By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services
June 12, 2023
Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. In the clinical research community, we’re already familiar with institutional review boards (IRBs) and their review for ethical considerations and participant risks – so what’s the difference between an IBC and an IRB?
How are IBCs Different from IRBs?
While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting research subject’s rights and welfare. IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents.
An IBC may also advise the IRB in assessing potential risks to the study subjects and how best to explain the unique risks of gene therapy and other genetically engineered treatments in the informed consent form (ICF).
What Does an IBC Review?
IBCs help researchers apply the necessary safety measures to ensure gene therapy research is conducted safely and responsibly.
Because of the risks involved, gene therapy research requires additional safety measures to ensure research subjects and study staff, as well as the community and the environment surrounding the research site, are not harmed by the modified genetic material or the infectious agents utilized to deliver them. These safety measures go beyond the human subject protection requirements IRBs enforce and include a required site inspection as part of the approval process.
The IBC’s review is intended to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials. The IBC also reviews to confirm a comprehensive risk mitigation plan is in place prior to starting the research.
How is IBC Membership Composed?
While a single IRB (sIRB) can oversee research protections for a protocol being conducted at multiple sites, the IBC uniquely focuses on biosafety at the site level. This means IBCs are constructed to focus their risk assessment locally at each research site.
IBC membership must include involving two local community members who reside within 50 miles of the research site. This local membership requirement provides the IBC with the local community’s perspective and concerns as they assess the risks of utilizing genetically engineered products in research within a community. The IBC’s membership roster is therefore unique to the individual research location it oversees.
For the sake of efficiency, IBC meetings can be centrally coordinated and synchronized similarly to a sIRB. However, each IBC ultimately is its own entity with a unique roster of members who remain responsible for localized risk review.
It’s possible an IRB’s membership might be similar to an IBC’s; however, the committees are composed to conduct their reviews for different purposes. IBCs include members who possess expertise in genetic engineering, biological safety, infectious diseases, and environmental protection. Each IBC is required to have at least two community members who are unaffiliated with the institution or research site and who represent the interests of the community and the local environment.
What do the Regulations Say about IBC Review?
Food and Drug Administration (FDA)and Office for Human Research Protections (OHRP) regulations require IRB review for research involving human subjects. For IBCs, National Institutes of Health (NIH) Guidelines require IBC review for:
- Any genetic engineering research receiving NIH support
- Research taking place at sites currently receiving NIH support
- Research taking place at sites who have previously received NIH support
Even if no NIH support is involved, NIH Guidelines suggest IBC review is a best practice for genetic engineering research: “[I]ndividuals, 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).
| IRB | IBC |
|---|
| Required when: | Research involves human subjects | Research involves gene therapy or genetic engineering of the treatments (e.g., mRNA) |
| Responsibility (oversight for): | Protecting human subjects participating in research | Protecting human subjects, study personnel, the community and the environment when conducting gene therapy or genetic engineering research |
| Composition: | Minimum five members with varying backgrounds, including:- At least one scientific member
- At least one non-scientific member
- At least one member not affiliated with the institution/IRB
| Minimum five members who collectively have the expertise to assess risks associated with recombinant DNA research, including:- At least two members from local community who are not affiliated with the institution/site
|
| Central vs local: | - Centralized review of multiple sites by a single IRB permitted
- Local review by site-specific IRB
| - IBC must be site-specific with local community members
- Central administration of IBC permitted
|
In a nutshell: IRBs are concerned with risks to human research subjects, and IBCs are concerned with risks to anyone who might come in contact with a study’s genetically modified material.
Note: This article was originally published September 22, 2017, and has been updated to include new and clarifying information.
BiosafetyResearch Compliance
Tagged in: CRO, IBC, institutions, IRB, sites, sponsors
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Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP
Executive Director, Biosafety Services, Advarra
Daniel holds a PhD in Molecular Biology and Immunology, as well as various professional certifications in biological safety, and is a regular speaker at research conferences.
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FAQs
In a nutshell: IRBs are concerned with risks to human research subjects, and IBCs are concerned with risks to anyone who might come in contact with a study's genetically modified material.
What is the difference between the IRB and the IBC? ›
While one IRB can oversee research protections for multiple sites, IBCs are locally based at the research site, include the involvement of community members and can only oversee research at that location.
What should the IBC consider when reviewing proposed research? ›
The committee looks at the ethics and the adherence to policy of the proposed research to determine if the research is allowable under the regulations for research with human embryonic stem cells or tissues.
What is the charge to the IBC which is different from the other local review and approval processes? ›
The IBC's charge is specifically related to overseeing the safe use of biohazardous materials, such as those involving recombinant or synthetic nucleic acid molecules, ensuring both environmental and public safety and compliance with NIH Guidelines, which is distinctive from other review processes that may focus on ...
What is an IBC in Advarra resource library? ›
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.
Which 3 main areas does the IRB verify? ›
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.
What does an IRB do? ›
Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.
What requires IBC review? ›
Institutional Biosafety Committee (IBC) approval is required before conducting research and teaching activities involving rDNA, biohazardous agents, materials, and toxins.
What is the role of the 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 the duties of the IBC? ›
The IBC is responsible for maintaining reviews, minutes, and reports in an orderly and retrievable fashion. The IBC Chair is responsible for ensuring that the IBC members are appropriately trained in research guidelines, regulations, and any mandated safety training.
The Institutional Biosafety Committee (IBC) must review and approve all clinical trial research involving potentially hazardous biological agents before they may be initiated.
What does not require institutional biosafety committee (IBC) approval? ›
Working with human cell lines requires BSL2 authorization (contact EH&S) but does not require IBC approval unless the human cell line is known to contain a pathogen or the cell line will be used in other activities that are covered by the IBC (pathogen work, use with recombinant or synthetic nucleic acids, etc.).
What does IBC stand for? ›
In simple terms, IBC stands for Intermediate Bulk Container. These containers are designed to store and transport bulk materials in intermediate quantities, both liquid and solid.
What is the difference between IRB and IBC? ›
In a nutshell: IRBs are concerned with risks to human research subjects, and IBCs are concerned with risks to anyone who might come in contact with a study's genetically modified material.
What is an IBC document for? ›
A: It is an application form completed by the principal investigator to describe research activities involving recombinant or synthetic nucleic acid molecules (often referred to as recombinant DNA or rDNA) or infectious agents. the Registration for Research with Recombinant or Synthetic Nucleic Acid Molecules.
What areas does the IBC Committee include experts in? ›
The committee is composed of ten to fifteen members with expertise in rDNA and/or biosafety. The committee will be comprised of the following required members: the IBC chair, the biosafety officer, two non-affiliated members, an animal expert, and a plant expert.
What is the difference between ICC and IBC? ›
Overview of the International Building Code
Much of the International Building Code focuses on fire prevention. While the ICC already maintains an International Fire Code, the main difference is that the IBC is specifically centered around fire prevention that pertains to construction and design processes.
What research requires IBC approval? ›
Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations require IRB review for research involving human subjects. For IBCs, National Institutes of Health (NIH) Guidelines require IBC review for: Any genetic engineering research receiving NIH support.
What is the difference between Institutional Review Board and independent ethics committee? ›
An Institutional Review Board (IRB) is a formally designated group assigned to monitor and review any medical research involving human subjects. An Independent Ethics Committee (IEC) is a group of pharmaceutical industry stakeholders (doctors, nurses, social workers, etc.)
