L. Syd M Johnson, PhD

The mandate from Congress was for the NIH to “critically evaluate the ethical policies and processes surrounding all nonhuman primate research” and to do so “in consultation with outside experts, to ensure it has appropriate justification for animal research protocols…” This mandate clearly signals an expectation that the ethics of continuing to use nonhuman primates (NHPs) in biomedical research will be up for debate. In announcing its September 7 workshop, the NIH signals it will not examine the ethics of research with NHPs – which would reasonably include considering whether such research can be justified at all — but will rather maintain the status quo and evade the Congressional mandate with respect to the use of NHPs. This intent is clearly indicated in the blog post “Ensuring Continued Responsible Research with Non-Human Primates,” which maintains that current welfare regulations are adequate, and that the continuation of NHP research should be ensured, based on past (sometimes long past) contributions to science.

The NIH appears unwilling to engage in critical self-reflection or ethical discussion, or to consider the actual meaning of “responsible research.” Given current, well-supported empirical evidence about NHPs, it cannot be responsible or ethical to rely on outdated, poorly informed animal welfare regulations, or to justify NHP research by looking to the past. The NIH must be impartial and forward-looking, both in its science and its ethics, so that it might support the best biomedical research and maintain the highest ethical standards. This mandate is an opportunity for the NIH to do both, by convening ethicists – as the IOM did in its report in its 2011 report on chimpanzees – to participate in honest, impartial discussion of ethical and responsible science involving NHPs.

L. Syd M Johnson, PhD
Department of Humanities, Michigan Tech

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The NIH Previously Acknowledged Questions About Expanding the Chimpanzee Report to Other Species, But Did Not Respond

In their “Announcement of Agency Decision: Recommendations on the Use of Chimpanzees in NIH-Supported Research,” the NIH included a large section of questions and responses.  Oddly, however, in one section, they included a question that asked about expanding the findings of the chimpanzee report to other species, but ignored this question in their response.  On page 34 of the announcement, the NIH included the following multi-part question:

NIH_IOM_Question

Their response, however, addressed only the question of whether this could apply to the private industry and private laboratories.  They did not address the “Other Animal Models” section of the question at all:

0000001_NIH_Chimp_Response

Nothing major to say here…just noting that it was odd that they decided to include the question but then didn’t attempt to address it.

Amber Barnes, AAVS

We endorse the request by Congress for the NIH to “review ethical policies and processes for appropriate justifications” for research involving NHPs. We commend the NIH for seriously considering this important matter.

However, we question whether the discussion questions listed in the agenda will adequately address the request to review NIH ethical oversight. In particular, the current questions listed for the second group discussion are factual descriptions that could be covered during the preceding presentation. Questions that elicit more valuable information and international insight, and better align with Congressional intent, should be considered.

We recommend the questions, 1. “What is the global state of ethics and new thinking about animals, and how can we apply this to the use of NHPs in research?” 2. “Given the cognitive abilities of and capacity for suffering in NHPs, is there a need for additional levels of review beyond IACUC and NIH committees to consider ‘justification’?” 3. “Could review by a multi- disciplinary team, particularly ethicists, provide more rigorous assessment?”

Dr. Wolinetz’s blog stated, “periodically reviewing agency policies and processes ensures that this framework (referring to welfare measures) evolves in a manner consistent with emerging scientific opportunities and public health needs.” Yet it must also evolve ethically. Internationally, the field of ethics has made tremendous strides since current policies have been in place. An open discussion and analysis of our evolving ethics and knowledge regarding the cognitive abilities and capacity for suffering in NHPs would be most productive and fulfill the congressional intent.

Amber Barnes, Policy Analyst, AAVS

My Concerns with the NIH Agenda

Here is my comment for the NIH after seeing their draft agenda:

I am writing to express my concern that the draft agenda for the NIH workshop is structured in a manner that fails to comply with Congress’s request. In the original Appropriations Bill Report, Congress asked for the NIH to “conduct a review of its ethical policies and process with respect to nonhuman primate research subjects, in consultation with outside experts, to ensure that it has appropriate justification for animal research protocols.” Asking for a review of procedures to ensure that they have appropriate justification clearly suggests that the workshop needs to address the following question: “are current animal research protocols with primates ethically justified?”

However, the current workshop format is structured in a manner that does not attempt to answer that question. Rather than asking what the appropriate ethical principles underlying primate research should be, the workshop simply asks for a description of what the current policies are and a description of the veterinary science that was used when those policies were first put in place. Moreover, by asking “how” these procedures address welfare concerns, the report assumes, without discussion, that such concerns are addressed, rather than asking if they are addressed, which is what Congress requested.

If the NIH wishes to be in compliance with Congress’s request, the workshop should devote significant amounts of time to discussing different ethical perspectives on primate research, in conjunction with current evidence about primate cognitive and affective capacities, including evidence from studies of primates in their natural environments.

I will also note that the original request from Congress made it clear that they wanted this review to be conducted in conjunction with trained ethicists. While I have heard that at least a couple ethicists have been invited to participate in the discussion, it seems to me that the format of the workshop has been designed in a manner that will minimize their ability to contribute their expertise.

NIH Publishes Draft Agenda

The NIH published a draft agenda for the workshop, which can be found here.

The workshop kicks off with a session titled, “State of the Science of NIH-Supported Research Involving Non-Human Primates.”

It then will hold a discussion on the following questions:

  • Why and how does a researcher decide to use a non-human primate model?
  • How do non-human primates uniquely contribute to our understanding of basic biological processes and disease states?
  • What are the emerging scientific opportunities and/or public health needs for which non-human primate research models may be required?

The only thing resembling a discussion of ethics, from what I can see, is the afternoon session discussion the following questions:

  • What are the policies and processes in place regarding the ethical use of non-human primates in NIH-supported research?
  • How does the current oversight framework address ethical and welfare concerns of using non-human primates in NIH-supported research?
  • What is the laboratory and veterinary science evidence base underlying current welfare standards and practices?

 

Cindy Tait, EMT-P, RN, PHN, MPH

NIH’s workshop to consider current policies and practices related to oversight of research involving nonhuman primates is a step in the right direction. The published plan in which NIH pledged to “catalyze powerful innovations, including molecule cross-coupling methods … and human 3D organoid technologies that will be better than animal models” must become a reality in the very near future.

It is the recommendation of the staff, faculty, and medical board of directors of Center for Healthcare Education, Inc. that:

  1. All primate experimentation be eliminated and replaced with computer/stem cell or other models for non-living animal research 
  2. Researchers be vetted for their motivation for participation – the suffering imposed on any living creature should not be without impunity. This should also include vetting of veterinarians, many who are only looking to build their resumes and/or find gainful employment making the animal’s comfort and physiological needs secondary to their own.
  3. The FDA’s requirements for animal experiments be eliminated or significantly be culled back.

Any animals used in experimentation be given the same protection as humans, i.e., IRB evaluations and full disclosure to the public with 24/7 live cameras on each animal both in its cage during awake, sleep, feeding, and other physiological care. Additionally, video observation of the actual experimentation including the use of chemical and physical restraints, impairing the animal with alcohol/drugs via forced nasogastric tubes, injections, sample taking, and the euthanasia as well as during the necropsy of the animal. The clandestine “behind closed doors” must stop.

Cindy Tait, EMT-P, RN, PHN, MPH
Director, Center for Healthcare Education, Inc.

Nora J. Johnson, MBA, MS, Psy.D.

I am pleased that the NIH is convening a workshop on primate research. I ask that the workshop organizers consider including an agenda item related to the retirement of nonhuman primates to sanctuaries after they have been used in research. I have long been troubled by the fact that in nearly all protocols involving primates, the animals are euthanized—even in cases where the animals’ tissues will not be harvested for analysis following the experiments. It seems that euthanasia is carried out as a matter of expedience, without consideration to the fact that the primates involved could be retired to a sanctuary. At sanctuaries, monkeys would be permitted to enjoy the rest of their days living in socially and environmentally enriched environments, just being monkeys. While relocating nonhuman primates to sanctuaries after they have served in research is the ethically appropriate action in cases where there is no scientific justification for euthanizing the animals at the termination of the experiments, this approach also benefits the morale of laboratory staff and researchers. Grant proposals should include funds for the eventual retirement of monkeys; and the NIH should develop policies aimed at ensuring that costs associated with retiring monkeys to sanctuaries are included in allocated grants.

Kerwin, A. M. (2006). Overcoming the barriers to the retirement of old and New World monkeys from research facilities. Journal of Applied Animal Welfare Science, 9(4), 337-347.

Dr. Nora J. Johnson, MBA, MS, Psy.D., University of Pennsylvania