I would like to thank ILAR for inviting me to speak today. I would also like to recognize my coauthor, who is in the audience today, Sari Tuominiemi. Unfortunately, I have to leave after my talk; Sari has agreed to sit in for me in the panel this afternoon.
We have heard before about general principles; we have heard about the Interagency Research Animal Committee (IRAC) principles. I think the IRAC principles probably were taken from some of the CIOMS (Council for International Organizations of Medical Sciences) principles, which you have also heard about. One of those principles is: “Because of differing legal systems and cultural backgrounds there are varying approaches to the use of animals for research, testing, or training in different countries. Nonetheless, their use should be always in accord with humane practices. The diverse approaches in different countries to the use of animals for biomedical purposes, and the lack of relevant legislation or of formal self-regulatory mechanisms in some, point to the need for international guiding principles elaborated as a result of international and interdisciplinary consultations.”1 You will notice, in talking about diverse approaches, it does not say that they are deficient approaches. I think it’s important for us to realize that there are multiple ways that we can approach something.
The Guide certainly recognizes the importance of performance standards. We have been hearing about performance standards again and again today. The above quote emphasizes the need for international guiding principles generated by international interdisciplinary consultations. I consider this meeting to be one such consultation that will get us where we want to be. I think that our goals are really similar, regardless of our approaches—that is, the goal of high-quality research done in the most humane way possible.
Training and education are really the cornerstone of effective performance standards. Such training is going to be based upon:
• The needs of the institution: This includes the types of research or testing that is being done as well as the resources of the institution. For instance, if you have access to the Internet, you will have access to different types of training materials and training opportunities that you might not have otherwise.
• The needs of the individuals: What types of procedures are they going to be conducting or performing? What is their previous training and experience? What are the cultural factors and learning styles that are involved?
The ILAR Guide for the Care and Use of Laboratory Animals discusses training. Examples of some of the types of training resources that are available include the Canadian Council on Animal Care (CCAC) guidelines, the 1991 ILAR report on developing training programs, and FELASA training guidelines for various levels of individuals.2 I would like to draw your attention to the ICLAS International Harmonization of Guidelines on Animal User Education and Training in Laboratory Animal Care and Use. We heard previously that for the last couple of years ICLAS has been working on harmonization guidelines. This is one that I believe was just recently approved by the ICLAS board and hopefully will be published so it will be available for everyone soon.3
The components of a training program should include regulation, the roles and responsibilities for all individuals involved (and this includes the IACUC or ethics committee), ethics and the 3Rs, experimental design and the influence of nonexperimental variables, recognition and minimization of pain and distress, euthanasia, principles of animal care, and study- or species-specific characteristics, procedures, techniques, and practices. Like any good training program, there should be some way of assessing the training, assessing competence, and then, of course, documenting training, because, as we all know, if you don’t document it, it didn’t happen.
As in developing any training program, you must understand your audience. This includes understanding the structure of the animal care and use program. You need to develop an appreciation for the culture of the audience. This includes the culture’s attitudes toward training—there are different approaches to training—and the attitudes toward animals. You also need to understand the current level of knowledge and have a sense for the audience’s ability
2Available online at www.ccac.org; Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs (NRC 1991; available at www.nap.edu); FELASA Recommendations for Education and Training (www.felasa.eu/recommendations)
3Published online in June 2010 (www.iclas.org/Document/Ethical%20review%20%20training%20article%20for%20Laboratory%20Animals%20-%20Official%20DOC%20Juin%202010.pdf).
to use or incorporate that knowledge. You need to keep your approaches flexible, but your goals firm. Your goal is to ensure the humane use of animals and quality research.
What do I mean by structure? We have heard about this a little bit today. For example, in the United States, the role of the veterinarian is pretty clearly spelled out in the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals. In addition to providing veterinary medical care, the veterinarian is charged with oversight of animal husbandry, nutrition, sanitation practices, zoonosis control, and hazard containment.
The role of the veterinarian in other countries may differ, particularly if the level of education and experience is substantially different. Such is often the case in non-Western countries. Western laboratory animal experts touring Chinese facilities recently reported that veterinarians may have only an undergraduate Bachelor of Science degree, with little concept of laboratory animal medicine as we know it. But they also noted an enthusiasm and commitment to learning, which has been referenced earlier today.
Initially, I think, veterinarians in China [and other Eastern countries] would be well served to develop open communication and mentoring programs with their Western colleagues—again, something that was discussed earlier. In addition, newly created distance learning programs offer opportunities for growth.
The role of the IACUC and ethics committee may also vary. The importance of these committees has been recognized as a global standard, and the importance of animal care and use oversight has also been recognized. As such, even if there is no regulatory requirement for such a committee, many companies will require such a committee if they have facilities in these locations. As we heard from Dr. Landi, companies may require such a committee if they are going to do collaborations. In fact, at the First Shanghai Animal Welfare Forum on International Standards, held in March of 2008, several laboratory animal experts who visited China were very impressed with the IACUCs and ethics committees that they observed. However, as with the attending veterinarian, there was some concern about the level of actual authority of the committee.
I think this concern can be addressed through a combination of training, institutional commitment, and policy. I think the fact that the Guide discusses the role of the institution in ensuring that people are appropriately qualified or trained if they are going to be using animals adds emphasis to this responsibility and should help ensure the IACUC’s role. Although the exact roles and responsibilities of the key personnel of an animal care and use program may vary, it’s important that the roles and expectations of all parties are well documented and well understood.
The importance of understanding the culture of your audience cannot be overemphasized. To develop a training program, you must understand the cultural attitudes and approach to training. For example, in China, the Confucian way of learning has been practiced for centuries. This method leads to differences in knowledge acquisition and application, and relies a great deal on read-
ing and memorization and practical application of what was learned. This can be enhanced with visual learning in which there is a repetition of practical examples. The Confucian way of learning is particularly well suited for learning steps of the process, such as learning an SOP. However, to be fully effective for animal care and handling, this must be accomplished by well-mentored, hands-on training.
In many Eastern cultures, the importance of saving face must also be considered when training. As in all cultures, when correction is needed, you may criticize the way a task is done, but you have to do so diplomatically, preferably in an impersonal way, and very carefully. You should avoid criticizing persons, particularly in front of others. The proposal method—“How about doing it this way instead of that way?”—is an alternative way of helping someone understand a different mechanism of performing a task.
The trainer also has to be aware of a cultural reluctance to speak up if a point is not understood or if someone thinks something is wrong. Frequent, open-ended questions can help develop topics and help ensure that they have been understood. Asking individuals to propose solutions to problems or events is another way to help ensure understanding and help individuals practice the concept of being comfortable speaking up.
It helps to determine the existing level of knowledge as well as the ability of the individual to apply that knowledge.
Another important cultural component to consider is the general cultural attitude toward animals. Globally, these attitudes have changed over time. In fact, they continue to change all the time, as humans and our standards of living have changed. In societies where providing humans with adequate sanitation and nutrition is problematic, it is more difficult to make the case for the importance of providing those for animals. However, the drive to modernize should not be underestimated. Many countries actively seek to assure the public and businesses of their understanding of animal welfare, and they do understand the importance of animal welfare to global reputation in the biomedical field.
Technical training is relatively straightforward and can be accomplished by providing detailed written guidelines, which can be read and memorized in the Confucian tradition. Competency can also be relatively easy to assess. Attitudes toward animals are more difficult. It can be useful to include a culture of caring, humane care and use of animals as part of a person’s written job responsibility. It helps to raise awareness of the importance of animal welfare and helps people understand that this is actually a duty. You will find that in many of these countries, the fact that it’s a duty helps to raise people’s awareness and provides some assurance of behavior. Many cultures are very sensitive to the idea of duty. Speaking up about something that is perceived to be wrong is also an example of something that you can say is a duty.
Repetition on the subject of gentle handling, respect, and minimizing the potential of pain and distress and the intrinsic value of animals is also recommended.
When Charles River decided to open a contract facility in China, it was not done to try to avoid any regulations or standards but rather, as we heard earlier, to meet the needs of a burgeoning research community that is responding to the health needs of a rapidly growing country. Maintaining our key corporate value of humane care of all animals produced and used in our facilities was always a key point. Also important was providing quality research and testing for the biomedical research community. To do this, we used a concept of knowledge transfer through participation in activities. This is sometimes referred to as the transfer of tribal knowledge.
To prepare us for this, we used intensive cultural training, to help us be most effective and sensitive to our Chinese colleagues. We had key staff from our new Shanghai facility spend one or more three-month rotations at our site in Montreal. These individuals were embedded in the day-to-day activities and were involved in both hands-on experience and decision making. In addition, key qualified individuals from Montreal have spent or are slated to spend one or more three-month rotations in Shanghai. Some individuals are going to spend two to three years at the site to help oversee the development of our corporate culture for quality and animal welfare.
This knowledge transfer allows us to more easily teach attitudes. It fosters personal connections and trusted relationships that are important in all cultures. It allows for immediate assessment of understanding and can more readily accommodate different learning styles. Although labor-intensive, we believe that this will lead to a stronger program.
We have internal animal welfare modules that cover such topics as euthanasia, reporting concerns, and species-specific training, which focuses on how an animal’s biology, physiology, anatomy, and so forth, create specific husbandry and handling needs, and how handling affects animal welfare in that species.
In addition to this internal training, personnel from the Shanghai site have attended regional meetings, such as the First Shanghai Animal Welfare Forum on International Standards and AAALAC’s accreditation process, as well as international meetings such as IACUC 101 and 201 in the US and the Charles River Short Course. This September, there is a joint workshop in Shanghai with CCAC and the Shanghai Animal Commissioning Agency. We also have ensured that personnel in key leadership roles, such as the attending veterinarian, the IACUC chair, and the operations manager, have extensive experience with programs such as those recognized by AAALAC.
As with all our animal care and use programs, there is a system of checks and balances in place to ensure adherence to the quality and humane care we expect. In addition to various standard regulatory audits and inspections, the Shanghai facility is in the process of pursuing both CCAC and AAALAC accreditation. Sponsors also make regular and thorough site visits. We also have a program of internal corporate audits, which look at all aspects of the program, including animal welfare. Of course, there is corporate review of all IACUC semiannual reviews from all Charles River sites.
In summary, animal research in different countries and different cultures may be different, but this does not mean deficient. I believe that the challenges of animal research in a global environment can be met using training and education. Meeting the challenges requires sensitivity and institutional com-mitment to doing it right. High-quality research and testing and animal welfare can be achieved at many geographic locations. Doing animal research in a different culture does not mean doing animal research using lesser standards. Flexibility, with a clear eye on humane care and quality research, is required.
The purpose of this conference is to discuss and address challenges in animal research in a global context. Education and training are closely linked to quality of performance. Two important features characterize biomedical research nowadays: the number of countries where research is done is continuously increasing and there is a global exchange of research results and of scientists. This creates two important challenges for education and training: an increasing demand for training, especially from emerging countries, and the need to establish globally accepted systems of accreditation. The Federation of European Laboratory Animal Science Associations (FELASA) has been focusing on (1) defining categories of personnel working with laboratory animals; (2) defining guidelines for the education and training of each category; and (3) developing a FELASA accreditation system, to ensure that courses comply with FELASA guidelines and are of a high standard of quality.
Personnel Categories as Defined by FELASA
FELASA has identified four categories of competence for personnel working with laboratory animals (FELASA 1995), which have been adopted by the Council of Europe and have therefore become a standard in Europe:
Category A, persons taking care of animals;
Category B, persons carrying out animal experiments;
Category C, persons responsible for directing animal experiments; and
Category D, laboratory animal science specialists.
Categories A and D personnel are professionals devoted to laboratory animals, while personnel in Categories B and C are professionals from different specialties who design and conduct experimental procedures with animals. The training for Categories A and D focuses on the development of a professional career, and the training for Categories B and C provides the training necessary
for the correct use of animals in research based on the 3Rs principles of replacement, reduction, and refinement.
The FELASA modus operandi is the establishment of working groups with experts from the associations that compose FELASA to define the guidelines, taking into account the diversity in Europe, and to promote high standards to promote good science and to fulfill the ethical demands in the use of animals that society and the European legal system require.
From 1995 to 2000, FELASA published guidelines for the education and training of each category of personnel (FELASA 1995, 1999, 2000). These guidelines are easy to find on FELASA’s website (www.felasa.eu) and they have also been translated into other languages (e.g., Spanish, www.secal.es).
The guidelines for FELASA Category A are under revision. However, according to current discussions in the working group, the main characteristics of this training will be three, instead of four, levels of training: A0, for new personnel taking care of the animals, this minimum training will consist of a short course of around 20-30 hours; A1 and A2 are more advanced levels and will require several years of training involving a combination of theoretical, practical, and hands-on training at work. A0 training will be able to be easily adopted by developing countries while A1 and A2 programs will be designed to fulfill the requirements of countries with a more developed animal welfare system.
This training is for animal technicians and laboratory technicians who conduct experimental procedures with animals. In some countries novel researchers (e.g., PhD students) are also included in this category.
FELASA (2000) guidelines recommend a 40-hour course with 50% of practical training supervised by accredited personnel. The practical content can be tailored to the trainee’s specific needs. Additional training will be necessary if the person needs to perform new experimental procedures.
For this category, FELASA (1995) requires the trainee to have a university degree that includes sufficient knowledge of animal biology. The specific training is acquired by way of a postgraduate course of 80 hours or equivalent. The syllabus must include the following topics:
• biology and husbandry of laboratory animals
• microbiology and disease
• health hazards and safe practices in the animal house
• design and conduct of animal experiments
• anesthesia, analgesia, and experimental procedures
• alternatives to animal use
• ethical aspects and legislation
• analysis of scientific literature
In some countries this training is achieved in two stages: a Category B training course at the initiation period, followed by a complementary module when the researcher is going to be responsible for the design of the experiments (scientist).
A comprehensive 80-hour course is becoming the standard in the majority of European countries. This training is provided when a postgraduate initiates his/her research career (e.g., a PhD).
In addition, Category C training is in high demand by scientists in emerging countries. ICLAS and FELASA and other European bodies have supported this training in several regions of the world: Southern Europe (early 1990s), Eastern Europe (late 1990s), Latin America (late 1990s), and more recently in Africa. In these cases the course has to have a broader perspective and be addressed to both scientists and personnel responsible for animal facilities. Experience has shown that the best results for continuity are obtained when:
• local professionals are incorporated as teachers,
• professionals who could take responsibility for teaching specific topics in future editions of the course are included as students (training the trainers), and
• only partial support is provided so that local agents, the student, and his/her institution are jointly responsible.
Quite frequently, the course is implemented with the financial support of an international body. Around $2,000-$5,000 per course per 20 students is the average financial support necessary to promote this training.
For this category, FELASA (1999) guidelines propose specialized postgraduate training of two years of full-time study or equivalent part-time (including 6 months for a research project). The background training required is a veterinary or other university degree with similar competence in animal biology and welfare knowledge.
This program is included as a requirement for veterinary specialists who hold the Diploma of the European College of Laboratory Animal Medicine (DipECLAM). ECLAM also requires further training on veterinary care.
To provide and/or obtain Category D training is a real challenge even for the well-established European universities and it becomes almost impossible for professionals working in emerging countries. The most common problems are: (1) it is expensive and the training lasts a long time, (2) it requires contact with high-level facilities and professionals who are often not available in the country, and (3) it is preferable that the trainee stays in his/her job/country while receiving the training. Therefore, improving access to specialized training for professionals who are responsible for the growing number of animal facilities around the world must be a goal both for international bodies (e.g., IACLAM, ICLAS, and FELASA) and for the private companies that employ this type of personnel.
Possible solutions are (1) to create an international fund for training, supported by IACLAM, ICLAS, and others and also by private companies; (2) to arrange the existing programs (mainly in Europe and North America) in a modular way or to facilitate online distance learning; and (3) to develop tutor supervision of hands-on training. All these measures will facilitate access to high-quality training for professionals from emerging countries. The fact that the trainee can apply the acquired knowledge in an immediate way will significantly increase the quality of science globally.
Accreditation systems have demonstrated that they are an important factor in improving standards. For this reason FELASA established an accreditation system of teaching and training in laboratory animal science. The guidelines to fulfill FELASA accreditation have been published (FELASA 2002) and an Accreditation Board was established in 2003; details and application forms can be found at FELASA’s website. This accreditation system is not limited to training based in Europe.
The current globalization of animal research is an excellent opportunity, but we need (1) to establish financial support systems for both training programs and personnel, (2) to promote training in countries with emerging demand, (3) to support the continuing education of professionals worldwide, and (4) to use existing international professional organizations (e.g., FELASA, IACLAM, ICLAS) to provide accreditation and validation of the training.
FELASA [Federation of European Laboratory Animal Science Associations]. 1995. FELASA recommendations on the education and training of persons working with laboratory animals: Categories A and C. Report of the FELASA Working Group on Education accepted by the FELASA Board of Management. Lab Anim 29:121-131.
FELASA. 1999. FELASA guidelines for education of specialists in laboratory animal science (Category D). Report of the FELASA Working Group on Education of Specialists (Category D) accepted by the FELASA Board of Management. Lab Anim 33:1-15.
FELASA. 2000. FELASA recommendations for the education and training of persons carrying out animal experiments (Category B). Report of the FELASA Working Group on Education of Persons carrying out Animal Experiments (Category B) accepted by the FELASA Board of Management. Lab Anim 34:229-235.
FELASA. 2002. FELASA recommendations for the accreditation of laboratory animal science education and training. Report of the FELASA Working Group on Accreditation of Laboratory Animal Science Education and Training accepted by the FELASA Board of Management. Lab Anim 36:373-377.