f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 480 [Entry Date] 04/24/2011 at 09:09:51 PM [Affiliation] Self [Comments] 
Comment 1: I received notice that the 8th edition of the "Guide for the Care and Use of Laboratory Animals" was in consideration for adoption as policy only on April 20. When I first saw a copy of the new Guide I thought that it had been thoroughly vetted and was adopted for use. Now I find that not only is it not adopted but, in fact, I had only a few days to respond. My Easter Sunday three-day celebration was seriously interfered with in order to prepare this response to the questions you ask. I have served on an IACUC for a total of 21 years. So I have seen changes that were accepted by the research community in order to better their research. However, there has not been such an upheaval of established procedures in these changes until now. The following are the main points of my response. 1. First, the existing draft of the 8th edition SHOULD NOT be adopted as PHS Policy in the proposed schedule. The proposed changes are so invasive but subtle that more time is needed to thoroughly comprehend the changes by researchers and digest their impact on the research community in the USA. 2. The 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies CONSTRAIN the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. These will add significantly to the cost which grants must pay and to their institutions. This comes at a time when grants are being decreased both in money and numbers. 3. Requirements for new cage sizes for some species (particularly rodent breeding) and for social housing of all species will require large expenditures. Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" are examples of items requiring additional IACUC staffing and researcher effort. We don't as yet know what these requirements are. 4. A major change in the Guide is the introduction of cautions against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries. This echoes a newly introduced caution against animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. These restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral research. 5. Further, the Guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating, "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." Thus for the first time, the Guide appears to want to step into the regulation of agricultural and invertebrate animals. 6. There are imprecise wording in this draft which needs to be straightened out before researchers are sure of the implications of this draft. 7. The Guide under consideration is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." 8. In CONCLUSION, this version of the Guide is not ready for acceptance and SHOULD NOT be accepted. It contains many statements that are not clear for their implementation. Researchers strapped for research funds will be hard pressed to put these rules into use. Comment 2: The date of March 31, 2012 in entirely TOO EARLY. By that time the Guide may not be accepted and if it is, IACUCs will not have time to change their policies.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals