Communications of the ACM

researchers’ due diligence in identifying and ameliorating potential physiological, psychological, and informational harms to human subjects. The Common Rule grew out of a regulatory process initiated by the 1974 National Research Act, a response to public scandals in medical and psychological research, including the Nuremberg Doctors Trial, the Tuskegee syphilis study, and Milgram experiment on obedience to authority figures. The Act led to a commission on human-subjects research ethics that produced the Belmont Report (1979). The Belmont authors insisted that certain core philosophical principles must guide research involving human subjects: respect for persons, beneficence, and justice. The HHS developed the specific regulations in the Common Rule as an instantiation of those principles. 12

Importantly, the Belmont authors understood that not all activities that produce knowledge or intervene in human lives are “research,” and not all research about humans is sensitive or personal enough to be about “human subjects.” To delimit “human-subjects research” within biomedicine, the Belmont commission considered “the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine.” 12 This boundary reflects the ethical difficulties posed by unique social roles of physician-researchers who are responsible for both patient health and societal well-being fostered by research knowledge. This unique role creates ethical dilemmas that are often not reflected in other disciplines. Research defined by the Belmont Report is, “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.” Practice is, “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.” 12

Not surprisingly, the first draft of the
Common Rule came under attack from
social scientists for lumping together
all forms of human-subjects research
under a single set of regulations that
reflect the peculiarities of biomedical
research. 2 Not all research has the same
risks and norms as biomedicine. A
single set of rules might snuff out legiti-
mate lines of inquiry, even those dedi-
cated to social justice ends. The HHS
responded by creating an “Exempt”
category that allowed human-subjects
research with minimal risk to receive
expedited ethics review. Nevertheless,
there has remained a low-simmering
conflict between social scientists and
IRBs. This sets the stage for debates
over regulating research involving big
data. For example, in her analysis of the
Facebook emotional contagion con-
troversy, Michelle Meyer argues that
big data research, especially algorith-
mic A/B testing without clear tempo-
ral boundaries or hypotheses, clouds
the distinction between practice and
research. 8, 11 Jacob Metcalf and Kate
Crawford agree this mismatch exists,
but argue that core norms of human-
subjects research regulations can still
be applied to big data research. 10

Big Data and
the Common Rule Revisions

The Common Rule has typically not been applied to the core disciplines of big data (computing, mathematics, and statistics) because these disciplines are assumed to be conducting research on systems, not people. Yet big data has brought these disciplines into much closer intellectual and economic contact with sensitive human data, opening discussion about how the Common Rule applies. The assumptions behind NPRM leaving big data science out of its purview are empirically suspect.

Excluded—A New Category

Complaints about inconsistent application of the exempt category have prompted HHS to propose a new category of excluded that would automatically receive no ethical review due to inherently “low risk” to human subjects (§___. 101(b)( 2)). Of particular interest is exclusion of:

˲ research involving the collection or study of information that has been or will be acquired solely for non-research activities, or

˲ was acquired for research studies other than the proposed research study when the sources are publicly available, or

˲ the information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to

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