Some of the most cutting-edge clinical studies are those that employ recombinant DNA (rDNA) therapies and utilize biotechnology and bioengineering methods. Because such studies often require Institutional Biosafety Committee (IBC)—in addition to Institutional Review Board (IRB)—approval, they necessitate increased coordination. Yet mastery of dual IRB and IBC review has proven elusive, whether this review is administered at the research site or outsourced to another company. Researchers, funders, and administrators must absorb the additional work and expense, and they are left wanting a new paradigm.
Quorum Review IRB delivers coordinated IRB and IBC review.
We recently launched a line of IBC services that integrates human subject protection and biosafety review. With the goal of minimizing the burden and cost for clients, we researched and implemented processes that heighten coordination and maximize efficiency. Needless to say, we are eager to share the results.
The Need for an IBC
An IBC is a committee of specialists and laypersons charged with reviewing research that involves recombinant or synthetic DNA molecules as well as certain other molecules, such as bloodborne pathogens, toxins, and infectious agents. In the broadest terms, IBCs evaluate the risk posed by accidental or unintended spread of these molecules from the experimental setting into organisms, other vectors, and/or the environment. IBCs are particularly concerned with the research practices, the research facilities, and the standard operating procedures that describe the handling, containment, inactivation, and disposal of rDNA molecules.
In its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the National Institutes of Health (NIH) requires IBC review for research that uses recombinant or synthetic nucleic acids under two broad categories:
- the research is sponsored by or conducted at an institution that receives support from the NIH for any nucleic acid research; and
- any experiment involving the deliberate transfer of recombinant or synthetic nucleic acid molecules (or DNA or RNA derived from these molecules) into one or more human research participants.
Industry-sponsored studies often require biosafety review for clinical trials that employ recombinant DNA therapies and employ biotechnology or bioengineering methods. Sponsors and institutions understand that voluntary compliance with the NIH Guidelines promotes the safe and responsible practice of research, and gives the public confidence that facilities remain vigilant in important safety matters.
To state the obvious, IBCs are not IRBs, which work to ensure that clinical research studies have appropriate risk/benefit ratios and participants receive adequate information about what will occur if they choose to take part in those studies. Their differences notwithstanding, IBCs and IRBs often review the same studies. Because that research cannot begin without the two bodies’ distinct approvals, a strong need for an expeditious and coordinated set of reviews exists.
Opportunities for Improvement
Typically, institutions establish and maintain their own IBCs. However, as independent committees, IBCs rarely coordinate their reviews with those of the IRB (even though the two bodies often review the very same documents). Inconsistency in both timing and outcome can, and frequently does, occur. Moreover, the latter can exacerbate the former; when an IBC requires modifications and the IRB does not, a study must be resubmitted to the IRB for approval. The cycle creates an unnecessary and expensive delay in the study start-up.
As scientific and medical research studies employing rDNA therapies and other biotechnology and bioengineering methods yield increasingly promising results, locally operated IBCs have become busier, and the issue of inconsistency has intensified. Institutions looking to break this cycle (or avoid it altogether) have begun to outsource their IBC review and administration. So far, contracted companies have struggled to deliver well-coordinated and consistent results.
The Quorum Difference: One-Touch Collaboration
Quorum’s approach to providing IBC services is unique. We leverage our One-Touch Collaboration service philosophy, and promise clients that when they submit their studies for both IRB and IBC review they will gain a far more streamlined experience than what’s available from any other company.
As a third-party administrator, Quorum will establish and maintain clients’ IBCs and coordinate their biosafety reviews with those of the IRB. While much of this will occur behind the scenes, clients will notice the difference, from study beginning to study end. To start, Quorum will provide one dedicated IBC contact who will work with clients to efficiently establish their committee, and who will communicate with them about their IBC review. Clients will also benefit from a flexible and integrated submission process. Quorum will identify when documents should receive dual IBC and IRB review—with minimal effort needed from the client. The coordination even extends to the release of approval documentation. Clients will receive their IBC approval the same day they receive their IRB approval. This coordination and consistency will ultimately remove the administrative burden and ensure an efficient study start-up. The result: comprehensive services and a superior client experience.
Beginning your collaboration with Quorum is easy. You can request IBC services with your initial study submission, or you can contact our IBC coordination team. Either way, our knowledgeable and detail-oriented staff will tailor our processes to ensure we meet your administration and review needs.