f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 17 [Entry Date] 03/04/2011 at 02:36:30 PM [Affiliation] Self [Organization Name] Indiana University [Organization City and State] Indianapolis, IN [Comments] 
Comment 1: As an investigator and as an IACUC member, I find the eighth edition of the Guide to be particularly unhelpful. I never thought that the earlier version was very helpful either. The Guide is full of generalizations that do not clarify questions of how an investigator should proceed or how an IACUC should judge the adequacy of a study protocol. For instance, in the section on Protocol Review (pp 25-26), a bullet point states: "appropriate sedation, analgesia, and anesthesia. (Indices of pain or invasiveness might aid in the preparation and review of protocols; see Appendix A, Anesthesia, Pain and Surgery)". However, there are no indices presented and there is no indication which of the many references in Appendix A might lead the investigator/IACUC member to such indices. This is akin to a travel guide saying: "Munich is a great town for eating schnitzel and drinking beer and there are numerous inexpensive zimmer freis where one can stay – to find these bed & breakfast places you should purchase the following 5 travel guide books and search through them thoroughly." Not very helpful – hardly what a guidebook is written to do. Sure, the section on Pain and Distress in Chapter 4 (pp 120-121) mentions some useful indicators of pain but it is not done in a way that is very helpful to an investigator when devising a set of specific criteria in a specific protocol. I think the authors of the Guide should have chosen a useful set of indices drawn from numerous sources and presented them in a usable fashion in a species-specific manner. The Guide is full of examples of vague guidelines that leave much room for interpretation and can only lead to confusion and frustration. In addition, there are examples where statements in the Guide serve to confuse the issue. For example, in the section on Program Oversight (p 25), the Guide states: "Program review and facilities inspections should occur at least annually or more often as required (e.g., Animal Welfare Act and PHS Policy)." Since the AWA clearly states that inspections should occur every 6 months, this statement is confusing and leaves the audience with questions rather than answers. The paragraph above is just a sample of the tenor my review of the new edition of the Guide would have were I asked to do so for a reporting agency or a journal. I would conclude my review by saying: The new edition of the Guide, like its predecessor, falls flat as a guidebook. It lacks specific recommendations for investigators and IACUC members, relying instead on general statements that can be left to interpretation. In some cases, it makes statements that are inappropriate with regard to the regulations in question. This so-called guide is a recommendation for a blind-folded walk through the maze of regulations imposed by PHS and USDA. As an IACUC member and as an investigator I have found it much more productive to refer to the Institutional Animal Care and Use Committee Guidebook published by ARENA and OLAW (the Guidebook). This text offers clear descriptions of the federal regulations, compares requirements of PHS and USDA, and gives clear examples of how to proceed on specific questions that often arise. My best recommendation is to scrap the use of the Guide as the basis for designing an animal use program and instead refer to the Guidebook. Comment 2: Stop the implementation plan. Do not use the Guide as the basis for evaluation. The Guide presents cogent arguments for setting ethical standards for the use of animals in research, but it does little to guide the individual in specific steps needed in devising schemes that meet the regulatory standards set by the Federal agencies. The regulations set forth by the AWA, as interpreted by OLAW and ARENA in the Institutional Animal Care and Use Committee Guidebook published by ARENA and OLAW (the Guidebook), require specific actions. The Guide most often offers generalizations that may be left to interpretation that can lead to non-compliance. Instead, refer individuals and animal use program directors to the Guidebook as the basis for program/protocol design.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals