2005 Animal Care and Experimentation Committee Report
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
Council Actions
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