21
Jul2017

By Karen M. Dobos, PhD, and Christine M. Johnson, MS, RBP

It can be frustrating for researchers to hear that they need to obtain approval from the institutional biosafety committee (IBC), IACUC, or IRB before starting their work, but hearing that they need approval from all three committees can be downright terrifying. Each of these bioethics committees has a different purview, is governed by a different set of regulations, and each often has its own different set of procedures for obtaining approval. It’s no wonder investigators often view these compliance committees as obstacles to rather than partners in their research.

More often than not, it is the compliance coordinator who is on the receiving end of this frustration. Compliance coordinators provide an important service to the investigator by bridging the gap between the investigators and the regulators in order to help facilitate research (because, let’s face it, without the research we wouldn’t have a job). In light of the ever-changing regulatory environment, it is more important than ever for the compliance coordinator to work collaboratively with  investigators, as well as with the other compliance committees.

IBCs are uniquely positioned among these committees, with much of the research they review overlapping with the work of at least one other compliance committee. But because the regulations governing IBCs do not carry the same weight as those governing their sister committees, IBC staff  feel less validated—like the IBC is a younger sibling sitting at the kids’ table at Christmas dinner. All committees face challenges, but IBCs are faced with issues the other committees may not  see.

IBCs were originally established by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules for the purpose of reviewing research involving recombinant DNA (rDNA), however over the past 40 years many IBCs have expanded their purview to also review research involving other types of biohazards, such as infectious agents, human samples, biological toxins, and nanoparticles, to name a few. This expansion makes a lot of sense because the IBC members assembled to review the potential hazards of rDNA are generally equally qualified to review the additional biohazards. But unfortunately, since the NIH Guidelines do not address these other biohazards, this added purview lacks regulatory backing, putting IBCs in a tricky situation.  

In addition to the challenges faced above, IBCs have less control over procurement of biohazardous materials. For example, you could not order, or even house, animals without IACUC approval, but you could easily obtain an infectious agent from a colleague and store it your freezer or grow it in your incubator without anyone knowing. Likewise, you would never ask to borrow a few human subjects from the professor down the hall, but you might not think twice about asking to borrow some plasmids. Because these agents are so easy to obtain, researchers often don't realize that they need approval to work with them. Appropriate outreach and communication in these instances, not only for compliance but also to engage in a conversation aimed at education, improvement in data quality, research integrity, and safety are key to building an appropriate culture of biohazardous materials research within the institution.

As described and reiterated above, many of the IBC processes and procedures are not spelled out in the NIH Guidelines, and unlike the networks built for IACUC/IRB members and professionals there are very few forums in which an IBC compliance coordinators can communicate and collaborate with other IBC coordinators and share best practices. Because of this, IBCs often adapt their processes and procedures from other compliance committees within their institution, which may or may not be appropriate.

Despite these challenges, IBCs can be successful with proper support, and that support can come in many different forms. As with any compliance program, support from the upper administration is crucial for IBCs. Leadership and management personnel at an institution have the ability to set the tone or culture of an institution. Meanwhile, as compliance coordinators, we must help them see the value and understand the consequences of compliance in order for them to send the appropriate message to researchers.

Support from and collaboration with the other compliance committees, such as IACUC and IRB, is also a necessity. Since many of these compliance areas overlap, these committees are often dealing with the same investigators. Not only does it help to know there is someone else out there who shares your compliance pain, but when these committees work together, it can help to reduce redundancies, making it easier for the researchers to stay in compliance. Also, with just a little bit of cross-training, these other committees can help identify and communicate compliance gaps.

Last, but certainly not least, cooperation with the Biosafety Officer (BSO) is essential for IBC success. The IBC and BSO have similar but different goals and must work together as partners to avoid undermining each other’s efforts.

Strategies on how to effectively communicate and collaborate among compliance committees, as well as how to leverage these support mechanisms will be discussed at PRIM&R's IBC Boot Camp, which takes place September 18-19 in Denver, CO. This 1.5-day workshop will provide information, tools, and guidance for IBC, IRB, and IACUC professionals to help them keep compliance intersections from turning into compliance roadblocks. Attendees will learn strategies for improving integration and communication among regulatory groups and investigators to best support research that is ethical, collaborative, and interdisciplinary. IBC personnel will have opportunities for benchmarking, sharing resources such as SOPs, and networking with colleagues in the field.  

We hope to see you in Denver this fall!

Karen M. Dobos, PhD, is the Director of the Research Integrity and Compliance Review Office at Colorado State University. Christine M. Johnson, MS, RBP, is the IBC Coordinator in the Research Integrity & Compliance Review Office at Colorado State University. Both will present at PRIM&R's IBC Boot Camp.

Leave a Reply

Your email address will not be published. Required fields are marked *