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primary mission of the IRB is to assure that, in research
involving human subjects, the rights and welfare of
the subjects are adequately protected. To achieve this
mission, the IRB will assist the investigators in designing
their research projects in a manner to minimize potential
harm to human subjects, review all planned research
involving human subjects prior to initiation of the
research, approve research that meets established criteria
for protection of human subjects, and monitor approved
research to ascertain that human subjects are indeed
protected.
In addition, the IRB exists to inform and assist Northwestern
Health Sciences University and its researchers on ethical
and procedural issues related to use of human subjects
in research, to facilitate compliance with federal regulations,
and to ensure continued support from federal agencies,
private foundations, industry, and the University itself
for research involving human subjects.
The IRB is authorized and organized to review any and
all types of research in which human subjects are involved,
including projects that are not subject to federal oversight.
The IRB employs a review process that conforms to the
Federal Policy for Protection of Human Subjects and
the Federal-Wide Assurance enacted between the Northwestern
Health Sciences University and the National Institutes
of Health Office for Protection from Research Risks.
The review process will be the same for all research
involving human subjects supported or otherwise subject
to regulation by any federal department or agency, sponsored
by any other extramural entity, or initiated and funded
within the University. The authority conveyed to the
IRB includes decisions to approve, disapprove, require
modifications, monitor, suspend, and terminate research
projects involving human subjects. Under no circumstance
may a decision of the IRB to disapprove a project be
reversed by another agency of Northwestern Health Sciences
University. The IRB does not evaluate the scientific
merit of the research; yet, the scientific merit is
a factor in weighing the risks against benefits of the
research.
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