Community Representatives and Nonscientists on the IACUC:
What Difference Should It Make?
Rebecca Dresser
D
uring the 1980s, Congress and federal agency
officials significantly revised US policy governing
laboratory animal care and use. Before the revisions, activities involving laboratory animals were evaluated
primarily by scientists and animal care staff employed by
research facilities. The revised federal policy was designed
to expand the evaluation to include other perspectives. New
requirements for the participation of community members
and nonscientists were established to further this aim.
The revised federal policy has been in effect for more
than a decade. In this article, I examine the requirements for
community and nonscientist involvement in animal research
oversight. First, I describe regulatory measures in the United
States and other nations on public and nonscientist participation in research oversight. Then I discuss empirical data on
and personal accounts of community representatives and
nonscientists in the review process. I next consider different
approaches to determining what these individuals can and
ought to contribute. I conclude with suggestions on enhancing the participation of community representatives and nonscientists in evaluating laboratory animal care and use. My
analysis draws on the relevant literature as well as my own
experience serving as a nonscientist member of four different institutional animal care and use committees (IACUCs1)
between 1985 and 1998.
Regulatory Provisions
In the United States, federal policy mandates public and nonscientist participation in evaluating the care and use of laboratory animals. The Animal Welfare Act (AWA1) (1995)
applies to publicly and privately funded research activities
involving certain species. In 1985, Congress adopted amendments requiring a new oversight system. The amendments
require each facility conducting research involving species
covered by the AWA to establish institutional animal committees to inspect laboratory animal housing and study areas
and to review animal use in potentially painful research and
education projects.
Rebecca Dresser, J.D., is Professor at Washington University Law School
and Medical School, St. Louis, Missouri.
'Abbreviations used in this paper: AWA, Animal Welfare Act; IACUC,
institutional animal care and use committee; NIH, National Institutes of
Health; PHS, Public Health Service; SCAW, Scientists Center for Animal
Welfare.
Volume 40, Number
1999
The AWA amendments also set forth membership requirements for institutional committees. According to the
legislation,"... at least one member... shall not be affiliated
with [the research] facility other than as a member of the
Committee." Moreover, the unaffiliated member may not be
a close relative of a person affiliated with the facility. These
provisions were intended to rule out potential conflicts of
interest. According to the law, the unaffiliated committee
member should "provide representation for general community interests in the proper care and treatment of animals."
In the same year, Congress adopted similar provisions as
part of the Health Research Extension Act (1985). These
provisions apply to research funded by the National Institutes of Health (NIH1). The legislation mandated that all
institutions receiving NIH funds for research involving vertebrate animals establish animal care committees to inspect
animal housing and to review proposals for laboratory animal use. Again, the law stated that at least one committee
member must be an individual having no other association
with the research institution.
The AWA and the Health Research Extension Act permit
persons with scientific training to serve as unaffiliated members on institutional committees. Yet the AWA amendments
direct all unaffiliated members to represent general community values. This suggests that Congress wanted the unaffiliated member to bring a broader values perspective to committee deliberations. Thus, in this paper, I assume that the
unaffiliated member's primary role is to ensure that institutional committees go beyond a purely scientific analysis in
making decisions on laboratory animal care and use.
A third federal policy explicitly mandates involvement
of nonscientists in institutional committeee activities. The
Health Research Extension Act directed the NIH to formulate
guidelines to implement the Act. In 1986, federal officials
issued the Public Health Service Policy on Humane Care and
Use of Laboratory Animals (PHS1 Policy) (PHS 1986). The
PHS Policy provides that committees, referred to as IACUCs,
must have at least five members. These must include an
individual "whose primary concerns are in a nonscientific
area (for example, ethicist, lawyer, member of the clergy);
and... an individual who is not affiliated with the institution
in any way other than as a member of the IACUC, and is not
a member of the immediate family of a person who is affiliated with the institution." Although the Policy allows one
person to fulfill both requirements, many institutions have
more than one nonscientist on their IACUC.
Since the late 1970s, other nations also have moved to
29
integrate nonscientific perspectives into animal research review. For example, in 1979, the Swedish Parliament amended
that country's animal welfare legislation to mandate ethical
committee review of all animal studies. One third of the
committee members must be laypersons (Obrink 1982).
Some nations have enacted laws explicitly requiring inclusion of individuals from animal welfare organizations on
committees reviewing animal research proposals. Germany,
Denmark, and Switzerland all mandate such appointments
(Orlans 1993, p 101). Australia requires committee participation of both animal welfare representatives and laypersons.
In the mid-1990s, the Australian Code was revised to state
that at least one third of committee members should be laypersons or representatives of animal welfare groups. The
revised Code added more specific descriptions of each membership category as well. Whenever possible, animal welfare representatives should be actively involved in and nominated by an animal welfare group. Lay or "independent"
members should not be persons who once used animals in
research or teaching. Ideally, such individuals should not be
affiliated with a research institution, but universities may
appoint persons from nonscientific divisions if such an appointment is adequately justified (Perry 1997).
Empirical Data and Other Reports on
Nonscientists' Participation
US policy gives research institutions great latitude in selecting unaffiliated and nonscientist committee members. Moreover, the policy supplies only a vague indication of the
desired role of these members. The general direction comes
from the AWA, which instructs unaffiliated members to represent "general community interests in the proper care and
treatment of animals." Empirical data and personal accounts
provide an indication of the experiences and contributions of
unaffiliated and nonscientist members since the new laws
were enacted.
The most extensive empirical data on unaffiliated members come from a recent survey. In the mid-1990s, the Scientists Center for Animal Welfare (SCAW1) conducted a general study of IACUCs. As part of the study, surveys were
distributed to the IACUCs' unaffiliated members. Completed surveys were obtained from 427 respondents.
A substantial percentage of unaffiliated members reported satisfaction in many areas. More than 85% felt free to
express their views, valued by other committee members,
and capable of fulfilling their committee role. However,
27% stated that the IACUC failed to seek their views, and
13% noted that they were intimidated by other committee
members. Nearly half (46%) reported that the committee
was less than thorough in weighing the ethical costs of research against its potential benefits. Relatively high percentages believed their committees fell short in assessing the
availability of nonanimal alternatives and the possibility of
reducing the number of animals used, as well as in monitoring ongoing research.
30
Many unaffiliated members also expressed some frustration with their position. One quarter believed they had had
little to no effect on committee function. Slightly more than
10% thought that their IACUC had had little to no effect on
laboratory animal welfare. Finally, 40 to 50% wanted to
receive more educational materials on topics such as animal
alternatives, selection of animal models, and the functions of
the unaffiliated member. In addition, many wanted information on how other community members addressed problematic research proposals and suggested that on-line information and discussion services could enhance their contributions
(Theran 1997).
Smaller surveys and personal accounts supplement these
data. In telephone interviews, 16 unaffiliated members presented mixed views of their experience. Persons from animal welfare organizations reported encountering significant
tension in attempting to avoid becoming obstructionist, on
the one hand, and co-opted, on the other. Most satisfied with
their experience were individuals who felt comfortable interacting with scientists. Many unaffiliated members believed
they provided balance and a degree of public accountability,
but few reported having more than a minor impact on committee decisions. Many believed "the value of being a committee member lies not so much in the specific reforms
effected but in the constant reminder to the institution of the
outside world" (Orlans 1993, p 112). Personal accounts by
nonscientist members present similar views (Robb 1993;
Welborn 1992).
Some evidence exists on how other IACUC members
view the unaffiliated member. In a survey of 114 IACUC
chairpersons, 84% responded that their unaffiliated member
was chosen to be an active participant in committee proceedings, but others reported choosing someone who would be
"seen but rarely heard" (Silverman 1997). A set of interviews with 10 IACUC chairpersons found none favoring
changes in the existing situation, even though four stated that
the unaffiliated member had had no effect on IACUC activities (Orlans 1993, p 115).
What Role Should the Nonscientist Have?
Clear outcome measures are necessary if we are to evaluate
the nonscientist member's performance and perceptions. Yet
the policy and data addressing nonscientist participation reveal a lack of formal and practical clarity on the appropriate
functions of the nonscientist. The regulatory provisions supply little information on the nonscientist's role and responsibilities, and the surveys and other accounts suggest that committee members have different views on these matters.
What goals did members of Congress and NIH officials
have in creating the requirements for unaffiliated and nonscientist committee members? The text of the legal revisions
offers few clues. The AWA instructs the unaffiliated member to "represent general community interests in proper care
and treatment of animals." This instruction presents more
questions than answers, however. What is the content of the
WAR Journal
general community's interests? How does the community
define "proper care and treatment" of laboratory animals?
By what process should a community member determine the
substance of the community's concerns? What measures
should this individual take to represent his or her constituency in IACUC deliberations?
None of these questions is easily anwered. Although
national surveys give some indication of the general
community's views on what constitutes appropriate care and
treatment of laboratory animals, these data are somewhat
inconsistent (Mukerjee 1997). In addition, there may be
variation in the attitudes of persons in different parts of the
country. Surveys of the general population fail to assist the
unaffiliated member seeking to represent the views of local
residents on animal care and treatment. A more substantial
problem is presented by the overall lack of public knowledge
on laboratory animal use. Many members of the public probably have no clear opinions on the topic; those who do may
be inadequately informed about the nature of laboratory animal use and the trade-offs at issue.
A close reading of the AWA suggests that Congress has
created an impossible task for the unaffiliated member. How
can an individual represent the interests of a community
whose position on an issue is unclear and probably to some
degree uninformed? An unaffiliated member who sincerely
and diligently undertakes to fulfill the AWA directive appears condemned to confusion and frustration.
The PHS Policy offers the only formal indication of the
nonscientist's desired role. The Policy mandates appointment of an IACUC member "whose primary concerns are in
a nonscientific area." As examples of such a person, the
Policy lists an ethicist, a lawyer, and a member of the clergy.
The wording of the provision implies that this individual
should bring to IACUC activities a set of values that depart
from those of the researchers and veterinary staff composing
the remainder of the committee. The underlying assumption
seems to be that other committee members will assign little
significance to values that could temper or conflict with a
pro-research perspective. As a general matter, this may be
true; however, many individual scientists and most veterinary staff members attribute substantial importance to promoting laboratory animal welfare.
The PHS Policy appears designed to increase the probability that persons on the committee will assign value to the
promotion of animal welfare, as well as to other nonscientific
values relevant to the use of animals in science. However,
the PHS Policy fails to clarify the values to be represented by
nonscientist participants in committee deliberations. What
"primary concerns" should the nonscientist bring to the table?
Should this individual attempt to voice the full array of nonscientific concerns that could influence judgments on laboratory animal care and use? Should this person be responsible
for becoming knowledgeable about the various philosophical and religious perspectives relevant to how animals are
used in science? What weight should nonscientists give to
their personal views on laboratory animal care and use?
Volume 40, Number
1999
Again, the text of the PHS Policy provides little guidance to
nonscientist members seeking to fulfill their duties.
In sum, the formal legal texts addressing unaffiliated and
nonscientist committee members furnish almost no meaningful assistance to individuals asked to serve in this capacity.
Members of Congress and NIH officials appear to have established the requirements for community and nonscientist participants without a clear or unified purpose in mind. What
can be discerned is a general desire to widen the perspectives
represented in the evaluation of laboratory animal care and
use in addition to some intent to increase the significance
assigned to laboratory animal welfare. Unlike other nations,
however, US officials failed to require that the views of
animal welfare representatives be incorporated into IACUC
deliberations. In essence, US government officials took a
symbolic step away from self-regulation by research facilities but left it to institutional and facility personnel to implement this move.
One way to define more precisely the unaffiliated and
nonscientist members' roles is to examine the IACUC's specific responsibilities and to consider the contributions such
members can make to meeting committee responsibilities.
Federal policy instructs IACUCs to apply certain substantive
principles in the review process. In inspecting animal facilities, IACUC members are to refer to standards on care and
housing of different laboratory species included in the Guide
for the Care and Use of Laboratory Animals ("the Guide")
(NRC 1996). Animals must be provided with an environment that is "appropriate for their species and contribute^]
to their health and comfort" (PHS Policy 1986, p 9). Committees reviewing proposals for laboratory animal use are to
ensure that pain, distress, and discomfort to animals are reduced to the lowest possible level consistent with sound research design. The regulatory provisions include numerous
requirements related to reducing animal pain and distress, as
well as directives to use the minimum number of animals
that will provide the desired scientific information. They
also encourage the use of nonanimal alternatives when this
will provide the desired scientific information. Finally,
according to the US Principles for the Utilization and Care of
Vertebrate Animals, which are included in the Guide,
"[procedures involving animals should be designed and performed with due consideration of their relevance to human
or animal health, the advancement of knowledge, or the good
of society" (NRC 1996, p 116).
Two general ethical judgments are implicit in the current
federal policy on laboratory animal care and use. One is that
laboratory animal experiences are worthy of some moral consideration. Basic standards on animal care, housing, and
relief of pain and distress must be followed, even when doing
so adds to investigator responsibilities and elevates the overall cost of animal research. The second moral judgment is
that human interests in promoting new scientific knowledge
and the health and welfare benefits flowing from such knowledge take priority over laboratory animal welfare. Thus,
harm may be imposed on laboratory animals when this is
31
scientifically necessary and relevant to advancing knowledge or the health and welfare of others.
What contributions can unaffiliated and nonscientist
members make to IACUC application of these specific provisions and general ethical judgments? Most nonscientist
members lack the expertise necessary to assess the quality of
laboratory animal care and housing. They also lack the expertise needed to determine whether an investigator has
adopted all available measures to reduce the pain and distress of the study animals. Nonscientist members are unlikely to know when investigators could reduce the number
of animals used or adopt a nonanimal alternative. Finally,
nonscientists are typically unable to evaluate whether a research proposal is relevant to advancing knowledge and the
health and welfare of others. To make all these judgments,
nonscientists must rely on information they receive from
researchers as well as the scientists and veterinary staff members participating in committee deliberations.
An examination of current US law and policy suggests it
is unrealistic to expect the presence of unaffiliated and nonscientist members to produce significant alterations in the
evaluation and conduct of animal research. Indeed, one could
argue that advocating for radical change would be inconsistent with the current regulatory framework. Congress has
adopted legislation endorsing humane treatment for laboratory animals. Current law incorporates the position that
humans are justified in using animals to improve human
health and welfare and to advance knowledge. At the same
time, the law provides that animal interests must be protected
when this will not interfere with research objectives. Like
other IACUC members, unaffiliated and nonscientist members are to adopt this moral stance when engaging in committee activities. New legislation would be required for
IACUCs to apply different moral principles in evaluating
animal care and use. Within the current regulatory framework, then, what can the unaffiliated or nonscientist IACUC
member contribute?
The Nonscientist as Public Witness
In my view, a realistic role for the unaffiliated or nonscientist
IACUC member is that of public witness to the activities of
the research facility. This view is consistent with the previously noted interviews in which many unaffiliated members
viewed their main contribution as providing "a constant
reminder of the outside world."
Unaffiliated and nonscientist members serve as reminders that animal research and education activities must be
defensible to the broader society, whose support is necessary
to continue these activities. Committee dynamics can change
with the presence of someone not directly involved in the
research enterprise. Nonscientists on the IACUC create pressure for investigators and facility staff to step outside the
narrow language and customs of the research community.
Once nonscientists become part of the committee, investiga-
32
tors and other committee members must explain and justify
scientific practices using terms and concepts accessible to
laypersons.
The preparation of ordinary language descriptions advances a variety of objectives. Besides empowering the nonscientist member, such descriptions assist other committee
members unfamiliar with the specific subject and approach
of a research proposal. Ordinary language descriptions also
can enhance ethical evaluation of research projects. As one
writer put it, the committee ought to ask "not just whether or
not the researcher is conducting an ethically acceptable experiment, but also whether or not he has considered it thoroughly enough, ethically, to understand what is needed for
anyone else to consider it ethically, too" (Nerlich 1997).
Finally, clear descriptions of research prepared for lay
IACUC members become documents that can be useful if
the research later becomes the focus of government or media
scrutiny (Nerlich 1997).
To be an effective witness, unaffiliated and nonscientist
committee members must be active and involved participants in IACUC deliberations. Effective service requires a
willingness to seek clarification of practices and ideas everyone else appears to take for granted. Nonscientists cannot be
afraid to pose obvious and unsophisticated questions. When
scientists and veterinary staff members translate and explain
various aspects of laboratory animal use, the general committee discussion often becomes more open and creative.
New ideas emerge, and previously neglected avenues for
addressing concerns are explored.
Unaffiliated and nonscientist members can take additional steps to improve committee deliberations. They can
encourage the institution to appoint members with the necessary training to help the IACUC evaluate when animal numbers could be reduced and nonanimal alternatives adopted.
They also can support veterinary and other IACUC members
seeking increased institutional resources to improve laboratory animal care and housing.
Research institutions and IACUCs have a responsibility
to enhance the effectiveness of unaffiliated and nonscientist
committee members as well. Committee service is demanding and time-consuming. In return for the nonscientist's
commitment to serve, the institution has a duty to provide
assistance to that individual. As the SCAW survey indicates,
unaffiliated members want and need education. Institutions
must provide meaningful training to new members that
should include an orientation session on IACUC activities,
relevant regulatory and committee policies, and common
practices used in animal research. References, bibliographies, and materials describing on-line services should also
be provided so that nonscientists can continue their education. Institutions should also consider providing funds to
enable unaffiliated and nonscientist members to attend educational conferences on IACUC issues.
The selection process is also important. Institutions
should make a good faith effort to recruit unaffiliated and
nonscientist members who will not be afraid to ask questions
WAR Journal
and challenge routine practice. Although some researchers
and facility employees may prefer someone who will be
"seen but rarely heard," this approach is shortsighted. Unaffiliated and nonscientist members can help institutions ensure that their activities are defensible to the broader public.
From an institutional perspective, it is better to address problematic practices at the committee level than to face public or
regulatory criticism of an incident involving questionable
treatment of laboratory animals.
Conclusion
In revising the federal provisions governing laboratory animal care and use, officials sought increased openness between the biomedical research community and the public.
The unaffiliated and nonscientist committee members became the primary link between these two worlds, but they
were given little guidance on how to proceed. By mounting
a cooperative effort, institutions and IACUCs can give substance to the unaffiliated and nonscientist members' roles.
This is an ongoing challenge, however, and a continuing
effort is needed for vague federal requirements to be more
than empty symbolism.
Volume 40, Number
1999
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