1. (1) Researchers must report Serious Adverse Events immediately to the DHHS IRB. The DHHS IRB will review and may impose additional conditions for continued approval of the research.
2. (2) Adverse events must be reported during ongoing review.

3. (3) In accordance with 45 CFR 46.103 (4), the DHHS IRB is responsible to ensure research is being conducted as written in the proposal and that material changes have not occurred since previous DHHS IRB review. To do this the DHHS IRB may:

   1. (a) Conduct an audit of the research with the assistance of the Department of Health and Human Services Office of Internal Audit.
   2. (b) Inspect research records.
   3. (c) Visit research site.
   4. (d) Observe consent process or research.
   5. (e) If any of the above activities indicate research has deviated from the approved proposal the DHHS IRB may suspend or terminate DHHS IRB approval. Researchers would be required to submit an updated proposal and received final approval of the updated proposal before continuing their research.

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