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The definition of research with human subjects is provided in the federal
regulations. Application of the definition is not always a straightforward
task because it includes both very specific constructs, e.g. research
development, and rather vague ones, e.g. reasonableness. However, it is
the tool we must use when determining whether or not a study is research
with human subjects.
Research means "a systematic investigation, including research development,
testing, and evaluation, designed to develop or contribute to generalizable
knowledge."
This definition includes pilot studies, feasibility studies and other
preliminary research.
Human subject means "a living individual about whom an investigator
(whether professional or student) conducting research obtains
- data through intervention or interaction with the individual, or
- identifiable private information."
Interventions include physical procedures through which data are gathered.
This is not common in social and behavioral sciences, but does occur. For
example, multiple resonance imaging might be used in a study of language
acquisition. Interventions also include manipulation of the subject or the
subject’s environment.
Interactions include communication or interpersonal contact between the
subject and the investigator. Communication does not have to be face to
face and may even be entirely virtual.
An important criterion for this type of research is that the investigator
must either know the subjects’ identities or be able to readily
determine their identities.
There are two kinds of private information included in the federal definition.
- information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place,
and
- information that has been provided for specific purposes by an individual
and which the individual can reasonably expect will not be made public,
such as a medical or school record.
Please check with the IRB staff
if you have a question about whether or not your study constitutes research
with human subject.
If a Duke researcher plans to conduct research at another site, the protocol
may be subject to review by both institutions' IRBs. The basis for determining
if review is needed at both sites is a concept called "engagement
in research."
If the other site is not engaged in the research, Duke review may be
sufficient. If both Duke and a collaborating site are engaged in the research,
the institutions need to either:
- Review the research separately, or
- Designate one of the institutions' IRBs to review the research.
If the other institution does not have an IRB or comparable committee,
Duke's IRB will need documentation that the institution’s policies
for protecting human subjects are at least equivalent to Duke’s.
When planning research with human subjects at or with another institution,
please contact the IRB staff so they can initiate the process of approving
the collaboration.
Research by Duke investigators conducted abroad is subject to review by
the Duke IRB, taking into account the norms of the culture in which it
will take place. If foreign institutions will be responsible for the conduct
of any components of the research, their policies for the protection of
human subjects must be reviewed by the IRB, or if the project is federally
funded, by the sponsor.
The IRB has developed a policy
that distinguishes between pedagogy and research and identifies which
categories of student research need to be reviewed.
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