f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 156 [Entry Date] 04/19/2011 at 10:24:49 AM [Affiliation] Self [Comments] 
Comment 1: I strongly recommend that the 8th edition of the Guide NOT be adopted. The new edition was originally intended to be an "update" of the 1996 Guide; however, the resulting document goes far beyond revision by invoking new restrictions that have not been adequately considered or discussed. Moreover, this edition is twice as long and contains new "policy" for which there is little or no empirical justification. Compliance with these new "policy" statements will increase the expense to institutions (e.g., cage size) and expense to investigators (e.g., drugs) without providing any clear benefit to research, the use and care of animals, to agencies funding this work, or to the public that benefits most from research. Most importantly, there is no scientific data provided to justify the proposed changes in "policy". Adherence to the 2011 Guide will require a large increase in paperwork burden (all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new guide may also negate the opportunity to diminish the burden resulting from over reactions to issues for which institutions already are "overregulated." Moreover, the new "Guide" policies infringe on scientific decision-making by PHS grantees, contractors, and IRGs. The policy changes implemented by the new Guide will result in significant additional expenses to the institution and the investigator with no real enhancement of animal welfare. Some specific examples include constraints on multiple procedures in animals, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" to give animals and specific guidance on "post-approval" monitoring (e.g., observation of procedures). In addition the new "Guide" requires an increased level of intra and post-operative surgical procedures. In summary, this edition of the Guide will seriously impede research activities without providing any clear benefit to any of the parties involved, including research animals. Comment 2: Institutional compliance with the new Guide should not occur before March, 2015 in order to allow for the collection of relevant data. These policies have been formulated without empirical support and any implementation of such a poorly concieved set of guidelines needs to be founded (or not) in information gathered over a broad range of conditions (institutions) and over several years of operation. Data, not opinion, should guide policy decisions.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals