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.