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ILAR Journal V40(1) 1999
Bioethics of Laboratory Animal Research
Rebecca Dresser
| Rebecca Dresser, J.D., is Professor at Washington University Law School and Medical School, St. Louis, Missouri. |
During 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 non-scientists 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 non-scientist 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.
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 (NIHI). 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 committee 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 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 lay-persons 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.
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 non-scientist 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 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 answered. 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? 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 .flor 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[s] 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, "[p]rocedures 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 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 non-scientist 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, investigators 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 non-scientist 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 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.
1Abbreviations 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.
References
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NRC [National Research Council]. 1996. Guide for the Care and Use of Laboratory Animals. Washington DC: National Academy Press.
Obrink K. 1982. Swedish law on laboratory animals. In: Dodds WJ, Orlans FB, editors. Scientific Perspectives on Animal Welfare. New York: Academic Press. p 55-58.
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