1. (1) Allegations of research misconduct by researchers shall be reported to the DHHS IRB chair or the DHHS Deputy Director. Upon receipt of research misconduct the DHHS IRB chair may initiate an investigation which includes:

   1. (a) Request a report of related adverse events.
   2. (b) Request an audit of the research by the Department of Health and Human Services Office of Internal Audit.
   3. (c) Review research records.
   4. (d) Suspend or terminate DHHS IRB approval during investigation in accordance with 45 CFR 46.113.
   5. (e) Review findings with DHHS IRB board at which time approval may be revoked.
   6. (f) Report research misconduct to the U.S. Department of Health and Human Services, Office of Human Research Protections.
   7. (g) Set up more frequent ongoing reviews.

   8. (h) Require changes to the protocol.

      1. (i) Suspend research until changes have been made, approved, or determination that research is following approved proposals.
2. (2) Research misconduct by the department's providers is also subject to Section R495-876, Provider Code of Conduct.

KEY: Institutional Review Board, research

Date of Last Change: December 5, 2023

Notice of Continuation: May 28, 2025

Authorizing, and Implemented or Interpreted Law: 26B-1-202