Utah Admin. Code R495-820-11 - Research Misconduct
(1) Allegations of
research misconduct by researchers shall be reported to the DHS IRB chair or
the DHS Deputy Director. Upon receipt of research misconduct the DHS IRB chair
may initiate an investigation which includes:
(a) Request a report of related adverse
events.
(b) Request an audit of the
research by the Department of Human Services Bureau of Internal Review and
Audit.
(c) Review research
records.
(d) Suspend or terminate
DHS IRB approval during investigation in accordance with
45 CFR
46.113.
(e) Review findings with DHS IRB board at
which time approval may be revoked.
(f) Report research misconduct to the U.S.
Department of Health and Human Services, Office of Human Research
Protections.
(g) Set up more
frequent ongoing reviews.
(h)
Require changes to the protocol.
(i)
Suspend research until changes have been made, approved, or determination that
research is following approved proposals.
(2) Research misconduct by the Department's
providers is also subject to Rule R495-876, Provider Code of Conduct.
Notes
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