%PDF-1.5 These new requirements will be challenging for investigators proposing NHP-based research and for peer reviewers, in part because of the expense associated with each animal in an NHP-based study and the potential difficulty of obtaining adequate numbers of females, neonates, or juveniles. The New England Anti-Vivisection Society (NEAVS) is a national, registered 501(c)(3) nonprofit organization "dedicated to ending the use of animals in research, testing, and science education" and replacing them with "modern alternatives that are ethically, humanely, and scientifically superior. These concepts are in quite early stages of development, and their eventual contribution to translational research is uncertain (see, e.g., a discussion in the SCHEER Report, 2017). The authors point out that there are still important medical issues regarding Hepatitis, such as the development of curative therapies for chronic Hepatitis B, as opposed to the successful development of vaccines to thwart new infections, and the development of a vaccine for Hepatitis C, as opposed to the successful development of antivirals. Although it would be impractical to publish the entire animal record for each experimental subject, these records contain a great deal of information that could be mined by qualified investigators to aid in the design of experiments and to form the basis of retrospective studies that could include animals or tissues derived from them from several different centers and investigations. This type of multi-center approach is often used for clinical studies by the medical community (Llovera and Liesz 2016 and references therein) and by the human genomics community for large-scale investigations of large human disease cohorts, using genome-wide association studies (Manolio 2013, 2017). [39] On June 11, 2013, FWS proposed changing the policy and opened a public comment period. This article provides a detailed review of the use of NHP preclinical models to study several aspects of conditions associated with metabolic syndrome, including glucose resistance, diabetes, dyslipidemia, and hypertension. NHPs are particularly relevant because of their highly developed cerebral cortex, cognitive functions, complex motor skills, and neuroanatomy, all of which are similar to the human. WebThe New England Anti-Vivisection Society (NEAVS) is a national, registered 501(c)(3) nonprofit organization dedicated to ending the use of animals in research, testing, and % ESEC is a proponent of dissection choice legislation and policies which provide students the right to choose alternatives to animal use in their education. 2017). Paper topics include findings of research chimpanzee autopsy reports, the implications of genetic differences between chimpanzees and humans, and the applicability of using chimpanzees as research models for cancer, hepatitis C, and AIDS. 2016). The rhesus macaque, which is the species most frequently used by academic investigators in the United States, can be obtained from the NPRCs, CROs, and other US centers, with reasonable waiting times. Webin researchan issue it has been working on for many decades. These experiments cause even greater suffering, high death rates, and other negative health consequences for the millions of animals used. Problems related to transportation can therefore be troublesome for researchers. Chimpanzees have also been moved by truck from various centers to the Chimp Haven sanctuary within the United States, as mandated by the NIH (Reardon 2015), following a complex review process that involved, among others, the US National Academy of Medicine and the NIH Council of Councils and Directors Office with input from researchers and stakeholders. Large animal models such as dogs and swine are also used in some fields, such as oncology and transplantation medicine. Identified 4 new grant, including a grant for, American Partnership for Eosinophilic Disorders (APFED), Supporters of Agricultural Research Foundation, The Howard and Georgeanna Jones Foundation for Reproductive Medicine, Private Foundation Excise Taxes on Undistributed Income, Gifts from Private Foundations to Donor Advised Funds, Interim Executive Director / Director of Development, Director of Government Relations and Policy, Net gain from sale of non-inventory assets. "[5], In anticipation of his retirement, Amory appointed a nominating committee that chose psychologist and former NEAVS board member, Theodora Capaldo, EdD, to succeed him. WebThe NADL (later renamed the National Animal Disease Center, or NADC) contained research and regulatory laboratories. Invasive research on chimpanzees is prohibited in Australia and New Zealand. , Olivier M, Spradling-Reeves K, Karere G, Comuzzie A, VandeBerg J. Cyranoski Animal Research is Hazardous Waste examines the millions of animals bred, used, and disposed as contaminated or hazardous waste. WebIn 2010, the European Commission passed legislation to prohibit the use of great apes in biomedical research. These authors also comment on emerging areas in the field of female reproduction, including infection with Zika virus and the potential use of transgenic technologies such as the CRISPR/Cas9 system, to create new disease models relevant to translational research related to womens reproductive health. A feature of NHP research is that the demand for some species waxes and wanes over time, for example for baboons and marmosets. "Yes, Dad, There Are Alternatives." These include: the expense of isolating oocytes or embryos from NHPs and the small numbers of these biological materials that can be obtained from any given female; the long generation time of NHPs relative to rodents (months or years rather than weeks); expense associated with maintaining colonies of genetically modified animals; and the relatively small numbers of laboratories that have command of all the technologies necessary for successful generation and propagation of mutant animals. JCI Chan Richard Stouffer and Teresa Woodruff review the use of NHPs to study critical issues related to womens reproductive health. Lanford [42] In 2012, NEAVS and others organizations submitted a rulemaking petition to the U.S. Department of Health and Human Services (HHS) asking for criteria defining when chimpanzees are no longer needed. Want updates when NEAVS has new information, or want to find more organizations like Rise for Animals (NEAVS)? M.J. Osmond, E. Korthals, C.J. , Kievit P, Bremer AA, Comuzzie AC. Amory died unexpectedly later that same year. There is no good solution to this problem, which is outside the control of the end users of the animals. Department of Pediatrics, Section of Hematology, Oncology, and Bone Marrow Transplant. [31], As part of this campaign, NEAVS published a number of scientific articles in peer-reviewed journals examining the utility of chimpanzees in biomedical research. K An example is the transfer of macaques and marmosets from the New England NPRC to four other NPRCs when the New England Center closed in 2015. These common disorders of the female reproductive system include polycystic ovary syndrome, endometriosis, placental dysfunction, and preterm labor, among others. WebThe American Fund for Alternatives to Animal Research (AFAAR) and the New England Anti-Vivisection Society (NEAVS) offer a $40,000, one-year postdoctoral fellowship grant (with possible renewal) to a woman interested in developing, validating, or using alternatives to animal methods in the investigation of women's health or sex differences. Proof of principal of this approach has been reported by Cornish et al. [83] K. Leiderman, S.S. Sindi, D.M. Can new tools and technology improve translational power? Kilkenny I am not aware of any publication that has examined the comparative rigor with which studies using different species (for example, rodents versus NHPs or other large animals) have been performed. Among other approaches, strategies such as pooling animals and resources from a number of centers for a single NHP-based study lead by multiple, collaborating investigators should be considered. WebNEW ENGLAND ANtI-VIVISECtIoN SoCIEtY Phone: Fax: Email: 617.523.6020 617.523.7925 info@neavs.org presidents Annual Message support to end chimpanzee use in biomedical research, our work has, as importantly, set the stage for arguments regard-ing the use of all species. x$jDifws'rC(w[X,NwO]nuYw>|}_"t]}~>?'Y\dZwElOWn7Wfm.RXTfy^.yx\}\..0m`;uY.V|?w>0x\r^8XhlEnVt_-*j&+r{?MnG&/@x\\^lRJ3jDxW.w)]I0sO1\P6S@]'AbW3(9o_Ms'j=:E^43=pe~"%e&D^@%\{tO?h.Gu]YPX0MKm!%y*D[@B\"@&'o/\^E+.tEA{](+}1%hVloPSD,E.j _^=_z E(s5|'soa nA^%S$(LCgz`{` i#i~\Pg9 . [25][28][26], NEAVS launched its national Project R&R: Release and Restitution for Chimpanzees in U.S. Laboratories campaign in 2003 to end the use of chimpanzees in invasive biomedical research and provide them permanent homes in sanctuary. Rodents may not be relevant models, because their physiology and response to infection are not sufficiently close to those of humans. M IA The petition aimed to reclassify captive chimpanzees as endangered. Animals often suffer greatly in these studies, as they are inflicted with diseases, traumas, and pain they would not normally experience in order to mimic human conditions. Animals provided by CROs are often used by pharmaceutical companies for toxicology testing and for some preclinical research. For example, Xue et al. Research using all vertebrate animals, including NHPs, and the characteristics of the facilities that house and breed animals are regulated in North America (Griffin and Locke 2016; Tardif et al. Capaldo and her newly elected board of directors came with extensive animal protection and animal rights experience and have included individuals with medical, veterinary, psychology, mental health, sociology, and legal credentials, such as Sarah Luick, Esq., a founding member of the Animal Legal Defense Fund (ALDF). J This issue of the ILAR journal brings together, in one place, articles that discuss the use of NHP models for studying human diseases that are highly prevalent and that cause extraordinary human suffering and financial and social burdens. E Maine Biomedical Research Cltn is categorized under Foundation Educational Philanthropic Research (SIC code 8733). This type of coordination will, among other benefits, identify enough animals of high potential in regard to a specific disease, such that a relatively small number of animals, prescreened as likely candidates, can be sequenced. CRISPR/Cas9-based approaches make it possible to rather easily modify virtually any gene, or to create inactivated or deleted genes (knockouts) or to introduce genes of interest into the genome (knockins). Details of these alternative approaches are outside the purview of this review. Arrowsmith Animal research is generally recognized to be costly, time-consuming, and unreliable, and much of this research is neither appropriate nor applicable to humans. There is a distinct disconnect between the very high level of support of the pubic for medical research aimed at ameliorating disease and the discomfort of many with the animal-based research that is essential for development of pharmaceuticals and vaccines. Genomic and exomic sequences of NHPs can now be obtained readily, at moderate, but still significant, cost. 333 Washington St Ste 850, Boston, Massachusetts, 02108, United States, Find your B2B customer within minutes using affordable, accurate contact data from Datanyze. 2010). Natural differences in physiology, metabolism, and anatomy between humans and other animals lead to very different reactions to various stimuli. L The website for the US National Primate Research Centers (NPRCs) includes short discussions of the use of NHPs to study several different diseases (https://www.nprcresearch.org). Coulston is cited for multiple violations of the The animal rights organizations are more successful at molding public opinion than are the research organizations that use animals. These new approaches cannot be pursued in the absence of an animal model that can replace the chimpanzee. 2014; other examples reviewed by Hewitt et al. I am a psychologist and President of New England Anti-Vivisection Society. Search for other works by this author on: Trial watch: Phase II and Phase III attrition rates, 20112012, Raise standards for preclinical cancer research, Whole-genome characterization in pedigreed non-human primates using genotyping-by-sequencing (GBS) and imputation, Whole genome sequencing predicts novel human disease models in rhesus macaques, Naturally-occurring nonhuman primate models of psychosocial processes, Contributions of non-human primates to neuroscience research, Progress and prospects for genetic modification of nonhuman primate models in biomedical research, Genome editing in nonhuman primates: Approach to generating human disease models, Functional disruption of the dystrophin gene in rhesus monkey using CRISPR/Cas9, Exome screening to identify loss-of-function mutations in the rhesus macaque for development of preclinical models of human disease, Baboons as a model to study genetics and epigenetics of human disease, Nonhuman primates and translational researchcardiovascular disease, Marmosets are stars of Japans ambitious brain project, A rhesus macaque model of Asian-lineage Zika virus infection, Translational research in the nonhuman primate model of tuberculosis, Comparison of the Canadian and US laws, regulations, policies and systems of oversight for animals in research, Progress in genetics and genomics of nonhuman primates, Genomic tools for the use of nonhuman primates in translational research, Use and importance of nonhuman primates in metabolic disease research: Current state of the field, Clinical development success rates for investigational drugs, Accelerating biomedical discoveries through rigor and transparency, A second generation human haplotype map of over 3.1 million SNPs, Development and validation of a SNP-based assay for inferring the genetic ancestry of rhesus macaques (Macaca mulatta), TALEN-based generation of a cynomolgus monkey disease model for human microcephaly, Improving bioscience research reporting: The ARRIVE guidelines for reporting animal research, The chimpanzee model of viral hepatitis: Advances in understanding the immune response and treatment of viral hepatitis, Autism-like behaviors and germline transmission in transgenic monkeys overexpressing MeCP2, The next step in translational research: Lessons learned from the first preclinical randomized controlled trial, Bringing genome-wide association findings into clinical use, In retrospect: A decade of shared genomic associations, Advances in vision science and prevention of blindness using nonhuman primates, National Association for Biomedical Research, National Research Council (US) Institute for Laboratory Animal Research, Laboratory animal laws, regulations, guidelines and standards in China Mainland, Japan and Korea, Protecting animals and enabling research in the European Union: An overview of development and implementation of directive 2010/63/EU, Generation of transgenic marmosets expressing genetically encoded calcium indicators. Failure of Phase II and III clinical trials can reflect lack of efficacy, safety concerns, or both (Arrowsmith and Miller 2013). NHPs have been critical animal models for development of all current approaches aimed at halting the AIDS epidemic in humans, including developing anti-retroviral therapies, decreasing maternal-fetal transmission of HIV, testing microbicides, and designing more effective strategies for development of efficacious AIDS vaccines. I also hope these reviews will provide critical basic information on the use of NHPs for translational research to the very large number of stakeholders, including patients, involved with these high-profile diseases and to the general public. Local Institutional Animal Care and Use Committees must approve any procedure at a given institution utilizing laboratory animals, including NHPs (Tardif et al. This article describes and discusses the details of this program (termed the Biobehavioral Assessment Program), the differences between these naturally occurring NHP models and induced models of conditions such as loneliness, and measurement of relevant physiological and genetic parameters in these animal models. One response by some researchers and funding agencies aimed at increasing the reproducibility and decreasing the cost of translational studies has been to develop alternatives to the use of whole animals, such as cell lines, artificial tissue arrays (tissues on a chip), in silico modeling, and micro-dosing of pharmaceuticals in human patients and volunteer controls. Approximately 2000 animals were transferred, without loss of a single animal; specific pathogen-free animals remained free of viruses. Promising approaches for developing immunogens and adjuvants must now be reapplied to NHP models to develop more efficacious vaccines that can then be retested in humans. [20] The resulting test better predicted human lethal blood concentrations. The cost of genomic sequencing is, at best, approximately $2000 per animal, not including the significant personnel costs necessary to analyze the data (Bimber et al. Y Presentation slides from the spring and fall conferences are now available to all registered attendees with password access. All Rights Reserved. Sasaki Michael Mustari reviews the use of NHP models aimed at understanding the causes of and ameliorating conditions that lead to blindness or lack of visual acuity in humans, including problems of eye alignment (strabismus), lazy eye (amblyopia), unsteady gaze (nystagmus), and defective eye movements. , Gautam A. Xue For nearly 20 years, Coulston conducts invasive experiments on chimpanzees. The New England Anti-Vivisection Society ( NEAVS) is a national, registered 501 (c) (3) nonprofit organization "dedicated to ending the use of animals in research, testing, and science education" and replacing them with "modern alternatives that are ethically, humanely, and scientifically superior." [1] began serving as executive director. 2016), microcephaly (Ke et al. JD Capitanio endobj Abstract and Figures. [48], In the 21st century billions of animals have been used for human's benefit through animal testing of consumer products, in the United States and dozens of other countries. AWS Neeves, [93] C.J. Domestic breeding colonies of animals, originally of Asian origin, such as rhesus (Macaca mulata), pigtail (Macaca nemestrina), and cynomolgus (Macaca fascicularis) macaques, and NHPs of African origin, baboons (Papio sp.) WebCommittee on Chimpanzees in Biomedical and Behavioral Research August 11, 2011 in Washington D.C. My name is Dr. Theodora Capaldo. There is increasing realization that variation in genetics or other factors such as the social interactions of individual rhesus or cynomolgus macaques can influence experimental results. E The field of NHP-based translational research will benefit from a direct comparison of requirements for animal welfare across centers in all countries that supply NHPs for translational investigations. Ovarian cancer is the second most common gynecological cancer among women in the United States, with an estimated 20,000 China has also increased its capacity to perform contract research that can be out-sourced to pharmaceutical companies (Xia and Gautam 2015). I dedicate this paper to the memory of Dr. Andrew Lackner: scientist, mentor, and great champion of translational research using NHPs. <> [49], The American Fund for Alternatives to Animal Research (AFAAR) is NEAVS' sister organization. However, this is often done with limited success, because many human diseases do not naturally occur in the animals used. In 2016, a white paper published by the National Association for Biomedical Research briefly discussed scientific breakthroughs that required the use of NHPs (National Association for Biomedical Research 2016). The literature cites many instances where NHPs have not been used and in which investigators have relied only on information from other models, particularly rodents. Monroe, C. Baird, J. Peterson, A. Mast, M. Manco-Johnson, M. Stobb, S. Sindi, A. Fogelson, K. Leiderman, K.B. There are, however, several challenges involved with the application of large-scale genomic sequencing to develop new NHP models for translational medicine. BN 2014, reviewed in Harding 2017). These conclusions regarding rigor appear mainly to be based on studies using rodents. 2013, 2017). 2016; Sasaki 2015; Sasaki et al. Hay In response to the general problem of reproducibility of both basic and preclinical research using animals, the NIH has recently published new requirements for grant applications, which will be part of peer-review and programmatic consideration (Hewitt et al. In response to a request by members of the US Congress, the US National Institutes of Health (NIH) convened a workshop in December of 2016 entitled, NIH Workshop on Ensuring the Continued Responsible Oversight of Research with Nonhuman Primates. The final report can be accessed at https://www.cnprc.ucdavis.edu/wp-content/uploads/2017/01/NIH-NHP-Workshop-Report.pdf. These classes of animals are needed to keep breeding colonies at optimal levels to support the number and diversity of NHP-based translational studies and thus can be in short supply for investigations. WebNEAVS was nominated in the public awareness category for our Project R&R: Release and Restitution for Chimpanzees in U.S. Laboratories campaign (releasechimps.org). If the three-stage model of human translational research is used as a reference (Rubio et al. As issue editor, I expect that these reviews will be of use to many different researchers, including clinical investigators as well as personnel in funding agencies, as would be expected. Our mission is two-fold: (1) To train the next generation of independent scientists and engineers in an inclusive and fun environment. endobj Within the continental United States, most species of NHPs can be moved very safely by truck. Parallel and coordinated use of whole animals with development of alternative technologies provides an opportunity to validate or abandon alternatives and to enlarge the suite of tools that can be applied to a given translational problem. The ability to lower costs, develop more cost-effective sequencing technologies and more sophisticated phenotyping assays, and increase coordination and cooperation among centers will likely be needed to realize this potential. WebThe Experimental Use of Chickens and Other Birds in Biomedical and Agricultural Research by Karen Davis, PhD, President of United Poultry Concerns, was graciously funded by the As this article was being written, the US Food and Drug Administration temporarily suspended research aimed at understanding aspects of nicotine addiction using squirrel monkeys, apparently based on a direct request of the primatologist, Dr. Jane Goodall, to the FDA Commissioner (McGinley 2017). Recent examples include the influence of the animal rights organizations on the NIH decision to prohibit research using chimpanzees (Reardon 2015, see also commentary in this issue by Veazey and Lackner 2017 and Lanford et al. This is, however, a highly nuanced issue. The New England Anti-Vivisection Society, founded in 1895, works to expose and replace animal experiments in laboratories and classrooms with ethically and scientifically responsible modern alternative research methods. For examples, New England Anti-Vivisection Society states on its website that it is dedicated to ending the use of animals in research, testing, and science education. These societies are well funded and skilled at communicating to the public. Harding 2016) should increase and contribute to the utility of NHPs for translational research. WebThe NIH announces an end to funding biomedical research on chimpanzees and that all federally-owned chimpanzees are eligible for retirement to sanctuary, 2015. This is a major goal of the US National Institutes of Health (NIH) and their partners efforts to develop a vaccine with sufficient efficacy, as discussed in the NIH Office of AIDS Research Strategic Plan for fiscal year 2018 (Office of AIDS Research 2017). Marr, [91] D. Disharoon, B.G. In practice, as is clear from the papers in this issue, several different animal models may be used to study a specific problem in translational science. Begley Mustari Environmental enrichment is required by the Animal Welfare Act and is essential for maintaining the welfare of NHPs, reducing stress, and maintaining optimal health in these animals. Translational studies using NHPs depend on the availability and characterization of animals, high-quality animal husbandry and welfare, and the development of assays and technologies. NEAVS funds scientists developing alternatives, and advocates for policies requiring use of validated animal alternatives in research and testing. 2017). John D Harding, Nonhuman Primates and Translational Research: Progress, Opportunities, and Challenges, ILAR Journal, Volume 58, Issue 2, 2017, Pages 141150, https://doi.org/10.1093/ilar/ilx033. The Secure Remote Viewer (SRV) C WebNew England Anti-Vivisection Society May 26, 2011. Northern New England Vascular Society was founded by Betty LaBombard, Maryann Waters, Anne Musson and Nancy Gardner in 1994 as an Affiliate Chapter of the 2016; SCHEER, 2017). Marr, K.B. Underpinning all of these studies is the close similarity in physiology between the NHP and human respiratory systems. . 2016; Ke et al. They point out that NHPs are more similar to humans than are rodents in a number of aspects of energy metabolism, including the major site of de novo lipogenesis (liver vs. adipose tissue), major classes of circulating lipoproteins, and the physiology of thermogenesis and insulin-mediated glucose utilization. In regard to transportation, a question still remains as to whether some chimpanzees experienced stress that can affect their longevity at the Chimp Haven sanctuary. They also discuss early experiments using chimpanzees, which, while unsuccessful in themselves, provided information that was useful for development of the SIV-macaque animal model. In the past several years, there has been considerable discussion regarding the reproducibility of animal studies and therefore the utility of animals for translational research. 4 0 obj Animals don't have to be used for human's wants. ARLO aims to Smaller colonies of the new world marmoset (Callithrix jaccus) are also housed at the NPRCs. , Sparman M, Sritanaudomchai H, Ma H, Clepper L, Woodward J, Li Y, Ramsey C, Kolotushkina O, Mitalipov S. Tardif Project R&R is committed to continuing to raise awareness and secure the release of all chimpanzees remaining in U.S. labs into sanctuary. [7], Today, NEAVS continues its work through public outreach, education, legislation and policy change, supporting animal sanctuaries, and funding the development of alternatives to animals in research and science education.[9].
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