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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