Sabai IBC Services

The Sabai Institutional Biosafety Committee (IBC) team leads the way with the most certified biosafety professionals within an organization.

IBC Review

Sabai IBC Services can provide a centralized IBC solution ~ or work with an Institution to create an additional HGT-specific IBC for their facilities.

  • Flexible and comprehensive support for IBC setup, NIH registration and administration
  • Personalized education on IBCs and NIH requirements for new sites
  • Resources and support for an existing IBC through staffing, a second HGT-specific IBC, or other institution specific needs
  • Coordination of concurrent reviews to deliver efficient, time-saving IBC and Institutional Review Board (IRB) reviews for all participating research sites throughout our services
  • Global support for IBC services as research with the NIH Guidelines goes beyond US borders

Why Do I Need An IBC?

Review of a clinical trial by an Institutional Biosafety Committee is required by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules when:

  • 1. The investigational product contains recombinant or synthetic nucleic acids that meet certain criteria under Section III-C of the NIH Guidelines, AND
  • 2. This research is conducted at an institution that receives support for recombinant/synthetic nucleic acid research from NIH, or
  • 3. This research is sponsored by an institution that receives support for recombinant/synthetic nucleic acid research from NIH, or
  • 4. The investigational product was developed with NIH funds if the Institution that developed the IP sponsors or participates in the trial.

5. Still unsure? No problem, contact us today to speak with an expert.

Sabai IBC Services has developed several frequently requested guidance documents to assist our clinicians and researchers. The following items are available for download below.

FAQ

IBC Initial Study Cycle

DOWNLOAD

Required Documents for IBC Review

DOWNLOAD

Accelerated Services Program

DOWNLOAD

Pre-Meeting Site Verifications

DOWNLOAD

Eyewash FAQ

DOWNLOAD

Guidance

Incident Reporting Guidelines

DOWNLOAD

Disinfectant Info for Sites

DOWNLOAD

Biosafety Levels (BSL) Guide

DOWNLOAD

Biosafety Cabinets (BSC) vs. Clean Benches

DOWNLOAD

Lab Hoods and Cabinets

DOWNLOAD

NIH Guidance – BSC Placement Requirements

DOWNLOAD

NIH Guidance – BSC Placement Requirements: Dos and Don’ts

DOWNLOAD

External Resources

CDC, OSHA, EPA and NIH Resources

VIEW RESOURCES

Healthcare Supplies and Equipment Resources

VIEW RESOURCES

WHAT SETS US APART

What Our Clients Say

"Christine was very patient with our questions and did a great job explaining and helping the site learn—[made] the process incredibly seamless and we look forward to our next project together."

Dakota Gaines CenExel

"Many thanks for your excellent service. [You’ve] been the easiest and most collaborative and communicative IRB to work with. Hoping to cross paths again!"

Gina Gorgone Simone Sr. Project Leader, Emmes

"The best vendor I have ever worked with."

Associate Director of Clinical Operations Merck

"We love you guys."

Research Safety Associate Director over Biosafety University of California-San Diego

"Accelerated our timelines and beat our projections for our sponsor, with the added complexity of IBC on top of IRB regulatory."

Study Start-Up Director MedPace CRO

"Every time I interact with your team I walk away with a smile. For Shield, Heidi has been my lifesaver: pragmatic, understanding, and action-oriented. I have come to her feeling overwhelmed and unsure of how to tackle complex issues, and within the span of a single call she develops a plan and I am able to walk away with 1000 pounds lifted off my shoulder."

BSO Pharmaceutical Company