Utah Admin. Code R495-820-13 - Oversight
(1) Researchers must report Serious Adverse
Events immediately to the DHS IRB. The DHS IRB will review and may impose
additional conditions for continued approval of the research.
(2) Adverse events must be reported during
ongoing review.
(3) In accordance
with
45
CFR 46.103(4), the DHS IRB
is responsible to ensure research is being conducted as written in the proposal
and that material changes have not occurred since previous DHS IRB review. To
do this the DHS IRB may:
(a) Conduct an audit
of the research with the assistance of the Department of Human Services Bureau
of Internal Review and Audit.
(b)
Inspect research records.
(c) Visit
research site.
(d) Observe consent
process or research.
(e) If any of
the above activities indicate research has deviated from the approved proposal
the DHS IRB may suspend or terminate DHS IRB approval. Researchers would be
required to submit an updated proposal and received final approval of the
updated proposal before continuing their
research.
Notes
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