Building the Case for Science-based Guidelines—Introductory Remarks
Hilton J. Klein
On behalf of the National Academy of Sciences, the National Research Council, and the Institute for Laboratory Animal Research (ILAR), I would like to extend my appreciation to the speakers and all of the attendees for participating in our meeting over the next several days. I especially thank ILAR Council Chairman Dr. Peter Ward, the members of the ILAR Council, and the members of the ILAR Council’s International Committee (Drs. Barthold, Hendriksen, Morton, Nelson, Rissman, and Stokes) for their help in organizing and planning this workshop. It is with sincere gratitude that we thank Dr. Joanne Zurlo, Director of ILAR, Ms. Kathleen Beil, and all of the ILAR staff for their expert guidance and assistance in making this workshop possible today.
It is appropriate to begin this workshop with a quotation attributed to Louis Pasteur: “When our scientific work finds practical application, the cup of joy is overflowing.” This quotation sets the tone for our meeting and for all of us who came here to discuss the issues surrounding the need for science-based guidelines in animal-based research. Our goal during this workshop is scientifically to find the optimal way to seek and develop science-based guidelines to serve the needs of the animals and to serve the needs of the scientists. To emphasize one key point, the guidelines must be practical and applied wisely through the use of performance standards, an outcomes-driven approach.
The key question is “What is the issue” that brings us all here? We believe it to be the following. As we move forward and make progress in
science and medicine, the issue of regulatory burden on science has emerged as a very important issue for all agricultural research, as well as other types of research. This issue is especially relevant in areas of research where animals are used or somehow involved. The problem of animal research being overburdened with regulations is further accentuated and amplified in complexity by social/cultural issues, animal rights concerns, and pressures from the public sector. This problem faces all of us on an international level. Simply said, the public places high expectations on all of us involved in science to address and solve the problems facing us mutually in medicine, health, and agriculture.
To change my emphasis slightly, we must realize that we face a dilemma. With limitations on government funding (e.g., the National Institutes of Health funding in the United States), the limitations on private industry (e.g., pharmaceutical cost controls), and other economic pressures from competing social, economic, and cultural issues, these issues place a demand on all of us in this room to be more effective and to address the need for more robust output from every scientific laboratory where animals are used in translating their scientific findings into something that has benefit for the public. The reality of the dilemma is very real and very clear. We must be careful as scientists, as laboratory animal specialists, and others to have regulations in place that promote animal welfare and facilitate scientific progress. On the contrary, we must be absolutely certain that we do not promote regulations that do not benefit animals used in research or those that do not facilitate science. In this workshop, I would challenge the laboratory animal experts to think as scientists think and, conversely, to have the scientists place themselves in the position of laboratory animal experts.
There are solutions. We can look to science to help us solve the regulatory burden issue and problem described above. However, the problem can be further presented at several levels.
First, it is clear that our regulations, standards, and guidelines may not be based on high-quality scientific literature. The quality of studies cited in the literature and the extent of the literature in any particular area may be scant. The extent of this problem varies by species of animal and by area of interest.
Second, it is clear that there are gaps in our scientific knowledge regarding how best to provide for the welfare of animals in a laboratory setting while facilitating the conduct of good science. We must therefore seek to identify the type of research that will fill the gaps in our knowledge regarding animal welfare issues.
Third, we must develop regulations, standards, and guidelines that are robust enough to be flexible and dynamic enough to meet the needs of the scientists using the animals and that will stand the test of time.
Ultimately, this effort is critical because this knowledge should allow us to spend our funding and use our limited resources (e.g., facilities and staffing) directly for research, rather than spend it unnecessarily for items the animals may not require. For example, these items may include larger cages, which require more space and decrease capacity, or expensive heating, ventilation, and air-conditioning (HVAC) systems, which are costly to construct and more costly to maintain and/or operate.
As we seek to define scientifically based regulations and guidelines, we should define the word “science.” “Science” is derived from the Latin scientia or “knowledge.” It is defined in the dictionary as the “systematic observation of natural phenomena for the purpose of discovering laws governing those phenomena.” It is somewhat ironic, therefore, that we are using this workshop to define regulations and laws regarding animal use in research based on science. We should examine how regulations, laws, and science can be better linked. This is a good challenge and hopefully one that will be intriguing and enjoyable. The challenge can be broken down further, as follows:
Identify the gaps in our knowledge in the science behind our regulations and standards.
Seek to identify the standards that are ideal, or identify the best processes from each country or area of origin.
Assure ourselves that the rule or regulation making or standard making/development process is not heuristic. That is to say that although representatives of each country or state may believe they have the ideal process or regulation, we must be certain that we do not develop new processes for regulations or guideline development or apply these processes by a simple trial and error method at the international level. More importantly, it must not be a random process.
Inspection of our processes used for regulation making and guideline development must occur. Inspection, review, and measurement of benefit of these processes will further our ability to identify the best, most effective regulations and standards that benefit animals and are permissive to conducting good science.
Use science critically and comprehensively to review the literature on which our regulations and guidelines are based. The review can be done by subject area, by species, and so forth.
Leave behind our other agendas, whether they are political, social, personal, or other, so that there is a dialogue and a meaningful exchange of ideas and information results.
Focus on ideas to create dynamic, flexible standards that are science based and that benefit animals and science.
The risk of not taking these steps is great and has an impact on all of us. Similarly, the work and effort to change and improve will be great. We are fortunate to have a wealth of expertise present, either with our speakers or with our workshop participants. The knowledge and experience here are significant. I encourage you all to engage and to participate actively. Our speaker sessions, our workshop, and the breakout sessions have been organized to allow you to be participatory and interactive.