Institutional Biosafety Committee (IBC) Services

BRANY IBC Process and Timelines

Step 1: BRANY Establishes IBC and Registers Committee with NIH

  • IBC Authorization Agreement (authorizes BRANY IBC Services to administer IBC on organization’s behalf)
  • BRANY Prepares IBC Roster & Membership Materials
    • Site identifies a Biosafety Liaison or Biosafety Officer (BSO) (click here for guidelines)
    • Identification of non-affiliated members (2 local members) via BRANY’s network or with site assistance.

Step 2 (concurrent with Step 1): Site IBC Application Submission

  • Site IBC application (click here for IBC Forms and Guidance)
  • Sponsor-provided materials for Study
    • If initial study site:
      • Sponsor provides materials specified in Appendix M of NIH Guidelines
      • IBC determines if RAC review required
        • If NO RAC REVIEW REQUIRED, proceed to IBC Meeting (Step 3)
        • If RAC REVIEW REQUIRED, submit to NIH and proceed to Step 3 after NIH/RAC review response received
    • If not initial study site:
      • Sponsor provides RAC review determination, or
      • If no RAC review, Sponsor provides copy of NIH documentation indicating that the initial protocol registration process is complete (from 1st site)

Step 3 (after Step 2): IBC Meeting – Review Site IBC Application

  • Review of site qualifications and preparedness, biological & physical containment requirements
  • Confirmation of facility and personnel ability to comply with containment requirements
  • IBC approval

3-4 Week Timeline from Submission to Approval, provided:

  • Information required to complete Step 1 is received in advance, and
  • No RAC review is required*, and
  • Receipt of complete submission (IBC Application & materials from Sponsor), and
  • Responses to IBC inquiries are prompt.

*NIH RAC currently meets quarterly (click here for future RAC meeting dates)