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Biology and Law: Challenges of Adjudicating Competing Claims in a Democracy
Prepared for The National Science Foundation* Acknowledgments This report developed out of two workshops sponsored by the National Science Foundation and organized by Arizona State University. The idea began when Allan Kornberg, then Director of the NSF's Division for Social, Behavioral, and Economic Research, challenged his program officers to explore issues of science and democratization. Ron Overmann, then Program Officer for Science and Technology Studies, encouraged us to look at questions raised by the rapid growth of the biological sciences and to think of intersections with other NSF programs and initiatives. We decided to focus on relations of biology and law and held the first workshop in Phoenix in March 1995. That first session yielded a draft report. We realized, however, that we could provide more helpful guidance for research by deepening the discussion and focusing more clearly on how to make sense out of this very broad and complex range of issues. Productive interdisciplinary work takes time, so we circulated several drafts, began to outline sample case studies, and held a second workshop in May/June 1996. Participants came from a variety of different disciplines and institutions, with both students and NSF officers taking part.
The result is the following report, which points to an area ripe for
research and development. We offer recommendations and suggestions,
primarily outlining a range of questions about democratization and a number
of other NSF initiatives. We encourage the NSF's continued investment in
such interdisciplinary efforts.
March 1995 Workshop Participants were:
John Beatty
James Collins
P. Michael Conneally
Carl Cranor
Greg Fowler
Steven Goldberg
Joseph L. Graves
Henry Greely
Sheila Jasanoff
Owen D. Jones
Ruth S. Jones
Bobbi Low
Jane Maienschein
Sandra Mitchell
STUDENTS:
This project would never have occurred without the support of Allan Kornberg, Ron Overmann, Mike Sokal, Neal Tate, and especially Rachelle Hollander at the NSF. Overmann continued to provide guidance and to nudge us onward, even after his move from the NSF to Hawaii. Among the participants, Sheila Jasanoff and John Beatty offered especially helpful support at various stages. David Kaye, from the College of Law, Arizona State University, although unable to attend the workshops, offered valuable suggestions. James Collins concentrated on environmental case studies, Dan Strouse on genetics, and Jane Maienschein on the entire project; questions or comments should be addressed to them or to the NSF officers.
Christy Bison, Nita Dagon, Rosalind Pearlman, and Rita Yordy all made the
workshops possible with their administrative support. Christy Bison and Rita
Yordy spent many hours deciphering handwritten notes and processing the
words herein. Anne Dresskell provided excellent editorial assistance.
Without their help, this report would never have actually come into
existence.
Jane Maienschein For further information or additional copies of this report, contact Rachelle Hollander, National Science Foundation, at (702) 292-8763, or RHOLLAND@NSF.GOV
Biology and Law The past decades have seen tremendous worldwide political, social, and economic upheaval, with significant institutional change as a result. Nations are being redefined and nationalism is on the rise in some arenas; global concerns and internationalism dominate in others. Political units are shifting and undergoing renegotiation, and increasing democratization is held up as an ideal. Science and technology sometimes are seen as particularly valuable in promoting progress and are accorded, therefore, a special status by many political leaders. Yet science and technology have undergone dramatic changes as well, raising new questions for law and for the social, political, legal, and scientific institutions that address legal issues. Furthermore, as science does not always provide clear, uncontested "facts," the interface of science and law requires adjudicating many competing claims to knowledge. The biological sciences, in particular, have virtually exploded with new knowledge, notably in genetics, and in the environmental and human sciences. This new knowledge has challenged our views of nature, life, and human identity. It also has produced new and different types of scientific expertise. Experts, holding competing views on issues of political significance, have challenged society's capacity for drawing on their expertise. Major scientific revisions raise questions about the appropriate interplay between science and law within political systems. Since both legal decision making and scientific development are central to the needs of democratic societies, developing productive approaches to study their interaction is clearly a high priority for the research community. With two intensive two-day, NSF-sponsored workshops, interdisciplinary groups of researchers explored a range of issues at the interface of biology and law. First, they considered the larger issues, hinting at ways to study them. Second, they developed focused case studies, outlining sets of researchable questions for scholars in the social, behavioral, economic, and biological sciences. The larger issues lie at the center of current NSF initiatives-including human capital, biotechnology, genome diversity, civil infrastructure, and human dimensions of global change. The following report provides a discussion of these issues and offers one framework for studying them. In addition, it takes a close look at cases of conserving biodiversity, bioprospecting, and genome control.
The group generated four recommendations for the National Science
Foundation:
a) Continue to encourage and support research in the areas outlined.
All researchers admitted the difficulties and challenges of engaging in
serious interdisciplinary work that crosses traditional boundaries. Yet all
acknowledged that such interdisciplinary work is essential to bring together
the multiple types of expertise and approaches. Such interdisciplinary work,
fostered by special initiatives, offers rich rewards because it encourages
researchers to take up areas or collaborate in ways they otherwise might not
pursue. Publicity about special initiatives and expanded support through
disciplinary programs are both vital.
b) Continue to develop ways that the NSF can take a leading role in, as
well as respond to, exciting research areas. We have a compelling need
now, early in the process of negotiating the boundaries of biology
and law, to develop various baseline studies. These will provide a source of
valuable data for comparison later, to document changes and impacts of
policy decisions.
c) Invest in the development of a research infrastructure. We need to
assess what is available now as research materials-for example, ELSI studies
at the NIH, records of the Recombinant Advisory Committee (RAC), and records
of several pivotal environmental legal challenges. The research community
and policymakers alike need to determine what data are now available and
develop plans to make it accessible by preserving and archiving that
information. Some participants suggested that the NSF might need an
archivist to oversee investment in and insure adequate quality of archival
efforts. While talk of archives sounds antiquarian to some, it is very
likely that many will use the available data, thereby avoiding preventable
mistakes or repetitions. d) Continue NSF-sponsored efforts to produce a more scientifically informed citizenry. Such events should target legislators, judges, and other policymakers as well.
Biology and Law
Rationale The past decades have seen tremendous worldwide political, social, and economic upheaval, with significant institutional change as a result. Nations are being redefined and nationalism is on the rise in some arenas; global concerns and internationalism dominate in others. Political units are shifting and undergoing renegotiation, and increasing democratization is held up as an ideal. Science and technology sometimes are seen as particularly valuable in promoting progress and are accorded, therefore, a special status by many political leaders. Yet science and technology have undergone dramatic changes as well, raising new questions for law and for the social, political, legal, and scientific institutions that address legal issues. Furthermore, as science does not always provide clear, uncontested "facts," the interface of science and law requires adjudicating many competing claims to knowledge. The biological sciences, in particular, have virtually exploded with new knowledge, notably in genetics, and in the environmental and human sciences. This new knowledge has challenged our views of nature, life, and human identity. It also has produced new and different types of scientific expertise. Experts, holding competing views on issues of political significance, have challenged society's capacity for drawing on their expertise. Major scientific revisions raise questions about the appropriate interplay between science and law within political systems. Since both legal decision making and scientific development are central to the needs of democratic societies, developing productive approaches to study their interactions is clearly a high priority for the research community.
While researchers have investigated selected aspects of biology and the law,
work on most of the important connections has just begun. Traditionally,
scholars in such areas as science studies, law, philosophy, history, and
political philosophy have examined separate disciplinary pieces of the
larger picture. Moreover, because they have different conceptions of
evidence and different approaches to addressing questions, it is difficult
to integrate their disparate research findings. Yet a host of recent
political actions have raised complex questions that call for more
multidisciplinary research that will bring together work in the social,
behavioral, economic, and biological sciences. Those pursuing legal studies
stand to gain from sharing ideas with those pursuing science studies, and
vice versa. For example:
the Supreme Court has ruled that the 1973 Endangered Species Act was
intended to prohibit destruction or harm to habitat as well as to
individuals of the species. Thus, even private land owners cannot destroy
timberland habitat for spotted owls. The Court's interpretation draws on the
scientific argument that habitat is essential for species survival.
a body of religious leaders and others have argued that the U.S. government
ought not to grant patents on living things or their parts, including DNA
fragments. Scientists have not created and thus should not own life, they
argue. Some scientists disagree, asserting that isolated or purified gene
fragments are as much a product of human ingenuity as they are of any other
technology.
the Supreme Court has instructed federal judges to make decisions about
which expertise to admit into evidence, but judges often have little
training in science.
a lawsuit contends that federal agencies ought to be required to hear
scientific evidence in making decisions about use of public lands. Current
law does not require such input, and critics argue that science should be
awarded no such special status.
some local school boards have accepted religious arguments that evolution
ought not to be mandated as part of the curriculum. They thereby question
either the scientific explanation of life forms as deserving of special
educational attention, or the theory of evolution as good science.
critics argue that genetically engineered foods, drugs, and pesticides may
be unsafe, while scientific experts maintain that the scrutiny to which such
products are subjected assures safety beyond that required for many
"natural" products, including those modified through conventional breeding
techniques. While science appears to many to move steadily forward, producing new knowledge as it goes, new knowledge frequently challenges both our established political practices and our legal system. The latter is charged with interpretation and decision making with respect to the existing laws. Such decisions must resolve, address, or intelligently incorporate into policy scientific issues that are themselves hotly debated by knowledgeable scientists. How can we best interpret and use competing and complex scientific claims? The judicial, administrative, and legislative branches of the legal system rely on hearing and evaluating testimony from scientists and representatives of various points of view to resolve disputes and make policy. Many recent biological advances, with potential political significance, raise questions about which experts do not agree. What happens when there is a conflict of expert testimonies or conflicting claims about the quality or probative value of evidence? What is to count as evidence? How are conflicting claims to be legally adjudicated? How are conflicts between local, national, and international participants with different interests to be resolved? Some members of the scientific community suggest that scientific claims should always be resolved in the scientific arena, and that political, social, and legal forces should be irrelevant. Who will decide how to import those scientific claims into political action and legal interpretation? How are decisions to be made in areas of uncertainty, at the borderline of science and policy? Whose rules will take precedence when law and science have different approaches and standards for evaluating evidence?
These are important questions concerning the nature, role, and institutions
of science; the nature, role, and institutions of the political and legal
systems in which science is applied; and the interactions between the two.
We can gain a better understanding of our own legal and political systems,
under whose ultimate governance the sciences are carried out, by using the
scientific approaches of analysis and data production derived from the
social sciences (and legal studies) as well as from the physical and
biological sciences. In today's climate of increasing scientific challenges,
a clear articulation of our existing legal system's handling of scientific
issues will give an advantage to those who wish to improve our own
political/legal/social system, and to those who desire to advise others.
The Workshop To begin the process of identifiying areas needing further study at the interface of biology and law, organizers at Arizona State University held a workshop sponsored by the NSF's Division of Social, Economic, and Behavioral Sciences (Phoenix, Arizona, March 24-25, 1995). Thirty-two representatives of biology, law, science studies, history, philosophy, and political science worked together to help define the NSF's research agenda in several areas related to democratization, global, environmental, and genetics concerns.
For purposes of organization, the workshop clustered discussions into three
core areas. Despite some overlap, each introduced different sets of
issues:
Environmental and Conservation Issues: Conflicting Values Along the way, our benchmark question was: Given the conflicts and controversies within science and the additional public conflicts about how to interpret the significance of the science, how can we adjudicate among competing claims within the scientific, legal, and political arenas?
The workshop participants agreed that future research will lead, first, to a
clearer understanding of the legal, political, social, and economic systems
in which law and science play out their differences. Second, it will require
further study of the nature of science and its political role. This includes
the need to explore ways in which the life sciences raise special issues
because they study life and thereby challenge our very interpretation
of ourselves and our place in nature. Third, we need a clearer understanding
of the role of law in society, and of the way that law deals with scientific
issues. The discussion of science and law reveals the underlying differences
in approaches, standards, and institutions in what counts as knowledge,
standards of evidence, burdens of proof, or levels of "certainty" and
confirmation, for example. Conflicting needs and interests in law and
science raise special problems for dispute resolution. Law provides no
overriding epistemology to resolve within the law among competing scientific
claims. Research in each of the core areas will illuminate the existing
relations as well as provide a sense of the appropriate relations between
law and science. These relationships are explored in the first three
sections:
Democracy, Science, and Law
Finally, four specific examples from the biological sciences are explored as
examples of special areas of study: Workshop participants concluded that the United States has already developed a tremendous knowledge base in our understanding of democracies, law, science, and the foundational aspects of biology. We have also raised a host of challenges to our existing legal, political, and scientific systems, often raising critical questions with increasing urgency. These new frontiers at the interface of science and law call for further research if we are to improve our understanding of science and conflicting values in complex political systems. Participants stressed that truly innovative research at these frontiers must include coordinated interdisciplinary studies crossing traditional academic boundaries that draw on multiple resources to develop wider insights. Workshop participants agreed that this is the strategic time to undertake larger and cross-disciplinary studies concerning a range of issues about biology and law: to pursue baseline empirical studies of the way those different approaches play out in political arenas, to explore how science intersects with legal and political processes, and to build on studies already begun. These data will underpin future studies and facilitate the exploration of changes over time. With such empirical work in place, scholars can begin to pursue comparative studies across different institutions, biological specialties, cultures, nations, and times. This ideal-to bring together scholars from a variety of backgrounds-is especially important in this time of volatile legal and scientific institutional change.
To carry the process further, and sharpen our questions by exploring clearly
developed case studies, we held a second workshop with the help of three NSF
officers and former NSF-officer Ron Overmann. The twenty-five participants
generated cases and expanded awareness of connections with diverse NSF
initiatives (such as the human capital, biotechnology, genome diversity,
civil infrastructure, and human dimensions of global change initiates). They
also explored ways to promote public understanding of science in order to
develop a more scientifically informed citizenry, legislators, judges, and
other policymakers. In addition, the group emphasized the importance of
developing infrastructural support for improving our understanding through,
for example, the development of archives, oral histories, and depositories
to preserve such records.
Democracy, Science, and Law Why does the understanding of science and law matter in a democratic society? At their most basic and idealized, democratic societies share a commitment to the equal worth of individuals, to political (and even some basic minimal levels of economic) equality, and to self-rule through law-at least among those defined as "citizens." Procedurally, the ideal is that the majority voice should prevail, although this is not always the actual practice. How the majority comes to exist and to be recognized differs among democracies. The U.S.'s representative, constitutional democracy acknowledges that all cannot vote on everything; we have no way, therefore, to achieve true majority rule without utilizing a system of elected representatives. We also accept the importance of recognizing and protecting certain fundamental rights and interests of individuals, whether or not they are in the majority. Those rights are safeguarded by the Constitution, both substantively and through the guarantee of due process. Another set of restrictions and responsibilities comes with the division of our government into separate legislative, executive, and judicial branches. Lawmaking is conducted in a matrix of institutions that, in our federal system, exist at the local, state, and national levels. Ordinances, statutes, administrative rules, and judicial decisions constitute the "products" of these institutions. All have the force of law. Subject to varying (and somewhat overlapping) limits of jurisdiction, most domestic policy problems raise a question about where law can and should be made. Lawsuits may be brought in federal or state court by private individuals, legislators at all levels may introduce bills addressing new policy problems, and agencies (relying on new or existing statutory authorization) may write rules, or investigate private activities, all in response to the same problems. The institutional competence and suitability of these different responses varies with the particular subject. The process is complicated and has been adapted to deal with the increasing complexities of large populations with a more highly technologically based lifestyle. This is especially true in areas where local, regional, state, national, and international interests are all clearly at play, and where there are competing values and needs. Science, technology, and the changing social world obviously create opportunities and challenges. One such challenge derives from the very nature of science, which creates a set of scientific experts, and its tension with democratic values, which seek to give all citizens an equal voice at least through their representatives. Both formally and structurally, the American lawmaking process leaves most ultimate decisions with nonexperts. Legislatures consist of a mixture of elected laypersons (who may be professionals in some field but who are elected to consider all issues rather than to exercise their expertise as such) who enjoy very broad jurisdiction over matters of policy. In many jurisdictions, the initiative and referendum provide for direct plebiscite. Judges, among other duties, preside over trials heard by citizen juries. In other cases, administrative agencies, created by legislatures to develop and manage programs requiring special knowledge and expertise, make final decisions through executives who may be presidential or gubernatorial appointees, or may be otherwise accountable to the agency's political constituencies. Judges may conduct bench trials; agencies may adjudicate cases without public imput. Although democratic values underlie the law's decision-making processes, they are sometimes in competition with reaching scientifically or technically sound results based on accurate, well-comprehended information. Science establishes experts, and not everyone is equally an expert on any given subject. Indeed, there are intricate hierarchies of both scientific and other expertise. Thus, to the extent that any legal issue depends on, or might be in any way influenced by, scientific expertise, it is by definition not based on equal voices. Scientific experts brought into the legal and political process may acquire a special, unequal, and hence potentially undemocratic role. Thus, questions about the legal status of experts and their expertise lie at the very core of many current legal debates. This tension is further complicated since some may be experts on the local scale, or may have special expertise about local factors. This is especially true with environmental issues. There may be competing local "experts" on different aspects of the scientific evidence, all of whom claim a privileged position in making decisions and hold different systems of expertise as more important. For example, Native American groups have claimed special expertise in some cases; long-term ranchers have stressed superior knowledge in others. Which experts, then, shall we believe, and for which purposes? Basic definitions about who qualifies for membership in the democratic polity and who qualifies for constitutional protection have depended, at least in part (although not exclusively), on available scientific knowledge. "Scientific knowledge," itself, has changed over time as blacks, women, and other disadvantaged groups have gained political status as deserving citizenship, education, and a place in the democratic process. Thus, biology raises basic issues that strike to the heart of any democracy. We need careful study to clarify the extent to which science does-and should-provide the driving knowledge base by which we make decisions about political status. When scientific claims are contested, whose expertise counts? In which arenas? How and when should we listen to experts rather than to the majority, and how do we balance diverse views? How do we adjudicate between competing claims-either competing scientific claims or competing claims about the proper political and legal uses of science?
Such questions become all the more complex when we move, as we have recently
in the U.S., to increasing the number of decisions made at the level of
administrative law and, in certain areas, returning more decision making to
the individual state governments. What happens when an even greater variety
of experts and systems of expertise operate at these levels? In many cases,
we have no standardized procedures for public deliberation or decision
making, especially when the goals and interests of law, legislation, and
science conflict.
The Role of Science
Why does science play a special role in legal and political decisions? In
the traditional ideal of science, the objective scientist is guided by the
pure pursuit of knowledge (or, usually, some presumed notion of truth). This
scientist gathers data by observing the natural or social world; formulates
hypotheses about those data and the phenomena from which they derive;
generates predictions; tests those predictions and thereby the hypotheses;
revises hypotheses; and continues the process, ever revising and improving.
Science seeks to explain phenomena by uncovering and understanding their
underlying causes. It is an analytical process that yields progress and
generates useful knowledge, even though the results are tentative rather
than certain, subject to considerable revision, and shaped by social
input. Scholars, as well as legal and scientific practitioners, recognize that this model is too simple and that a wide range of personal, political, social, and other factors actually complicate the process. While the search for truth is an ideal for both law and science, science as actually practiced is more complex and does not lend itself easily to direct use in legal problem solving. Sociologists and historians of scientific knowledge have led the way for analysts of science to see that, to some extent and in some senses, science is socially constructed. The particular problems pursued at any given time and place, the preferred approaches, and the roles or conventions for interpreting results are strongly influenced by the context in which the science is done. In other respects, science conforms to the ideal presented. Disputes arise within science because theory and methods differ, but in each case there is a fact of the matter about which the participants are arguing. Careful exploration of how the dominant scientific views are developed and what level of reliability science carries should provide guidance about how best to import science into the legislative process and judicial proceedings. We need to acknowledge the challenges that science brings to law and to study them carefully. In particular, scientific change, competing epistemologies within science, and the uncertainties of results raise three areas of concern for those who wish to import scientific knowledge into the legal world. First, what we consider scientific knowledge can change rapidly, which can be a problem for legal and political processes. A specific legislative act or judicial case may proceed assuming one set of "facts," while those facts are being undercut or replaced by others. This does not in itself make experts or their testimony unreliable, but it challenges any process that depends (as law does and must) on a state of evidence tied to a particular moment. Thus, the process of doing science creates a changeable set of specific evidentiary claims, even while the standards for what will count as evidence change more slowly. We need research into the nature of science and its context to develop the necessary translations between scientific and legal communities for such central concepts as the nature of evidence or what is the applicable standard of proof. Second, there are also different approaches and epistemologies within science. Part of the strength of the scientific process lies in the coexistence of different approaches and the dialogue that results about the interpretation of how the available data support or refute conflicting hypotheses. Obviously, disagreement over the correct interpretation of scientific data makes it much more difficult to carry scientific knowledge into the legal and political processes. In some cases, and at certain stages in the early development of a topic, disagreements within science prohibit a unified "certainty" or "confidence" from emerging. Yet, the legal and political decisions that must be made now require the best of what we know. Inconclusiveness within science should not be interpreted by decision makers as ignorance. Rather, we need to develop means of interpreting uncertainties that will allow scientific knowledge, uncertain though it may be, to inform our practices and policies. Whose science shall we accept, and by whose standards shall we judge its acceptability? Finally, scientific knowledge is especially contested in areas where that knowledge is inevitably uncertain. Many phenomena behave stochastically and simply cannot be known in other than probabilistic terms, with some degrees of uncertainty. The law struggles with scientific uncertainty, either because it generates an unacceptable level of doubt (e.g., criminal law where life or freedom may hang in the balance), or because it demands that choices be made notwithstanding the inability of science to provide needed guidence. The cost of error, whether through false positives or false negatives, may be very high in such cases. This is particularly an issue in risk assessment studies with significant political and social implications where many people will be affected, although there are cases where the law has worked out ways to deal with different levels of probabilities. With knowledge-and especially with knowledge gained through public support of science-comes responsibility as well as privilege. Physicists realized this after the dropping of the first atomic bomb. As J. Robert Oppenheimer noted, "Scientists have known sin." Biologists, concerned about unknown risk and eager to avoid a similar predicament, initially proposed a voluntary moratorium on certain kinds of recombinant DNA work that might be seen as crossing natural boundaries and, thus, as "playing God." Agreement to go on with research gave rise to many different and often conflicting responsibilities. One form of responsibility stems from the public funding of science. Accepting public funds, the scientist may have some prima facie responsibility to make the results public. If the contract does not specify how and when the knowledge must be shared, however, there will be times when it may be better to wait. Perhaps the data set is not as rich as ideally would support the conclusions others inevitably will wish to draw, or to support any conclusions at all. Or perhaps the conclusions would have significant social consequences, leaving the researcher to feel that it is more responsible to seek corroborating evidence from other lines of research than to report the preliminary results. Scientists' sense of responsibility to the public-as-individuals who may be affected may conflict with their sense of responsibility to the public-as-funder-of-science, especially when the individual may be harmed but the larger public may gain from the dissemination of knowledge. Tension emerges because responsibility to the scientific community requires adhering to the standards of evidence and other internal requirements of the scientific process, and to the profession that carries out that process. Social responsibility introduces other factors that may be at odds with those norms and standards of scientific practice. Imagine a scientist who takes into the courtroom a preliminary finding about the population of a protected species. Having not counted all individual organisms in the field, this scientist nonetheless knows that therecould be many more. There probably are not, but there could be. Admitting this in court, he hands the anticonservationists the ammunition they need to oppose any special protection of that species. Yet not to admit that limitation on our knowledge would be untrue to established standards of knowledge. Scientific practice may dictate a slow and careful study of all potential causes of a phenomenon, for example, while political and legal pressure may push for immediate answers to urgent questions. When to make data available-how, where, with what explanatory framing, and through what nonprofessional channels-remains unclear.
To insist on further detailed and compelling data, the gathering of which
takes time while species disappear, raises additional concerns. Has the
scientist done wrong? If such a scientist felt that there likely were many
individuals but spoke only of one sampling method that revealed few, and
that was the only one asked about, would he or she have done wrong? Would it
matter if the scientist were prodevelopment or proconservation? Should any
such scientist have revealed the complexities of the situation? What, then,
are the responsibilities of the scientist-qua scientist and qua economic
participant with claims to the results of the research, and qua citizen with
legal, moral, professional, and personal interests?
Law and Science There are some basic differences in the ways that law and science work, since they have different underlying institutional needs and requirements, standards of evidence, burdens of proof, and such. Many of these differences stem from the disparate goals of the two enterprises. When an issue is presented to the legal system, it often must be resolved with some answers. Suppose the law provides that a medicine cannot be sold unless it is shown to be reasonably safe, or that it is to be taken off the market if safety concerns emerge. Even if experts disagree about the safety issue, the tribunal must decide. Failure to act results in victory for those who oppose selling or who wish to keep selling the medicine. Moreover, the question of reasonable safety turns in part on an expert agency's judgment about assessments of acceptable risk made by numerous people. Under the circumstances, the legal system stresses adversarial procedures through which people get to express opposing views. The goal is a socially acceptable set of results-a resolution of the current dispute-rather than a timeless truth. In science, when there is insufficient information or insufficient interest in the subject, a matter simply remains unresolved. The scientific community as a whole seeks an ever-growing base of hypotheses that have withstood vigorous testing. While individual scientists may compete with each other, the goal is a broad consensus among scientists about how the natural world works. Accordingly, the scientific community stresses a system of professional certification and peer review through which consensus is generated (this despite the vigorous persuasive efforts by the science studies community to demonstrate the local contingencies and social conventions that, in fact, influence science). Nonetheless, the scientific community as a whole retains an ideal of science-as-reasonably-definitive-knowledge. In addition, there are fundamental differences in the style of discussion. Courtroom lawyers, and most judicial processes, depend on an adversarial approach with a debate model of exchange. One side will win; the other will lose. The orientation in science is toward consensus, and the goal is to find one answer to any given question-or at least to agree to disagree. Individual scientists disagree and debate about specifics, but they all accept the goal of working through the disagreements to achieve the best available view. It may be heuristically useful at any given time to look at more than one theory, and individual scientists may have a considerable stake in having their particular theory and approach "win." Yet the scientific community, in principle at least, seeks the best view that will work with all the evidence. According to this concept, nature behaves in one way only. Typically, therefore, one side will not clearly win; compromise, periodic revision, and open questions will prevail.
As science is drawn increasingly into the legal process through all levels,
from the court system to the regulatory administration, research exploring
the significance of these differences of style and approach will prove
useful. Considerably more interdisciplinary study of differences and
possible translations-or at least ideas about how to reconcile scientific,
legal, and political differences-will improve our ability to deal with
tensions between law and science.
Biological Sciences: A Special Case "Environment" is a fuzzy term generally taken to include the earth and its natural resources. Usually this means the natural world of rocks, trees, and other animals, although it can also mean the social or human environment. Thus, for example, the "urban environment" includes inanimate buildings, subways, and rats. It also includes such phenomena as human violence, culture, and garbage. Environmental sciences, then, cover a vast range of subjects from architecture to zoology. The workshop concentrated on the natural environment, and on issues relating to law and a socially and politically negotiated treatment of that environment. Biology (especially zoology, botany, and ecology), geology, and geography all contribute in important ways to the scientific study of the natural world, and they all produce claims of scientific knowledge about that world. Yet those sciences include divergent goals. While one botanist or zoologist may focus on the presence of a particular rare plant or animal species, another may emphasize the ecological interactions of plants and animals within an ecosystem. The former thus stresses individual species while the latter stresses a system, perhaps in terms of the habitat needed to support greater biodiversity. Science does not tell us which to value more. Such decisions require the introduction of other values. Similarly, it may be aesthetic or social values that push one scientist to rely on local sampling over only a season or two while another scientist chooses to continue long-term studies over many years. The first seeks to capture and describe the situation now, at one slice of time, while the latter seeks to understand the dynamics of change over time. Which of these knowledgeable parties shall the legislature and courts count as experts? To what extent shall we rely on science to make environmental decisions at all? Perhaps the natural environment is a special shared resource like the traditional town common, with diverse competing claims on it. Some argue for the existence of a special vernacular knowledge according to which those who know the local environment best are viewed as having the most valuable knowledge. In particular, indigenous populations are presented as possessing special knowledge about the land and its living populations. They often have special claims to the ethnic and historical right to use endangered species, for example, such as eagles, panthers, or whales. As the Constitution seeks to protect religious freedoms, some of these claims come in the form of religious rights; other claims concentrate on the right to make a living through continuing to hunt or fish in traditional ways. Others argue that property rights prevail and that some knowledge supposedly accrues to those who have owned or used the land for such pursuits as hunting, grazing, agriculture, or mining development. According to this view, ranchers and farmers supposedly "know" the environment better and should prove better stewards of the land and its resources than government agencies charged with protecting some abstract public interest. > What is the public interest, then, and whose word should we believe? How shall we make decisions about environmental matters, and what do we need to make such decisions? How can we adjudicate the complex of competing values, including the various scientific views? Our political conviction in the U.S. has been that we need collective management of at least some of our environmental commons for the larger community interest. With the National Park Act, we began setting aside natural preserves, beginning in 1916 with Yellowstone National Park. The emphasis here was on preservation-on setting aside these precious lands for the enjoyment of both current and future generations. Buoyed by arguments from sportsmen and hunting clubs, such movements have underpinned the private efforts of groups such as the Nature Conservancy. Further arguments along these lines have motivated government action to protect wetlands, or to protect and preserve individuals of certain flora and fauna through the Endangered Species Act. Underlying such actions is the sense of a transcendent aesthetic principle of such high value that it overrides individual economic interests and leads to confident moral claims about what should be done. Other environmental strategies have focused on the management of resource use-on conserving while using intelligently. The mission of the Forest Service began in 1891 when Congress established the first Timber Reserve in Yellowstone, followed by the establishment of the U.S. Forest Service in 1905 to protect and allow development of timber and water resources for the public interest. The Departments of Agriculture and the Interior have worked through various programs to protect and pursue practices for sustainable use of land and resources. U. S. government efforts have set aside vast tracts of land, especially in western states, in the public interest. Ranchers have often complained bitterly, although such private interests have gained considerably from very inexpensive access to grazing rights and other use of public resources. Recreational land users complain about the lack of developed camp sites or fishing areas, although they have access to considerable expanses of public lands. Scholars have begun to make comparisons between U.S. land-use policies and the policies of other countries with quite different approaches to land and resource management (e.g., the former Soviet Union, Cuba, or Costa Rica). Further comparative research will prove valuable in understanding the choices faced by democratic governments. Debates about preservation versus managed use have gained wide public attention in the past decades. They have been centered on such unlikely protagonists as the snail darter, red squirrel, and spotted owl. Current disputes include the consideration of what counts as a legitimate wetland warranting legal protection, and the often acrimonious debate between forest managers, commercial interests, and local populations over timber development. What is remarkable in these cases is the lip service given to scientific knowledge even when the decision-making process may virtually ignore available scientific evidence. Science, while providing the appearance of value neutrality, sometimes seems to play a much more rhetorical than substantive role in many environmental cases. Aside from scientific considerations, the legal process in land-use cases often prescribes regular sessions for public input. Generally, there is a report based on past experience that includes lots of data. Independent scientists, however, are rarely consulted. A group of leading environmental scientists who met July 22-23, 1994, in Madison, Wisconsin, to draft a plan for federal land managers to implement in conserving public lands, felt that their efforts to infuse public discussions with scientific content were largely ignored. A recent news report pointed to a lack of consideration of the available science in the formulation and administration of federal wetlands policy. And the examples go on and on. The problem is not that federal, state, or local agents charged with conserving land use are antiscience. It is true that they do not have access to all the scientific knowledge since selected experts present only part of the larger picture. More important, however, they are charged with carrying out policy in a manner that may lack any adequate forum for scientific input. Scientists can join other local "experts" at public hearings, but often they are not called as experts. This is due, in part, to not knowing what expertise to seek. The contested nature of scientific results-Just how much land is necessary for adequate habitat protection? Are there "enough" marine mammals or bald eagles?-plus competing public and private values confound the decision-making process. Another area of federal, state, and local intervention concerns protection of environmental quality. The Environmental Protection Agency seeks to reduce automobile pollution in large cities, and California is leading the way in legislating a reduction of gasoline-powered vehicles by calling for an increase in electric vehicles. Yet a recent study in Science argued that the use of lead in batteries required for electric storage creates a much worse environmental hazard than gasoline emissions (Lester B. Lave, Chris T. Hendrickson, Francis Clay McMichael, "Environmental Implications of Electric Cars," May 19, 1995: pp. 993-95). The concentration of pollutants moves away from the cities, to be sure, but the problem is spread to areas that may benefit only from an increase in jobs in the waste-disposal industry. The result, as in many issues of toxic waste disposal, quickly becomes one of "environmental racism," or more properly in this case "environmental classism." Concern with racism and economic burdens arises in more difficult ways when we confront global issues of land use and environmental protection. It is easy for us in wealthy industrialized countries to call for restrictions on the use of tropical rain forests, or to urge others to avoid polluting. Without any way to enforce global policies, however, we are left with political persuasion and economic incentives to effect change. It is hard to argue that we know best how Brazil or Cuba, for example, should oversee or use its valuable biodiversity if we also want to call for local self-determination and democratic ideas. Global protectionism and control is, by its very nature, problematic and potentially not driven by democratic values. Rather it appeals to a set of presumably higher values, much as if there were an environmental constitution to protect environmental rights-but whose rights, and to what end? Many legislators are joining scientists in calling for a more careful discussion of how to provide the best stewardship of our lands, how best to draw on available scientific knowledge, and how to do both while maintaining respect for the values and standards of environmental quality of other countries. Comparative studies of U.S. policy with other, especially neighboring, countries may be of immediate practical significance. This would be an excellent time to document each state's procedures and track the results in various arenas. How do different hunting policies in neighboring states, for example, affect wildlife populations? What effects do different states' policies concerning water use, toxic waste disposal, and differential enforcement have on the environment? Which states have long histories of fisheries development, and with what outcome? Which states, besides California, have their environmental impact statements on line, and what impact has the availability of electronic data had on state practices and policies. What results have lobbying efforts by private concerns such as the Sierra Club, the Audubon Society, or Greenpeace had? What is the impact of media presentations, considering that we are assaulted with dramatic visual images of baby seals and tiny birds, but not of insects or diverse bacteria that inhabit salt marshes? Such species-specific efforts undercut broader arguments for the protection of the larger ecosystem, and for preservation of biodiversity in particular. The ultimate question is: What role does and should scientific knowledge play in our attempts to balance development, stewardship, and regulation?
One means of appreciating the complexity of these environmental and legal
issues is to consider specific cases. Public and legal decisions to protect
species and habitats have raised both specific and general questions. The
following case involves an effort to protect a subspecies of salamander
proposed for listing under the Endangered Species Act. It raises questions
related to the contingency of scientific knowledge, the qualifying of
experts in a democracy, the tensions between values and democracy, and the
right of access to gather scientific information.
In 1954, the Sonora tiger salamander, a previously unrecognized subspecies, was described from the San Rafael Valley in southern Arizona. Subsequent research into the systematic status of the subspecies revealed that this race has the genetic properties of a hybrid, and likely originated by the union of two other subspecies whose closest populations are now in northern Arizona and eastern New Mexico. Sonora salamanders presently live only in ponds (stock tanks) created and maintained for supporting livestock since as early as 1822. Salamanders live in none of the aquatic habitats-especially river margins, marshes, and ponds-that are most similar to what habitats in the valley were like before the arrival of European-derived settlers. In 1993, conservationists from New Mexico petitioned to have Sonora salamanders listed as an endangered subspecies based on their restricted range and special genetic characteristics. One consequence of such listing could be the limiting of grazing rights of local ranchers on these lands. A researcher studying the Sonora salamander has been asked by the U.S. Fish and Wildlife Service to help develop a plan for ensuring the protection of the subspecies.
Federally and privately managed lands comprise the San Rafael Valley.
Ranchers on private land prefer that the subspecies not be listed, thus
avoiding any restriction of grazing rights that might result from
implementing the Endangered Species Act. Often, the first question in such
cases focuses on the basis for concluding that a species or subspecies is
"endangered." How do categories specified in legal policies constrain or
structure the ways in which biologists theorize and describe phenomena?
Do "rare, threatened, or endangered" statuses have conceptual or theoretical
significance within biology? What, for example, is the explanation for an
increasing interest among ecologists in "rare" species?
How are the boundaries characterizing a species determined and how does the
legal system influence who gets to define a species?
How do particular extensions of legally defensible rights, like property
rights, alter research practices and types of scientific information
accessible to the researchers?
How are the "rights" to information determined in these complex contexts
with competing claims of authority?
Since salamanders now live only in "artificial" habitats, some opponents of
listing the subspecies argue that this diminishes the claim that this is a
"natural" evolutionary unit worthy of protection, raising questions about
values. How does what is natural and what we are trying to preserve get
defined in law and science?
How do conceptions of nature based on belief systems and values outside of
science and the law affect legal policy and scientific practices?
How do different groups construct boundaries between humans and nature, and
in what ways do these boundaries influence or impede social activism?
How and when do environmental values of policy makers like legislators,
judges, administrators, and scientists differ from those of the general
public, and how do legal and scientific processes interact in resolving
value conflicts?
Local ranchers claim that they are effective stewards of natural resources,
arguing that the persistence of salamanders in habitats they manage supports
this claim. Environmentalists challenge this claim. Numerous governmental
agencies have authority to adjudicate the issues and insist that it is they
who properly should determine who has expert status. All of these groups
asked the scientific researcher to play a mediating role. Who qualifies
as an expert in society and how do these qualifications as an expert vary
among societies and over time?
How does the concept of expertise vary among and within disciplines, like
environmental studies versus genetics, or as a function of institutional
association, like employer or society membership?
How does the participation of scientists within legal and policy venues
affect their standing and authority in the scientific and policy
communities?
How do scientists playing active roles in other social institutions
negotiate dual or multiple identities?
How does litigation, and other legislative processes, adjudicate between the
competing interests and knowledge claims of different stakeholders,
allocating privilege to different views? How and why are certain viewpoints
systematically included or excluded in such decision-making processes?
In areas of conflict and uncertainty, how are opinions developed at various
levels of organization, from local to state to international bodies?
How are conflicts among these organizations resolved?
How does the representation of multiple stakeholders in environmental
disputes affect understandings of scientific uncertainty?
In general, how do law and science deal with ambiguity, as in definitions of
"species," "subspecies," and "nature?"
To ensure the protection of Sonora salamanders, and as an alternative to
formally listing the subspecies as endangered, the U.S. Fish and Wildlife
Service asked all parties concerned to participate in a "conservation
agreement" that detailed tactics for all to follow. Enforcement of this
agreement requires sampling on private land, and some landowners have
refused access to their property for the collecting of data, raising
questions about access to scientific information. How is access to
scientific knowledge affected by other rights, such as legal property
rights?
How does differential distribution of these rights affect participation in
environmental decision making?
What special problems of scientific access arise when environmental issues
cross borders of multiple sovereign entities?
To what extent are new legal doctrines needed to recognize scientific access
to environmental data?
A few of the issues raised by this case are specific to the Sonora
salamander. On the whole, however, the questions stimulated by this case are
general and apply, therefore, to other situations such as the managing of
salmon in the Pacific northwest of the U.S., the managing of fisheries along
the Georges Banks in the North Atlantic, and the controlling of acid rain in
both the southeast of Canada and the northeast and upper Midwest of the
U.S.
Bioprospecting "Bioprospecting" and "gene hunting" have been used to refer to the search for agriculturally, pharmaceutically, or otherwise useful organisms and germ plasm. Often, the terms refer to cases where the "prospectors" are on foreign soil, or cooperate with foreign companies. This raises issues of compensation, exploitation, and property rights. Concerns over these issues have intensified during the 1990s because of increasing attention to loss of biodiversity, together with growing tensions over the disparities between resource-consumptive, industrialized countries and biodiversity-rich, less-industrialized countries. Industrialized countries have not only the biotechnology demand, but also the capital-both scientific and technological capital-to develop biotechnology products from biological materials acquired beyond their borders. Indicating the importance of concerns about this disparity is the change in international agreements between the 1983 International Undertaking on Plant Genetic Resources and the 1992 Rio Biodiversity Convention. According to the former, plant genetic resources should be considered "the common heritage of mankind," whereas Article 15 of the Rio Biodiversity Convention asserts "the sovereign rights of States over their natural resources," and stipulates that "the authority to determine access to genetic resources rests with the national governments and is subject to national legislation." Extended property rights over biological and genetic resources, and increased compensation for the use of those resources, are seen by some not only as an economically just end, but also as a promising means of promoting the study and effective protection of biodiversity in less-industrialized countries. This rationale for extending property rights rests on a variety of assumptions from conservation biology in addition to economic and political considerations. Bioprospecting issues also arise in connection with human specimens and germ plasm as, for example, in the highly publicized case of a U.S. patent issued on a cell line derived from a Papua New Guinean containing a human t-lymphotropic virus (HTLV). Concerns about bioprospecting of human materials are reinforced by developments related to the Human Genome Project (to map and sequence the human genome) and the Human Genome Diversity Project (to survey genetic variation worldwide). The possibility now exists for widespread patenting of human gene sequences by biotechnology companies, on the presumption that practical (primarily pharmaceutical) use can be made of such information. The rationale for issuing patents on human gene sequences to biotechnology companies in industrialized countries is very different from the rationale for extending property rights over biological and genetic resources to less-industrialized nations. Concerns about human gene patents, together with general concerns about bioprospecting, have led many detractors to raise questions about what they see as the underlying motives of the Human Genome Diversity Project, which has to date been promoted and organized primarily by U.S. researchers. Although not well substantiated, these doubts have caused the Diversity Project to be put on hold, seriously stalling the project. The general area of bioprospecting is a rich source of case studies for analyzing changing interactions and relationships between science and law, including international law and science. Developments in conservation biology and genetics are influencing conceptions of property, property rights, and even trade diplomacy. In turn, changing concerns about property and property rights are influencing the direction and practice of conservation biology and genetics, and also of scientific cooperation and noncooperation across national borders. These pressing areas of study could well influence policy decisions in the near future. Consider a concrete example involving human specimens and genetic material. This is a very recent-indeed, ongoing-case that is worth documenting now for careful scrutiny. In the past, biologists in India have been quite willing to send blood and DNA samples from indigenous groups to researchers in the U.S., but some Indian biologists have recently decided not to cooperate in this manner, at least until suitable property rights and trade agreements are worked out in India, and between India and the U.S. The requests have sometimes come from sources with clear biotechnology interests; some Indian researchers report that they have recently received substantial monetary offers, which they refused, for providing clinically interesting genetic samples. All requests, however, have not come from biotechnology companies. Many requests, which will also not be honored during the moratorium on exchange, have come from population geneticists organizing and promoting the Human Genome Diversity Project. Meanwhile, the Indian government has initiated legislation to restrict export of all genetic material, conditional on appropriate compensation for the development of products based on the material, including transfer of the technology. A second example is currently receiving considerable attention from biologists, economists, rural sociologists, and science-studies researchers. In 1989, the Costa Rican government set up a private, nonprofit, and public interest organization, Instituto Nacional de Biodiversidad (INBio), devoted to "putting biodiversity to work for society." To that end, INBio staff work to inventory and conserve biodiversity, and they enter into agreements with foreign companies that wish to use Costa Rica's biological resources. To carry out the inventory, INBio has provided training in systematics and curation for Costa Ricans who have elementary or high school education, who live in rural areas, and who serve as local biodiversity experts. In addition, INBio promotes collaborations with researchers from foreign universities and museums to help with the inventory.
In 1991, INBio entered into an agreement with the multinational
pharmaceutical company Merck. For a specified period, Merck has exclusive
rights to develop and market products based on material provided by INBio;
in other words, whatever material INBio provides to Merck, INBio cannot also
provide to other corporations. In exchange, INBio receives $1 million plus
royalties on any products developed from these materials. These funds
support the national parks of Costa Rica, as well as INBio's inventory and
training programs. This second case again illustrates the complexity of
issues involving biology and law.
One mechanism suggested to conserve natural resources is a form of
protection based on property rights. This has recently been attempted in
Costa Rica, where the government established a research organization (INBio)
dedicated to developmental projects. Merck, one of the largest U.S.
pharmaceutical companies, has agreed to a contract with INBio where Merck
has exclusive development and manufacture rights to any useful discoveries
made by the scientists of INBio in exchange for a $1 million fee as well as
a percentage of the royalties on any natural products that might be
discovered. Although this might be seen as a fairly uncomplicated,
noncontroversial arrangement, it raises several pertinent questions relating
to issues like biodiversity and property rights. How is biodiversity
defined in scientific and legal communities, both national and
international?
How do these definitions relate to each other and to public understandings
of biodiversity?
How do competing values or ethical principles shape these definitions of
biodiversity?
How do the concepts of biodiversity constrain or structure the types of
normative understandings and agreements within differing communities?
How does framing biodiversity issues in economic terms influence scientific
research in biodiversity?
How are the divisions between public and private knowledge affected by
social, scientific, and legal structures, and by the interpretations of
biological entities?
How do different discourses about nature-e.g., military, aesthetic, ethical,
and religious-affect legal and scientific practices concerning
biodiversity?
Although treating biological organisms as commodities might be seen as a way
to protect the interests of countries possessing these resources, it raises
the specter of "training the locals" to recognize organisms considered
valuable by others, who then exploit the resources as well as the relatively
disenfranchised. Questions arise about the value of alternate arrangements
that may be used to accomplish the same ends with fewer negative impacts.
How are policies and strategies created relative to biodiversity?
What are the influences of various preservation strategies like ecotourism,
comanagement, economic partnerships, nature preserve planning, or
debt-for-nature swaps on biodiversity?
What forms and types of these strategies are most effective in defining
contexts to achieve preservation aims?
What are the mechanisms for assessing the benefits and burdens associated
with such strategies for exploiting natural resources?
What are the effects of various legal mechanisms, such as property rights,
on the distribution and redistribution of these benefits and burdens? Should
property rights be awarded, and, if so, by whom and what kind?
How does the discovery, extraction, and development of these resources
variously affect the distribution processes?
How do different legal, economic, and scientific arrangements for the
management of biodiversity affect its protection and cultivation?
Examining issues related to bioprospecting is complicated by the fact that
scientists themselves are divided on the relevant definitions of
biodiversity as well as the value of preserving biodiversity in the first
place. Added to this is the question of whether agreements such as this one
are even effective in preserving the biodiversity that made this
bioprospecting possible. What roles do the various participants play in
shaping policy relative to biodiversity?
What role do institutions like NGOs, international banks, or transnational
organizations play in developing and implementing legal agreements about
biodiversity?
How do globalizing influences, such as media, and localizing influences,
such as grassroots organizations, affect legal and scientific practices
regarding biodiversity?
Given the current abundance of biological diversity in less-industrialized
nations, how does the dominance of scientific, economic, and legal
institutions in industrialized nations constrain and structure the
involvement of less-industrialized participants in its management?
To what extent do the interests of the national government reflect the
values of the local communities? And whose interests should be represented?
Should indigenous peoples have special rights, and if so, what rights and
decided by whom?
What are the mechanisms by which these local communities have a voice in the
international arena? How do the competing claims get adjudicated-locally and
internationally?
Similarities exist between many of these issues and those like the awarding
to an indigenous Indian tribe of the intellectual property rights to the
active ingredient of "Indian ginseng," a plant known for helping to combat
stress. These diverse cases differ in their details, but are advantageous to
study as a way to appreciate the rich opportunities for research at the
interface of biology and law.
Genetics When genetics confronts the law and social policy, it is often in the form of human genetics. There are, however, some agricultural concerns with bioengineered products. Society does not object to centuries of traditional breeding to create "better" crops (by which we mean crops more desirable to us-bigger, more flavorful, easier to ship, cheaper to grow, etc.). Yet public concern emerges when animal and plant life forms are genetically engineered, particularly across species lines through the insertion of foreign DNA. This method raises the specter of "playing God," and challenges the public perception of what is "natural." Thanks to the Human Genome Initiative's mandate, through the ELSI project, to explore ethical, legal, and social issues as well as the science, considerable research has been done to outline a wide range of issues and to begin exploring them. Two different types of issues predominate: those where genetics serves as a tool for law, and those in which the genetics research itself raises legal issues. The most common of the first type, where genetics provides a tool, began with expert testimony by geneticists in paternity cases. Here the geneticist as expert witness provides key evidence concerning identity, or at least the probabilities and possibilities thereof. More recent and controversial is DNA profiling. Also helping to indicate identity, such DNA profiling has in the past caused confusion, in part because it is probabilistic and not as certain in its interpretation as the courts would prefer, and in part because there is not yet one method that all researchers accept. For all its power, the technique remains in its early stages of development-it is imperfect, dependent on the careful collection and processing of data, and subject to interpretation. One problem arises when some scientists present the techniques as more advanced or more reliable than it is actually possible for them to be, a problem exacerbated by the use of apparently neat pictures from standard gel runs. These clear visual images appear more "true" or definite than they may be; this visual artifact, however, carries considerable warrant with it. We would benefit from further careful study of the science and its limits, its use in courts by trial lawyers (both for the defense and for the prosecution), and its effect on juries. In the foregoing areas, as well as in the ones that follow, judges and lawyers need to gain sufficient expertise to make wise use of evidence. It is therefore all the more important that they have access to the guidance they need. Recent handbooks for judges, such as those distributed through the Federal Judicial Center, should reflect not only the best scientific knowledge, but also the best available assessment of how to use that knowledge. It would be valuable for social scientists to examine the impact of the dissemination of such materials, and to assess what differences they make in the courtroom or in the various stages of the case. Another valuable study would look at what science is taught in law school, how this has changed over time, and to what effect. Similar questions would hold for legislators and managers in regulatory roles. How can we assess what science they know, what they know about how best to use that science, and what difference it makes? Then there is that second class of issues, those raised by the science itself. Genetic technology now enables us to isolate naturally occurring DNA from organisms; treat, purify or genetically modify it in the laboratory; and develop useful processes and products. More dramatically, we can alter the DNA of living organisms-by inserting foreign DNA we create recombinant "trans-species" life forms such as the Harvard mouse. Similarly, through somatic cell gene therapy we can correct genetic errors in individual organisms (a technique now done experimentally on humans), and through germ-line gene therapy we "treat" all of an organism's descendants (this technology, not yet approved for humans, is employed with some plants and animals). Finally, the onrush of human gene mapping and sequencing, along with the ability to ascertain individual variance from the assumed genetic ideal, enables us to generate predictive genetic information about individuals. For simplicity, the issues that spring from these scientific advances can be clustered under property, privacy, and public health and safety. Property issues might seem straightforward. Who "owns" the genome-or can DNA (and the genome) be property? Patent law has accommodated genomic plant and animal material under traditional legal requirements. Can a similar patentable interest be asserted in human DNA? The U.S. Patent and Trademark Office and lower federal courts have ruled that human DNA sequences are patentable, at least where isolated or purified by human intervention, but objections raised earlier to patenting life have been renewed and amplified. These objections, along with the proliferation of patent applications on human-derived materials, are likely to continue for some time, barring reversal of current legal policy by Congress or the Supreme Court. In fact, the era of proprietary biotechnology began in 1980, when the United States Supreme Court ruled in Diamond v. Chakrabarty that recombinant bacteria, able to break down components of crude oil (useful for oil spills), were patentable subject matter. We now recognize the patentability of higher trans-specific life forms as well-for example, the Harvard mouse (1987). An industry has developed under the law's promise of patent recognition for a wide variety of bioengineered products and processes utilizing genetic materials. Recurring, strongly held objections have been raised by interest groups and some scientists to the patenting of life forms and their constituent, or derived, elements during this period. Concerns include animal welfare, environmental safety, agribusiness economics, control of the underlying technology, and adequate protection of those most affected. Often, though, the challenges are on fundamental ethical or metaphysical grounds, including religiously based objections to the patenting of "God's creatures." How are such competing sets of values to be reconciled by law? For purposes of patent law, should genetically engineered organisms be distinguished from strains created by the other kinds of human intervention described above? Forms of plants have been patentable for decades; so we need to consider whether and how patenting genetic material of animals or "higher" organisms might be different. Fundamental questions are: Who should be allowed to "own" the genome? How are competing values to be reconciled by law? Second arise issues about the privacy of an individual's DNA sequences, and the confidentiality of the genetic information stored within. Public expectations (or, at least, public hopes) for the confidentiality of such information are presumably high. Concerns appear most vividly in connection with information gleaned from genetic testing. Such testing already occurs in a variety of settings for widely varying purposes, including newborn screening for metabolic disorders, adult screening for reproductive planning, prenatal fetal diagnosis, and testing for familially linked, late-onset disorders. An important first question is how we understand the meaning of genetic test results. Unlike the often used example of Huntington's disease, the vast majority of genetic conditions (coronary heart disease, diabetes, hypertension, various cancers, and rheumatoid arthritis, for example) are multifactorial, depending for their expression on genetic variation at multiple loci, on environmental influences, and on the interactions among them. Understanding that their occurrence is a matter of probability rather than of absolute determinism and certainty is as critical for law and policy as it is for science. Yet many succumb to the temptation to speak of genetics in straightforwardly deterministic terms. Current law governing genomic privacy is limited and variable, and law reform efforts to date have produced uncertain results. How, and to what extent, should the law protect the privacy and confidentiality of individuals' genetic information? Of genetic information (or inferences) gleaned from other sources? To the extent that particularly sensitive characteristics-such as mental disorders, "criminality," or homosexuality-may have genetic components, are particularly stringent protections needed? At what point might the value of privacy give way to other interests that would justify, or even require, disclosure of genetic information to blood relatives, for example, where genetic information necessarily generates information about them, or to third parties such as insurers or employers? What care needs to be taken to prevent unjust uses? Obviously, the law has many questions to decide. There are many fundamental issues, however, where careful research by scientists, social scientists, and legal scholars, working together, can inform the law. One starting point for further study would be a closer look at the policy proposals resulting from the ELSI project discussions, the nature and extent of genetic discrimination by various institutions, and the real-world impact of laws enacted to date. In the third area, safety and public health, there are many complex issues. First, concrete concerns have emerged about the safety of genetic manipulations. Courts and regulatory bodies have generally addressed the legal challenges raised, listened to arguments, in some cases tasted the results, and allowed the research to continue. Such controversies, however, also illuminate governance issues for science and law as mediated by public perceptions. There seem to be two main types of safety concerns: risks to humans-from the use of genetically engineered foods and drugs as well as from research-related exposures-and risks to the "environment"-from mutation and "escape" of dangerous organisms, the evolutionary impact of incorporated genetic material, or economic damage from new pests or pathogens. How do we evaluate such risks? Nature itself, of course, is not "safe," and human intervention does not inevitably increase risk or upset a presumed natural ecological balance. What risks does a particular genetically modified organism pose to the environment or to other species? We know much more about genetic hazards and appropriate precautions in some areas than others. What risks should the law attend to, and what standard should define acceptable levels of hazard? By what measure of confidence or standard of proof? When legal institutions consider such questions, it is not always clear whose views should count. Some scientists worry that human interventions may cause a degraded gene pool. How widespread is that concern? Where scientists from different disciplines (e.g., ecologists and molecular geneticists), or even from the same discipline, disagree about risks, how should lawmaking bodies choose among them? Does (should) scientific stature determine public influence? What factors (e.g., source and amount of research funding) influence that stature and the content of views? In short, how can we identify, obtain, and use "publicly interested" science for advice and decision making in law and policy? Further, what influence do industry and other interests have on law and regulatory policy in this area? There may be much to learn from law's management of "genetic hazards" to date. Public beliefs about genetic safety are clearly important for law. Where are the loci of perceived "genetic risk?" Just what is it that makes people uneasy: modified organisms, the scientists conducting genetic research, government regulators? What does the public want the law to attend to? How do the answers vary among different constituencies? Closely related are issues of public participation in democratic policy-making. What kinds of public discourse about genetic safety actually occur, and what is the impact of such discourse on decisions allocating risk? What model of participation is optimal? For example, have the lay members of the federal Recombinant Advisory Committee (RAC) had a significant impact on policy in comparison with the scientist members? How important have the RAC's open meetings been? On a related point, what models do we have to address conflict of interest in government advisory bodies? What models ought we to have? What kind of oversight should exist for arguably sensitive research, such as defense-related genetic research (a category that might include "biological warfare")? What oversight should exist for monitoring threats of genetic terrorism? How much secrecy is justified? Safety issues have important international dimensions. American policy has been rather careful and strict, at least concerning research done in the U.S., while other countries (China, for example) have held large field trials with little concern about safety in the face of at least equal risks. Yet consequences are unlikely to respect borders. How can international cooperation be achieved? What do we know that can usefully be "exported?" Finally, very difficult problems arise concerning public health policy. These include population control issues and easily slide into eugenical concerns. As we learn more about human genetics, we get a clearer sense of what is perceived to be normal and what abnormal. Such genetic "abnormalities" can appear diseased, and the carrier can be thought of as a public health threat. A commitment to medical and reproductive autonomy generally favors voluntary, rather than mandatory, medical care and diagnostic testing. Yet there are public health issues that arise if we do not identify and correct genetic "disease" where we can. Failure to require testing allows individuals to carry disease-determining or disease-contributing genes into the gene pool that affect others. What are the limits of our concern for public health, and when do they outweigh presumptive individual reproductive rights? To what extent does the collective gene pool take precedence over individual genomes? Who decides such questions, and according to what criteria? Such pressures easily become racially or class biased as we identify genetic "diseases" with particular groups and seek-again quite rationally from some perspectives-to"cleanse" our population genetically. More careful scientists will caution against adopting too simplistic or too strongly hereditarian assumptions. Biological science shows that although genes provide information and directions to guide development, in most cases there also is tremendous developmental plasticity and ability to respond to changing environmental conditions. This is particularly true for those genes that seem in preliminary studies to direct behavior. The claims for genetic determinants of violence, for example, need much more exploration, as do the biological and behavioral studies into the causes of homosexuality. Some genes are more deterministic in their action than others, and we need far more research into the nature and developmental effects of the human genome. At the same time, we need further study of the social, political, and legal implications of the science to guarantee fair and democratic treatment of all citizens. It is not too early to ask why the "biologization" of such behaviors seems to have special power in framing debate and influencing thought about social policy. We can also begin to evaluate the impact of such claims on law development. (It seems to be tempting for legal decision makers to accept and act upon genetics-based claims-the eugenics movement early in this century and screening for sickle cell anemia are two examples). We need to better understand the processes that generate, make use of, and criticize claims about these kinds of complex behaviors-and about "traits" and characteristics (such as race or intelligence) as well. How do people's beliefs about such matters get supported by science, and how do beliefs become linked to the idea that they are "scientific" (or "social," or something else)? Are assertions about the importance of genetics systematically inflated or understated in efforts to shape law and public policy? If so, by whom and why? A recent development appropriate for study might be the use of the bell curve to advance arguments about race and intelligence in the debate over affirmative action, and the impact that use has had. How do political groups use the work of scientists, and what effect are they having? What determines whether particular claims are accepted? What groups fund research that is used for political purposes? If research programs lacking scientific validity are being funded, by whom are they funded, and why? This area strikingly raises questions about which scientific voices enter important policy and legal debates, and which should be heeded. Suggestion was made at the workshops that the accomplishments of molecular genetics in recent years may have cast an undeserved "halo" upon genetics as a whole, helping to revive discredited behavioral genetics claims. Deterministic behavioral arguments are sometimes advanced by persons (educational psychologists or political scientists, for example) who themselves lack training in genetics-while molecular geneticists refrain from criticism on the ground that such claims are not within their own expertise. Whose job is it, then, to think about issues at the boundaries between scientific specialties? Who should speak, and who should be heard? Under what circumstances do scientists attack public misrepresentations of their work? Scientific views of the complexity of the causal role of genes in the production of traits and behaviors diverge from the public's seemingly naive perceptions of genetic determinism and raise serious questions of social responsibility. Presumed ignorance of the projected misperceptions and misinterpretations of genetic discoveries documented in popular science writing creates dilemmas. Should knowledge be made public in a context in which it will be misused? On the one hand, knowledge is a social product and the public has a right to know; on the other hand, the potential for abuse has led to calls for restrictions on such information. How might public education about this complex issue ameliorate the situation? How should genetic information be framed to make it understandable to the general reader? Finally, what roles do legal institutions themselves play in fostering, sorting, and evaluating the merits of competing scientific claims, and what more might they do? We generally agree that the state should not (scientifically) and cannot (constitutionally) prohibit the positing of hypotheses or the ethical conduct of most research. Nonetheless, are there questions that democratic lawmaking institutions can appropriately ask-and public structural models they might apply (such as regulatory systems for the approval of drugs and medical devices)-in seeking to evaluate the validity of claims relating to behavioral genetics? Are there other roles for lawmakers to play?
The balance of individual rights and community concerns through public
health and population control is a delicate one. Eugenical considerations,
for example, have resulted in laws to sterilize the mentally defective. The
Supreme Court upheld one such law in Buck v. Bell (1927). Since then,
U.S. law has generally upheld a citizen's right to reproduce. Some
significant portion of the population certainly views that as a basic,
fundamental right. Yet, increasingly, others challenge that right-whether
because they desire to control population size or to control the quality and
public health of the population. There are many partial precedents here, but
we are moving into largely uncharted territory. Thus, detailed and
cooperative explorations by historians, ethicists, legal scholars, and
scientists will help inform policy and regulatory decisions as science moves
onward and scientists continually make new discoveries that add to our
knowledge base. Preliminary evidence suggests that 5-10 percent of the 185,000 annual cases of breast cancer in the United States are linked familially. The lifetime risk of developing this form of the disease is eight times higher (80-85 percent) than with nonfamilial breast cancer (10 percent), and symptoms often appear earlier (before age 50). The presence of a single mutated copy of the gene known as "BRCA1" (discovered in 1994), or of "BRCA2" (1995), appears to be associated with the heightened risk. Certain forms of mutation in BRCA1 also create up to a 50 percent lifetime risk of developing ovarian cancer.
Scientists have developed and made available tests to detect defects in
BRCA1, but the predictive significance of these tests for individual cases
has not been established. There are over 100 known mutations of BRCA1, the
effect of many of which is unknown. Moreover, in people with no family
history of early breast disease, the incidence of the mutations identified
by current tests is unknown. There is little evidence, further, that the
available medical options following a positive test improve health or
survival, and extreme interventions such as prophylactic mastectomy involve
significant risks of their own. How should the scientific validity and
clinical utility of genetic tests be established?
Are the uncertainties surrounding genetic tests and their interpretation
adequately understood by scientists? By the public? By regulators, insurers,
judges, the media?
How should law exercise its regulatory power over the relevant professions
and industries? What are the social and ethical implication of these
choices?
Extensive media coverage of the genetics of breast cancer has tracked the
rapidly unfolding shifts (and attendant uncertainties) in scientific
understanding. Media coverage has also emphasized concerns about
confidentiality of test results and genetic discrimination. In one recent
study, less than half the women in at-risk families opted to be tested for
BRCA1 defects, citing concerns that insurers would discriminate against them
and that false-positive test results could lead to stigmatization, as well
as to unnecessary surgery. What role do the media play in negotiating the
supply of and demand for genetic tests?
How do the media cover genetic testing, whom do they consult (and not
consult) in preparing stories, and what effect does coverage have on public
understanding of the science of genetic testing and its implications for
health?
What factors can, do, or should influence ownership of, control over, and
access to the results of genetic tests? The human-derived materials on which
they are based?
What are the identifiable interests, public and private, in the results of
genetic tests? Do advances in understanding of genetics itself shape the
determination of what is considered "public" or "private" information? What
are the relationships between particular technological developments and
legislative and regulatory proposals (e.g., DNA data banks and the proposed
Genetic Privacy Act)?
Some states have enacted laws addressing confidentiality and discrimination
based on "genetic testing," and a limited provision of federal disability
law applies to employment discrimination on the basis of genetic tests.
What are the different meanings and understandings of the term "genetic
test," as used in law, science, and public understanding?
Do genetic tests raise different legal and ethical issues than other
biomedical tests, such as those based on phenotype (which can sometimes
support genetic inferences), drawn from family pedigree, or gleaned from
other kinds of health-related information?
How do different groups, with varying interests, gain or fail to gain access
to public debate (legislative, scientific, and other) regarding genetic
testing? What sorts of arguments and evidence do they employ? Which views
prevail and why? What are the ethical and social implications of the answers
to those questions? How can the (legitimate) interests of affected groups be
adequately represented?
To what extent, and by what mechanisms, should discrimination (in
employment, insurance, and other areas) be allowed or prevented on the basis
of genetic test results?
While these debates persist, companies are developing tests for BRCA1
mutations. Some clinicians are proceeding to offer them, lending momentum to
work in the area and raising the stakes for policy decisions. Intimate
health decisions will be made, therefore, in a context shaped by business
strategies, research priorities, and patenting tactics. What is the
relationship between genetic technology and demand?
What social and commercial interests create demand for genetic tests? What
interests generate, or influence, the scientific research agenda that
underlies the development of genetic testing?
Myriad Genetics, a biotechnology company, has applied for a patent on BRCA1.
Contributors to the project included scientists from the private sector,
government laboratories, and academic institutions, and involved researchers
from two countries (the United States and Canada). The patent application
generated some controversy because not all of the researchers involved in
the collaboration that identified the gene were named as inventors. This
controversy was followed by a related debate concerning the BRCA2 gene, when
a group of English researchers posted a sequence on the Internet-in part
with the hope of provoking public debate about the patentability of BRCA2
and of genes in general. What are the implications of gene patenting?
How do the values and perceptions of different interest groups (e.g.,
scientists, lawyers, academics, and their institutions and professional
associations) affect their positions regarding the application of patent law
to emerging genetic technologies?
How do shifts in scientific practices and cultures (e.g., a transition from
the independent "gentleman scientist" to highly collaborative and
interactive science) and belief systems shape legal notions of patentable
property over time, and vice versa?
What impact does gene patenting, which renders fundamental knowledge and the
tools for applying that knowledge proprietary, have on the financing and
conduct of further genetic research-including research anticipated to
provide limited financial gain-and vice versa? How does this affect
disclosure and the free exchange of scientific information?
Opponents of patenting BRCA1, including a coalition of women's and health
advocacy groups, find gene patenting objectionable for various reasons
(e.g., commodification of the human genome) and express specific concerns
that a patent may restrict scientific research on breast cancer. Others
oppose patenting any components of life on religious grounds. Some, however,
endorse patenting on the ground that it is necessary to promote investment
and progress in scientific understanding and therapy. How do the power
relationships among stakeholders -companies, inventors, providers of genetic
material, and the public-shape the content of patent law?
What factors are influential in creating and settling disputes over what is
private and what is public property? Do these factors differ in countries
that do not share a contemporary western framework for considering property
interests? Do they differ from Native American and other cultures that also
do not share such a framework?
What impacts do particular social movements or groups have on the content
of, and changes in, law concerning protection of intellectual property? How
do such movements/groups cause shifts in broadly embedded understandings of
what constitutes intellectual property?
Evolution Evolutionary theory raises special challenges for our legal and political institutions, and the assumptions on which these are predicated. Foremost among these challenges is the need to resolve the extent to which the science of evolution can be taught in a country composed of diverse religious groups-each with different beliefs concerning the origin of the world and the proper place of humankind within it. Influential creationist groups, for example, have repeatedly argued that evolution should not be taught in public schools. Alternatively, they maintain, creationism ought to receive equal time and emphasis. Although polls indicate that a majority of the voting public favors creationism, our courts have thus far held that the federal Constitution prohibits the states from teaching religious views through the public education system. Further research into the complexity of this debate, and the several instances of its uneasy resolution, would prove valuable precisely because the tension provides a case study in which constitutional concerns about the first amendment's prohibition against the "establishment" of religion have prevailed over majority opinion. It would be instructive to discover what it is voters and legislators actually understand about evolution, where they got their ideas, and what-if anything-might change their minds. A second challenge has emerged from modern discoveries concerning the effects of evolution-derived human behavior. Should law, which is fundamentally about the regulation of human social behavior, be influenced by insights into the evolutionary origins of some of those behaviors? How will, or can, the legal system incorporate such knowledge? Evidence that biological factors such as hormones or neurotransmitters can strongly influence behavior either contradicts widely held notions of unbounded personal responsibility and freedom, or results in overzealous, exorbitant interpretations. Moreover, lawyers typically are not trained in evolutionary theory, and often do not see its relevance. Yet instinctive responses that are derived through evolution seem to be implicated in a variety of behaviors, from impulsive crime and suicide to depression. Should we modify our notions of legal responsibility-and if so, how? A third challenge concerns the extent to which evolutionary thinking might be relevant to our understanding of the origins of political and legal processes themselves. For example, what can we learn about the evolutionary development of law? Many biologists are currently studying the extent to which the particular genetically influenced patterns of sociality, perceptions of fairness, and moralistic aggression may have evolved through complex mechanisms following game-theoretic models. They have observed complex protolegal patterns of reciprocities giving rise to cooperation, and have witnessed uncooperative behavior that yields coordinated ostracism and hostility. Does this have implications for our understandings of the foundations, evolution, and dissolution of democratic order? What was it about the social development of humans that has led to the conviction that some form of democratic government among free men and women would protect equality in a way that was considered desirable? Is democracy in any meaningful sense a "natural" form of government for humans (as biological beings)? If so, does this "naturalism" have implications for our understanding of the foundations of our sense of justice? If we should "naturalize" law and social practices, what illumination might evolutionary perspectives provide concerning our "commonsense" notions of right and wrong? Or of fair bargains and unjust results? <
R> Contemporary educational and research institutions largely have been
built around the principle of disciplinary specialization, which has
reinforced the gap between natural and social sciences. Two hundred years
ago, many scholars in biology or medicine were reasonably well versed in
philosophy, political science, economics, law, or history. Today, as these
disciplines have become highly technical, there is far less communication
from one specialty to another. As a result, within each of the social
sciences, attempts to bridge the gap between the life sciences and the study
of human behavior confront methodological criticisms as well as political
prejudices. The role of evolution in the interaction of biology and law is
one area patently ripe for further study within the psychological,
historical, legal, and biological disciplines; yet, for most, it is not a
part of the core curriculum. It is important, especially in these early
stages of interpreting the social and political implications of evolution,
that we carry out careful research, including baseline studies of what we
know now and what may change as we learn more. This is simply a necessary
step in furthering efforts to adjudicate among competing scientific claims
within the legal and political arenas.
Conclusion
The liveliness of the discussion during these two workshops demonstrates
that we only have begun to plumb the depths of the exciting questions and
richness of research possibilities within the various National Science
Foundation initiatives that were included. Nationally and internationally,
we are all facing increasing challenges to some of our most basic
assumptions about science, the law, and their relations-many of these coming
about because of advances within the biological sciences. Some of these
challenges question our very understanding of ourselves; others question our
understanding of nature or of our place in it. This is an ideal time to take
up the most basic research into how our scientific and political systems
deal with scientific controversy and change as they seek to address the
challenges of adjudicating between competing claims.
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