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In the United States, there are increasing levels of protection for various animals, based roughly on how close they are to humans. See a general illustration (PDF - 148KB).
Laws governing the protection of human subjects encourage use of animal testing prior to human trials, to increase safety for human subjects. Thus animal testing cannot be restricted without decreasing the protections given human research subjects.
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The use of animals in research has enabled scientists to identify new ways to treat illness, extend life, and improve health and well-being. Chimpanzees are our closest relatives in the animal kingdom, providing exceptional insights into human biology and the need for special consideration and respect. While used very selectively and in limited numbers for medical research, chimpanzees have served an important role in advancing human health in the past. However, new methods and technologies developed by the biomedical community have provided alternatives to the use of chimpanzees in several areas of research.
In December 2010, the National Institutes of Health commissioned a study by the Institute of Medicine to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. The IOM now has issued its findings, with a primary recommendation that the use of chimpanzees in research be guided by a set of principles and criteria. The committee proposed three principles to analyze current and potential future research using chimpanzees.
- That the knowledge gained must be necessary to advance the public’s health;
- There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed on human subjects; and
- The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments (i.e., as would occur in their natural environment) or in natural habitats.
Based on its deliberations, the IOM committee concluded that “while the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary.” The committee also concluded, however, that the following areas may continue to require the use of chimpanzees: some ongoing research on monoclonal antibody therapies, research on comparative genomics, and non-invasive studies of social and behavioral factors that affect the development, prevention, or treatment of disease. The committee was unable to reach consensus on the necessity of the chimpanzee for the development of prophylactic hepatitis C virus vaccine. While the committee encouraged NIH to continue development of non-chimpanzee models and technologies, it acknowledged that new, emerging, or re-emerging diseases may present challenges that may require the use of chimpanzees.
I have considered the report carefully and have decided to accept the IOM committee recommendations. NIH is in the process of developing a complete plan for implementation of the IOM’s guiding principles and criteria. I will be assembling a working group within the NIH Council of Councils to provide advice on the implementation of the recommendations, and to consider the size and placement of the active and inactive populations of NIH-owned or -supported chimpanzees. We will not issue any new awards for research involving chimpanzees until processes for implementing the recommendations are in place.
NIH is committed to conducting and supporting high-quality science in the interest of advancing public health, and to the humane care and use of animals used in NIH research. I am grateful to the IOM for their careful and thoughtful assessment of this important and sensitive topic.
Thursday, December 15, 2011
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training (“U.S. Principles”)
(PDF - 32KB)
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KEY QUOTE: “Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.”
Animal Welfare Act of 1966 ("the AWA") (7 USC 2131, as modified)
(PDF - 52KB)
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KEY QUOTE: “Although Federal requirements establish acceptable standards, they are not ideal. Regulated businesses are encouraged to exceed the specified minimum standards.” -- USDA APHIS.top of page
9 CFR 1 A, parts 1 - 3
Implementing regulations of the AWA.
Part 1: Definition of Terms (PDF - 44KB)
Part 2: Regulations (PDF - 132KB)
Part 3: Standards (PDF - 312KB)top of page
Health Research Extension Act of 1985 (PL 99-158, "Animals in Research")
(PDF - 3.1MB)
The HREA directs the Secretary of Health and Human Services, through the Director of NIH, to create guidelines for the care and treatment of animals used in research. The result was the PHS Policy.
Public Health Service Policy On Humane Care And Use Of Laboratory Animals ("PHS Policy") (National Institutes of Health, Office of Laboratory Animal Welfare (OLAW). Revised August 2002)
(PDF - 284KB)
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KEY QUOTE: “PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals.”top of page
Guide to the Care and Use of Laboratory Animals ("the Guide")
(Web Link)
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KEY QUOTES: “All who care for or use animals in research, teaching, or testing must assume responsibility for their well-being;" "The Guide charges users of research animals with the responsibility of achieving specified outcomes but leaves it up to them how to accomplish these goals.”top of page
NIH Revitalization Act of 1993 (PL 103-43 § 205)
(PDF - 2.3MB)
Requires creation of a Plan for Use of Animals in Research at NIH. View the current plan.top of page
Federal Food, Drug, and Cosmetic Act as implemented by the Good Laboratory Practice Regulations (GLP) (21 CFR Part 58)
(PDF - 112KB)
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ENFORCEMENT: Compliance is "voluntary", but the GLP regulations allow FDA inspections
ICCVAM Authorization Act of 2000 (PL 106-545)
(PDF - 40KB)
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The NIH Office of Laboratory Animal Welfare (OLAW) is responsible for administration of the PHS Policy.
Animal Welfare Act Amendments of 2002 (PL 107-109)
(PDF - 76KB)
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Agreement to share information and avoid redundant effort in monitoring research at or sponsored by the Veterans Administration. Authority to implement the PHS Policy remains with OLAW.
Endangered Species Act of 1973
(PDF - 140KB)
In the case of some species, protections adminstered by the Department of the Interior may apply.
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