Application To The Institutional Review Board For The Protection Of Human Subjects Page 2
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8Submission of a proposal to the institutional review board for the protection of
human subjects requires that the PI sign this page which includes the following
definition of “misconduct” and implies that the PI understands the definitions and
will conduct this research in such a manner that acts of misconduct will not be
committed.
DEFINITION OF MISCONDUCT
“Misconduct” shall be considered to include the following:
1.
fabrication, falsification, plagiarism of language or concepts, deception
or other practices that seriously deviate from those that are commonly
accepted within a research community for proposing, conducting or
reporting research;
2.
material failure to comply with Federal requirements for protection of
researchers, human subjects or the public;
3.
failure to meet other material legal requirements governing research;
4.
failure to comply with established standards regarding author names
on publications; or
5.
failure to disclose any conflicts of interest or potential conflicts of
interest between the PI (and his/her co-investigators, if any) and the
involved funding source or drug or device provider.
The IRB reviews all research involving human subjects, regardless of funding
source, to ascertain that the rights & welfare of subjects are being protected.
The University’s Assurance with the Department of Health and Human Services
applies to all research involving human subjects, whether funded or not. The
Assurance specifically states that involvement of human subjects in research will
not be permitted until the protocol and informed consent procedures have been
approved by the IRB. In addition, the IRB is responsible for assuring that
recruitment advertising is not misleading or coercive to the research subject. All
projects using human subjects are to be reviewed no less than annually.
Anyone who conducts and/or supervises studies or experiments involving human
subjects without such approval may be personally responsible for legal or other
liabilities that my consequently arise. In addition, the researcher may be subject
to disciplinary action by the University. Failure to comply with IRB guidelines or
procedures for an approved research protocol or consent form will be cause for
immediate suspension and withdrawal of approval.
Signature of Principal Investigator
Date
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