Regulatory Focus™ > News Articles > NIH Committee Calls for Dramatic Reduction in Use of Chimps, Raising Hurdles for Animal Rule

NIH Committee Calls for Dramatic Reduction in Use of Chimps, Raising Hurdles for Animal Rule

Posted 23 January 2013 | By

A new report just published by the National Institutes of Health (NIH) has called for the eventual phase out of the use of most chimpanzees in NIH-supported or -sponsored research, saying through the animals have been valuable to supporting research in the past, their current use is largely unnecessary.

The 22 January 2012 report, "Use of Chimpanzees in NIH-Supported Research," was published by an NIH Working Group of the same name, and focused on the approximately 700 chimpanzees now owned by, or used in research in support of, NIH.

The animals were widely used in the past in biomedical research due to their genetic similarities to humans, but a prior report by the Institute of Medicine (IOM) found that the current uses of the animals are, with rare exception, unnecessary.

In cases where it may still be necessary, that research must be "governed by a set of principles and criteria," including the importance of the research, the necessity of the use of chimpanzees, and the condition of the accommodations for the chimpanzees, the IOM report said.

Report's Recommendations

NIH officials adopted the terms of that report, and directed its Working Group to implement the IOM's recommendations. The group responded to that request by setting out recommendations across three different areas: ethologically appropriate physical and social environments, colony size and placement, and the review process used to oversee research.

The first two categories focus primarily on the creation and maintenance of environments for research chimpanzees such that they are not subject to adverse conditions. Chimpanzees are social creatures, and thus should not be in colonies smaller than 7 individuals with 7,000 square feet of space and at least 20 feet of vertical space in which to climb. A number of other recommendations for diet, staff training and animal enrichment programs are also outlined in the report.

For animals already in use in federal research programs, the group recommended that the majority be retired into the federal sanctuary system.

"Planning should start immediately to expand current facilities to accommodate these chimpanzees," the group wrote. "The federal sanctuary system is the most species-appropriate environment currently available and thus is the preferred environment for long-term housing of chimpanzees no longer required for research."

Still, some chimpanzees "should be maintained for future potential research that meets the IOM principles and criteria," the group said. The size of that research reserve colony would number about 50 animals, and the need for it should be reassessed at least every five years to make sure the facility is needed and that its animals are not "overused."

Trouble for the Animal Rule?

The group also called for strengthened oversight reforms to be more transparent and independent and for a more stringent review process for studies proposing to use chimpanzees. That review process would require companies to "provide sufficient detail" about why the animals are needed, the protocol of the study, why the number of animals used is statistically sufficient, and the use of investigational products on the animals.

In the case of some tests, such as those testing experimental therapies for dangerous pathogens under the "Animal Rule," many animals would not be expected to survive unless given the experimental treatment.

The report indicated that testing under the Animal Rule, which allows FDA to approve products based on safety testing in humans and efficacy testing in animals, would be allowed for NIH-supported research on Chimpanzees only if smaller numbers of animals could be used, and in "staged experiments."

The NIH panel conceded that, "Whether the FDA Animal Rule would accommodate this is unknown."

Tags: Chimpanzees, NIH

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