The Advantages of Outsourcing IRB and IBC Reviews to One Partner

Gene therapy studies are a relatively recent addition to the world of clinical research. As a result, the unique requirements for these trials are new to many of the sponsors and researchers undertaking the studies. One of these unique requirements is the institutional biosafety committee (IBC) review.

IBCs in clinical research focus on reviewing safety aspects of research involving engineered genetic material. They are responsible for assessing the risks associated with genetic modifications and experimental procedures, as well as occupational and environmental safety. While institutional review boards (IRBs) focus on protecting the rights and welfare of human beings participating in clinical research, IBCs, on the other hand, are tasked with protecting study personnel, the community, and the environment from exposure to engineered genetic material and other biohazards. An IBC may also advise the IRB in assessing potential risks to the study subjects.

IBC requirements can be challenging for sponsors in that many people have not had much, if any, experience with such committees. Another potential issue is IBCs at academic institutions often focus primarily on preclinical and non-clinical work; they may have less experience or expertise with clinical trials.

Gene therapy study sponsors are best served when their IBC and IRB reviews are aligned. There may be some overlap in the two committees’ responsibilities, and at some institutions, they may share the same personnel. However, a second review entity adds events and complexity to study startup timelines, potentially delaying the start of a clinical trial.

Fortunately, sponsors have the opportunity to streamline IRB and IBC reviews by coordinating the activities of these two committees via a vendor that offers both resources in-house.

Two Committees, One Vendor

Making use of dedicated, highly experienced review resources like those offered by an expert vendor can facilitate more streamlined processes, providing the opportunity for faster trial startup. Leveraging such resources to coordinate the activities of two separate review committees is an especially smart move for efficiency. Consider:

• Relying on individual and locally administered IBCs and IRBs involves different submission deadlines, meeting schedules, policies, and procedures, increasing the likelihood of review outcome variability
  • On the other hand, working with a centralized expert allows for optimal coordination
• A dedicated vendor offers the benefits of a dedicated team
  • Whereas the local committee staff members typically wear multiple hats and may be under-resourced
• With coordinated IRB and IBC reviews, a single vendor can eliminate the duplicative reviews characteristic of unaffiliated IRBs and IBCs
• With the key stakeholders on the same team and part of the same organization, aligned decision making is far more likely across the two committees

Together, IBC and IRB services offered by a single vendor are typically designed and built from the ground up to work well together. You can reasonably expect to work with a single point of contact for both committees, enjoy the benefits of state-of-the-art technology to help streamline submissions, and allow up-to-the-minute review of process status. And you will undoubtedly find fewer hurdles standing between you and your study’s startup goals.

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