f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 401 [Entry Date] 04/22/2011 at 08:26:50 AM [Affiliation] Self [Comments] 
Comment 1: As a physician and NIH-funded researcher, I am greatly concerned with the changes that are proposed to be implemented in the new Guide. While my concerns are many and deep, below are the points that I feel are most concerning. I strongly request that the changes in the Guide not be implemented until a careful consideration has been given to their multiple detrimental impacts and substantial changes made. 1. There is no indication that wholesale changes needed to be made in the Guide. There were only a few areas that needed updating in the previous edition. 2. Many (~60) of the changes aren't "guidelines," they are mandatory changes that will need to be made, removing investigator and IACUC scientific judgment from the process. 3. There is no scientific justification (and often conflicting evidence) for many of the changes suggested. This is especially true for the cage sizes. Implementing these changes for rodents will cost several hundred million dollars in direct (infrastructure) and indirect (impaired research) costs. 4. Implementation of regulatory guidelines like these that are projected to cost >$100,000,000 should receive more careful consideration as to their benefits and costs, and be backed by accepted scientific findings. 5. Strongly discouraging multiple use of animals (even for a "within subject design") will have the unintended consequence of driving up animal use and associated expenses. This is a direct conflict with the "Reduce" part of the "3-R's", which is a guiding fundamental animal use in research. 6. Recommending that positive reinforcement rather than mild food restriction be used in conditioned response experiments ignores substantial data that positive reinforcement does not work well to train behaviors such as self administration. 7. The introduction of the requirement that IACUC approve the use of non-pharmaceutical grade chemicals including formulation and a host of details that are required for FDA approval of drug administration to humans is unworkable, inappropriately transfers responsibility from the investigator to the IACUC (who generally lack the expertise to make these evaluations), and ignores the fact that the data required to implement this requirement is lacking for most drugs that would be administered to animals. 8. Additional duties assigned to the IACUC are excessively burdensome to the IACUC members and to the experimenter, again slowing down research and increasing the administrative burden, with no measurable benefit to the experimental animals. The most onerous of these is direct comparison of approved protocols to what is being done in the lab, and "formal review" of unexpected outcomes. Comment 2: Semiannual investigations are fine, basing them on the eighth edition is not. (Since the 8th edition is fundamentally flawed.)
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals