IX. IBC Annual Review / Annual Reporting of Approved Protocols

  1. Approved DNARDs will be reviewed annually for two years and expire three years after initial approval.
  • Eleven months after initial approval, and again one year and 11 months hence, a notification will be sent to the PI by the Biosafety Office with a request that he/she review the previously-approved project.
  • The PI must reply by return email, marking one of the following responses:
    • the project is inactive;
    • the project no longer involves rsNAM;
    • the project is active, no changes; or
    • the project is active and changes are anticipated, e.g., changes in title, funding source, personnel involved in the research, inserts, hosts, vectors or animals used (the changes must be specified)
  • When a PI indicates that changes as listed above are planned, the changes may be approved administratively (title, funding, or staff changes), approved by the IBC Chair (host/vector/insert changes that do not change the BSL/ABSL of the protocol) or approved following full committee review (significant changes to the scope and/or BSL/ABSL of the protocol).
  • Two years and 11 months after initial approval, a notification will be sent to the PI stating that the project was approved three years ago and can only be renewed by submitting a newly-completed rDNARD. The PI must reply and indicate that the project is not active or, if the research is to continue, a new rDNARD will be submitted.
  • When submission of a new rDNARD is not required, the date of the PI’s review and changes indicated by him/her will be entered into the electronic rDNA database. If the project is inactive, the related information in the database will be archived, thereby precluding additional reminder cycles.
  1. Investigators who have protocols involving human subjects must comply with annual data reporting requirements. Annual data report forms will be forwarded by NIH OBA to investigators. Information submitted in these annual reports will be evaluated by NIH OBA and the RAC, and possibly considered at a future RAC meeting. Send a copy of the annual data report form to Haley Sinn, Biological Safety, Environmental Health & Safety (100 EHS).