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.