Pain and Distress Management Issues
In 2005 the Animal Care and Experimentation Committee (ACE) Committee identified the management of pain and distress in laboratory animals as a policy priority. This is a matter of concern both to the scientific community and the public. Animal research protocols are required to include provisions to relieve pain and avert distress consistent with the scientific aims of the study, and while researchers support animal welfare, they sometimes find themselves at odds with their institutional animal care and use committee (IACUC) about what measures are actually needed. This disagreement over appropriate measures is potentially problematic since public support for animal research is known to vary depending upon whether the research is seen as scientifically necessary and humanely conducted.
The Humane Society of the United States (HSUS) has chosen pain and distress as the focal point of its biomedical research programs. In 1999, the HSUS petitioned the USDA to implement a regulatory definition of �distress� and a new system for categorizing and reporting pain and distress in regulated species, and the following year, the USDA asked the public for comments on issues raised in that petition. Consequently, in August 2000, APS worked with FASEB to organize a conference in which research scientists and lab animal veterinarians evaluated regulatory requirements in the context of current scientific knowledge. The summary of these discussions was widely disseminated within the research community, which led to an outpouring of comments. The USDA has not pursued efforts to change its pain and distress management requirements, but this remains a topic of ongoing policy discussions.
At its EB 2004 meeting, the ACE Committee recommended that the APS initiate a round of discussions about pain and distress that would include both scientists who study these phenomena and lab animal veterinarians. One motivating factor for this undertaking was the view of some researchers that certain widely accepted beliefs about pain management may be erroneous. For example, the prevailing assumption is that analgesics are benign, but in some cases non-drug interventions such as training, pair-housing or nursing care may do more to enhance animal welfare than drug regimens, which may have deleterious side effects. The Committee recognized that both researchers and IACUCs would benefit from guidance on pain and distress categorization and management.
Council subsequently approved a request for funds to support an APS-sponsored workshop on pain and distress. ACE Committee member William Martin agreed to chair this workshop, which was held on January 28, 2005, in Bethesda. Participants included scientists, laboratory animal veterinarians, and research policy specialists who work in this field. The scientists present strongly agreed on the importance of clarifying the distinction between pain and distress and de-coupling pain from distress in terms of regulation and oversight. The group also tried to arrive at a definition of distress that would be a scientifically valid definition, as well as something that IACUCs can easily use. At the conclusion of the workshop, those present agreed to stay in touch as an informal expert working group.
As a result of efforts by working group participants, Martin, along with participant James Herman of the Endocrine Society, were invited to present a workshop session on pain and distress issues at a March 2005 annual conference on IACUC issues sponsored by Public Responsibility in Medicine and Research (PRIM&R). Martin and other working group members have also been invited to present a session at the AALAS National Meeting in November in St. Louis. The strong recommendation of the working group concerning the need to de-link pain and distress, as well as the need for a scientifically valid working definition of distress, were also seen as an influential factor in subsequent discussions about how the Institute for Laboratory Animal Research (ILAR) should approach updating its 1992 report on pain and distress.
Another objective of the working group meeting was to discuss the development of resources that may be helpful to physiologists and other scientists. To this end, the working group acknowledged the importance of publishing journal articles on topics related to the management of pain, stress or distress. Workshop participant Linda Toth, who recently became the editor of Contemporary Topics in Laboratory Animal Science, indicated that such articles provide veterinarians, scientists and IACUCs with the latest research on topics relevant to the design and review of protocols involving pain or stress. APS member and non-member scientists are encouraged to submit articles on these topics to the relevant journals.
APS Resource Book for the Design of Animal Exercise Protocols
One on-going ACE project that is nearing completion is the development of an APS Resource Book for the Design of Animal Exercise Protocols. This project is an effort to provide information to assist investigators in how to design exercise research protocols. It is also intended to provide guidance to IACUCs that must review such protocols, as well as to journal reviewers and editors. Council charged the ACE Committee with this project in 2002. A group of exercise research experts agreed to serve as an authoring committee and met several times from 2002 through 2004. Other members of the authoring committee provided expertise in laboratory animal medicine and other scientific disciplines that utilize exercise as an experimental intervention. In February 2005, the draft was completed and was circulated by Kenneth Baldwin for external review. Final revisions were expected to be completed by mid-summer and the resource book should be published by the end of 2005.
Animals in Education Task Force
The ACE Committee, along with the Education Committee, have long been concerned about issues related to the use of animals in teaching. In 2003, Council established a task force on the use of animals in education that involved representatives of both committees. In support of the task force�s work, APS Public Affairs Officer Alice Ra�anan conducted a review of the literature in which she documented the decline in the use of animal laboratory exercises and identified important questions about the educational impact of this trend. In Spring 2004 the task force presented Council with a draft policy statement on the use of animals in education. In Fall 2004 Council approved the revised statement and asked Education Committee Chair Robert Carroll to detail the rationale for this position, which is based upon the educational benefits to students with differing learning styles when instructors provide a variety of pedagogical approaches. The Council statement and the rationale were published in the August 2005 issue of The Physiologist. Council also asked Ra�anan to revise her background paper for submission to Advances in Physiology Education.
IUPS 2005 Symposium: International harmonization of animal welfare standards
New animal welfare regulatory standards under development by the Council of Europe and efforts to promote international "harmonization" of animal welfare standards are emerging areas of concern to APS members. The ACE Committee organized a symposium on "Transnational impacts of animal welfare regulations" that was presented at IUPS 2005. (A summary of the symposium was published in the August 2005 issue of The Physiologist.) The symposium was well-attended and attracted participation from both US and international scientists. Both the presenters and the audience acknowledged that this informational session was a necessary first step to ensure that researchers recognize the potential impact of changes in animal welfare regulations that are currently under discussion.
Presentations of ACE Committee Members at Animal Welfare Meetings
ACE Committee members regularly attend specialty meetings that deal with animal welfare oversight issues. There are several national meetings each year that offer ongoing education and training opportunities for IACUC members, veterinarians and scientists. Participation enables committee members to obtain the latest information about regulatory initiatives and current controversies. These meetings also represent opportunities for APS members to provide information to IACUC members about APS projects such as the Resource Book for the Design of Animal Exercise Protocols.
Collaboration with States United for Biomedical Research
For the past several years the APS has provided modest financial support to the state biomedical research associations and their umbrella organization, States United for Biomedical Research (SUBR). In addition, the Public Affairs, Education, and Communications offices at APS have been providing outreach materials. The APS offers links from its website to the SUBR websites and has encouraged these organizations also to link to our pages. This year the ACE and Public Affairs Committees recommended to Council a new collaboration in which SUBR would provide training and ongoing assistance to encourage physiologists to get involved in public outreach.
Congressional Advocacy on the Animal Welfare Act
The federal farm bill is due to be reauthorized in 2006, and it is anticipated that animal rights groups may once again seek to use this legislation as a vehicle to add new provisions to the Animal Welfare Act that would increase the regulatory burden associated with animal research. At a May 2005 National Association for Biomedical Research (NABR) conference, it was suggested that the research community make the members of the House and Senate Agriculture Committees aware of their support for animal welfare and opposition to excessive regulation. The APS Public Affairs Office intends to work closely with the ACE and Public Affairs Committees in this undertaking.
Kevin C. Kregel, Chair
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