Under The Poliscope: Bringing Science Policy Into Focus

Ensuring Continued Responsible Research with Non-Human Primates

May 24, 2016

Research with animals, including non-human primates, has enabled the development of treatments and cures for a host of devastating diseases and conditions in humans, and continues to revolutionize our understanding of health and disease.  Because non-human primates are anatomically, physiologically and behaviorally similar to humans, they are particularly valuable for answering some of the most complex questions germane to human health.  These research models have been instrumental to significant scientific and medical advances such as deep brain stimulation to treat Parkinson’s disease, experimental vaccines aimed at preventing the spread of Ebola virus, developing the polio vaccine, and new strategies that improve organ transplant survival today.  Non-human primate research retains a critical position in the biomedical research enterprise.

Equally important to their scientific value is upholding the highest possible standards of animal welfare, including ensuring that a proposed animal model is appropriate to the research and with an expectation of scientific rigor for every experiment. These precepts have been codified in research policy for many decades (https://awic.nal.usda.gov/government-and-professional-resources/federal-laws/animal-welfare-act) and are a central value of all biomedical research funded by the National Institutes of Health (NIH). NIH remains confident that the oversight framework for the use of non-human primates in research is robust and has provided sufficient protections to date. However, we believe that periodically reviewing agency policies and processes ensures that this framework evolves in a manner consistent with emerging scientific opportunities and public health needs.

Toward this end and in response to Congressional interest (refer to Page 72), the Office of Science Policy is taking the lead in planning a workshop on September 7th, 2016 that will convene experts in science, policy, ethics, and animal welfare.  Workshop participants will discuss the oversight framework governing the use of non-human primates in NIH-funded biomedical and behavioral research endeavors.  At this workshop, participants will also explore the state of the science involving non-human primates as research models and discuss the ethical principles underlying existing animal welfare regulations and policies.  NIH is committed to ensuring that research with non-human primates can continue responsibly as we move forward in advancing our mission to seek fundamental knowledge and enhance health outcomes. 

The workshop will be broadcast live and archived for future viewing on the NIH Videocast website.  Comments regarding the workshop may be submitted online in advance of and during the workshop for consideration. Please save the date, and stay tuned for more information, including a detailed agenda.

 

Comments

Strong consideration should be given to include Kathy Warren and her work using NHP to study treatment strategies for children suffering from brain tumors.

Thank you for your suggestion and for your feedback

I would recommend the participation of Eric Hutchinson who is the Veterinary Behaviorist at the Division of Veterinary Resources at the NIH. He has a strong NHP background and recognizes the value of refinements surrounding social housing, group housing paradigms and training for cooperative behavior.

Thank you for that suggestion.  I appreciate your feedback.

Consideration should also be given to participation by Larry Carbone , currently at the University of California San Francisco and participant in the 2012 Hastings Center Report on Animal Research Ethics, as well as Bernard Rollin, professor of philosophy, animal sciences, and biomedical sciences at Colorado State University.

I appreciate your comment, Mark.  Thank you for the recommendations.

Jeffrey Kahn, Deputy Director for Policy and Administration at the Johns Hopkins Berman Institute of Bioethics should be encouraged to participate.

Thank you for your comment and for your recommendation, Rick.   

Please take care to assure that the interests of those tied to the continued use of animals are not over-represented.
Similarly, please take care to ensure that the interests of those tied to the abolishment of primate models are not over-represented.
Please be sure to share the following recent Opinion published in the NYTs from a former NHP experimenter and student of Harlow. http://www.nytimes.com/2016/09/04/opinion/sunday/second-thoughts-of-an-animal-researcher.html
If the NIH is interested in including a European view on this issue I am happy to provide it. As the Director of the German Primate Center (http://www.dpz.eu/en/home.html), the head of EUPRIM-NET, an EU-funded network of the European Primate Centers (http://www.euprim-net.eu) and co-initiator of the Basel Declaration (http://www.basel-declaration.org) I have been involved in science and policy development on the responsible use of non-human primates in biomedical research.
Please note that the URL provided in reference 1 of the announcement is not valid.

Thanks for the feedback, Stefan.  The link has been updated.

I would recommend Tom Beauchamp of Georgetown University Kennedy Institute of Ethics, John Gluck of Kennedy Institute of Ethics and University of New Mexico, and David Wendler of National Institutes of Health Department of Bioethics.
By non human primates are you referring to great apes too or just monkeys? Why is this conversation surrounding only non-human primates? Shouldn't this conversation be about ALL animals used in research?
Please consider Ray Greek, MD for participation. He is president and co-founder of Americans for Medical Advancement. www.curedisease.com.
USDA/APHIS-Animal Care would like to be involved since we enforce the Animal Welfare Act hence relevant to the discussion In addition, I recommend allowing the Animal Welfare Information Center (AWIC) of the National Agricultural Library/ USDA to participate since the Animal Welfare Act regulations names it as a resource for alternative methods to painful/distressful procedures in research. Kristina Adams is the contact.
Please consider inviting Kimberley Phillips to participate in the workshop. Kim is the incoming president of the American Society of Primatologists.She has considerable experience in both captive primate research and institutional and federal regulatory processes.
The UK's NC3Rs has extensive experience of working with the academic community, including funders, to effectively embed the 3Rs principles in research involving NHPs. It also has an ambitious NHP programme with the global pharmaceutical industry. For examples see www.nc3rs.org.uk/welfare-non-human-primates and www.nc3rs.org.uk/reducing-animal-use-monoclonal-antibody-development# It would be a missed opportunity to not include the NC3Rs experience and expertise in the workshop.
I recommend Megan Albertelli, DVM, PhD, whos is a board certified laboratory animal veterinarian at Stanford University. She is an experienced veterinary clinician with clinical care and oversight responsibilities.
I second the motion to have Dr. Jeffrey Kahn involved in the workshop, as an independent bioethicist who does not have vested interests in the outcome. Thank you for accepting public comments.
I recommend including Jarrod Bailey, PhD, geneticist and science advisor for the New England Anti-Vivisection Society (Boston, MA) and its major campaign, Project R&R: Release and Restitution for Chimpanzees in U.S. Laboratories, and also scientific advisor to Cruelty Free International (UK). Dr. Bailey has published extensively in peer-reviewed journals on the human relevance and efficacy of chimpanzees for the development of AIDS vaccines, cancer research, and Hepatitis C, as well as the relevance and validity of nonhuman primates and other laboratory animals to human disease in general, most recently in March 2016 in the peer-reviewed journal Alternatives to Laboratory Animals (ATLA). Dr. Bailey was also invited to testify before the Institute of Medicine of the National Academies of Sciences regarding its 2011 study, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. Dr. Bailey’s full papers were submitted to the Committee prior to their invitation. Additionally, Dr. Bailey was the chief architect of a Petition for Rulemaking to the U.S. Food and Drug Administration for Mandatory Use of Non-Animal Methods in the Development and Approval of Drugs and Devices, and contributed has written on the effects of stress in laboratory animals on research results in a Petition for Rulemaking to the U.S. Department of Agriculture, entitled To Establish Criteria to Promote the Psychological Well-Being of Primates as Required by the Animal Welfare Act, as well as in peer-reviewed articles.
Perhaps we should consider obtaining input from the scientists that use NHP to summarize the overall scientific intramural and extramural portfolio and thecontinous effort in animals enrichment programs
NIH was asked “to conduct a review of its ethical policies and processes with respect to nonhuman primate research subjects, in consultation with outside experts, to ensure it has appropriate justification for animal research protocols” [emphasis added]. We have concerns that this intention is not being addressed based on language present in the NIH workshop announcement, which presumes that “the oversight framework for the use of non-human primates in research is robust and has provided sufficient protections to date.” NIH should not begin the process of review with the assumption that nonhuman primate experimentation is justified. This workshop was scheduled because a review of maternal deprivation studies, prompted by experts and animal advocacy organizations, resulted in research protocols being modified and procedures eliminated. Congress, in requesting this review, intends that NIH conduct a careful examination of current nonhuman primate use that includes bioethicists and primate behaviorists. This workshop should include an examination of the kinds of research that use primates, current ethical policies and processes, the number and source of primates, the direct and indirect costs, and an examination of alternatives to the use of primates. The statements of all participants, findings and recommendations should be made public. NAVS recommends that the following experts participate in the workshop: David DeGrazia Brian Hare Steven Ross Adam Shriver Thank you for your consideration. Peggy Cunniff National Anti-Vivisection Society
I understand Congress requested a nonhuman primate ethics review from the NIH. However, when I go to the link in this announcement about their request, the link just leads me to a general page for Congress with no relevant information. NIH, can you please update this link with the pertinent text and background information, so that the public has a comprehensive understanding of this workshop? The link which needs to be updated is found in the near end paragraph of this announcement under "in response to Congressional interest". Thank you.
People for the Ethical Treatment of Animals (PETA) asks that the National Institutes of Health (NIH) take immediate action to ensure that its September 7, 2016, workshop on the use of nonhuman primates in NIH-funded biomedical and behavioral experimentation will fulfill the mandate explicitly outlined in the Consolidated Appropriations Act, 2016 and requested by U.S. members of Congress. If the workshop will serve only to maintain the status quo, NIH will be squandering a critical opportunity to strengthen protections for nonhuman primates and eliminate studies that aren’t contributing to the body of useful scientific knowledge. NIH Director Dr. Francis Collins has himself acknowledged the need for additional scrutiny of primate research proposals, and NIH bioethicists have called for restricting primate research. In light of the controversial maternal deprivation and psychopathology experiments on infant monkeys that had for more than 30 years received approval from the National Institute of Child Health and Human Development oversight body and been carried out at NIH’s facility in Poolesville, Md., Congress added language to the Consolidated Appropriations Act, 2016 that called on NIH “to conduct a review of its ethical policies and processes with respect to nonhuman primate research subjects, in consultation with outside experts, to ensure that it has appropriate justification for animal research protocols.” In January, members of Congress wrote to Dr. Collins to request his “personal involvement in ensuring that this review is productive and comprehensive.” In his February 17, 2016, response, Dr. Collins stated that the NIH would “convene a workshop in the summer of 2016 to review the ethical policies and procedures associated with the conduct of … research [with non-human primates]” and confirmed that this meeting “will include outside experts in animal health and welfare, to ensure that NIH has the appropriate policies and procedures in place for conducting research with non-human primates.” Yet the recently posted draft agenda for the workshop appears to show a disregard for the original directive of the Consolidated Appropriations Act. It appears that the first of the two sessions, “State of the Science of NIH-Supported Research Involving Non-Human Primates,” focusing on questions such as “How do non-human primates uniquely contribute to our understanding of basic biological processes and disease states?” and “What are the emerging scientific opportunities and/or public health needs for which non-human primate research models may be required?,” will be fully dedicated to extolling the use of nonhuman primates in experiments—something that is entirely outside the review mandated by the Consolidated Appropriations Act. The second session, “Oversight of NIH-Supported Research Using Non-Human Primates,” which includes as one of three group discussion questions “How does the current oversight framework address ethical and welfare concerns using non-human primates in NIH-supported research?” would appear to be an effort to legitimize the false notion that current practices are adequate to protect nonhuman primates used in experimentation. These are issues the panel should address: Primates are used in studies with little or no public health implication and that are unlikely to translate to humans and/or for which alternatives exist. Primates are subjected to painful experiments, sometimes without pain relief. Standard laboratory housing for primates lacks sufficient space, meaningful cognitive stimulation, and adequate social contact, causing significant psychological and physical distress. Thousands of primates are singly-housed, often without adequate scientific or veterinary justification. We suggest that the NIH rules instituted to reform chimpanzee experimentation may address problems with all nonhuman primate research. Specifically, NIH’s chimpanzee research criteria state that (1) knowledge gained must be necessary to advance public health, (2) no other research model could be used, and the research cannot be ethically performed on humans, and (3) the animals used must be maintained either in ethologically appropriate environments or natural habitats. We therefore ask that you take immediate action to radically revise the current agenda to bring it in line with the mandate of the Consolidated Appropriations Act and the request of the members of Congress. We also ask that you release the names of the workshop participants. If fair and balanced, this workshop can help ensure that primate experimentation rules are updated to reflect the current science on animal welfare, research translation, and non-animal methods.
Where is the workshop being held and can any and all attend?
After reading the draft agenda for the nonhuman primate workshop, the National Anti-Vivisection Society(NAVS) feels it necessary to reiterate concerns we had previously expressed. The NIH workshop, in its current form, does not align with the intent of Congress, which requested that the NIH “conduct a review of its ethical policies and processes with respect to nonhuman primate research subjects, in consultation with outside experts, to ensure it has appropriate justification for animal research protocols and to provide an update on these efforts in the fiscal year 2017 budget.” Instead the NIH has organized a workshop based on the assumption that nonhuman primate experimentation is justified. Discussion questions on the agenda are biased. “How do non-human primates uniquely contribute to our understanding of basic biological processes and disease states?” presumes that non-human primates make unique contributions. When the chimpanzee model was similarly assessed to determine its “necessity,” chimpanzees were deemed not necessary, only after the presumption of necessity was removed by a bioethicist. For the NIH workshop to fulfill its purpose as intended by Congress, it should discuss: • Whether current research on nonhuman primates is justified in its endpoints; • Whether ethical considerations are given sufficient weight, given the phylogenetic proximity of nonhuman primates to humans; and • Whether animal welfare is adequately considered prior to and during the approval process for research protocols. It is our hope that this draft agenda is merely a working copy and will be modified to address the concerns of Congress. Thank you. National Anti-Vivisection Society
Greetings, I applaud everyone's efforts to review the ethics practices at NIH. I have some feedback I would like to share, with any open-minded person. 1) I would like to second PETA's concern that the objective of the review is in danger of not being met. It is incorrect to make the assumption that current NIH practices are already ethical, and that the review is a forum for distributing justification. 2) Please be aware that the most central term in the review, the word "ethics", is poorly defined at best. You must agree on a working definition early on if you are hoping to make progress. 3) I can find no reasonable working definition for the word "ethics", that justifies any person taking the life of any living creature. The reason for taking the life is _irrelevant_ in this case. Intentionally taking life is theft of the highest degree, known as 1st Degree Murder in the western legal system. Even if you believe you are doing the human race a net good by taking the life of innocent beings (possibly in the name of "science"), you still cannot construe that in any reasonable way into an ethical act. If you can make the claim that killing is "ethical", than either your word "ethics" is meaningless, or your entire legalese and language are meaningless... Because "Ethics" is meant to prevent such acts from occurring, not justify them. Ethical killing is at best an act of mercy, but these animals have asked for no mercy. 4) It is a tragedy that in an intelligent discussion of a subject so critical to civilization as "ethics", that the two most important stakeholders of the discussion are either not present at all, or barely present at the last moment, to make censored comments which cannot be responded to. 4a) Let me dig deeper. The very animals who are forced to sacrifice their lives, have no representation. Why? They are not compensated for their ultimate sacrifice, they are not even acknowledged. Let us "see" what NIH "ethical" practices look like from the eyes of its victims. Unfortunately you cannot do that. Wait, you can. YouTube exists, and we can do a few cursory queries to "see" what "ethics" looks like from behind the closed doors. It looks more like "evil" to me than "ethics". 4b) Lets go deeper. Where is the taxpayer represented? The taxpayer, the investor, the guy who pays the bill. Why is his/her opinion and definition of "ethics" not being factored? As a taxpayer, I feel I have been left out of this discussion, much like I am left out of _every_ government level discussion. The NIH is pinnacle of taxpayer funded medical research. Not private moneys, but public moneys. You have an ethical duty to involve taxpayers in your discussions, regardless of what the house and senate require you to do by law. I seriously question any understanding of ethics now, if stakeholders are not represented well and fairly. This does not appear to be a fair lineup. 5) As an intelligent, aware individual, who uses the internet actively to research facts and data, and leverages YouTube, WikiPedia, journals, papers, etc... And generally tries to come to informed understandings of situations... 5a) I cannot think of a single animal sacrificed life that has led to any medical advancement that has helped any human whatsoever BEYOND the harm that human industrialization and expansion has itself caused. SPECIFICALLY, none of your animal testing can save man from man-made cancers such as (and not limited to) cancers caused by petroleum based pesticides, GMOs, bovine growth hormones, hormones in general, lead in water supplies, inhalation of asbestos, smoking tobacco, and the list goes on and on. It would be pretty reasonable to think that all of the leading causes of death in the US are related to/caused by either toxic environments or food. That is to say, these top health issues are all things we already have reasonable control over, all the way from diabetes to cancers to you name it. Anyone who claims otherwise is part of the industry or in some other way profiting. 5b) As a taxpayer, if you want to improve health outcomes, instead of torturing and murdering animals, you could: - regularly test all american tap water for poisonous lead levels - educate consumers about the fact that pesticides are quite close to gasoline - educate consumers that GMOs involve modifying the DNA of their food, which has unknown outcomes on their own DNA, and that DNA is essential to life - you could even have prevented the US Surgeon General from endorsing cigarettes to the US citizens, or you could have outright had the US Surgeon General not lie 6) I would like you to realize that the reason you do not sense levity in my prose is because there is none. You do not realize that this is in fact a situation of Life and Death. You do not realize this because it is not _your_ life on the line. Please remember that. Increase your consciousness. Seek to understand compassion and empathy, and realize that you cannot improve the human condition by acts of murder and torture. No logical reasoning can help you make that argument. You simply commit evil acts which don't prevent people from contracting man-made illness. 7) In summary, I am well informed, well educated, and well aware that there has been little real provable medical progress in last 50 years. Data shows clearly epidemic level growth of Alzheimers, Cancers of all types, heart disease, >75% clinical depression in US metro areas, antibiotics are almost useless, and I could go on. US Cancer survival rates, specifically, are appalling to boot, despite so called progress. I don't need to bring up the apparent challenges that some US scientists have in non doctoring their statistical data, or simply incorrectly interpreting data. Data is not on your side. Many of these practices are only still existing because of... drum roll... lack of oversight. The state of the US medical industry is tantamount to fraud of the american people. 8) I challenge you to PROVE that your acts of torture and murder have done more benefit per taxpayer dollar than if you did simple things like keep america's water from containing lead, or letting taxpayers know that their food is covered in poison (many dont know that). Anyone who accepts this challenge, I am happy to meet with online personally, or if possible in person. I am a Computer Scientist, an informed taxpaying citizen, and do not believe that the NIH can justify animal torture (or even its own existence), given a clear understanding that the real US health concerns DO NOT have their solutions in the domain of western medicine. They have their solutions in the domains of common sense and education. And I don't profit from making any of these statements. Thank You for Your Time, Ian
You have examples by European agencies regarding using primates for testing. Use those guildes instead of making the animals you have suffer!
Representatives from NIH have a vested interest in keeping alive their pro animal torture agenda. Please present a balanced view by including scientists that do not benefit financially from supporting NIH. It would also behoove NIH to videotape their experiments and put them on social media for all to enjoy, since the NIH scientific community are so proud of their results and consider their work ethically responsible.
A recent NYT opinion piece written by John Gluck, professor emeritus of psychology at the University of New Mexico, faculty affiliate at the Kennedy Institute of Ethics, and former animal researcher, disputes the NIH claim that laboratory animals are essential to research. "Like many researchers, I once believed that intermittent scientific gains justified methods that almost always did harm ... What did I learn from my research? ... There is no research more valuable than our own integrity and ethical coherence, and our treatment of animals is a direct reflection of our values toward life and one another." http://www.nytimes.com/2016/09/04/opinion/sunday/second-thoughts-of-an-animal-researcher.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-right-region&region=opinion-c-col-right-region&WT.nav=opinion-c-col-right-region&_r=0 That panel needs representation from bioethicists and members of the animal rights community who can speak on behalf of the animals.
NIH appears not yet to have taken account of how major public funders of NHP research in other countries - such as those in another scientific ‘superpower’, the UK - address the issues. The UK's national centre for the 3Rs (NC3Rs), Medical Research Council and Wellcome Trust have developed procedures and initiatives that support excellent science using NHPs and proper/effective implementation of the 3Rs (and the advancement of both), helping to assure public confidence. Isn’t this what Congress and NIH wants? I hope there will be more focused discussion of NIH policies and procedures in this area; whilst the talks are interesting, it’s not at all clear how the workshop format will advance primate welfare and scientific discovery in the USA. I would be very happy to share information on our initiatives and experiences offline (around peer review, targeted research funding, training opportunities, resources).

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Under The Poliscope: Bringing Science Policy Into Focus
Dr. Carrie D. Wolinetz

Carrie D. Wolinetz, Ph.D.
Associate Director for Science Policy, NIH

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