WCG IBC Services has reviewed more human gene transfer clinical protocols than any other organization. We provide the experience, personalized service, and streamlined process you need for safe and compliant oversight of gene transfer research.

By coordinating the IRB and Institutional Biosafety Committee (IBC) review of gene transfer studies, we are able to eliminate the duplicative reviews characteristic of unaffiliated IRBs and IBCs, ensuring an efficient and thorough turnaround for each review.

Our experts have extensive experience in all aspects of site startup 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 IBC Services 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?

About IBC Review

Human gene transfer (HGT) is a growing, promising area of medical research studying drug products that incorporate engineered or artificial DNA or RNA.

HGT research subject to the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines) must be approved by an NIH-registered Institutional Biosafety Committee. IBCs ensure that research with potentially biohazardous agents is conducted according to the NIH Guidelines and current best biosafety practices.

The requirement for IBC review is separate from—and in addition to—the requirement for IRB review.

IBC Services 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 startup 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

IBC Services for Research Institutions

Our IBC network includes more than 400 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 their 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

By coordinating the IRB and IBC review of gene transfer studies, we are able to ensure that regulatory requirements across all facets of review are satisfied thoroughly and consistently.

Gene Therapy Advisory Board

The WCG Gene Therapy Advisory Board is made up of thought leaders in gene transfer research who provide WCG and our clients with guidance and strategic counsel on the changing landscape of research in gene therapy.

Arnold J. Levine, PhD

Institute for Advanced Study, School of Natural Sciences

Mark Bagarazzi, MD

Chief Medical Officer, Neuvogen

Carl June, MD

Director of Translational Research, Penn Medicine

Tony Reid

Tony Reid, MD, PHD

Professor, Department of Medicine, University of California San Diego Health Sciences

Hans-Peter Kiem, MD, DR MED

Former Chair, Recombinant DNA Advisory Committee (RAC); Head of Heme Malignancy Program, University of Washington/Fred Hutchinson Cancer Research Center