This question frequently arises with respect to nonroutine medical procedures, and may arise with respect to public-health surveillance, as were mentioned earlier, but it also arises with respect to many secondary analyses of data.
What, for example, is the status of studies performed by, or for, private-sector managed- care organizations on data they collect in providing care? As care-providers and as businesses, they review the ways their patient-members utilize services, the effectiveness of screening and diagnostic tests, the patterns of clinical practices, use of pharmaceutical and surgical and other resources, outcomes, costs incurred and cost-effectiveness achieved, the "market" need and demand for aspects of health care, and so on. For such analyses they use both their own and others' data. The formality of the studies ranges from casual internal scanning to scholarly analysis.
"Research" is defined by the Federal Common Rule this way (§_.102(d)):
"Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
The Belmont Report, from which the above statement was adapted, expressed it more the way scientists would:113
The term "research" designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).
While some investigations within, say, managed-care organizations are of such scientific quality as to be generalizable (perhaps, publishable in peer-reviewed journals), many are not. Moreover, even if of quality to be generalizable, the findings may possibly be held internally for business advantage and not made generally available; they could, however, be thought of as being generalizable to the patient-member population.
An activity deemed to be "research on human subjects" may, depending on the context, fall under the Federal laws discussed, and require supervision by an IRB and the like. Private- sector organizations should work their way carefully through the issues of consent and data- subject protection, including the coverage of secondary studies that might formally be considered research.
(113) As cited in endnote (18), at (§ A).