8

Summary of Workshop Topics

The topics highlighted in this chapter are based on closing remarks made by each of the session chairs during the final session. Additional comments by session participants that related to those closing remarks were included as noted. Comments should not be construed as reflecting on any group consensus or endorsement by the Institute of Medicine.

SESSION I: INTERNATIONAL ANIMAL RESEARCH REGULATIONS

Global Harmonization

Well-established regulatory systems in the United States and European Union may seem disparate at first, but various speakers noted, this is due more to different terminology than to real differences in principles and outcomes, session chair Judy MacArthur Clark observed. For example, it was discussed that the United States has no standardized animal study proposal form comparable to the UK project license form. However, what must be included in protocols submitted for Institutional Animal Care and Use Committee (IACUC) approval is standardized. Institutions have the flexibility to adapt forms and systems to the intricacies of their own animal research program as long as they meet the standards required by regulation.

Emerging systems, such as those in Brazil and across Asia, are learning from both the successes and challenges of established systems. MacArthur Clark suggested that international collaborations and multinational companies are helping to drive regulations and raise standards in emerging regions, and contribute to global harmonization.



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8 Summary of Workshop Topics The topics highlighted in this chapter are based on closing remarks made by each of the session chairs during the final session. Additional com- ments by session participants that related to those closing remarks were included as noted. Comments should not be construed as reflecting on any group consensus or endorsement by the Institute of Medicine. SESSION I: INTERNATIONAL ANIMAL RESEARCH REGULATIONS Global Harmonization Well-established regulatory systems in the United States and European Union may seem disparate at first, but various speakers noted, this is due more to different terminology than to real differences in principles and outcomes, session chair Judy MacArthur Clark observed. For example, it was discussed that the United States has no standardized animal study proposal form comparable to the UK project license form. However, what must be included in protocols submitted for Institutional Animal Care and Use Committee (IACUC) approval is standardized. Institutions have the flexibility to adapt forms and systems to the intricacies of their own animal research program as long as they meet the standards required by regulation. Emerging systems, such as those in Brazil and across Asia, are learning from both the successes and challenges of established systems. MacArthur Clark suggested that international collaborations and multinational com- panies are helping to drive regulations and raise standards in emerging regions, and contribute to global harmonization. 71

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72 INTERNATIONAL ANIMAL RESEARCH REGULATIONS Costs Bureaucracy in regulatory systems is a challenge shared by those involved in animal research; however, it may be more of a hindrance in some countries than others, MacArthur Clark noted. Regulatory systems have costs that include finances and time for regulators and scientists (i.e., administrative burden). Some participants noted the need to reduce bureau- cracy that could impact the progress of science. Several participants noted that opening a dialogue with the public and politicians about the scientific process, the role of animals in research, and the animal research regulations in place would be beneficial. Other par- ticipants noted the need to develop appropriate goals/metrics of success of animal welfare measures to ascertain whether increased costs and burdens result in improved animal welfare. SESSION II: FREEDOM OF INFORMATION LAWS Session chair Arthur Sussman observed that there seems to be strong support among workshop panelists and participants for a regulatory envi- ronment that is both ethical and intelligent. In addition to regulations specifically governing the use of animals in research, various participants noted that other laws impact research (e.g., animal rights laws, the Freedom of Information Act [FOIA], state sunshine laws, and the False Claims Act). Several presentations discussed how individuals and groups are using FOIA and sunshine laws to obtain information on principal investigators, grants, and matters of noncompliance. In some cases, session speaker Richard Cupp noted that the courts have found connections between release of information under FOIA and subsequent criminal activity against animal researchers. However, it was noted that exemptions to the release of such information are becoming infrequent. Workshop participants noted that increased transparency might not result in decreased information requests, and that transparency needs to be balanced with potential risk. Several panelists and participants emphasized that the suggestion of exercising care when corresponding about animal use in research might be worth particular consideration by scientists. SESSION III: THE ROLE FOR ANIMALS IN NEUROSCIENCE RESEARCH Much of the discussion on the impact of animal research regulation on neuroscience research focused on the use of non-human primates, noted session chair Roberto Caminiti. Panelists outlined the current role for non- human primates in biomedical research, including neuroscience research.

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73 SUMMARY OF WORKSHOP TOPICS It was noted that primate studies can complement in vitro studies, in silico modeling, human brain imaging, and parallel investigations in rodents. A few participants described how public pressure and politics have phased out certain fields of research in some countries by making it difficult, if not impossible, to study non-human primates. The high cost of using non- human primates was also indicated as creating difficulties in developing this field. Many participants acknowledged, however, that new regulations and laws have produced a significant improvement in animal care, which has led to improved science. Refinements to animal models used in neuroscience have resulted in reductions in the number of animals required for a study, making the use of non-human primates more feasible. Although long-term data collection from an individual animal allows for the use of fewer animals, it includes numerous independent assessments, which have raised the issue of reuse and severity classification. New regulations present a host of challenges for institutions, investiga- tors, and IACUCs. Several participants raised concerns about regulations that result in increased costs of conducting biomedical research, without evidence that additional regulations result in improved animal welfare. SESSION IV: REPLACEMENT, REFINEMENT, AND REDUCTION IN NEUROSCIENCE RESEARCH Session chair Colin Blakemore briefly reviewed the session’s focus on the 3Rs (replacement, refinement, and reduction), the ethical framework for the human use of animals in research. Panelists described an in vitro model of spinal cord injury that replaces the use of animal models and a new model of epileptogenesis that relies on refining previously described techniques. Some participants noted that both of these models have led to the reduction of animal use in experiments. Implementation of the 3Rs principle has a positive impact on improving neuroscience research, noted several participants, as demonstrated by the studies presented. Publication in the peer-reviewed literature is the primary way informa- tion is disseminated in the scientific community. Blakemore observed that a few panelists, however, faced challenges in getting refinements to animal models or replacement methods published, especially when the submitted manuscript proposed to refine or replace an animal model that has been used broadly for decades. Systematic Reviews Some participants discussed how systematic reviews of preclinical data could potentially support the 3Rs, thereby improving the quality of animal

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74 INTERNATIONAL ANIMAL RESEARCH REGULATIONS studies. Participants also noted that systematic reviews provide informa- tion about the validity of preclinical data for advancing therapeutics for humans. The value of a systematic review depends on the quality of studies included. Many participants stressed the need for preclinical animal data to be more accessible, including primary data, precompetitive data, and nega- tive data. Establishing repositories of preclinical data is one approach, and issues of funding, location, oversight, and access were raised. In addition, several panelists and participants called on publishers and journal editors to examine current publication requirements for animal studies in hopes of improving the quality of published studies involving animal models. SESSION V: BUILDING PUBLIC CONFIDENCE Many participants stressed the importance of transparency, or being honest and open with the public about the regulations, laws, and policies that govern the use of animals in biomedical research. Some participants noted that educating the public about the societal benefits of research using animals is important, but potential harms to the animals is often not discussed. Many participants acknowledge that the public may already understand the value of animal studies and their concerns may be focused more on the quality of life of the animals. Explaining how the care and the husbandry of the animals is managed might be of more interest to the public than scientific details of research studies. Scientists Talking Science Session chair Frankie Trull emphasized that scientists have a respon- sibility to inform and educate the public. Several participants noted that neuroscientists may have an additional responsibility to talk more practi- cally and pragmatically about public outreach programs, as neuroscience research involves animal models that may invoke greater public concern. A few participants suggested that government policy makers should hear directly from scientists about the ongoing need for animals in research. It was noted that the patient advocacy community does not generally pub- licize their support of research involving animals for fear of losing donor support. As patients are the ultimate recipients of the benefits of basic and clinical science, a few participants suggested that the scientific community could engage the patient advocacy community to encourage more open discussion.

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75 SUMMARY OF WORKSHOP TOPICS SESSION VI: CORE PRINCIPLES TO ACHIEVE CONSISTENT ANIMAL CARE AND USE OUTCOMES Throughout the workshop many panelists and participants empha- sized the need for animal research regulations that balance quality science, animal welfare, and public confidence. Science must be subject to strong evaluation of experiments and experimental design, observed session chair Richard Nakamura. Key animal welfare considerations are to minimize pain and distress and improve overall well-being. Many participants em- phasized that public confidence stems from the assurance that animals will be appropriately protected and that science will not be inhibited from discovering much-needed solutions to global problems. Nakamura suggested that animal welfare should not be considered in isolation from scientific goals or the larger needs of society. Several par- ticipants stressed the importance of scientific validation of animal welfare practices and standards to ensure that they actually do make a difference in terms of animal welfare. Some panelists and participants said it is also important to consider the overall costs in terms of resources on animal welfare measures. Animal welfare issues are global, and participants urged more discussion among governments, regulators, and scientists to further the understanding of differences in regulation and impacts on animal welfare outcomes. Participants discussed core principles for the regulation of the use of animals in research, asserting that alignment/harmonization of animal research principles may be achieved independent of differing policies or practices. Many participants believe that while there may be a need for recommendations or guidance on specific neuroscience procedures, the core principles by which animal studies should be conducted are the same for any discipline, including neuroscience.

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