Services, 1991:28,013).
The National Bioethics Advisory Commission (NBAC) recently called attention to flaws in the Common Rule definition. The NBAC observed that the definition omits the additional important point that research is done primarily to benefit society, while practice activities primarily aim to benefit patients, clients, or specific populations. In this respect, the NBAC noted, the Common Rule definition fails to recognize the possible conflict of interest that “always exists between investigators’ desires to pursue knowledge and their obligation to protect the rights and welfare of research participants” (2001:35). Moreover, the NBAC noted that the Common Rule definition provides little assistance to those seeking to distinguish research from activities such as public health and quality improvement projects.
As a result of these regulatory shortcomings, it can be difficult to determine when various data-gathering activities should be considered research. Three authors addressing this problem suggested that as a general rule, “[r]esearch projects are done to change the way the [health or social services] community thinks about a specific issue,” while “[n]onresearch investigations are done to give a specific group the information they need to make a specific decision” (Amdur et al., 2000).
Consistent with this approach, the Centers for Disease Control and Prevention Guidelines for Defining Public Health Research and Public Health Non-Research (1999) provide as follows:
The major difference between research and nonresearch lies in the primary intent of the activity. The primary intent of research is to generate or contribute to generalizable knowledge. The primary intent of nonresearch in public health is to prevent or control disease or injury and improve health, or to improve a public health program or service. Knowledge may be gained in any public health endeavor designed to prevent disease or