2. What
Research Must Be Reviewed?
All research at the University that involves humans (or records gathered
on humans) requires IRB review. This is true regardless of its funding
source or area of research.
Research that requires IRB review includes
any research on humans that:
-
is conducted by University faculty, staff, or students;
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involves University students, staff, or faculty as participants;
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is performed on the premises of the University;
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is performed with, or involves the use of, facilities or equipment belonging
to the University;
-
satisfies a requirement imposed by the University for the award of a degree
or for the completion of a course of study; or
-
is certified by a dean or department head to satisfy an obligation of a
faculty/staff appointment at the University, including clinical or adjunct
appointments.
In addition, the following circumstances will
require IRB review:
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Research requiring "continuing review"
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Affiliated faculty/staff research
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Research conducted at another institution by DePaul affiliated persons
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Research in foreign countries conducted by DePaul affiliated persons
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Research conducted in courses (courses in research methods and class assignments
involving research with human participants require IRB approval)
-
Faculty-supervised student research (Faculty must take an active role in
ensuring that research projects are conducted in accordance with the IRB's
requirements)
-
Research at a pilot or feasibility stage (pilot and feasibility studies,
even those with only one human participant, require the same review as
full-scale research projects. Applications to the IRB for pilot studies
should be identified as such, and participants must be told during the
consent process that the study is a pilot)
-
Research involving secondary use of data (projects that use data on humans
gathered in earlier projects and in which individual identifiers are present
require IRB review. However, data gathered by someone who has legitimate
access to the records and who gives the investigator only data that does
not permit identification of the participants may qualify for exemption.)
-
Research using "waste" and "extra" material (i.e., human tissue or fluids)
"Waste" material is material that is collected originally for clinical
or diagnostic purposes but is no longer needed. "Extra" material is material
that is collected above and beyond what is needed for a clinical or diagnostic
procedure but for investigational purposes.
-
Research projects in which the researcher is a consultant under contract
with the University (IRB review is not required if the researcher has a
strict consulting relationship in which:
a. the researcher is hired
on his or her own time,
b. the researcher holds
no rights in the work, and
c. neither the researcher
nor the University retains any data.
-
Some oral history activities constitute human subject research. Many oral
history projects are exempt either because subjects are not identifiable
or the content could not reasonable place subjects at risk. Many other
oral history projects are appropriate for expedited review. The Oral History
Association has rather extensive guidelines, which may be found at: http://www.dickinson.edu/organizations/oha/EvaluationGuidelines.html