1 – Application Process
- Sponsor submits a general study application
- Site Completes site-specific application
2 – Site identifies a Biologic Safety Officer (BSO) – see guidelines for BSO qualifications and functions
3 – BRANY prepares the IBC registration package to be provided to the site for submission to the NIH.
This will include
- The IBC roster.
- IBC member biosketches/CV
- Signature authorization letter acknowledging the IBC’s authority for oversight of the study (must be on site letterhead and signed by the signature authority at the site)
4 – IBC Meeting
- BSO will be available to answer questions
- Two members will be local to the site but not affiliated with the site. BRANY has a wide network of potential members. Site may also provide assistance in identifying appropriate individuals.
- The IBC will review the application and all pertinent study documents
Note: The IBC application process may start prior to IRB approval, but the IRB approved consent form must be provided to the IBC for review before the study may begin.
5 – Meeting Follow Up
- Following the meeting, the BSO will provide additional documents as required by the IBC. These documents may include facility “checklist” (see guidelines for BSO functions), training records, vaccination records, procedures, further staff qualification information if not clear on the CVs, etc.
- Upon completion of the review, the IBC will send a letter to the Principal Investigator documenting the IBC decision.