 |
Pursuant to federal law and University policy, all
research involving human subjects, conducted by IUSB
investigators, must be reviewed and approved by the IUSB
Institutional Review Board for the Protection of Human
Subjects (IRB). These policies and procedures are
designed to provide an efficient avenue for the
processing of applications. The smooth flow of
applications is the only way to ensure that each
research protocol is provided the level of review it
deserves. Cooperation by faculty, students and staff
with the IRB is essential if we are to comply with
federal and University regulations. The IRB recognizes
that the federal regulations and our interpretations of
the regulations can be daunting to an investigator on
first encounter. The IRB will provide whatever
assistance it can to investigators or departments to
explain our procedures and to secure compliance with a
minimum of delay or disruption of research.
The legal basis for review and approval of Human Subjects
research is detailed in Title 45 Code of Federal Regulations Part 46
(45
CFR 46) and succeeding regulations. While these regulations
apply specifically to research funded by federal agencies (i.e., NIH,
NSF, DOD, DOE, FDA, Veterans Administration), Indiana University has
determined that ALL research
involving human subjects, regardless of funding source (i.e.,
federal, departmental, or University funding, or no funding at all),
must conform to the same standards. This requirement is codified in
the University's approved Federal-wide Assurance, on file with the
federal Office for Human Research Protections. The ethical basis for
the regulations come from the
Belmont Report.
We welcome suggestions for improvement of the
information that is provided here on the WWW. Feel free
to send an e-mail
message.
The IRB office is located within the IUSB Office of
Research, A247, South Bend, IN 46634, 574-520-4181,
sbirb@iusb.edu.
IUSB POLICIES
IUSB FORMS
**
|
