Leader: David Whittaker
Rapporteur: Randall J. Nelson
Participants discussed the questions that appear below, in general consideration of the guideline revision process—Who, How, and Outcomes:
How should the next revision of the Guide for the Care and Use of Laboratory Animals (the Guide) (NRC 1996) be conducted?
Participants believed that expert groups chosen to address specific issues should conduct the revision of the Guide.
Is the lack of scientific knowledge in an area sufficient reason not to move forward with revision?
Session Leader David Whittaker believed not.
The Council of Europe (CoE) formed expert groups to deal with formulated guidelines, but eventually legislative recommendations for acceptance or nonacceptance of guidelines developed. The CoE participants believed that competent authorities (i.e., ministries) who implemented laws protected against conflict of interest.
Is a smaller group of experts more efficient in developing guidelines?
Participants affirmed small-group efficiency in contrast to the inertia of larger groups. They also opined that competent authorities should agree in advance to abide by the recommendations of the expert groups unless they vary radically from socially accepted norms. Moreover, they felt that: (1) expert groups should provide technical information early in the process because subsequent change is difficult to implement; (2) large groups are more costly and difficult to manage; and (3) industry should be involved from the beginning, as should all of the stakeholders.
To what extent has social housing of nonhuman primates (NHPs) been accomplished in Europe?
Individuals in the group indicated that only about 1% of NHPs in the United Kingdom are singly housed and in those cases only for scientific reasons. Many felt that positive reinforcement training is beneficial in facilitating the handling of socially housed NHPs. Some also felt that regulations should influence, rather than require, compliance with factors such as social housing and that influence should be exerted to achieve “best/good practices.”
How does one determine best/good practices?
There was no consensus among the participants on this question. It was pointed out that the United Kingdom maintains a central clearing-house for best/good practices However, the UK does not promote the blanket utilization of justification of exceptions because doing so discourages the consideration of alternatives and refinements. Nevertheless, participants felt that there should be ready access to information about best/ good practices so that refinements can be made with a minimum of regulatory burden.
Further discussion elicited the following opinions from the participants:
- Consistency in the guidelines and the authority to impose them is lacking in instances in which few scientific studies are available to sub-stantiate expert opinion and professional judgment.
- The scientific and animal care communities need to convince competent authorities to be supportive of the need to gain more scientific data on factors such as cage sizes. They also need to convince society that such studies are worth the initial investment, because it may be perceived that funds are being redirected from health-related research.
- The fundamental issues are economics and politics.
- In studies that will have an impact on welfare issues, expert groups should agree on the range of experimental variables before the studies are performed, to avoid instances in which the scientific validity of the results is called into question.
How do we legitimize the science needed to fill gaps in the literature related to welfare issues?
Participants provided perspectives and outlined the following potential strategies for change:
- Scientists and veterinarians need to be proactive with legislators from the very beginning to effect the change in societal attitudes needed to make funding of these studies more likely. The Medical Research Council gives monies for appropriate changes in approaches to be made, but if they give monies, the resultant changes are required. Thus, they have the “force of law” behind their support.
- Data mining may be beneficial in obtaining needed scientific data with little or no cost. The data may already be available in some instances.
- Veterinary outreach to investigators and to the community is an important way to educate others about best/good practices.
- Qualified experts should attempt to identify the “bad science” in extant guideline documents, thus increasing the validity and applicability of the documents before refining them or rewriting them.
- Participants recommend that a list of perceived gaps in the scientific basis for welfare decisions should be maintained. Although not all gaps may be filled at the time of any revision of guidelines, maintenance of these lists will facilitate their consideration at a later date. These lists act as bellwethers for areas where additional guidance may be needed. Additional indicators may come from indirect observations. For example, in instances in which guidance is less than adequate, interinstitutional variation in the implementations of guidelines due to professional judgment may indicate areas where additional guidelines are necessary to promote consistency in welfare and care.
- Minimum acceptable standards may need to be established to facilitate consistency in enforcement. Without minimum standards, enforcement may be perceived as arbitrary.
- Difficulties may arise when members of expert groups are included for political reasons. All stakeholders should be included, but representation should be balanced to ensure efficiency.
- Some participants asked whether the questions being asked are the right ones. It was suggested by some that the goal should be the maximum improvement in welfare relative to the amount of effort generated to reach that goal.
What concerns exist relative to the way the Guide deals with NHPs?
Participants identified four concerns:
- Occupational Health—Occupational health is fraught with variability across institutions as a result of vagaries in guidelines. Personal protective equipment in laboratories and proximity issues were discussed. Exposure as a function of proximity to NHPs and duration of exposure should be dealt with more specifically because investigators are looking for guidance.
- Positive Reinforcement Training—Positive reinforcement training is not dealt with in detail but could facilitate welfare in instances of social housing.
- Social Housing—Species-specific considerations are not extensive in the Guide. Social contact without social housing (by touch windows) may allow animals to withdraw when necessary, which achieves welfare goals. However, it may also reduce the vulnerability of individuals to injury, which is of concern to those who question the utility of social housing as a default condition.
- Animal Welfare—There is a need to think about welfare from the “standpoint of the animal.”
The participants stressed that “one size does not fit all,” especially with respect to NHPs. Individuals of the same species often behave quite differently under the same environmental and behavioral situations. Participants felt that the “Redbook” (NRC 2003) successfully maintains this philosophy throughout discussions of individual experimental situations and other documents should be continued in this stance. It was felt that guidelines should include the consideration of an individual's needs, experimental contingencies, and ethical responsibilities.
- NRC [National Research Council] Guide for the Care and Use of Laboratory Animals. 7th Ed. Washington, DC: National Academy Press; 1996.
- NRC. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research. Washington, DC: The National Academies Press; 2003.
National Academies Press (US), Washington (DC)
National Research Council (US) Institute for Laboratory Animal Research. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington (DC): National Academies Press (US); 2004. Breakout Session: Nonhuman Primates.