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A-1. This recommendation would allow experimenters to receive an expedited review by just one committee member, and it should not be implemented. Animals used in experiments can’t give informed consent—and those who do cry out or resist being used in experiments are ignored. As such, they must be considered a vulnerable population. In the realm of research involving humans, it is impermissible to use an expedited review process for vulnerable populations, including individuals unable to give informed consent (such as children and prisoners). It would be similarly inappropriate to use an expedited review process—using a “risk-based methodology” based on a newly constructed set of study categories—for any experiments involving animals.
A-2. It’s reasonable to allow research facilities to submit their annual reports to the Office of Laboratory Animal Welfare and the U.S. Department of Agriculture on the same reporting schedule. However, if a single report is to be submitted through a shared portal, the requirements should be harmonized in a way that maximizes transparency, accountability, and animal welfare.
A-3. Experimenters and the laboratories for which they work should spend more time, not less, searching for and implementing alternatives to procedures that cause animals pain and distress. If a laboratory allows a more painful procedure to be done rather than requiring that an equally effective, less painful procedure be used, an animal has unnecessarily endured more pain. Furthermore, each time a laboratory allows a painful procedure on animals when a non-animal alternative is available, it violates not only the spirit of federal law but also public sensibilities and the fragile foundation of public trust on which the oversight system—and, indeed, public support for animal experimentation—rests. Each time a laboratory allows a redundant or useless experiment to continue, it is not merely an administrative failure but, indeed, a moral failure to adhere to the minimal animal-welfare regulations and guidelines for the practice of animal experimentation.
A-4. This action would be acceptable.
A-5. In order to ensure that the welfare of animals isn’t compromised, existing federal requirements stipulated by the federal Animal Welfare Act (AWA) and Public Health Service Policy should be harmonized while ensuring the highest standards of care. In particular, the mantle of the AWA, with its legally enforceable animal-welfare standards, should be extended to all vertebrate animals—including “birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research”; “horses not used for research purposes”; and other farmed animals as well as amphibians, reptiles, and fish—currently excluded from the definition of “animal” in the act.
B-1. Institutions that use animals in experiments should be encouraged to give more, not less, thought to the nature of their experimentation programs. Allowing them simply to copy responses from one form and paste them into another doesn’t encourage thoughtful reflection on whether appropriate standards and programs are being implemented to minimize the pain, discomfort, and distress endured by animals. The federal government shouldn’t be encouraging such copying and pasting.
B-2. If the use of a repository of best practices by Institutional Animal Care and Use Committees is encouraged, the public should have an opportunity to view the complete repository and comment on the practices that are being recommended before they’re adopted. In addition, all materials within this repository should be made freely available to the public at all times. Individuals outside the regulated community, such as veterinarians or animal-welfare experts, should be allowed to submit best practice suggestions to this repository and comment on selected best practices. All such comments should also be made freely available to the public.
B-3. If the use of a repository of best practices by Institutional Animal Care and Use Committees is encouraged, the public should have an opportunity to view the complete repository and comment on the practices that are being recommended before they’re adopted. In addition, all materials within this repository should be made freely available to the public at all times. Individuals outside the regulated community, such as veterinarians or animal-welfare experts, should be allowed to submit best practice suggestions to this repository and comment on selected best practices. All such comments should also be made freely available to the public.
B-4. This action should not be implemented. While there are times when immediate changes to protocols must be made to reduce the potential for animal suffering—and in such cases a system such as Veterinary Verification and Consultation may be appropriate—attempts to reduce the number of eyes that review an animal-use proposal will overwhelmingly have a negative impact on animal welfare.
B-5. Multiple audit reports filed by the U.S. Department of Agriculture Office of the Inspector General have outlined the chronic failure of Institutional Animal Care and Use Committees (IACUCs) to carry out their mandate. Individuals who serve on IACUCs are in dire need of meaningful, comprehensive instruction—in particular, with regard to the basic 3R’s foundation of the experimental use of animals—to replace, reduce, and refine—and priority should be given to such training above any instruction to reduce the perceived “burden” on experimenters.
B-6. The simplest way to reduce regulatory burden and improve the efficiency of biomedical research would be to eliminate or reduce the use of animals in experiments intended to enhance the understanding, prevention, and treatment of human disease and other health issues. A great deal of scholarly research shows that animal experiments are flawed and divert both economic and intellectual resources from methodologies better suited to curing human disease. There are many factors—including reporting and publication bias, poor study design, and inadequate sample size—at play in the failure of animal experimentation to predict human outcomes reliably. But most significantly, intrinsic biological and genetic differences between species contribute significantly to problems in extrapolating results from nonhuman animals to humans. The National Institutes of Health, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture must reexamine their priorities and make a conscious effort to move away from experiments on animals and toward human-relevant research.