IBC | Institutional Biosafety Corporation | Resources
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Resources

FREQUENTLY ASKED QUESTIONS

Do I need Institutional Biosafety Committee (IBC) oversight?

Federal regulations require institutions to have IBC oversight if they are (1) conducting research involving recombinant and/or synthetic nucleic acid molecules (r/sNA) and (2) at least one such study is in-part NIH-funded.

 

Even if only one research project involving r/sNA molecules benefits from NIH support, all such projects conducted at that institution must comply with the NIH Guidelines.

 

Many privately-sponsored studies voluntarily implement our IBC services due to their interest in seeking NIH funding, other third-party regulatory requirements, and/or simply for first-class research safety oversight.

What is an IBC?

Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules.

What are my responsibilities with regard to IBC compliance?

Each institution conducting or sponsoring research involving recombinant or synthetic nucleic acid molecules that is covered by the NIH Guidelines is responsible for full compliance with the NIH Guidelines, which can be accessed here.

 

These responsibilities can broadly be broken down into the following categories:

 

  • IBC registration and establishment
  • Implementation of compliant biosafety Standard Operation Procedures (SOPs)
  • Initial protocol compliance review
  • On-going research compliance review
  • Annual regulatory reporting

 

Learn more about how we can manage all of these responsibilities for you, here!

How do I get started with Biosafety Corp?

For Sites: First select a point person to contact us. We can establish and register your local IBC even before study specifics have been finalized! This allows you to hit the ground running once all of the research details have been finalized.

 

For Sponsors: We encourage you to contact us early to discuss your anticipated requirements and timeline goals. We can be helpful in developing SOPs for safe handling of your research products, drafting compliant consent forms, and identifying sites that with proven experience in r/sNA trials.

Approval Timeline

IBCTimeline

RESEARCHER RESOURCES

IBC Investigator’s Handbook

NIH Guidelines