ILAR Journal Online, Volume 35(3/4) 1993: Issues for Institutional Animal Care and Use Committees (IACUCs)

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ILAR Journal V35(3/4) 1993 [FORMERLY ILAR NEWS]
Issues for Institutional Animal Care and Use Committees (IACUCs)

Personal Reflections: The Role and Value of the Unaffiliated Member and the Nonscientist Member of the Institutional Animal Care and Use Committee
J. Wesley Robb

Dr. Robb was a member of the Institute of Laboratory Animal Resources (ILAR) Council from 1987 to 1993. He is Professor Emeritus in the School of Religion and the School of Medicine (Biomedical Ethics) at the University of Southern California. He is an unaffiliated member of the IACUC at the University of Washington and a former member of the IACUC at the Fred Hutchinson Cancer Research Center in Seattle, Washington.

The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) (PHS, 1986) and the Animal Welfare Regulations (AWRs) mandate that one member of the Institutional Animal Care and Use Committee (IACUC) be 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" (PHS Policy IV A 3 b 4 and 9 CFR 2.31 b 3 ii).

PHS Policy gives no criteria that should be applied in the selection of this person or no indication of what the role of this person should be, while the AWRs state that it is intended that the "person will provide representation for general community interests in the proper care and treatment of animals" (9 CFR 2.31 b 3 ii). The PHS Policy further requires that one member of the committee be someone "whose primary concerns are in a nonscientific area" (PHS Policy IV A 3 b 3). It is possible for the unaffiliated member and the nonscientist member to be the same person.

Beyond this, administrative officers of institutions operating under either PHS Policy or the AWRs are left to their own judgments. There is a paucity of material that addresses this issue and considerable variation in practice exists among institutions (see Orlans (1993) pp. 99-117, which deals with many of the issues addressed in this article). The purpose of this essay is to explore some of the questions that are pertinent to the selection and role of the unaffiliated member that is required by both PHS Policy and AWRs and the nonscien-tist or lay member required by PHS Policy.

WHY AN UNAFFILIATED MEMBER?

When PHS Policy and AWRs require appointment of an unaffiliated member, it is intended that the person should represent the interests of the public in the humane use of animals in research, testing, and education. Whether or not this stipulation was prompted by the increasing concern of the public for the welfare of research animals over the last decade is an open question. Nonetheless the question remains: What should be the role that an unaffiliated member plays in the deliberations of the committee? In a pluralistic society "general community interests" are increasingly difficult to identify. Since a majority of the American public approves research with animals that will contribute to human health and well-being (from a 1990 poll by the National Association for Biomedical Research), "general community interests" could be interpreted as supporting this position. However, to what extent should the unaffiliated member represent the concerns of animal protection groups (this term is used to denote groups and people who are, to varying degrees, critical of the use of animals in scientific research), particularly those concerns directly related to animal welfare?

Supposedly, legislative bodies that are elected by a constituency are responsible to their public. But in the case of lay members appointed to IACUCs by the administrative official of an institution, there is no provision that they represent any special group other than that of the general public. The unaffiliated member is usually chosen from people who are likely to be cooperative with the review process and not by a public vote nor a comprehensive survey for members of the public willing to serve. (This type of selection process is often followed for the appointment of Institutional Review Board (IRB) and hospital ethics committee unaffiliated members as well.) As the result, far too often, some benign individual is selected who may accept the appointment out of a sense of public service or because of a friendship within the institution. The letter of the obligation to appoint a person not affiliated with the institution is fulfilled, but the spirit of the rule is neglected. The committee then proceeds with its work unchallenged. Neither committee members nor people in animal protection groups are entirely happy with the "outside member." The term "outside" often indicates how the committee feels about the interloper and how the unaffiliated member feels about his or her role. Thus, committee decisions may not be rigorously subjected to debate nor viewpoints of the mythical average layperson represented.

The informed unaffiliated member can be of inestimable value to the committee by (1) acting as a liaison between the community or several communities and the institution and (2) bringing a fresh and different perspective to bear upon the research enterprise.

The Unaffiliated Member as Liaison

People are becoming aware of the fact that large amounts of money are being spent by both public and private sectors on research that uses animals. The press has reported both accusations by animal protection groups of the inhumane use of animals and reports by the scientific community that indicate the benefits for humankind resulting from the carefully monitored use of animals in research. However, what sticks in the mind of the public are reports that raise questions whether the use of animals is humane. As a result, the public receives a negative message regarding research and often fails to hear responsible spokespersons who are either intimately involved with research or are lay members of an IACUC. Animal protection groups (that is, that part of the animal protection movement whose aim is to abolish all use of animals in research) are so committed to their cause that dialogue with them is very difficult, if not impossible. Others in the animal protection movement are frequently well-informed and raise plausible concerns about the moral appropriateness of specific research protocols.

On the whole, investigators within the research community, as ardent defenders of their work, find it counterproductive to engage in discussions with these groups. One of the productive roles of the unaffiliated member, who has no vested interest in any particular research project involving animals, is to engage in dialogue with those groups that are critical of, or oppose specific research projects involving animals and who are willing to enter into a rational discussion of the issues.

A far more productive dialogue, however, can be initiated with people in the animal protection movement who recognize the necessity for using animals in research, but who want humane care and use of animals in that research. For the most part, the central issues for these people are: minimization of any pain that animals might suffer, reduction of the number of animals used, and exploration of the possible use of non-animals methods. These principles were first clearly enunciated by Russell and Burch (1959) as the three Rs--Refinement, Reduction, and Replacement. They called for a Refinement of experimental techniques to reduce animal pain and distress, a Reduction in the number of animals used and, where possible, a Replacement of animals by in vitro methods. These principles are widely adhered to by research scientists including those at the National Institutes of Health (Whitney, 1989). The unaffiliated member can suggest bibliographical sources to people in animal protection groups and can cite standards that are being practiced within the local research community. As a result, both animal protection groups and the general public can be reassured that the institution is following high standards in caring for animals. It has been my experience that prejudicial and negative attitudes of many people of good will in the scientific community are based upon misinformation regarding the standards that are mandated and practiced. The unaffiliated member can serve as a resource person in a liaison role with the community.

A Fresh Perspective

The unaffiliated member can bring to the IACUC a fresh, different, and questioning perspective to the animal research enterprise. Some people within the research community believe that almost any type of research that uses animals is justified. Other scientists think that animal welfare can be "objectively" determined. Justification of research and assessment of animal welfare are value judgments and strongly held opinions on this issue often compromise the researcher's ability to be open and receptive to counter-vailingjudgments. Tannenbaum (1991) contends that investigators who have a "pure science" conception of animal welfare investigation make value judgements without realizing it and thus such a "model fundamentally misconstrues the nature of animal welfare." A significant contribution can be made by the unaffiliated member who has less of a vested interest in the conduct of any given research protocol than a scientist and can approach the evaluation of each protocol in a more dispassionate way. The problem of special interest is particularly applicable when the research is to be reviewed and approved for funding by a peer group. Peer review does not include, by definition, non-expert participation, and the only point in the review process where unaffiliated persons are involved is at the IACUC level. As an unaffiliated member of an IACUC, who holds a Ph.D. in comparative literature, states

There are, however, some very real advantages to being a layperson on the Committee. Because I am not involved in biomedical research, I believe I can be more objective about the outcome of particular research proposals. I have no vested interest...I have no personal stake in the outcome of the individual projects; nor do I personally know most of the faculty members submitting proposals for our review .... [Laypersons play an essential role] in keeping the Committee 'honest' and ensuring that it conducts its business in a manner and language understandable to all (Baker, 1987).

Another unaffiliated member, who had a background in Greek philosophy and biochemistry, underscored the importance of the liaison role and stated that his task "is to build trust between the community and the research community" (Farr, 1989).

We will now turn to an examination of the role of the lay member, mandated by PHS Policy, on the IACUC. As noted above, the lay member may or may not be the same individual as the unaffiliated member. It should also be noted that the AWRs do not call for a lay member although it is stated in the regulations that it is intended that the unaffiliated member represent community interest in IACUC discussions. This does not say that a scientist could not represent community interests but it is usually interpreted to mean just that.

Review by a lay member is often troubling to investigators because the individual is not a researcher and not a scientist. Conversely, the technical language in the protocol, at least for the lay member, may obscure both the ethical issues and the science involved in the research proposal. Over the years, I have frequently had to inquire, "What are you really doing with these animals? How invasive is the procedure?"

In other words, I want to be informed, in layperson's language, exactly what the protocol entails. I have often asked the investigator or the chairperson of the review committee to summarize in ordinary words the nature of the protocol and the scope and methods involved in the proposal before it is discussed by the committee. Lay members of the committee invariably applaud this suggestion. This is a simple suggestion, but it makes the lay member feel that there is a desire on the part of the committee to communicate on a non-technical level. Lay members are often intimidated and frustrated because they are not in the scientists' circle and are often hesitant to ask questions that might facilitate communication.

We come now to the very delicate issue of recognizing pain and distress in animals and the validity of anthropomorphic projection. It is generally recognized that there is a subjective element in addressing the question of pain while at the same time a trained person can recognize patterns of behavior manifested when the animal is experiencing discomfort and pain (NRC, 1992, P. 32). However, it is possible for the investigator to focus on the goals of the research effort and become inured to the stress or pain the animal is experiencing. One of the functions of the committee is to review situations where this might occur. But the question remains: Does the lay member have a unique or special role in protocol review by bringing an intuitive dimension to the process that might be based upon an unsophisticated experience with animals? I raise this as a question only. I recognize full well the dangers of anthropomorphic projection based upon intuition but comments by the lay person that express such feelings might serve to enhance the review process. The committee has the responsibility to consider such views respectfully. As one commentator puts it, "The community member should be made to feel that he will receive prompt, honest answers to his questions about animal care and use" (Gerrity, 1989).

While formerly an affiliated and lay chairperson of an IACUC, I now serve as an unaffiliated and lay committee member. I must confess that, in my present role, I have felt at times that my comments and concerns were considered by some members of the committee as a form of harassment having little or no substantive value. Unless this type of feeling is openly addressed by the "outside member" with the committee, mutual respect and dialogue will be threatened. Lay members are not scientists, that is why they are on the committee. Lay members should not be treated in a patronizing way, nor should lay members have a chip on their shoulders; they should be equally respectful of the scientist's interests and professional expertise. Mutual understanding and respect is fundamental to fulfilling successfully the intent of the mandate that a community representative serve on the committee. When an adversarial relationship develops among committee members, it defeats the purpose of the interdisciplinary nature of the group. This is why selection of the unaffiliated member and the lay member should be made with great care and deliberation.

THE SELECTION OF THE UNAFFILIATED AND LAY MEMBERS

First, who should be appointed? A general profile of the qualifications of both unaffiliated and lay members can be inferred from the preceding discussion of the productive roles these members might play on the committee. The frequent comment is made: Where do we find such people or a person if the unaffiliated member is also to be the lay member? The task is difficult, but not impossible. A few of the desirable characteristics that these members might possess are as follows:

Someone who owns animals and cares deeply about their welfare but, at the same time, recognizes the value of animal research.
A member of a local (city, county, or state) animal regulation body who is involved in formulating laws pertaining to animal use and care, who hears claims about the abuse of animals or is responsible for enforcing animal care regulations.
A member of a local humane society or animal welfare group who understands the legal and ethical standards that apply to the appropriate use of animals.
A person who loves animals, who has been a patient and who has personally benefitted from research with animals. A helpful resource is the Patient Coalition, a national voluntary health organization. (For more information contact incurably ill For Animal Research (iiFAR) National Headquarters, Box 27954, Lansing, MI 48909. Tel: 1-517-887-1141).
A science or biology teacher who uses animals in the classroom for instructional purposes.
A professor of ethics in a neighboring institution.
A lay volunteer in a medical institution who is concerned about patient care and new developments in medical research that will enhance the well-being of patients (such as an IRB member in another institution).
A public-spirited citizen who is active in community organizations that serve the needs of the community, e.g. ministers, lawyers, and non-professionals.
Geologists, engineers, physicists, or other non-biological scientists

You will note that I have not mentioned a veterinarian or a biomedical scientist. These professionals are already amply represented on the committee. I believe that the unaffiliated member should be truly a lay person, i.e. a non biomedical scientist, who can faithfully represent the interests of the public. There are others, however, who feel that the unaffiliated member can be a scientist, even a veterinarian in private practice or a biological scientist. This is based on the belief that possessing a scientific background means that they can understand the science in the protocols and what is actually happening to the animals and, thus, are able to better represent community interests during protocol review.

The second issue relates to the question of the selection process of the unaffiliated member. The following suggestions may be helpful:

Canvas the groups mentioned above and solicit their recommendations.
The chairperson of the committee and the administrative liaison officer should interview the candidate.
Before selection, take the candidate on a tour of the facility, meet investigators and vivaria staff. Respect the staff's reactions to potential members.
Inquire about what experience the candidate has had with other community and public service organizations. What does the candidate believe to be his or her constituency?
What does the individual understand by the term, "humane'' care and use of animals in research? Is the candidate in sympathy with the principle that research with animals is necessary for the progress of medical science and the advancement of knowledge? Discuss the possibility that the candidate may feel that a particular research protocol is ethically or legally inappropriate and indicate the procedures that are available, in the pursuit of such a grievance, within the administrative structure of the institution other than a negative vote within the committee. I feel strongly about this matter. Occasionally the unaffiliated member will give the only dissenting vote. The vote is properly recorded and that is the end of the matter. The established methods of appeal (which may vary from institution to institution) should be clearly explained to each member. Otherwise, unaffiliated members may find their experience on the committee very frustrating and their voice unheeded.

CONCLUSION

These are some personal observations about the role and selection of unaffiliated and lay members after having served as both as affiliated chairperson of an IACUC and as an unaffiliated member over the past ten years. Hopefully these reflections will be provocative in order to elicit careful consideration of the role of the unaffiliated member. It is my belief that the appointment of unaffiliated members is frequently taken too lightly and is often considered an unwelcome burden that has been necessitated by legal mandate. There is no question that institutions doing research involving the use of animals are often challenged. Therefore, it is very important that they retain or regain the confidence of the public and that their research follows the highest ethical and legal standards. A credible unaffiliated member can be of immeasurable assistance in this regard.

REFERENCES

Animal Welfare Regulations. 1985. Code, Title 7, Sections 2131-2157. (Available from: Regulatory Enforcement and Animal Care, U.S. Department of Agriculture, Federal Building, Room 268, Hyattsville, MD 20872).

Baker, M.J. 1987. A layperson's role. Lab. Anim. Sci. 37(Special issue):84-85.

Berry, D. 1991. Reference material for members of animal care and use committees. National Agricultural Library. p. i. A bibliography especially developed for the unaffiliated and lay members of IACUC.

Farr., C.E. 1989. Community responsibility and the role of community members in public education. P. 139 in Science and Animals: Addressing Contemporary Issues. Guttman, J. Mench, Simmonds, eds. Scientists Center for Animal Welfare.

Gerrity, L. W. 1989. Committee knowledge of protocol adherence, p. 137 in Science and Animals: Addressing Contemporary Issues. Guttman, J. Mench, Simmonds, eds.

Moskowitz, J. 1989. NIH animal welfare initiatives. Pp. 1-3 in Animal Care and Use Policy Issues in the 1990s. Office of Animal Care and Use, National Institutes of Health, Bldg. 14A, Rm. N44, Bethesda, Md.

NRC (National Research Council). 1992. Recognition and Alleviation of Pain and Distress in Laboratory Animals. National Research Council. Washington, D.C.: National Academy Press.

Orlans, F. B. 1993. In the Name of Science: Issues in Responsible Animal Experimentation. New York: Oxford University Press.

Public Health Service (PHS). 1986. Public Health Service Policy on the Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. (Available from: Office for Protection from Research Risks, Building 31, Room 4B09, National Institutes of Health, Bethesda, MD 20892).

Russell, W. M. S., and R. L. Burch. 1959. The Principles of Humane Experimental Technique (Special Edition). Hens, England: Universities Federation for Animal Welfare.

Tannenbaum, J. 1991. Ethics and animal welfare: the inextricable connection. JAVMA, 198(8): 1360.

Whitney, R. A., Jr., (Moderator). 1989. The three R's: Refinement, reduction and replacement. Presentation by Richard Traystman. Pp. 69-71 in Animal Care and Use Policy Issues in the 1990s. Office of Animal Care and Use, National Institutes of Health, Bldg. 14A, Rm. N44, Bethesda, Md.