The researcher had previously justified the need to use only female rabbits in the study. It is absolutely reasonable for the IACUC reviewer to request full committee review (FCR) since the modification to the protocol contradicts the original request by the IACUC reviewer for the PI to consider both sexes. Physiologic variation due to sex is a known influence in many types of experiments. Recent NIH guidance regarding “Consideration of Sex as a Biological Variable in NIH-funded Research” requests that scientists evaluate the potential role of gender as a variable in studies which use vertebrate animals1. Although this guidance was set to be effective for NIH applications starting in late January 2016, Great Eastern University does not indicate if Rothman's work was funded after the guidance date, nor, in fact, if it was NIH funded. Prior to initial approval by the IACUC, Rothman was asked by the IACUC reviewer to provide justification for the use of female rabbits only. According to the IACUC, Rothman provided sufficient evidence supporting the concerns that the results were independent of the influence of the sex of the animal.
The IACUC chair cited federal regulations preventing an expedited processing of the protocol, however, the IACUC chair did have the ability to call for an off-cycle full committee meeting to discuss the modification request. As per the “Guide for the Care and Use of Laboratory Animals” (The Guide), the committee “must meet as often as necessary to fulfill its responsibilities”2. Facilitation of a timely review could have been met through this method. This may have allowed for a review that would meet the publication deadline if the IACUC felt like the researcher now provided adequate justification for additional animals.
This is a preview of subscription content, access via your institution
