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Institute of Medicine (US) and National Research Council (US) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research; Altevogt BM, Pankevich DE, Shelton-Davenport MK, et al., editors. Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. Washington (DC): National Academies Press (US); 2011.

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Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity.

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Summary

At the request of National Institutes of Health (NIH), and in response to congressional inquiry, the Institute of Medicine (IOM) in collaboration with the National Research Council (NRC) convened an ad hoc committee to consider the necessity of the use of chimpanzees in NIH-funded research in support of the advancement of the public’s health.

Specifically, the committee was asked to review the current use of chimpanzees for biomedical and behavioral research and:

  • Explore contemporary and anticipated biomedical research questions to determine if chimpanzees are or will be necessary for research discoveries and to determine the safety and efficacy of new prevention or treatment strategies. If biomedical research questions are identified:
    • Describe the unique biological/immunological characteristics of the chimpanzee that make it the necessary animal model for use in the types of research.
    • Provide recommendations for any new or revised scientific parameters to guide how and when to use these animals for research.
  • Explore contemporary and anticipated behavioral research questions to determine if chimpanzees are necessary for progress in understanding social, neurological, and behavioral factors that influence the development, prevention, or treatment of disease.

In addressing the task, the committee explored existing and anticipated alternatives to the use of chimpanzees in biomedical and behavioral research. The committee based its findings and recommendations on available scientific evidence, published literature, public testimony, submitted materials by stakeholders, and a commissioned paper, as well as its expert judgment.

To conduct this expert assessment and evaluate the necessity for chimpanzees in research to advance the public’s health, the committee deliberated from May 2011 through November 2011. During this period, the committee held three 2-day meetings and several conference calls, including two public information-gathering sessions on May 26, 2011, and August 11–12, 2011. Each information-gathering session included testimony from individuals and organizations that both supported and opposed the continued use of chimpanzees. The committee also reviewed a number of background documents provided by stakeholder organizations and commissioned a paper, “Comparison of Immunity to Pathogens in Humans, Chimpanzees, and Macaques.”

The committee identified a set of core principles and criteria that were used to assess the necessity of chimpanzees for research now or in the future.

Ethical Considerations

Neither the cost of using chimpanzees in research nor the ethical implications of that use were specifically in the committee’s charge. Rather, the committee was asked for its advice on the scientific necessity of the chimpanzee model for biomedical and behavioral research. The committee agrees that cost should not be a consideration. However, the committee feels strongly that any assessment of the necessity for using chimpanzees as an animal model in research raises ethical issues, and any analysis of necessity must take these ethical issues into account. The committee’s view is that the chimpanzee’s genetic proximity to humans and the resulting biological and behavioral characteristics not only make it a uniquely valuable species for certain types of research, but also demand a greater justification for conducting research using this animal model.

Summary of Chimpanzee Research

The committee was asked, as part of its task, to review the current use of chimpanzees for biomedical and behavioral research. To assess the use of the chimpanzee as an animal model, the committee explored research supported by the NIH and other federally and privately funded research over the past 10 years.

The largest percentage of federally funded chimpanzee research has been supported by the NIH, with additional projects funded by other federal agencies, including the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Science Foundation. Of the 110 identified projects sponsored by the NIH between 2001 and 2010, 44 were for research on hepatitis; comparative genomics accounted for 13 projects; 11 projects were for neuroscience research; 9 projects were for AIDS/HIV studies; and 7 projects were for behavioral research. The remaining projects funded a limited number of studies in areas such as malaria and respiratory syncytial virus and projects supporting chimpanzee colonies.

Committee analysis of the use of chimpanzees in the private sector was hindered by the proprietary nature of the information. However, based on limited publications and public non-proprietary information, it is clear that the private sector is using the chimpanzee model, especially in areas of drug safety, efficacy, and pharmacokinetics. Although its use appears to be limited and decreasing over the 10 years examined by the committee, the chimpanzee model is being employed by industry in the development of antiviral drugs and vaccines for hepatitis B and C as well as in the development of monoclonal antibody therapeutics.

Principles Guiding the Use of Chimpanzees in Research

The task given to the committee by the NIH asked two questions about the need for chimpanzees in research: (1) Is biomedical research with chimpanzees “necessary for research discoveries and to determine the safety and efficacy of new prevention or treatment strategies?” and (2) Is behavioral research using chimpanzees “necessary for progress in understanding social, neurological, and behavioral factors that influence the development, prevention, or treatment of disease?” In responding to these questions, the committee concluded that the potential reasons for undertaking biomedical and behavioral research as well as the protocols used in each area are different enough to require different sets of criteria. However, the committee developed both sets of criteria guided by the following three principles:

  1. The knowledge gained must be necessary to advance the public’s health;
  2. 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
  3. The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments or in natural habitats.

These principles are the basis for the specific criteria that the committee established to assess current and future use of the chimpanzee in biomedical and behavioral research (see Recommendations 1 and 2).

Conclusions and Recommendations

The committee based the following conclusions and recommendations in large part on the advances that have been made by the scientific community using alternative models to the chimpanzee, such as studies using other non-human primates, genetically modified mice, in vitro systems, and in silico technologies as well as human clinical trials. Having reviewed and analyzed contemporary and anticipated biomedical and behavioral research, the committee concludes that:

  • No uniform set of criteria is currently used to assess the necessity of the chimpanzee in NIH-funded biomedical and behavioral research.
  • While the chimpanzee has been a valuable animal model in past\ research, most current use of chimpanzees for biomedical research is unnecessary, based on the criteria established by the committee, except potentially for two current research uses:
    • Development of future monoclonal antibody therapies will not require the chimpanzee, due to currently available technologies. However, there may be a limited number of monoclonal antibodies already in the developmental pipeline that may require the continued use of chimpanzees.
    • The committee was evenly split and unable to reach consensus on the necessity of the chimpanzee for the development of a prophylactic hepatitis C virus (HCV) vaccine. Specifically, the committee could not reach agreement on whether a preclinical challenge study using the chimpanzee model was necessary and if or how much the chimpanzee model would accelerate or improve prophylactic HCV vaccine development.
  • The present trajectory indicates a decreasing scientific need for chimpanzee studies due to the emergence of non-chimpanzee models and technologies.
  • Development of non-chimpanzee models requires continued support by the NIH.
  • A new, emerging, or reemerging disease or disorder may present challenges to treatment, prevention, and/or control that defy non-chimpanzee models and available technologies and therefore may require the future use of the chimpanzee.
  • Comparative genomics research may be necessary for understanding human development, disease mechanisms, and susceptibility because of the genetic proximity of the chimpanzee to humans. It poses no risk to the chimpanzee when biological materials are derived from existing samples or minimal risk of pain and distress in instances where samples are collected from living animals.
  • Chimpanzees may be necessary for obtaining otherwise unattainable insights to support understanding of social and behavioral factors that include the development, prevention, or treatment of disease.
  • Application of the committee’s criteria would provide a framework to assess scientific necessity to guide the future use of chimpanzees in biomedical, comparative genomics, and behavioral research.

Recommendation 1: The National Institutes of Health should limit the use of chimpanzees in biomedical research to those studies that meet the following three criteria:

  1. There is no other suitable model available, such as in vitro, non-human in vivo, or other models, for the research in question;
  2. The research in question cannot be performed ethically on human subjects; and
  3. Forgoing the use of chimpanzees for the research in question will significantly slow or prevent important advancements to prevent, control, and/or treat life-threatening or debilitating conditions.

Animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments or in natural habitats. Biomedical research using stored samples is exempt from these criteria.

Recommendation 2: The National Institutes of Health should limit the use of chimpanzees in comparative genomics and behavioral research to those studies that meet the following two criteria:

  1. Studies provide otherwise unattainable insight into comparative genomics, normal and abnormal behavior, mental health, emotion, or cognition; and
  2. All experiments are performed on acquiescent animals, using techniques that are minimally invasive, and in a manner that minimizes pain and distress.

Animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments or in natural habitats. Comparative genomics and behavioral research using stored samples are exempt from these criteria.

The criteria set forth in the report are intended to guide not only current research policy, but also decisions regarding potential use of the chimpanzee model for future research. The committee acknowledges that imposing an outright and immediate prohibition of funding could cause unacceptable losses to research programs as well as have an impact on the animals. Therefore, although the committee was not asked to consider how its recommended policies should be implemented, it believes that the assessment of the necessity of the chimpanzee in all grant renewals and future research projects would be strengthened and the process made more credible by establishing an independent oversight committee that builds on the Interagency Animal Model Committee and uses the recommended criteria.

Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK91439

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