Institutional Biosafety Committee (IBC) Services
Leverage the world’s largest integrated IRB and IBC service, combined with the most comprehensive Gene Therapy Ready site network, to advance your research safer, smarter, faster. Advarra provides comprehensive review and oversight of clinical trials involving investigational products containing engineered genetic material.
Trusted By Clinical Research Leaders
Why Advarra IBC?
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Accelerate study startup
Minimize delays with rapid review using our network of Gene Therapy Ready sites.
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Rely on optimized collaboration
Save time and resources with truly integrated IRB and IBC reviews for all participating sites.
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Mitigate risk
Get expert biosafety consultation and support for highly specialized and highly complex clinical trials.
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Reinforce safety oversight worldwide
Leverage Advarra’s global reach to ensure compliant research across sites and around the world.
When Is IBC Review Required?
IBC review and oversight are essential for mitigating risks to study participants and researchers conducting clinical trials involving genetically engineered treatments and vaccines. Sites are required by NIH Guidelines to have IBC oversight if the following apply:
- The research involves the use of recombinant DNA (rDNA), including messenger RNA (mRNA), synthetic nucleic acid (sNA) molecules, or other genetically engineered treatments AND
- Either the site or the sponsor has received NIH support for rDNA or sNA research in the past; or is currently conducting NIH-supported studies involving rDNA or sNA
This includes sites and sponsors outside of the United States.
Even if there is no NIH support involved, IBC review is a best practice. Privately sponsored studies routinely employ Advarra biosafety services to enable them to qualify for NIH support, to support third-party regulatory requirements, or for enhanced research safety oversight.
NIH Guidelines state “individuals, corporations, and institutions not otherwise covered by the NIH Guidelines are encouraged to adhere to the standards and procedures set forth” in the Guidelines (Section IV-D-1).
Learn about the submission process and requirements on our materials required for submission page.
Want to Learn More About IBCs?
Developed and Led by Key Experts in Biosafety and Institutional Research
Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP
Executive Director, Biosafety Services
Daniel Eisenman is Executive Director of Biosafety Services at Advarra. Eisenman heads Advarra’s commercial IBC service, which represents hundreds of clinical and basic science research sites across North America. Prior to joining Advarra, Eisenman was the Biosafety Officer at the Medical University of South Carolina and UNC Chapel Hill. Eisenman holds a PhD in molecular biology and immunology, as well as various biosafety certifications (RBP, SM(NRCM), CBSP). He has taught microbiology and infectious diseases at the undergraduate and graduate level and frequently speaks at conferences on matters pertaining to genetic engineering, gene therapy, biosafety, and microbiology.
Biosafety Solutions to Make Your Research Safer, Smarter, Faster™
Expertise
Biosafety Expertise for Every Program
Our IBC professionals have expertise in all prevalent types of genetic engineering and gene transfer technology employed in research on rare diseases, infectious diseases, and oncology (e.g., CAR T, cancer vaccines, oncolytics, etc.).
This includes nearly a roster of 20+ scientific subject matter experts with experience working in various settings, including:
- NCI designated cancer centers
- High containment infectious disease laboratories
- Biomedical laboratories
- Diagnostic microbiology laboratories
- GMP manufacturing facilities
- Research animal facilities
- Plant research facilities
We have a national network of community members representing 500+ sites across North America.
Study Types
Support for Research and Clinical Trials Involving:
- Recombinant DNA
- Synthetic nucleic acid molecules
- mRNA engineered vaccines
- Genetic engineering/gene therapy
- Infectious microorganisms
- Hazardous biological materials
- Non-clinical plant and animal research
IBC-Ready™
Local IBC Submission Support With IBC-Ready™
Reduce confusion and administrative burden when Advarra coordinates with the sponsor, site personnel, and local IBC(s). Advarra’s experts can help complete local IBC forms accurately and efficiently, regardless of the IBC of record.
- Decrease timelines for local IBC submission and review
- Eliminate confusion for investigators and study coordinators unfamiliar with IBC questions
- Coordinate submissions for all local IBCs through a single entity
Service provided by biosafety professionals experienced in local IBC requirements and processes.
Services
Biosafety Services Include:
IBC setup and registration support
- Establishment of local biosafety committee administered by Advarra
- Recruitment and staffing of qualified personnel
- Implementation of industry-leading laboratory safety procedures
- Management of regulatory registration
Protocol review and approval
- Review of research protocols
- Issuance of regulatory approvals
- Ongoing monitoring and support solutions
- IBC compliance and management
- Year-round compliance management
- On-demand review services
- Site audit capabilities
- Compliance reporting to NIH
Education, training, and operations consulting
- Research staff training
- Laboratory safety
- Biohazard education
- Protocol, SOPs, and ICF consulting
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IQVIA and Advarra partnered to advance Operation Warp Speed COVID-19 vaccine trials and deliver exemplary service to sponsors and clinical research sites.
Get Your Site Gene Therapy Ready
Is your site prepared to conduct gene therapy and mRNA engineered vaccine research?
Turnaround Time
Turnaround can depend on a site’s experience with and preparation for IBC review. Sites part of Advarra’s Gene Therapy Ready network have an existing IBC and prior experience with human gene transfer studies. These sites can often be reviewed and approved for a new study in a few days.
For sites that don’t have a registered IBC and may be new to gene therapy research, it usually takes 5-7 weeks from submitting a registration request to the NIH to IBC review and site inspection.
days or less
from complete submission to IBC review
IBC FAQ
What is an institutional biosafety committee (IBC)?
An institutional biosafety committee performs a biosafety risk assessment of research involving engineered genetic material, such as recombinant DNA or synthetic nucleic acid molecules (r/sNA). The committee’s review includes an evaluation of:
- Risks associated with genetic modifications and experimental procedures
- Occupational and environmental safety
The committee must be comprised of at least 5 members who collectively have the expertise to assess risks associated with the proposed recombinant DNA research. At least 2 members must be local community members not affiliated with the institution/site.
Each IBC is registered with the NIH Office of Science Policy. IBC registrations are updated annually. For more information, read our IBC 101 handout.
What does the IBC do?
NIH Guidelines require IBC review when:
- The investigational product involves introducing includes rDNA, sDNA, or mRNA into a living being (e.g. genetically engineered material such as messenger RNA vaccines); AND
- The research and development of the gene therapy compound was/is supported by NIH; or
- The sponsor has accepted NIH support for gene therapy research; or,
- The research takes place at a site that has previously accepted any NIH support.
For clinical trials, IBC review takes place in addition to IRB review. Both committees focus on risk, but their purposes and mandates differ. While the IRB focuses on protecting the rights and welfare of human research participants, the IBC focuses on risks posed by recombinant DNA (genetically modified material) to study personnel, the community, and the environment.
Who serves on an IBC?
An IBC is comprised of:
- A minimum of five members who collectively have the expertise to assess the risks associated with the proposed recombinant DNA research.
- At least two members who must be local community members who are not affiliated with the institution/site. The community members represent the interests of the community in regard to public health and protection of the environment.
The IBC must be able to provide documentation to the NIH Office of Science Policy that:
- The IBC has knowledge of local institutional characteristics — such as investigator training, laboratory conditions, and operating procedures; and
- An individual at the registering institution has the authority and responsibility to implement the IBC’s directives
This is accomplished through the IBC setup and registration process. Each IBC is registered with NIH, including member CVs. Registration is updated annually.
Why does the IBC prefer researchers use biosafety cabinets (BSCs) rather than clean benches or laminar flow hoods?
While both pieces of equipment are hoods with directional airflow, they function differently and are intended for different purposes. BSCs protect the investigational product as well as the user and the environment. They operate under negative air pressure (i.e., suck inward), protecting the user from exposure to aerosolized infectious agents. The air sucked into the hood is sterilized by HEPA filtration before being exhausted out, thereby protecting the environment.
Clean benches or laminar flow hoods work under positive air pressure (i.e., blow outward) and are only intended for work with non-hazardous materials. Use of hazardous materials in a clean bench can increase the risk of occupational exposure and contamination of the room in which the work is being done.
Read our Related Resources
Daniel Eisenman, Paul Gulig, and Adam Soloff Explore The Exponential Rise of Gene Therapy and Unlocking Its Potential Promise
In this podcast, Daniel Eisenmann talks with Adam Soloff and Paul Gulig for a discussion on the growth and the promise of gene therapy.
Does Warp Speed Vaccine Development and Testing Compromise Safety?
Fiction often shows warp speed travels not going as planned, but what does warp speed mean for vaccine development in clinical research?
Institutional Biosafety Committee Reviews 101
What is an IBC? How long does an IBC review take? Read our IBC 101 handout to get answers to some of your most frequently asked questions.
