By Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, Executive Director, Biosafety Services
November 9, 2021
One of the fastest growing areas in clinical research is clinical trials involving recombinant DNA, or gene therapy research. It’s an exciting space that is full of promise, but because of the risks involved, it’s also a highly regulated space. As many clinical research professionals are new to gene therapy research, confusion is common regarding the regulatory requirements.
When is IBC Oversight Needed?
While clinical research professionals are familiar with the role of the IRB to protect research subjects, most are unfamiliar with the added need for an Institutional Biosafety Committee (IBC) to review the risks associated with engineered genetic material in clinical trials. NIH Guidelines require IBC review for any genetic engineering research, including gene therapy research, that receives NIH funding or takes place at sites receiving NIH funding. This means any funding—even $1 of NIH funds for the site or the study means the study must be reviewed by an IBC.
Studies and sites completely independent of NIH funding may still require IBC review if the R&D that led to the investigational product was funded by the NIH. Even if there are truly zero NIH funds involved, IBC review is a best practice: NIH Guidelines state that “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).
The rationale behind IBC review is to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials and a comprehensive risk mitigation plan is in place prior to conducting the research. Gene therapy research requires safety measures to ensure that research participants 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 that may be utilized to deliver them. An IBC can help researchers utilize the appropriate safety measures to ensure research is conducted safely and responsibly.
Key Words for Determining Whether IBC Review is Needed
Certain key words can aid in determining if IBC review is likely required. The following is a list of common terms found in research protocols requiring IBC review:
| Likely Needs IBC Review |
|---|
Viral vector / Virus based gene delivery vector
Common viruses include:
• Adenovirus (Ad)
• Adeno-Associated Virus (AAV)
• Retrovirus
• Lentivirus (e.g. HIV based vector)
• Herpes virus (HSV)
• Pox virus (e.g. vaccinia, canary pox or fowl pox) |
| Genetically modified or reprogrammed immune cells/white blood cells (e.g. CAR T cells) |
| DNA vaccines |
| Plasmid |
| Genetically modified |
| Recombinant DNA (rDNA) |
| Messenger RNA (mRNA) |
| Synthetic Nucleic Acids |
| Gene editing: CRISPR-Cas9, TALEN, Zinc Finger Nuclease (ZFN) |
Gene silencing:
Micro RNA (miRNA), RNA interference (RNAi), short hairpin RNA (shRNA), silencing RNA (siRNA) |
| Institutional biosafety committee (IBC) |
The following list includes terms associated with types of clinical trials that increasingly utilize genetically modified materials and, in such cases, may require IBC review. The latter list includes terms that generally do not point to requiring IBC review.
| Maybe Needs IBC Review (need more info about the design of the investigational product) |
|---|
| Vaccines, especially for cancer and infectious agents (e.g., Ebola, SARS, MERS, Zika, etc.) |
| Immunotherapy |
| Cellular therapy |
| Regenerative therapy |
| Not Likely to Need IBC Review |
|---|
Genetic screening or testing
(e.g., 23 and me) |
| Gene/genome sequencing |
Monoclonal antibody based therapy
(Anything with a name ending in “Mab”) |
| Tests that do not involve extraction and manipulation of genetic material (e.g., routine blood or urine tests) |
Additional Help in Determining Whether IBC Review is Necessary
If you’re still unsure about whether your study requires IBC review, contact your IBC office for assistance. A quick call or email can likely resolve the question. If your site or institution lacks an IBC, or your IBC lacks the expertise to review a particular study, feel free to contact Advarra’s commercial IBC service. Our panel of experts is comfortable with the diverse challenges associated with genetic engineering research regardless of whether it is clinical, pre-clinical, non-clinical.
IBC review shouldn’t be an obstacle to conducting innovative research. Rather, consider the IBC your guide to understanding proper safety measures with gene therapy research. Gene therapy is inherently risky, and IBC review helps make sure those risks are minimized and properly managed.
BiosafetyResearch Compliance
Tagged in: CRO, IBC, institutions, 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
Institutional Biosafety Committee (IBC) approval is required before conducting research and teaching activities involving rDNA, biohazardous agents, materials, and toxins.
What should the IBC consider when reviewing proposed research? ›
The Institutional Biosafety Committee (IBC) will confirm during its review that the proposed risk group(s) is appropriate for the proposed protocol. The risk assessment is to be evaluated based on requirements for using recombinant DNA, as well as biological agents and toxins, particularly select agents.
What is the IBC study review? ›
The Institutional Biosafety Committee (IBC) reviews any proposed research involving the use of biological items like recombinant DNA, select agents, bloodborne pathogens, or other areas, depending on your institution.
What is IBC review? ›
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 IBC mean? ›
Intermediate bulk containers, otherwise known as IBCs, are industrial-strength containers used to store or transport a variety of liquids and solids.
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.
How often does the IBC review registrations? ›
At the end of three years, a new registration must be submitted for approval. Registrations must be updated whenever there are changes. The registration updates are done by completing an amendment.
What are the responsibilities 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.
What is IBC risk assessment? ›
• Risk Assessment & Biosafety Containment Levels
The main goal of the IBC process is to collectively perform a risk assessment of the work proposed and determine the appropriate mitigation measures and Biosafety Containment Levels for the safety of staff, students, and the environment.
What does IBC mean in education? ›
An Industry-Based Certification is an independent third party credential that is industry-accepted and results from a process whereby an individual's knowledge and/or skill in a particular area is verified against a set of pre-determined standards.
Institutional Biosafety Committee Member Training provides training for members of the organization's IBC, with a focus in general biosafety and the requirements of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. View Series Page for FAQs.
What is IBC in pharma? ›
An Intermediate Bulk Container (IBC) is defined as a container used for transport and storage of fluids and bulk materials.
What is an IBC submission? ›
An organization requesting institutional biosafety committee (IBC) review of a new study protocol and site credentials must meet submission requirements. Note: These requirements are for human gene therapy research. Advarra's IBC also reviews non-clinical studies involving genetically engineered plants or animals.
What is IBC compliance? ›
The International Building Code (IBC) is a comprehensive set of regulations addressing both the structural design and the installation requirements for building systems – including HVAC and Industrial Refrigeration equipment.
How long is the fixed approval period for IBC approval? ›
What is the approval period for IBC protocols? Most IBC protocols are approved for up to three years. All protocols require a yearly continuing review.
What does the IBC at UTSA review studies using? ›
The UTSA Institutional Biosafety Committee is a registered committee with the National Institutes of Health. This Committee reviews research protocols that involve potentially biohazardous materials and agents, recombinant and synthetic nucleic acids and the use of tissue isolated from vertebrates.
What are the following prerequisites for IBC protocol approval? ›
All personnel, including the PI, must complete biosafety training and lab safety/ chemical hygiene plan training prior to approval. Additional trainings are are dependent on project type. The PI is responsible for providing the necessary training to their personnel prior to their commencing the experiments in the lab.
What types of incidents must be reported to the NIH OSP? ›
The NIH Guidelines require that any significant problems, violations, or any significant research-related accidents and illnesses” be reported to OSP within 30 days.
What types of biological materials need to be registered and approved by the IBC? ›
What Needs IBC Approval?
- Recombinant/synthetic nucleic acid molecules, as covered by the NIH Guidelines.
- Infectious agents (viruses, bacteria, fungi, parasites, prions, etc.) ...
- Human materials (including all fluids, tissues, excretions, secretions, or cell lines), as covered by the Cal/OSHA Bloodborne Pathogens Standard.
