Agency adopts strict conditions set out in IOM report
R. Scott Nolen
February 01, 2012
This article is more than 3 years old
Late last year, the National Institutes of Health froze all new grants for studies involving chimpanzees after an Institute of Medicine review found little scientific necessity for using man's closest genetic relative as a research model.
Dozens of ongoing, federally funded projects will be evaluated according to the new stringent conditions adopted by the NIH, which the IOM says are necessary to justify conducting research on chimpanzees.
Advances in alternative research tools and methods, including cell-based tests and other animal models, have made chimpanzees largely nonessential as research subjects, concluded the IOM report, issued Dec. 15, 2011.
Chimpanzee-related research must, therefore, meet the following criteria: 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, 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 or in natural habitats.
Immediately after the IOM released its findings, NIH Director Francis S. Collins called the assessment "compelling and scientifically rigorous" and announced the agency would adopt the guiding principles and criteria recommended in the report.
An internal working group will devise a plan for implementing the IOM's proposals, Dr. Collins said, as well as decide what to do with the 612 federally owned chimpanzees housed at five national primate research facilities.
In the meantime, the NIH will award no new grants for studies involving chimpanzees and will review the approximately 37 agency-funded projects that currently do. Dr. Collins predicts half of them won't satisfy the stricter criteria.
Chimpanzees are used in a fraction of the estimated 90,000 studies the NIH supports each year, the IOM committee noted, explaining that between 40 and 50 studies using the nonhuman primates received agency funding each year from 2001-2010.
Research on chimpanzees is not limited to federally supported colonies and investigators. Chimpanzees owned by private and public entities are used in a variety of research applications including, but not limited to, studies of disease, drug and vaccine production, behavioral analyses, and conservation work. Research involving chimpanzees not owned by the NIH and studies not funded by the agency will not be directly impacted by the NIH decision.
Jeffrey Kahn, PhD, professor of bioethics and public policy at Johns Hopkins University, chaired the IOM committee that wrote the report, which was prompted by requests from Congress and the NIH for an evaluation of the current uses and potential future need for chimpanzees in agency-funded biomedical and behavioral research.
"The consensus of our committee was that we could not talk about the scientific necessity of the use of chimpanzees in research without talking about ethics. It's really at the core of any discussion about necessity," Dr. Kahn explained.
The committee determined that using chimpanzees should be allowed only if forgoing their use would prevent or substantially hinder advances necessary to prevent or treat life-threatening or debilitating conditions.
Additionally, the committee advised the NIH to limit the use of chimpanzees in behavioral research to studies that provide otherwise unattainable insights into normal and abnormal behavior, mental health, emotion, or cognition.
"The committee concluded that research use of animals that are so closely related to humans should not proceed unless it offers insights not possible with other animal models and unless it is of sufficient scientific or health value to offset the moral costs. We found very few cases that satisfy these criteria," Dr. Kahn explained.
"Our considerations were suffused with an awareness of the moral costs of research involving chimpanzees, and these concerns were manifest in the very high level of justification that we required as a committee to support claims of necessity of chimpanzee use in the two research areas we identified," he said.
The IOM committee stopped short of calling for an end to all federally funded research involving chimpanzees, however. Chimpanzees may be of value in developing a limited number of monoclonal antibody therapies and in comparative genomics research, the committee noted, as well as aiding in the development of a vaccine to prevent hepatitis C virus infection.
Chimpanzees might also be needed for future research to develop treatments or preventive measures for yet unknown diseases or disorders, the committee found.
Dr. Christian Abee, director of the Michael E. Keeling Center in Bastrop, Texas, one of the NIH-supported primate research centers, says the IOM principles are no different from what is already being practiced. "Considerable effort is devoted to making sure that the use of chimpanzees in a given study is justified," Dr. Abee explained. "NIH's implementation of these principles should help make certain that judicious use of chimpanzees continues."
And while he generally agrees with the IOM findings, Dr. Abee takes issue with the conclusion that most studies using chimpanzees are unnecessary. "This is a matter of debate among scientists," he acknowledged.
Dr. Abee noted the IOM report is the first authoritative document acknowledging the possibility that new and emerging threats to human health may require access to chimpanzees for research purposes. A plan will have to be developed to ensure that chimpanzees are available in the future, he observed, along with an assessment of the number of chimpanzees that might be needed to meet future needs.
Despite the IOM committee's claims, critics say the panel failed to provide any new rigorous requirements that would justify conducting research on chimpanzees. The Kennedy Institute of Ethics responded to the report, stating: "Only human interests play a role in this justification; there is no detailed discussion of the many costs to chimpanzees as subjects; and, yet, as this IOM committee correctly notes, the problem of harms to chimpanzees and their moral status is what gave rise to the controversy to which the report is responding."
The IOM report only heightens the importance of the problem, the Kennedy Institute continued, by repeatedly highlighting the many similarities between chimpanzees and humans. "Given that a chimpanzee is as close to a human being as this report correctly indicates a chimpanzee is, it is hard to understand why the same level of protections should not be provided to chimpanzees as are provided to humans."
The full report, "Chimpanzees in biomedical and behavioral research: Assessing the necessity," is available at www.iom.edu/chimpstudy.