COUNCIL OF COUNCILS
Summary of Public Comments from February 2012 RFIs
Summary of Public Comments from February 2012 RFIs to Inform the Working Group’s Deliberations
National Institutes of Health Request for Information:
Input into the Deliberations of the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research
In February 2012, the National Institutes of Health (NIH) issued two requests for information (RFIs) seeking public input into the deliberations of the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research. The purpose of the RFIs was to obtain broad input on issues underlying NIH’s implementation of the recommendations made by the Institute of Medicine (IOM) in their report“Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity” and subsequently accepted by the NIH. The first opportunity for public input was published in the NIH Guide for Grants and Contracts on February 10, 2012, as Notice number OD-12-052 (NOT-OD-12-052). An identical, second request was published in the Federal Register on February 23, 2012 to reach out to members of the public not typically reached through the NIH Guide for Grants and Contract. This document summarizes the comments received in response to both RFIs.
In December 2010, the NIH commissioned a study by the IOM to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. Specifically, the IOM committee reviewed the current use of chimpanzees for biomedical and behavioral research and explored contemporary and anticipated future alternatives to the use of chimpanzees in biomedical and behavioral research that will be needed for the advancement of the public’s health. The IOM issued its findings on December 15, 2011, with a primary recommendation that the use of chimpanzees in research be guided by a set of principles and criteria. The committee proposed three principles that must all be applied to analyze current and potential future research using chimpanzees.
1. That 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 (i.e., as would occur in their natural environment) or in natural habitats.
Based on its deliberations, the IOM committee concluded that “while the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary.” The committee also concluded, however, that the following areas may continue to require the use of chimpanzees: a limited number of ongoing studies on monoclonal antibody therapies, research on comparative genomics, and non-invasive studies of social and behavioral factors that affect the development, prevention, or treatment of disease.
The committee was unable to reach consensus on the necessity of the chimpanzee for the development of prophylactic hepatitis C virus vaccine. While the committee encouraged the NIH to continue development of non-chimpanzee models and technologies, it acknowledged that new, emerging, or re-emerging diseases may present challenges that may require the use of chimpanzees.
The NIH Director decided to accept the IOM recommendations and announced that the NIH was in the process of developing a plan for implementing the IOM’s guiding principles and criteria. This plan involved assembling a working group within the NIH Council of Councils to provide advice on the implementation of the recommendations, and to consider the size and placement of the active and inactive populations of NIH-owned or -supported chimpanzees. On February 2, 2012, the Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research officially charged to:
- Develop a plan for implementation of the IOM’s guiding principles and criteria;
- Analyze currently active NIH-supported research using chimpanzees to advise on which studies currently meet the principles and criteria defined by the IOM report and advise on the process for closing studies if any do not comply with the IOM recommendations;
- Advise on the size and placement of active and inactive populations of NIH-owned or-supported chimpanzees that may need to be considered as a result of implementing the IOM recommendations; and
- Develop a review process for considering whether potential future use of the chimpanzee in NIH-supported research is scientifically necessary and consistent with the IOM principles.
The NIH subsequently requested public input through two RFIs to inform the Working Group’s deliberations on actions the NIH can take to implement the IOM recommendations and to consider the size and placement of the active and inactive populations of NIH-owned or -supported chimpanzees.
Summary of Comments
One-hundred ten (110) comments were received in response to the RFIs. Twenty-three (23) comments were submitted on behalf of organizations while eighty-seven (87) were prepared on the submitter’s behalf, or “self”. Fifty-six (56) respondents submitted identical information (i.e., a form letter). The remaining 54 comments were considered unique and were summarized.
RFI Comment Topic #1: Developing a plan for implementation of the IOM’s guiding principles and criteria
Respondents expressed considerable support for the IOM process, the recommendations that resulted, and the NIH’s immediate acceptance of the criteria and principles for the use of chimpanzees in research. Commenters agreed that the use of chimpanzees in biomedical and behavioral research should be governed by an additional set of standards, and the reliance on chimpanzees in research should be reduced and, if possible, eliminated altogether. Differences of opinion surrounded the proposed timing to reduce their use. Some suggested immediately ceasing all research involving chimpanzees, stating that this animal model is entirely unnecessary and/or has been replaced by other methods. Others proposed to continue using chimpanzees to study specific conditions permitted by the IOM report and phase out areas of research where the chimpanzee is not necessary. It was universally accepted, however, that the housing for any chimpanzee, whether used in research, inactive, or retired, be consistent with the highest standards of care and living environments. Others believed that the Working Group should consider the ethical implications of research using chimpanzees.
Some respondents suggested that the Working Group’s charge also include the option for chimpanzee retirement. Because the Working Group was charged with advising on the size and placement of active and inactive populations of NIH-owned or-supported chimpanzees that may need to be considered as a result of implementing the IOM recommendations, the size and placement of retired animals is outside the purview of the Working Group. However, given the number of commenters that raised retirement as a concern and interest, those remarks are summarized in RFI Comment Topic #3.
Some commenters encouraged the Working Group to consider the financial, personnel, and other resources would likely be needed to implement the recommended oversight process, funding for alternative in vivo and in vitro models, and costs to implement recommended care and housing standards. To the extent that certain types of research would continue, respondents noted that budget support would be needed to address the bolstered psychological and physical welfare of the animals. Several commenters proposed that stopping research with chimpanzees would enable the NIH to divert those resources toward alternative models. Commenters also urged the Working Group and the NIH to increase investments in finding alternatives to the chimpanzee model.
RFI Comment Topic #2: Factors to consider in reviewing currently active NIH-supported research using chimpanzees to advise on which studies currently meet the principles and criteria defined by the IOM report and advising on the process for closing studies if any do not comply with the IOM recommendations. For example: Criteria to assess “minimally invasive” procedures for comparative genomics and behavioral research and “ethologically appropriate” physical and social environments; Criteria to balance phasing out of the existing research without causing “unacceptable losses to research programs” or an unacceptable “impact on the animals”.
The IOM report states, “The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments (i.e., as would occur in their natural environment) or in natural habitats.” Due to the uncertainty of the term “ethologically appropriate” environments, the NIH requested input on how to assess such environments.
Respondents universally were supportive of the concept of “ethologically appropriate” environments to more fully enhance the physical and psychological needs of chimpanzees. Commenters discussed the applicability of existing standards set forth by the Animal Welfare Act and various housing and environment practices as enforced by accrediting entities. Many stated, however, that “ethologically appropriate” sets a higher bar for chimpanzee habitats than existing laws and/or regulations.
Concerns surrounding the term “ethologically appropriate” pertained mainly to it lacking a definition and that, as a new concept, may not be fully represented in the terminology or site visit standards of the accrediting organization, the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), or the agency charged with federal oversight, the U.S. Department of Agriculture (USDA). Many commenters stressed the importance of defining and operationalizing “ethologically appropriate” because, by itself, the concept is subjective. Rather than provide a definition for “ethologically appropriate”, several respondents instead proposed a range of characteristics to help resolve ambiguity surrounding the term. Suggestions included:
- Accreditation from AAALAC and registration with USDA
- Environments that facilitate foraging and nesting behavior; traveling, climbing, and brachiating
- Enrichment programs that support chimpanzee problem-solving behaviors
- Social housing that supports the social needs of captive chimpanzees, including conspecific social
- Socially compatible grouping with a minimum group size of at least three chimpanzees to more closely approximate the size of wild chimpanzee communities. Pair housing when an animal does not do well in a group
- Space for subgrouping behavior, i.e., fission-fusion social rhythm of chimpanzees
- Inside and outside housing with daily access to outside environment
- Environment free of threat or a spatial opportunity to escape threats
- Mixed age and gender groups
Another commenter suggested that the Working Group consider AAALAC accreditation as sufficient evidence that appropriate environments are provided.
Minimally Invasive and Acquiescence
With respect to comparative genomics and behavioral research, the IOM recommended that “All experiments are performed on acquiescent animals, using techniques that are minimally invasive, and in a manner that minimizes pain and distress.” Some commenters proposed that the Working Group defer to the definition of invasive research as written in the proposed draft of the Great Ape Protection and Cost Savings Act, which states: “The term ‘invasive research’ is defined to include any research that may cause death, injury, pain, distress, fear, or trauma to a great ape.” Some respondents characterized invasivity as including methods to induce sedation, surgeries, implantation or attachment of devices, removal from “ethologically appropriate” environments or natural habitats for research purposes, and removal of blood or tissues other than what is necessary during prescribed examinations or procedures to monitor or maintain the health and well-being of the chimpanzee. Another respondent proposed to align the concept of invasive procedures with the Animal Welfare Act’s definition of major surgery, i.e., invading a body cavity. Minimally invasive procedures, in general, would be those conducted in human medicine on an outpatient basis.
Others suggested that “minimally invasive” could be described as a procedure that does not permanently alter the anatomy or physiology of the chimpanzees, such as blood collection, imaging procedures, and behavioral studies. It was suggested that some limits be placed on sedation, including the number of times a chimpanzee can be anesthetized per year for research purposes, the duration of sedation, and scheduling tests requiring anesthesia to coincide with the annual exam. Some suggested that certain laboratory tests could be minimally invasive and conducted on acquiescent animals if the chimpanzee voluntarily presented for blood draws and accepted injections for anesthesia – something that would benefit both the annual veterinary check-ups and imaging studies, for example.
RFI Comment Topic #3: Factors to consider when advising on the size and placement of active and inactive populations of NIH-owned or-supported chimpanzees as a result of implementing the IOM recommendations. For example: Ways to address capacity issues that would accompany an increase in ‘inactive’ animals; Factors to consider in transitioning the animals that are newly inactive; How many and what would be the characteristics of animals held in reserve for future research, if any; The number of animals needed to maintain a viable number of research naïve animals but also genetic and social stability and sufficient diversity for unanticipated research needs.
For purposes of this summary, the NIH clarifies that “active” means the chimpanzees are needed for current research projects that fit the IOM criteria. In comparison, “inactive” means the animal is not currently needed for research but may be needed for new projects that fit the IOM criteria. “Retired” means the chimpanzee is no longer needed for research.
Some respondents remarked that all chimpanzees should be retired immediately and not held in reserve for future research. Others were supportive of a limited number of “inactive” animals and diminishing numbers in “active” status. In the limited circumstances when chimpanzee use would be permissible, it was suggested that NIH-funded investigators take steps to increase the quality of life of laboratory-housed animals by working with organizations that specialize in these matters. In addition, it was recommended that facilities housing chimpanzees for biomedical research should document animal-specific plans that limit the prolonged and repeated use in research protocols, and specify plans for their retirement. In addition, ongoing and regular review of the research should be conducted to assess alternative methods or models that may have emerged since the last approval.
Respondents largely were unsupportive of keeping a reserve of chimpanzees available for research; however, some were amenable to an “inactive” population if a plausible need exists and if the laboratory environment can be made more akin to the chimpanzees’ natural habitat, in effect “ethologically appropriate”. See Future Research.
Retirement from Research
Some commenters recommended the creation of a committee to oversee, in a transparent fashion, the retirement of chimpanzees from NIH-funded research. Respondents encouraged the Working Group to recommend a national chimpanzee management system unaffiliated with the NIH to oversee the transition of chimpanzees out of medical research laboratories and into sanctuaries. Responsibilities of this committee would include determining which chimpanzees are eligible for retirement based on pre-defined criteria, such as:
- Age of chimpanzee
- Medical and psychological status
- Number of years in research
- Anticipated medical and social needs after retirement which could affect the place of retirement
Proponents of retirement mostly advocated for moving chimpanzees to sanctuaries that are inspected by the USDA and accredited by AAALAC. Most commenters lauded the sanctuary environment as a model ethology for the chimpanzee, providing ready and often unrestricted access to a foraging and forest environment, social groupings, and opportunities to exercise decision-making (making choices). However, some voiced concerns about the staffing and infrastructure currently available to care for animals with chronic conditions (e.g., HIV and advanced diabetes) and other special health and housing needs. Others expressed concerns about insufficient capacity in existing sanctuaries to house a considerable influx of newly retired animals, and new facilities would be needed to house chimpanzees retired from research and relocated to sanctuaries. Others expressed confusion over which federal laws and regulations apply to sanctuaries.
Several commenters expressed dissatisfaction with the option of retiring the chimpanzee “in place” (i.e., in the laboratory environment) versus retirement to a sanctuary largely due to concerns that the laboratory enclosures would not be “ethologically appropriate.” Others expressed that laboratory facilities, to the extent that they are not currently “ethologically appropriate”, could take steps to to improve the housing and well-being of the chimpanzees. This approach could be an alternative to retiring the animals to a sanctuary. Some contended that the veterinary and diagnostic capabilities of the research laboratories are superior to those of sanctuary environments and could offer better health care to aging and possibly ill chimpanzee populations.
The IOM report suggested that 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.” The NIH asked for input on the number and characteristics of animals held in reserve for future research, if any, and the number of animals needed to maintain a viable number of research naïve animals but also genetic and social stability and sufficient diversity for unanticipated research needs. To the extent that a reserve colony is needed, it was suggested that retaining animals with breeding potential (e.g., proven breeder, good mother, mother reared, socially housed) would help maintain a self-sustaining population. It was suggested that one small colony, possibly ages ten to 20 years old should be retained for a brief period (e.g., five years). Other commenters separately suggested that the requirements for conducting invasive research mirror those of the Chimpanzee Health Improvement and Maintenance Protection Act (P.L. 106-551). That is, offer a public comment period and Department of Health and Human Services Secretarial approval for such research.
In contrast, many commenters stated that no future research on chimpanzees is necessary, and therefore, holding a reserve population for future research is similarly unnecessary. If all chimpanzees owned by the NIH are retired, one commenter suggested that chimpanzees owned by private entities (not the NIH) could be made available for future research.
Several respondents remarked that some sanctuaries permit scientists to utilize excess specimens collected from annual veterinary check-ups and necropsy tissue for research. In addition, observational research reportedly can be conducted at some sanctuaries. The Working Group was asked by one respondent to consider allowing researchers liberal access to sanctuary populations of chimpanzees for specimen and behavioral research, should it recommend retiring some animals to sanctuaries.
RFI Comment Topic #4: A review process for considering whether potential future use of the chimpanzee in NIH-supported research is scientifically necessary and consistent with the IOM principles. For example: Factors to consider in determining whether other models (e.g., in vitro, other in vivo) would be a “suitable model” for answering the research question; Research areas where alternative model development is recommended; Whether NIH should have a plan to maintain a minimal population of federally-owned chimpanzees and input on the design of the plan; Circumstances under which chimpanzees should be considered as a model for “a new, emerging, or reemerging disease or disorder that may present challenges to treatment, prevention, and/or control that defy non-chimpanzee models and available technologies"; Characteristics of the oversight committee responsible for reviewing future research proposals and determining whether they are consistent with the IOM criteria and whether they can be conducted.
Review Committee for Future Research
The IOM report recommended 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…” Several commenters proposed characteristics of the oversight committee responsible for reviewing future research for compatibility with the IOM criteria. Suggestions included developing a process that is transparent (i.e., open to the public and/or having a public comment period), able to be completed quickly, have committee membership composed of individuals without a personal or institutional conflict of interest, and have membership representing the following disciplines:
- Laboratory animal veterinarian for chimpanzee-specific medical and behavioral needs and to advise on the likely health effects of the research during and after the study
- Primatologist to advise on chimpanzee colony size and maintenance
- Bioethicist and member of an Institutional Review Board to provide input on the ethics of conducting the proposed research in humans
- Public health official to advise on whether foregoing the use of chimpanzees in research would result in significant delays in making medical advances for life-threatening or debilitating conditions
- Statistician to advise on the statistical power of the number of animals proposed for use
- Technologists and other experts in alternative methods and models
- Virologist to advise on Hepatitis C virus biology
- Immunologist with expertise in monoclonal antibody development
- Social scientist/neuroscientist for insights into whether proposed behavioral research would provide unattainable insights into behavior, mental health, emotion, or cognition
- Geneticist specializing in comparative genetics and transgenic models
- Patient advocates representing areas of research proposed for study
- Member of the public
Another respondent recommended having a Chimpanzee Institutional Animal Care and Use Committee (IACUC) at the national or regional level to oversee their research use. Some commented that the existing NIH scientific peer review process could serve to review research applications proposing to use chimpanzees in research because the vertebrate animal section of grant applications could contain the requested details. As an outcome of these reviews, one commenter suggested that if an application is denied because alternatives exist, the investigator may need options for learning how to utilize the alternative model or method.
Respondents were universally supportive of exploring alternative methods for studying diseases and conditions and emphasized the importance of continuing to study, develop, and commit resources to finding alternatives to the chimpanzee model. Several commenters who discussed alternatives also remarked that the development of new or novel methods might be hampered by continuing to use chimpanzees in research, suggesting that there would be little incentive to find alternatives so long as the chimpanzee model is available. Others posited that suitable alternative models are already currently available and should obviate the need for any further research using chimpanzees, even in the areas the IOM suggested were appropriate to continue. Several commenters suggested making available to researchers and the review committee a reference list of suitable alternatives for the chimpanzee model.
Some respondents debated the conclusions of the IOM report with respect to the Hepatitis C virus and monoclonal antibodies, asserting that chimpanzees are not a good model of human disease and existing alternative methods and models obviate a role for chimpanzees in research. Others stated that chimpanzees cannot give informed consent, and therefore, should not be used in research. In contrast, several others presented comments strongly favoring the use of chimpanzees to study the Hepatitis C virus, for example, and offered additional rationale as to why this research should be continued.
One commenter disagreed with the NIH Guide Notice announcing the policy on the NIH Research Involving Chimpanzees (NOT-OD-025), suggesting that the NIH should accept and review grant applications proposing to use chimpanzees in research pending the establishment of the formal oversight process. It was speculated that disallowing grant application review in the interim penalizes the investigator seeking NIH funding.
Several comments were largely supportive of research involving stored biological samples, specimens collected passively from the chimpanzee habitat (e.g., feces), specimens resulting from annual veterinary check-ups, and observational research where no interaction with the chimpanzee takes place. One commenter was opposed to obtaining new material for research without scientific justification as to why the existing and stored materials are unsuitable.
This page last reviewed on November 12, 2013