Neiman is justifiably frustrated. This is an instance where someone in the IACUC office needs a deep understanding of, and experience with, the regulations to guide the institution with regard to federal requirements involving research animals. This is also an opportunity for Great Eastern University to look at their policies and procedures pertaining to the use of research animals to decrease self-imposed regulatory burden. Hopefully, this can result in increased PI satisfaction and compliance.

In its June 8, 2017 report “Reducing Regulatory and Institutional Burden Associated with Animal Research,” the Council on Governmental Relations questioned the increasing incidents of self-imposed regulatory burden and challenged institutions to decrease what is perceived to be significant roadblocks to research that do not improve laboratory animal welfare. This is an important activity for all institutions, including Great Eastern University, to do.

Great Eastern University may have legitimate reasons to have the Department of Occupational Health and Safety (OHS) involved with controlled substance use in laboratory animals; however, it is unclear how and why this would entangle IACUC approval. The OHS approval only concerned information on drug safety, security, record keeping, and disposal of the controlled substances—nothing that had to do with the actual use in research animals; this information is in the IACUC protocol.

Let's assume that Great Eastern University's management team had performed a risk assessment for this process and felt that, in order to mitigate risks, the IACUC had to have oversight of the OHS approval. The process could have been simplified by having the required IACUC re-approval be administrative; the IACUC office could have confirmed that there was OHS approval and then given the final approval of the protocol. This action conforms to OLAW FAQ D.4 (https://grants.nih.gov/grants/olaw/faqs.htm).

In this case, the re-review requirements of the Great Eastern University IACUC also requires refinements. If, for some mysterious reason, it was necessary to have the IACUC re-approve the protocol, it could have been performed by the Designated Member Review system (DMR). The IACUC should tailor the time it takes for DMR reviews with what is being reviewed. A simple review to verify OHS approval should not take two weeks to perform; this is unnecessarily delaying research. The IACUC should develop guidelines for timeframes when using the DMR review process.

Given all the regulatory and financial burdens faced by PIs today, it is imperative that the IACUC do what it can to facilitate research. The IACUC should always be looking to streamline its review processes and this can involve critical self-examination. We propose that self-imposed regulatory burden is driven by the institution's need for the lowest possible risk when working with research animals. Institutions need to balance this need with the need for PIs to perform their animal work without undue hindrance. It is a difficult challenge for all of us working with research animals, but one that must be met.

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