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The Common Rule contains exemptions for some research involving human
beings. For security research the relevant exemptions are:
-1ex
- Research to be conducted on educational practices or
with educational tests(§46.101(b)(1&2)).
- Research involving
``existing data, documents, [and] records...'' provided that the data set is either ``publicly
available'' or that the subjects ``cannot be identified, directly or
through identifiers linked to the subjects''(§46.101(b)(4)).
- Research involving ``survey procedures, interview procedures or
observation of public behavior,'' unless information is obtained
that could identify the human subjects, and ``any disclosure of the
response outside the research could place the subjects at risk of
criminal or civil liability or be damaging to the subjects'
financial standing, employability, or reputation''(§46.101(b)(2)(i&ii)).
Few Organizations allow investigators to decide if their own research is exempt under the
guidelines--that would create a conflict-of-interest. For example, Harvard requires that ``all
research using human subjects'' to be ``reviewed or designed as exempt
from review by a Harvard Institutional Review Board''[#!harvard-irb-2!#]. In practice,
all requests at Harvard to involve human subjects in research goes to a
staff member at one of the Harvard IRBs; the staff then decides if the research
is actually exempt or in need of review.
Next: IRB Myths and Facts
Up: Legal Framework
Previous: IRB Coverage
Simson L. Garfinkel
2008-03-21