Utah Administrative Code
Topic - Human Services
Title R495 - Administration (Human Services)
Rule R495-820 - Institutional Review Board
Section R495-820-13 - Oversight
Universal Citation: UT Admin Code R 495-820-13
Current through Bulletin 2024-06, March 15, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Utah may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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