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U.S. Department of Energy Human Genome Program 
Projects in Ethical, Legal, and Social Issues

published October 1999

Foreword 1999 Projects Related Web Sites Completed ProjectsCompleted Workshops Retrospective

Current ELSI Projects

An Economic Analysis of Intellectual Property Rights Issues Concerning the Human Genome Program

David Bjornstad

and Steven W. Stewart1
Oak Ridge National Laboratory; P.O. Box 2008, MS 6205; Oak Ridge, TN 37831-6205
423/574-5152, Fax: -8884, bjornstaddj@ornl.gov
1University of Tennessee, Knoxville

A combination of circumstances has led to concerns that intellectual property rights issues will result in the underutilization of information produced by the Human Genome Project. These issues include U.S. patent policy, recent legislation to encourage technology transfer and leveraging of private research funding, a diversity of actors carrying out the research, and research technologies that identify fragmentary pieces of genetic information that may individually be patentable.

These circumstances could lead to a multiplicity of individual ownerships of intellectual property rights that could in turn discourage efficient market penetration of the technologies. This condition has been described as a tragedy of the "anticommons," whereby over-issuance of property rights leads to the underutilization of a resource. Knowledgeable observers, however, disagree as to the severity or even the existence of this problem. Resolving these differences is hampered because the unique circumstances of the Human Genome Project make it possible to argue that past patenting experience is not fully relevant.

We will construct a microeconomic model of the research, discovery, and patenting process and gather data using the methodology of experimental economics. Doing this will identify incentive structures inherent in the current system and permit us to analyze how alternative rules and institutions could add to or detract from efficient utilization of intellectual resources.


Hispanic Role Model and Science Education Outreach Project: Human Genome Project Education & Outreach Component

Clay Dillingham

Self-Reliance Foundation; Institute of Genetics Education; 501 C St. NW; Washington, DC 87505
505/995-0886, cdillinham@gened.org
http://www.hrn.org

Currently, Hispanics make up 11 to 15% of the U.S. population; about 30 million people. Hispanics are also the fastest growing minority in the United States. Spanish is the dominant language of 64% of all Hispanics living in the United States. Furthermore, Hispanics feel discriminated against by the U.S. health care system. According to the American Journal of Health Promotion (Vol.9, No. 4, 1994-95):

  • 78.3% of Hispanics report they are most comfortable speaking Spanish at home
  • 27% believe they face discrimination in the quality of health care to which they have access
  • 30% believe they are not treated with respect at clinics
  • 28% believe they do not have the same opportunities as others in obtaining health care information

Hispanics are outside the mainstream of information about health, science, the Human Genome Project (HGP), and its ethical, legal, and social implications (ELSI).

Hispanics are largely "out of the loop" of the public health information mainstream because of the substantial linguistic preferences of Hispanic residents. For example, Spanish-speaking residents may not be targeted or may not receive information on how and where to access health care services. They are unlikely to learn about rapid advances in such health and science programs as HGP-ELSI.

This DOE-funded project is completing its second year of providing Spanish radio programming and outreach services that focus on the HGP and its scientific, medical, and ELSI implications. The purpose of this project is to help inform the U.S. Spanish-speaking population and motivate them to access the resources available for further education and information on these issues.


Competition Between Public & Private Research Funding in Genomics

Rebecca S. Eisenberg

University of Michigan Law School, Hutchins Hall; 625 S. State St.; Ann Arbor, MI 48109
734/763-1372, Fax: -9375, rse@umich.edu

The field of genomics exhibits considerable overlap in the type of research that is supported by public and private funding. Recent announcements from two private firms that they plan to complete the DNA sequence of the human genome ahead of the publicly funded HGP is the most recent, and perhaps the most dramatic, example of this phenomenon. Sometimes public and private institutions commingle funds and work together collaboratively, but sometimes they are openly competitive. These interactions shed an interesting light on the relationship between public and private funding of scientific research. A number of features of public-private interactions that have been highly salient in this particular setting play little role in standard accounts of the relationship between public and private research funding, including scientific rivalry for priority in achieving overlapping if not identical goals, a tortoise-hare struggle over the relative virtues of speed and thoroughness, and recurring controversies over intellectual property and terms of access to data and discoveries.

A standard account of the relationship between public and private research pictures publicly-funded research as promoting activities that are entirely distinct from the sort of research that private firms are likely to pursue with their own funds. In his classic argument for continued government funding of research following the conclusion of World War II, Vanevar Bush called for government funding of "basic research" to compensate for inadequate commercial incentives to invest in the pursuit of fundamental knowledge, as distinguished from "applied technology." Economists have similarly suggested that government research funding should compensate for "market failure" that limits private motivation to invest in research, despite the high social value of such investments, because of uncertainty as to who will profit from research results and difficulty in appropriating results as intellectual property. An alternative justification for public funding of research that finds little support among economists but nonetheless enjoys considerable political popularity emphasizes promoting technological innovation by U.S. firms. In this account government-funded research is pictured as an advanced scouting mission to identify promising opportunity for short-sighted or risk-averse firms. None of these accounts contemplates public funding of research that is competitive with private sector research.

When does it make sense to allocate taxpayer dollars to funding research that that resembles work being pursued in the private sector? Are there circumstances in which public funding of research may be justified as a means of forestalling private appropriation of research results as intellectual property? When are judgments about the wisdom of patenting certain types of discoveries best left to the patent system in its determinations of what may be patented, and when are such judgments appropriately made by funding agencies in deciding what sort of research to fund and in limiting the rights of grantees to pursue patent rights? What are the proper roles of the patent system and research funding agencies in mediating the boundaries between public and private in research science, and what sorts of judgments on this issue are within the competence of the institutions that manage these systems?


Individualizing Medicine Through Genomics: Medical and Social Implications

Henry T. Greely

, Barbara A. Koenig, and Laura L. McConnell
Stanford Center for Biomedical Ethics; Stanford Law School; Stanford, CA 94305-8610
650/723-2517, Fax: /725-0253, hgreely@stanford.edu

This grant partially supported a process that led to a conference at Stanford on October 17, 1998 on the implications of the increasing use of genetic variation in medicine. Scientists, physicians, and industry increasingly are recognizing the potential medical importance of such variation. The genetic variation involved can be that of a pathogen, a tumor, or healthy human tissue; the medical implications may be in prevention, treatment, or prognosis. In all these respects, the potential for applying individualized genomic information to medicine is an extension of existing knowledge based on the growing availability of inexpensive and convenient determination of DNA sequence in known genes. Among the specific topics examined were

  • Ethical issues in the research necessary for greater medical use of genetic variation, such as research correlating vast amounts of phenotypic data to vast amounts of genotypic data.
  • Consequences of individual genomic variation for public health initiatives.
  • Possible uses of individualized genetic information by managed care to make treatment decisions.
  • Effects of greatly expanded use of individual genetic data in medicine on privacy.
  • Implications of studies of medically relevant genetic variation for public and medical views of race.
  • Problems raised by the commercialization of treatments involving genetic variation, including intellectual property and FDA issues.

The videotaped conference included presentations from, among others, Drs. Anthony Carrano, Francis Collins, Paul Berg, Barbara Koenig, Laurie Zoloff-Dorfman, and Robert Cook-Deegan and Law Professors Rebecca Eisenberg, Alta Charo, and Henry Greely. At least one publication, a summary article, will be forthcoming from the conference; a broader set of articles may also result.


The Responsibility of Oversight in Genetics Research: How to Enable Effective Human Subjects Review of Public and Privately Funded Research Programs

Barbara Handelin

and Susan Katz
Public Responsibility in Medicine and Research (PRIM&R); Fourth Floor; 132 Boylston St.; Boston, MA 02116
617/423-4112, Fax: -1185, prmr@aol.com, bhandelin@compuserve.com,
http://www.aamc.org/research/primr

IRBs are under extreme stress to provide adequate review of all manner of protocols. A central assumption, whicht underlies the IRB's charge to protect the rights and welfare of human subjects involved in research, is that each individual IRB will possess or develop the requisite expertise to accomplish this mission adequately. The increasingly complex ethical, regulatory, and scientific issues presented to IRBs in reviewing genetic research protocols challenge the validity of this assumption. Individual IRBs have inadequate time and resources to develop the necessary genetics expertise and facility to deal with this new challenge. Thus, our project has been developed to solicit specific needs from IRBs so that specific working "tools" can be created to address those needs.

We also are addressing the concomitant increased pressure on biotech and genomics companies to conform to a standard of practice in conducting research studies and in developing marketing plans for gene-based products and services. As such companies become engaged in clinical studies involving human subjects or tissues, they may need help in effecting quality, IRB-like review. In this project we are seeking to exploit the synergistic needs and expertise found in these two types of organizations: the ethics-oversight capabilities and systems of IRBs and the genome expertise in industrial R&D shops. We are studying the dynamic interplay and relative perspectives of IRBs and the biotech communities, and we propose to weave common solutions to critical issues in the safe and ethical participation of human subjects in genetic research.


Dilemmas in Commercializing Human Genome and Biotechnology Products: Developing a Case-Based Business Ethics Curriculum for Industry

Barbara Koenig

Center for Biomedical Ethics; Stanford University School of Medicine; 701 Welch Rd. #1105; Stanford, CA 94305-5015
650/725-6103, Fax; -6131, bkoenig@leland.stanford.edu

This project will be conducted jointly by the Center for Biomedical Ethics and the Graduate School of Business of Stanford University. The general aim of the project is to research and develop instructional material on business ethics decision making for those involved in commercializing biotechnology products. There are four specific aims. They are to (1) research and identify the ethical and social issues that are raised when biotechnology and genomic research is commercialized, (2) develop an analytical business ethics decision making model or process that can be used by pharmaceutical and biotechnology corporations when their managers face these ethical and social issues, (3) develop comprehensive case studies in business ethics based on past pharmaceutical and biotechnology corporate behavior, and (4) apply the decision making process to these case studies as examples of how corporate managers can incorporate ethical reflection, debate, and analysis into business practices.

This project falls within the Department of Energy's interest in the preparation and dissemination of educational materials that will enhance understanding of the ethical, legal, and social aspects of the Human Genome Project. The educational materials developed will foster corporate decision making that enhances responsible use of genomic and biotechnology information and products from research to postmarketing phases of development.

The results of this research project will be directed primarily to pharmaceutical and biotechnology corporate executives, managers, board members, and attorneys. The detailed case studies developed through collaboration between the Center of Biomedical Ethics and the Graduate School of Business will be utilized within Stanford's Executive Education Program. This unique program attracts leaders from the international business community, providing a singular opportunity to educate decision makers in the biotechnology and pharmaceutical industries. The case studies developed also will be available to augment ethics curricula of graduate schools of business. Case material will be distributed via the World Wide Web and eventually through a conventional textbook format. In this way, the case material will be accessible to anyone interested in the ethical and social consequences of commercializing human genome research.


Medical Confidentiality in the Market Driven Managed Care Setting: Does the Law Protect Against Misuse of DNA-Based Tests?

Jeroo Kotval

, Anthony Clarizia, and Patricia Salkin
School of Public Health; University of New York at Albany; One University Place; Rensselaer, NY 12144-3456
518/402-0301, Fax: -0414, jkotval@eve.albany.edu, jsk03@health.state.ny.us

The rise of managed care as the primary method of healthcare delivery raises new concerns regarding the misuse of confidential medical information especially the misuse of DNA-based tests that predict the likelihood of late-onset, high-cost disorders. We have surveyed state and federal law related to protection of medical confidentiality and find several gaps in the legal framework intended to protect individuals from misuse of their genetic information in the managed-care setting. These gaps stem primarily from reliance on a patchwork of state laws, regulations, and case law to protect confidential medical information through professional licensure laws, medical malpractice laws and regulations, and by direct protection of an ill-defined entity: the medical record.

These measures have become inadequate to protect medical confidentiality within the context of many managed-care contracts. In addition, large numbers of persons insured through managed-care plans that fall under ERISA are not touched by the state policy framework. No laws directly address the misuse of genetic information within managed-care plans; this has the effect of discriminating against individuals with high-cost illnesses. Furthermore, the lack of uniformity among states with regard to law and public policy creates confusion for managed-care organizations (MCOs) that operate in multiple jurisdictions and for consumers who seek care in more than one state.

In the absence of federal or state law to protect individuals from unconsented dissemination of genetic information, there are few legal grounds for a successful cause of action against an MCO. Legal theories that could serve as bases for successful causes of action include vicarious liability through respondeat superior and ostensible agency theories. In assessing the merits of a plaintiff's case claiming discrimination, courts are likely to consider issues including the structure, administration, and internal procedures implemented by the MCO; representations and disclosures made in contracts, brochures, and advertising; financial incentives and cost-containment and utilization-review procedures used by the MCO; and, of course, the selection, control, and contracts between the MCO and the physician. Even if plaintiffs do have "the law on their side," it would take years to resolve a matter, not to mention the expenses involved. This creates a disincentive to seek redress and a hostile environment for advocating consumer rights. Recommendations regarding appropriate federal and state law are being explored.


The Science and Issues of Human DNA Polymorphisms

David Micklos

, John Kruper, Scott Bronson, and Matthew Christensen
DNA Learning Center; Cold Spring Harbor Laboratory; 1 Bungtown Road; Cold Spring Harbor, NY 11724
516/367-7240, Fax: -3043, micklos@cshl.org
http://www.dnalc.org/

The DOE Program introduces high school biology faculty to a laboratory-based unit on human DNA polymorphisms that provides a uniquely personal perspective on the science and ELSI aspects of the Human Genome Project. Thus far, 170 high school faculty have participated in eight 3-day workshops held in Atlanta, Boston, Denver, Los Angeles, New York, Richmond, Salt Lake City, and San Francisco. Participants learn simplified lab techniques for amplifying three types of DNA polymorphisms: an Alu insertion, a VNTR repeat, and point mutations (SNPs) in the mitochondrial (mt) control region. These polymorphisms illustrate the use of DNA variations in disease diagnosis, forensic biology, and identity testing, and provide a starting point for discussion of the uses and potential abuses of genetic technology.

During the past year, we developed ready-to-use teaching kits to support the three human PCR experiments introduced in the DOE workshop. The kits, which are now available through Carolina Biological Supply Company, incorporate a three-part PCR chemistry that greatly simplifies reaction set-up and improves reproducibility. Template DNA (obtained from cheek or hair cells) is added to primer mix and a freeze-dried reagent pellet (containing Taq polymerase, deoxynucleotide triphosphates, and buffer). Loading dye is incorporated in the primer mix, allowing amplified reactions to be loaded immediately for gel electrophoresis.

We also provided proof of concept for a Sequencing Service to process mt DNA samples submitted by teachers around the country. During each DOE workshop, participants amplified the mt control region, and the samples were returned to the CSHL Genome Sequencing Center for cycle sequencing. The completed sequences were then posted at the DNA Learning Center's Web site (http://www.dnalc.org/) in a Student Sequence Database, which currently contains 350 sequences. This process was replicated with 59 student samples submitted, by mail, from teachers in New York, Maryland, Utah, and Virginia. A dedicated DNA sequencer to support student sequencing is included in the capital budget for a 6,000-square-foot DNALC BioMedia addition, on which construction will begin next year.

We have continued to develop step-by-step Internet templates that allow students to use their own polymorphism data to solve cases illustrating key principles of genomic biology. In one case, the Student Allele Database facility is used to compare students' Alu insertion data with data from world populations. In another case, multiple sequence alignment is used to compare student and reference mt DNA sequences to determine whether Neanderthal hominids were our direct ancestors. We currently are developing Bioforms that further simplify data submission and presentation, allowing students to focus on the biological question at hand rather than being overwhelmed by navigating complex forms at Internet genome servers. The initial Bioform allows students to analyze mt DNA sequences to identify the remains of the Romanov family and determine if Anna Anderson was the missing princess Anastasia.


The High School Human Genome Program

Maureen Munn

and Leroy Hood
Department of Molecular Biotechnology; University of Washington, Box 352145; Seattle, WA 98195
206/616-4538, Fax: /685-7344, mmunn@u.washington.edu
http://hshgp.genome.washington.edu

The discovery that DNA is the information molecule of living organisms is one of the most significant scientific breakthroughs of the 20th Century and is critical to our understanding of inheritance, development, biodiversity, and evolution. Advances in genetics, molecular biology, and biotechnology have revolutionized biological research, medicine, agriculture, and manufacturing, and will continue to do so in the 21st Century. Along with many benefits, genetic research and biotechnology evoke complex ethical and legal issues that impact individuals and society as a whole. Pre-college genetics education should do the following:

  • present genetics as a unifying concept of biology;
  • provide knowledge and experience with experimental approaches used in genetics and biotechnology;
  • inform students about career choices in genetics and related fields;
  • challenge students to consider related ethical issues so that they can develop the critical thinking skills needed to understand and evaluate them.

The High School Human Genome Program (HSHGP) encourages high school students to think constructively about the scientific and ethical issues of genetic research by enabling them to participate in both. This program was developed through a partnership of scientists at the University of Washington (UW) and several Seattle-area high school teachers. Students sequence a portion of human DNA as part of an ongoing research project being carried out at the University of Washington. Our current project is focused on understanding the molecular basis for nicotine addiction by sequencing one subunit of the nicotine-binding receptor in the brain. This project is being carried out in collaboration with Dr. Carl Ton, an acting assistant professor in the Department of Medicine, Division of Medical Genetics at the University of Washington. Sequencing is carried out either in classrooms, using a manual technique, or at the UW Genome Center, using fluorescent sequencing. Each student group sequences a small portion of the overall segment of DNA being studied, and then their data is merged using the DNA assembly program, Sequencher. Students and their teachers can access Sequencher through a tutorial called "Virtual DNA Sequencing" that is available on our Web site (http://hshgp.genome.washington.edu).

The Ethics unit focuses on presymptomatic genetic testing. This module was developed by Sharon Durfy and Robert Hansen from the UW Department of Medical History and Ethics. The module utilizes a role-playing scenario to involve students in the complex issue of whether, as a character in the scenario, they would choose to be tested presymptomatically for Huntington's disease (HD). Materials include background information on the genetics, molecular biology, and clinical aspects of HD, directions for constructing a pedigree and analyzing laboratory data to determine whether someone carries the HD gene, a tool for assessing student learning, and a teacher's guide. Students use a decision-making model to assist them in making a justifiable ethical decision.

Our program offers professional development for teachers from Washington State and other locations in the United States and Canada during a one-week summer workshop. Activities include completion of the DNA sequencing and ethics modules, presentations by guest speakers, and informal discussions about classroom implementation and student assessment. During the academic year, local teachers are provided with the necessary equipment and reagents to carry out the experiment in their classrooms. Teachers from outside the Seattle area can borrow equipment through the loan program of the Howard Hughes program at Washington State University (WSU), while teachers in the Vancouver area are supported by a partner site at WSU Vancouver. Scientist volunteers from UW and local biotechnology companies assist during classroom experiments. This program currently is serving over 50 high school and college teachers in Washington State, as well as 20 teachers outside the state.

Molecular Biotechnology's Education Outreach contributes to K-12 science education through a variety of outreach efforts. These outreach programs share several important features, including a strong emphasis on presenting science as inquiry and the development of partnerships between teachers and scientists. Genetics is an integral part of many of these outreach programs. For example, in conjunction with the Seattle Partnership for Inquiry-Based Science, Education Outreach presented one-week workshops on genetics and biodiversity for Seattle elementary teachers in the summer of 1998. The Integrated Science Partners, a Howard Hughes-funded program focused on the development of curriculum for middle-school science teaching, has developed a module on genetics. We currently are coordinating a project called the Genetics Education Partnership, in conjunction with teachers and genetics professionals from around the state. The purpose of this project is to examine genetics teaching in grades K-12, identify useful materials for teaching genetics at different grade levels, and foster the development of genetics learning communities throughout the state.

Recent Publications Munn, M. M., O'Neill Skinner, P., Conn, L., Horzma, G. and Gregory, P. "The Involvement of Genome Researchers in High School Science Education." Review submitted to Genome Research.

Internet-Based Publications and Projects Genetics Education Database http://chroma.mbt.washington.edu/outreach/; High School Human Genome Program http://hshgp.genome.washington.edu; Genetics Education Partnership http://genetics-education-partnership.mbt.Washington.edu


Microbial Literacy Collaborative: Intimate Strangers: Unseen Life on Earth

Cynthia A. Needham

and Susan E. Kee1
1American Society for Microbiology; 1325 Massachusetts Ave. NW; Washington, DC 20005
202/942-9301, Fax: -9329, skee@asmusa.org
http://www.microbeworld.org

The Microbial Literacy Collaborative (MLC) is a partnership of organizations committed to advancing scientific literacy through a focus on the microbial world. Four components of the initiative are (1) the science documentary for public television entitled Intimate Strangers: Unseen Life on Earth, (2) the set of 17 hands-on community-based microbial activities entitled Microbe Mania, (3) youth leadership training for pre-college students from traditionally under-represented communities, and (4) a 12-part telecourse for undergraduate use. The organizations that comprise the MLC include the American Society for Microbiology; National Association of Biology Teachers; Oregon Public Broadcasting; and Baker & Simon, Associates, an independent production company. Other organizations include the Association of Science-Technology Centers, Inc., and American Association for the Advancement of Science.

MLC is funded by the Human Genome Program of the Department of Energy, National Science Foundation, American Society for Microbiology, Annenberg-CPB Project, Corporation for Public Broadcasting, and the Archer Vining Davis Foundations.

Intimate Strangers: Unseen Life on Earth has been completed and is expected to air on PBS in the fall of 1999. The four hours of the series include: (1) "The Tree of Life," (2) "Dangerous Friends and Friendly Enemies," (3) "Keepers of the Biosphere, and (4) "Creators of the Future." "The Tree of Life" delves into our evolutionary past. The key message of this hour is that all living things today evolved from microbes and share fundamental biologic properties with them. "Dangerous Friends and Friendly Enemies" examines our ancient rivalry with the microbial world. "Keepers of the Biosphere" explores the central role that microbes play in sustaining the earth's ecosystems. "Creators of the Future" examines our present and future use of microbial technologies to solve longstanding problems that affect the way we live.

Microbe Mania is a collection of 17 hands-on activities designed for use in both informal and formal learning environments. The activities complement the major themes within the television documentary. They require little or no equipment or knowledge of microbiology to conduct. The activities will support open-ended experimental design and help to address elements of the National Science Education Standards.

Microbe Mania Youth Leadership Training is a week-long experience designed to introduce youth leaders and their adult sponsors to the microbial world and prepare them to implement the hands-on activities in their local community programs. The first of two summits was held in August 1998 on the St. Paul campus of the University of Minnesota. The training experience was organized with the Association of Science-Technology Centers, Inc., and their Youth Alive! Program. Participants represented 12 science museums from around the country, with youth leaders drawn primarily from challenged home environments.

The Unseen Universe is a 12-part telecourse for use in both undergraduate and pre-college classrooms. Each 30-minute film focuses on a different aspect of the microbial world. The telecourse was designed to address the curriculum standards endorsed by the American Society for Microbiology and will be accompanied by teacher and student guides. The telecourse will support a full distance learning course in microbiology or serve as supporting materials for traditional classroom environments.


Electronic Scholarly Publishing: Foundations of Genetics

Robert J. Robbins

Fred Hutchinson Cancer Research Center; 1100 Fairview Ave. North; Seattle, WA 98104
206/667-4778, Fax: -6223, rrobbins@fhcrc.org
http://www.esp.org

As the Human Genome Project (HGP) moves toward its successful completion, more and more people are becoming interested in understanding this project and its results. Since the HGP has significant ethical, legal, and social implications for all citizens, the number of individuals who do, or should wish to become familiar with the project is very high. In addition to its importance in the training of professional geneticists, the HGP is of special relevance for undergraduate training in basic biology, and even for high-school and other K-12 education. In a world soon to experience a flood of information and technology from genomic research, a basic understanding of genetic principles may become part of the expected knowledge base of the educated citizen.

Understanding the results of HGP research, however, requires a familiarity with the notions of basic genetics, and this is often not available to most individuals. We have created an educational resource at which material related to the foundations of classical genetics is being republished in readily available, typeset-quality electronic form. We also publish additional material, such as pedagogical materials, items of general interest, biographical and autobiographical memoirs, and historical or analytical treatments. Together, this collection should be of great use to those wishing to appreciate and understand genetics and genome research.

Materials at our site are of interest to individual users, but they are especially valuable for teachers and other educators in the preparation of their course materials. Several textbook publishers are providing links to our site at their value-adding textbook support sites. Many junior college and secondary school sites are also now referencing our site.

The site is intended to be useful not only to students, teachers, scholars, but also to general readers. Indeed, we consider the general public to be our primary audience. Data currently available suggest that we are succeeding in reaching our target audience. The bulk of our users are accessing the site from clients that use a dial-up Internet service provider. Since scholars and scientists usually have full Internet access from their university facilities (that all have *.EDU domains), the data suggest that the bulk of our users are from the general public. We specifically have logged visits from more than 100 high-school sites and we know of several high-school web projects that have established links to the ESP site.

In the past year, we have emphasized software development to improve the efficiency with which we can publish works at our site and to improve the functionality of our site for users. By January 1999, we will move our site to a different physical server that will allow us much more control over the functionality that we can deliver. This will allow us to offer custom services to the user, including personalized searches and file storage, as well as custom annotated versions of classic texts.


Truth & Justice: Science and Its Appeals

Noel Schwerin

Backbone Media; 1327 Church St.; San Francisco, CA 94114
415/282-5620, Fax: -0230, schwerin@backbonemedia.org
http://www.pbs.org

Truth & Justice is a three-part, three-hour documentary special for national broadcast on PBS. Produced by Backbone Media (a public-benefit, nonprofit charitable corporation*) in association with Oregon Public Broadcasting, Truth & Justice will stimulate the public to think critically about the real strengths and important limits of science in both framing and resolving social conflict. In three parts, the program will profile individuals judges and scientists, lay people and lawyers as they grapple with questions of science and law in a handful of actual cases. In Part One, "Novel Cases" will demonstrate how new technologies, particularly genetic technologies, create unexpected, unprecedented legal conflicts that challenge fundamental legal, ethical, and social principles. In Part Two, "Judging Science" will look at what happens when new laws oblige the courts to distinguish between "good" and "bad" science. In Part Three, "Due Process" will examine science as one "way of knowing the world," often in conflict or competition with other ways of knowing in the courts.

In the style of A Question of Genes, the PI's recent award-winning DOE-funded PBS program, each hour will closely observe two or three pairs of people as they grapple with science and technology in a handful of actual legal cases. Through the interactions of these central "characters," the program will explore the critical interplay of science and the courts. By profiling people at the center of actual conflicts, it will use compelling, accessible human drama as its vehicle.

Use of DOE funds has focused on four goals; half has been spent on the first three goals, and the rest has been reserved for the fourth goal: (1) development of the conceptual framework and specific story content and treatment for the program; (2) development of a substantial body of institutional and individual support for the project, including an active and distinguished Board of Advisors, a community of academic and professional support and advice, an experienced production and promotion team, a distribution plan, and direct and ongoing relationships with story participants; (3) development toward other funding, including extensive foundation research and the submission of proposals to targeted foundations and federal agencies; (4) the production of a story from the program to aid in fund-raising and to launch the project.

*Formerly NoelEye Documentaries


Science Training Initiative

Barinetta Scott

SoundVision Productions; 2991 Shattuck Ave., Ste. 304; Berkeley, CA 94705
510/486-1185, Fax: -1287, bariscot@aol.com
http://www.dnafiles.org

This project will build on its public radio documentary series, The DNA Files, to increase the general science literacy of public radio producers, reporters, and editors. Supported by DOE, the National Science Foundation, and the Alfred P. Sloan Foundation, the nine 1-hour documentaries were broadcast in late 1998 and early 1999.

SoundVisions will plan and produce a series of workshops that will bring together scientists and science educators with public radio news and information producers to create a venue for information sharing. The goal is to improve the overall news coverage of science issues currently offered to the public radio audience.

The centerpiece of this training initiative will be two 4-day workshops that will offer intensive and comprehensive information and practice in the art of presenting complex science and related technology stories to the public. These workshops will explain the basic scientific concepts that form the backdrop for the majority of science and technology stories prominent in the media today.

Training will involve about 15 reporters, producers, and editors, in addition to core SoundVision staff and invited scientists who will act as trainers and participants.


AAAS Congressional Fellowship Program

Elaine Strass

The American Society of Human Genetics; 9650 Rockville Pike; Bethesda, MD 20814-3998
301/571-1825, Fax: /530-7079, society@genetics.faseb.org
http://genetics.faseb.org/genetics/ashg/ashgmenu.htm

Few individuals in the genetics community are conversant with federal mechanisms for developing and implementing policy on human genetics research. In 1995 the American Society of Human Genetics (ASHG), in conjunction with DOE, initiated an American Association for the Advancement of Science (AAAS) Congressional Fellowship Program to strengthen the dialogue between the professional genetics community and federal policymakers. The fellowship will allow genetics professionals to spend a year as special legislative assistants on the staff of members of Congress or on congressional committees. Directed toward productive scientists, the program is intended to attract independent investigators.

In addition to educating the scientific community about the public policy process, the fellowship is expected to demonstrate the value of science-government interactions and make practical contributions to the effective use of scientific and technical knowledge in government. The program includes an orientation to legislative and executive operations and a year-long weekly seminar on issues involving science and public policy.

Unlike similar government programs, this fellowship is aimed primarily at scientists outside government. It emphasizes policy-oriented public service rather than observational learning and designates its fellows as free agents rather than representatives of their sponsoring societies.

One of the goals of DOE and ASHG is to develop a group of nongovernmental professionals who will be equipped to deal with issues concerning human genetics policy development and implementation, particularly in the current environment of health-care reform and managed care. Graduates of this program will serve as a resource for consultation in the development of public-health policy concerning genetic disease.

Fellowship candidates must demonstrate exceptional basic understanding of and competence in human genetics; hold an earned degree in genetics, biology, life sciences, or a similar field; have a well-grounded and appropriately documented scientific and technical background; have a broad professional background in the practice of human genetics as demonstrated by national or international reputation; be cognizant of related nonscientific matters that impact on human genetics; exhibit sensitivity toward political and social issues; have a strong interest and some experience in applying personal knowledge toward the solution of social problems; be a member of ASHG; be articulate, literate, adaptable, and interested in working on long-range public policy problems; be able to work with a variety of people of diverse professional backgrounds; and function well during periods of intense pressure.


Getting the Word Out on the Human Genome Project: A Course for Physicians

Sara L. Tobin

and Ann Boughton1
Program for Genomics, Ethics, and Society; Stanford University Center for Biomedical Ethics;
701 Welch Rd., Bldg. A, Ste. 1105; Palo Alto, CA 94304
650/725-2663, Fax: -6131, tobinsl@leland.stanford.edu
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Progressive identification of new genes and implications for medical treatment of genetic diseases appear almost daily in the scientific and medical literature, as well as in public media reports. However, most individuals do not understand the limitations or the promise of the current explosion in knowledge of the human genome. This is also true of physicians, most of whom completed their medical training prior to the application of recombinant DNA technology to medical diagnosis and treatment. This lack of training prevents physicians from appreciating many of the recent advances in molecular genetics and may delay their acceptance of new treatment regimens. In particular, physicians practicing in rural communities are often limited in their access to resources that would bring them into the mainstream of current molecular developments. This project is designed to fill two important functions: first, to provide solid training for physicians in the field of molecular medical genetics, including the impact, implications, and potential of this field for the treatment of human disease; second, to utilize physicians as informed community resources who can educate both their patients and community groups about the new genetics.

We are engaged in the development of a flexible, user-friendly, interactive multimedia CD-ROM designed for continuing education of physicians in applications of molecular medical genetics. We have designed the navigational system, completed a prototype, carried out a preliminary evaluation of the prototype by physicians, and continued to create content. The courseware will provide training in four areas: (1) Genetics, including DNA as a molecular blueprint and patterns of inheritance; (2) Recombinant techniques, stressing cloning and analytical tools and techniques applied to medical case studies; (3) Current and future clinical applications, encompassing the human genome project, technical advances, and disease diagnosis and prognosis; and (4) Societal implications, focusing on issues such as privacy and impact on the family. The CD format permits the use of animation, video, and audio, in addition to graphic illustrations and photographs. A hypertext glossary, user notes, practice tests, and customized settings will be utilized to tailor the CD to the needs of the user. Brief, multiple-choice examinations will be evaluated for continuing medical education credits by the Stanford Office of Postgraduate Medical Education. The CD will function as a hybrid' product, capable of seamless interaction with Internet resources. This capability permits continuous updating of the course content.

The development of the CD is supervised by a Board of Advisors, and the completed courseware will be evaluated by physician focus groups. Commercial distribution will be arranged through the Stanford Office of Technology Licensing. The courseware is designed to provide a powerful tool for the education of physicians and the public about the potential of the Human Genome Project to benefit human health.


Genetics Adjudication Resource Project

Franklin M. Zweig

Einstein Institute for Science, Health, and the Courts; 5505 Connecticut Ave. NW; Washington, DC 20015
301/913-0448 or 202/879-1693, Fax: 301/913-5739, einshac@intr.net

During the first 19 months of project operation beginning in March 1997, the Genetics Adjudication Resource Project (GARP) has operated from the center of the judicial system. It has provided basic science and ELSI in the District of Columbia orientation to about 884 judges in attendance at nine "Genetics in the Courtroom" conferences. Around 60 federal and state judicial faculty members experienced several conferences and now comprise a sophisticated teacher core within the Judicial Branch . Another 25 judges attended the first and last conferences in the series, experiencing both the basic orientation and an advanced course that extended the basics to biomarker testing in the toxic tort context.

GARP has designed and implemented a unique and effective judicial educational technology. GARP has created a collaborative relationship with the Lawrence Livermore and Lawrence Berkeley national laboratories and has mobilized the participation of 250 neutral, independent scientists. By participating, many of these scientists have increased their knowledge of the legal system, thereby building bridges across the deep institutional chasm separating science and the courts.

GARP has collected the most thorough genetics-related legal literature to date, covering case law and exact statutes in 20 legal categories. This collection was published in August 1998 as an Adjudication Source Book in conjunction with a 22-judge, 16-scientist Working Conversation on "Genes as Property in the American Law Tradition." GARP has published a primer for courts as a dedicated theme issue ("Genetics in the Courtroom") in the American Bar Association's mainline judicial-division magazine, The Judge's Journal (Vol. 36, No. 3, 1997.) One article (Walsh, Admissibility) was selected as the best of the ABA for 1997. GARP has produced a durable hypothetical-case library and workbooks as initial archives for judges' use in early case assignment. These accomplishments provide a platform for ELSI- and genetics-related Judicial System leadership as the Human Genome Project's research moves toward establishing a reference map and sequence.

GARP objectives for the next 3 years include: (1) Conduct of a 1999 national "Neurogenetics in the Courtroom" conference and regional conferences on "Genetics in the Courtroom" in California, the Southeast, and Arizona/Southwest for 500 additional federal and state, trial and appellate judges; (2) In conjunction with Lawrence Livermore National Laboratory, conduct hands-on training for an expanded judicial faculty, a dedicated leadership conference for the Chief Justices of our state courts, and a joint legislative-judicial conference; (3) Develop a model and procedural guidelines for the real-time teleconferenced and videotaped testimony of court-appointed expert witnesses in genetics-related cases; (4) produce an Alternative Dispute-Resolution Techniques Guide Book with respect to ELSI and genetics issues, a means for courts to manage genetics-related conflicts without subjecting the parties to the stress of formal trials; (5) Create a plan for international judicial dialogues on gene testing and therapy issues; (6) Complete a videotaped ELSI and genetics curriculum for courts to accompany the volume entitled Genetics in the Courtroom: Judge's Handbook to be printed for distribution in January 1999; (7) Complete a background paper for courts on the state of genetic property doctrines and issues; (8) Complete a law-school moot court initiative to orient future judges and law faculty to the management of ELSI- and genetics-related cases; (9) conduct a working conversation on the legal status of genetic counselors; (10) institute an ELSI and genetics teaching courtroom as part of EINSHAC's newly established Law and Science Academy in the Courts of the District of Columbia; and (11) develop a case-tracking and GARP impact-evaluation system.

These resources will promote judicial leadership on behalf of our society. Given the patchwork, inconsistent nature of state legislation concerning genetic property, privacy, and discrimination, the courts will be the bulwark of our ability to integrate new science with our framework of emerging and established rights. Given the paralysis of Congressional action, the Judicial Branch will be pushed front and center to interpret and adapt the existing law to rapidly spiraling new technological domains. It is timely and feasible to provide a durable and full toolbox for a judiciary that will be tested as never before at the margins of changing ethical precepts, social aspirations, and high-velocity science.

Human Genome Project 1990–2003

The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.

Human Genome News

Published from 1989 until 2002, this newsletter facilitated HGP communication, helped prevent duplication of research effort, and informed persons interested in genome research.