Nonhuman Primate Models in Biomedical Research State of the Science and Future Needs (2023) / Chapter Skim
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1 Introduction
1 Introduction
Pages 15-34
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From page 15... ...
Congress, NIH asked the National Academies of Sciences, Engineering, and Medicine to convene an ad hoc committee of relevant experts to conduct a landscape analysis focused on describing the state of the science of NHP model systems and exploring their current and future role in NIH-funded biomedical research. The committee was also asked to examine opportunities for new approach methodologies to complement or reduce reliance on NIH-supported research using NHPs.
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. To inform its examination of the current role of nonhuman primates in NIH-funded research, the committee will: • Examine the present state of biomedical research studies relying on nonhuman primate models, including: 0 A landscape analysis of scientific opportunities and contributions to human health ad vancements; and 0 Analysis to augment the 2018 Office of Research Infrastructure Programs study Nonhu man Primate Evaluation and Analysis to identify gaps in nonhuman primate availability (i.e., the new demand related to COVID-19 as well as the general importance of aspects such as genetic variability, species type, transportation limitations, and colony size)
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The committee recognizes that research utilizing NHPs, like all scientific animal research, must be conducted for ethically appropriate reasons and in ethically appropriate ways. However, as clarified by the sponsor of the study during the committee's first meeting, the charge did not include specific examination of ethical standards and principles that underlie NHP research, or current ethical issues and disputes relevant to this research.
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It is important to note that the committee was not asked to prioritize research disciplines in terms of their relative importance or the value of NHP models to each field of research. Finally, in contrast with other reports of the National Academies on the use of largeanimal models -- specifically, chimpanzees (IOM, 2011)
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STUDY CONTEXT NHP Models in the Broader Context of Biomedical and Animal Research Humankind is plagued by a multitude of diseases, illnesses, and forms of infirmity and disability that shorten or end lives; cause significant pain, distress, fear, anxiety, and sorrow; impair quality of life; and impose substantial economic costs on sufferers and society at large. The steady annual growth in federal expenditures on biomedical research in recent years -- the vast majority of which represent investments by NIH (Research!
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. However, accurate estimation of this figure in the United States is hindered by the absence of requirements to report on subsets of commonly used vertebrate animal models, including rodents and fish, under the Animal Welfare Act of 1966 (AWA)
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. Private industry accounts for just under half of all NHPs reported to USDA (see Appendix B for USDA-reported listings of all research facilities holding and using NHPs in FY2021)
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For example, the CD28-specific monoclonal antibody TGN1412, which was found to be safe in nonclinical toxicity testing using NHPs, in combination with other animal models, caused unexpected morbidity during first-in-human clinical trials (Pallardy and Hünig, 2010; Suntharalingam et al., 2006) owing to human-specific T cell subtype expression of CD28 unknown at the time.
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Evaluation of Scientific Merit Like all research proposals submitted to NIH, research proposals involving NHP models receive careful and comprehensive evaluation. The process of obtaining NIH funding is highly competitive.
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and confirms that everything funded by the grant is approved in the IACUC protocol. NOTES: ACP = animal care policy; AWAR = Animal Welfare Act and Animal Welfare Regulations; HREA = Health Research Extension Act; IACUC = institutional animal care and use committee; NIH = National Institutes of Health; OLAW = Office of Laboratory Animal Welfare; PHS Policy = Public Health Service Policy on Humane Care and Use of Laboratory Animals; the Guide = the National Research Council's Guide for the Care and Use of Laboratory Animals; USDA = U.S.
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In any proposed project involving NHPs funded by NIH, the IACUC must also determine that an NHP model is required to address the questions posed by the project; that no more NHPs will be used than is necessary for addressing these questions; and that all animals receive appropriate housing, care, and environmental enrichment that fosters species-typical behaviors and well-being. IACUCs receive their authority from federal law, specifically from the AWA and the Health Research Extension Act (HREA)
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Principles, the PHS Policy, and the Guide for its use of NHPs and other vertebrates in intramural research. Guidance regarding the role of the IACUC, the protocol review process, and how IACUCs should determine whether animal welfare is being protected in a research setting is provided by the AWAR, USDA animal care policies,6 the U.S.
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Topics included institute forecasts, challenges, and emerging technolo gies and needs in NHP research. Key recommendations from the organizing committee included – establishing a trans-NIH NHP working group; – increasing funding levels for NHP grants; – determining the genetics of all domestic NHP colonies supported by NIH; – providing NIH resources to expand existing colonies of rhesus macaques; – expanding NIH-sponsored marmoset colonies; – establishing domestic breeding colonies of cynomolgus macaques; – providing support for the development of species-specific reagents, assays, and technologies; and – providing training opportunities for personnel.
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. Similarly, researchers using different nonanimal models that may be classified as new approach methodologies (e.g., microphysiological systems, organoids, artificial intelligence/ machine learning)
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A public meeting held in November 2022 provided further opportunity for the committee to hear from the NIH Office of Research Infrastructure Programs and representatives of individual NIH institutes, centers, and offices that support NHP research. This meeting also included a session with researchers involved with or having insights on the use of new approach methodologies to complement or reduce reliance on NHP research.
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Chapter 3 presents the current landscape of NHP use and availability for NIH-supported intramural and extramural biomedical research. In Chapter 4, the committee examines the status of new approach methodologies with the potential to complement NHP research or reduce reliance on NHP models.
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2022b. USDA animal care: Animal Welfare Act and Animal Welfare Regulations.
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2015. PHS policy on humane care and use of laboratory animals.
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2010. Validating animal models for preclinical research: A scientific and ethical discussion.
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