Chapter 63

WCG IBC Services

Human gene transfer (HGT) is a growing, promising area of medical research studying drug products that incorporate engineered or artificial DNA or RNA. Clinical trials involving HGT products must meet the specific oversight requirements found in the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines).

Before clinical research subject to the NIH Guidelines can begin, it must be approved by an NIH-registered Institutional Biosafety Committee (IBC). IBCs ensure that research with potentially biohazardous agents is conducted according to the NIH Guidelines and current best biosafety practices.

Why Choose WCG for IBC Review?

WCG IBC Services provides the experience, personalized service, and streamlined process you need for efficient, safe, and compliant oversight of gene transfer research. With a dedicated WCG IRB team partnering on your review and remote IBC meetings scheduled on demand, we’re committed to providing an efficient and thorough turnaround for each review.

Our experts have extensive experience in all aspects of site start-up for human gene transfer research and are ready to answer your questions, including:

  • Is my research subject to the NIH Guidelines?
  • How can I prepare for a multicenter trial involving human gene transfer research?
  • Which sites are best prepared to start enrolling subjects as soon as possible?
  • How does WCG IRB register an IBC on behalf of a new site?
  • What are the requirements for IBC approval?
  • What are best practices for transportation, storage, administration, and disposal of genetically modified products?
  • What are the timelines associated with IBC review for different types of studies?
  • How does WCG IBC Services work in tandem with IRB review, site selection, contracting, and billing?

For Clinical Trial Sponsors and CROs

Most drug products that incorporate engineered DNA or RNA qualify as human gene transfer products. Our experts can help you determine whether your clinical trial requires IBC review and review prospective site lists to advise on the best start-up approach for each site requiring IBC review. 

We recommend that sponsors and CROs contact WCG IBC Services during the project planning phase to discuss: 

  • Timelines and enrollment dates
  • Applicability of NIH Guidelines and IBC review requirements
  • Document preparation (protocol, investigators’ brochure, pharmacy manual) for IBC review
  • Qualification of prospective site list (identification of sites that are in-network or that require registration)
  • Distribution of study documentation to sites

For Research Institutions

Our IBC network includes nearly 450 active sites, ranging from small clinics to community hospitals and major academic medical centers. Our review teams work closely with clinical coordinators and investigators at each site to learn about your needs and concerns and advise on best practices for safety and compliance.

For each new study at your site, we provide a customized biosafety standard operating procedure (SOP) and walk you through the steps required to get to IBC approval. IBC operations are transparent and interactive and allow sites to fully understand and direct compliance activities related to gene transfer research. 

Coordinating IRB and IBC Reviews

Clients that utilize both WCG IRB and WCG IBC Services reap greater synergies as smoother communications between our IRB and IBC teams accelerate both review processes.

In March 2016, WCG announced the creation of the WCG Gene Therapy Advisory Board. Through the Board, our clients have access to the best and most current thinking in this new and emerging field. Go to the IBC administration and review page on the WCG website for more information.