24
Apr2018

At the recent PRIM&R IACUC Conference (IACUC18), I was excited to see that there was a preconference program dedicated to improving communication and reducing burden between the IACUC and Institutional Biosafety Committee (IBC). Like many of you, I wear multiple hats, and I serve as both the IACUC and IBC Administrator. I am always looking for ways to streamline processes and reduce burden while improving communication across compliance groups. Even if you only oversee the IACUC, animal research is beginning, more and more frequently, to involve biological agents that will require IBC review and oversight. Having a solid understanding of the IBC regulations and practices can help reduce burden on investigators and improve communication between compliance committees.

The intermediate- to advanced-level program I attended was aimed at providing tools and best practices to improve communication between IACUCs and IBCs, as well as opportunities for benchmarking and sharing best practices. A level of background knowledge regarding IBCs and IBC regulations was assumed, however resources are readily available for IACUC administrators to gain knowledge for themselves. Most IBCs cover both recombinant and synthetic DNA as well as biological agents such as viruses, toxins, bacteria, and human/animal cell lines. The NIH Guideline for Recombinant and Synthetic Nucleic Acids as well as Biosafety in Microbiological and Biomedical Laboratories (5th Edition) are both used as references. One way that IACUC administrators and compliance associates can assist the IBC is to look for biological agents and recombinant DNA within the IACUC protocol. If these items are seen, the investigator can be notified that an IBC is required. This improves communication between the IACUC and the IBC.

Opportunities to reduce administrative and investigator burden were also identified during the session. Most IACUCs withhold approval of an animal protocol until a related IBC protocol has been approved. However, this is only regulatorily required for IBC protocols involving recombinant or synthetic DNA and select agents and toxins. IBC protocols involving other biological agents, such as viruses, bacteria, fungi, or human/animal cell lines and tissues fall outside the NIH Guidelines and would not necessarily require IBC approval occur prior to the animal protocol approval. An IACUC could vote to only withhold approval until a related IBC protocol that involves work that falls under the NIH Guidelines is approved. If the related IBC protocol does not involve work that falls under the NIH Guidelines, the protocol is approved as any regular animal protocol. This change could improve turnaround times for investigators.

This is only one example of reducing burden by carefully examining the regulations and ensuring that you, as an administrator or a committee, are not overreaching. Many other examples surely exist with programs and opportunities to streamline processes, reduce burden, and improve communication between the IACUC and IBC. I will be carefully examining my processes against the regulations over the next several months with this in mind. I hope I have inspired you just a little bit and maybe you will too!

Elaine Joseph, PhD, is a Compliance Analyst at the University of Toledo. She currently manages the IACUC and IBC for the University of Toledo, as well as performing grant reviews. She has been in regulatory compliance for over 14 years. Prior to working in regulatory compliance, Dr. Joseph received her doctorate in Zoology from Miami University of Ohio.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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