Human Genome 1993 Program Report: Ethical, Legal, and Social Issues
Date Published: March 1994
Human Genome Management Information System
Oak Ridge National Laboratory
1060 Commerce Park, MS 6480
Oak Ridge, TN 37830
423-576-6669, Fax: 423-574-9888
Internet: bkq@ornl.gov
Projects New in FY 1993
Guidelines for Protecting Privacy of Information Stored in Genetic Data Banks
George J. Annas and Leonard H. Glantz
Law, Medicine, and Ethics Program; Boston University School of Public Health; Boston, MA 02118;
617/638-4626, Fax: -5299
This 16-month project will answer the following questions to develop proposed policies and laws for safeguarding personal genomic information stored in "genetic data banks":
1.In what ways are genomic and medical information similar and different?
2.Under what circumstances should private entities or public agencies be permitted legally to obtain DNA samples from individuals?
3.When is consent required for the storage of DNA samples and genomic data? Is informed consent possible for such storage when the material might someday reveal personal health-related information about individuals and their genetic relatives?
To answer these questions, we will review the legal literature, case law, and statutes on privacy with an emphasis on issues specifically related to highly personal information stored in computers. We will identify policies and laws that are most analogous to genetic data-banking concerns and adapt them to special privacy issues raised by the use and storage of genetic data. The product will be a monograph on genetic privacy, including proposed guidelines (with explanations and justifications) that could be adopted as laws or regulations governing the collection, storage, and use of genomic information and DNA samples. The guidelines will be presented at national meetings and submitted for publication in the medical and legal literature.
The goal of this project is to develop and conduct workshops for instructing high school science teachers in the latest developments in human genetic research and its ethical and social implications. The workshops are designed to help teachers incorporate this information into their everyday classroom curriculum.
Two 5-day continuing-education workshops will be conducted for 25 participants at the Human Genome Center. Educators will be trained in the pedagogy of molecular genetics and in methods for bringing the latest in biotechnology and its implications to the attention of their students. The workshops will be open to teachers throughout the Great Lakes states, in cooperation with the education subcommittee of the Great Lakes Regional Genetics Group. These workshops will not only introduce teachers to biotechnology but will also promote partnerships among education specialists, clinical geneticists, research scientists, and teachers.
This project has the goal of planning over a 9-month period how to create inexpensively and efficiently a resource of information and analysis under the aegis of the Human Genome Organization (HUGO) Ethics Committee. This resource will consist of a data bank and an annually published compilation, the HUGO International Yearbook: Genetics, Ethics, Law, and Society (GELS). The yearbook will enable people around the world in science, medicine, government, law, and ethics to stay abreast of pertinent statutes, regulations, guidelines, and analysis produced in other nations and by international organizations. Keeping track of developments is difficult because work on ethical, legal, and social implications (ELSI) of human genome research is not only international but also interprofessional and interdisciplinary.
Besides a compilation of documents presented in an organized fashion, the yearbook will contain original material analyzing ELSI information by topic and describing national, regional, and international trends. Thus, persons or groups interested in comparative information on topics of concern to genome research efforts--such as accessibility and confidentiality of genetic information, policies on patenting gene sequences, and implications for employment and insurance--will have a ready source of governmental policies and rulings to allow informed
appraisal of such policies in light of developments in other fields and other countries. Presentation of this material should also enrich thinking in the field by facilitating the discovery of connections (in principles, objectives, and practical methods) among ELSI topics that are not always analyzed together.
The yearbook will be planned by a 12-person committee consisting of internationally representative ELSI experts and specialists in bibliographic and documentation methodologies. The committee will include representatives from Europe and North America and at least one person with firsthand knowl- edge about developments in Central and South America, Asia and India, Australia and Oceania, and Africa. The project is supported by DOE and the Canadian Genome and Technology Program.
The Exploratorium is continuing a long-term commitment to increase public awareness of the Human Genome Project, the basic science of genetics, and the implications for society. The comprehensive multiyear program has produced five interactive exhibits on DNA and the highly successful September 1992 genetics and biotechnology symposium entitled Winding Your Way Through DNA, which was cohosted with the University of California, San Francisco. Other components of the plan include a DNA extraction demonstration, 13 new interactive exhibits about genetics, and the Genetics Pathway for teachers and students to address the basic science of genetics. A lecture series focusing specifically on ethical, legal, and social issues will serve as both a public forum and a means of creating video records for a freestanding exhibit about ethical considerations. These exhibits, demonstrations, and programmatic activities will involve collaborations with regional biotechnology firms, universities, and museums.
Important concepts addressed by exhibits and programs are DNA as the molecule of heredity; mutation; variation; and the relationship between genes and proteins. Focus is on the Human Genome Project as an example of how basic research can result in practical applications and raise important social and ethical questions. This effort will produce a major museum section on the Human Genome Project and genetics that will serve as a model for other museums nationwide. It will be viewed by more than 625,000 visitors annually and used by more than 500 teachers attending training programs.
The Biological Sciences Curriculum Study (BSCS) will produce and distribute free of charge to all 50,000 U.S. high school biology teachers an instructional module and software titled The Human Genome Project: Information Management, Access, and Regulation. BSCS will use the process of curriculum development that it has refined in the 35 years since the organization's inception. The module will provide about 25 pages of background information for teachers on information technology as it relates to the Human Genome Project and on ethical, legal, and social issues related to genomic databases. Five days of classroom instruction will involve students directly in manipulation of hypothetical mapping and sequence databases; online searches of the Genome Data Base; and classroom analyses of the ethical, legal, and social issues.
An eight-person advisory committee will oversee the 22-month project. This committee will have expertise in clinical genetics, molecular biology, genome databases, classroom teaching, ethics, and law. The education committees of the American Society of Human Genetics, National Society of Genetic Counselors, and Council of Regional Networks for Genetic Services will review the project materials at two critical junctures, at no cost to the project.
As we approach the end of the twentieth century, the pace of scientific discovery and technological innovation is so rapid that society confronts an almost continuous stream of difficult new philosophical questions regarding the social consequences of its own inventiveness. These questions are particularly acute in research into molecular genetics and new therapeutic possibilities for treating genetic-based disorders. Critics and proponents have expressed concern about the nature and direction of this new research, social implications of new genetic technologies, and potential disruptions to traditional definitions of our own humanity. Conflicting arguments and perspectives involving an array of emotionally charged individual issues make it all the more difficult to grasp how traditional philosophy will change as a result of these scientific advances.
Rigorous new scholarship must be generated to examine philosophical issues surrounding uses and potential misuses of molecular genetics research. Rethinking philosophical paradigms in approaching these difficult questions will greatly benefit practicing scientists, end users of these new technologies, policymakers who must regulate them (often with too little information), and society as a whole.
Given that the Human Genome Project has mandated a portion of its funding for examining the ethical implications of this work, DOE and the Library of Congress (LC) are sponsoring a 1-year Senior Research Fellowship in Bioethical Issues in Molecular Genetics. The fellow's task will be to (1) conduct a critical review of existing bioethics literature on molecular genetics and (2) generate new frameworks for analyzing ethical questions and public-policy implications arising from research on the human genome. The fellow will produce both oral and written presentations of his or her work for DOE, LC, Congress, the greater scientific community, and the general public.
The research objectives of this project are to focus on issues of genetic privacy in critically analyzing selected aspects of DNA banking and DNA data banking. Such banking presently takes place in four sectors: (1) DNA banking by the military to assist in identifying human remains; (2) state-based DNA forensic data banking to assist in resolving violent crimes, identifying missing persons, and analyzing crime patterns; (3) academically based repositories housed in the laboratories of scientists who are studying particular genetic disorders; and (4) commercially based repositories that offer DNA banking services to researchers and individuals. The primary goals of our research are to learn how informational privacy and related issues are handled, especially in computer security; analyze current approaches; and suggest guidelines for the future.
Although we will study all four sectors, our primary focus will be on academically and commercially based DNA data banking, which we believe carry the broadest potential for harm to the privacy interests of individuals. These banks remain essentially unregulated, unlike the military, which has implemented strict rules limiting access to stored DNA information (Weedn, 1992, 1991). Similarly, state forensic laboratories operate under statutory mandates that typically include generalized directives on the need for confidentiality (Armed Forces Institute of Pathology/American Registry of Pathology, course materials).
The objectives of this project are to completely update social science theoretical and empirical work on privacy, confidentiality, and individual rights of access to personal records since the publication of Westin's Privacy and Freedom in 1967; to refine the concepts and operative dynamics first formulated by Westin in light of research and social developments since 1967; and to relate this updated research and reconceptualization to privacy, confidentiality, and access issues likely to arise from the use of genetic data generated by the Human Genome Project, including the uses of genetic information in computerized data banks.
This research will also examine the development, implementation, and effectiveness of legal and organizational privacy-protection measures in the United States since the late 1980s; current debates about updating such measures to reflect scientific, technological, social, and cultural
changes in the early 1990s; and implications for selection of social, organizational, and legal policies to deal with genetic testing and the application of genetic data in the late 1990s and early 21st century.
In addition to an overall project monograph and five to seven topical area reports in hard copy, the project will produce a set of computerized resources on disk, CD-Rom, or online. These resources will include the monograph and area reports, an annotated master bibliography, a master classification system for privacy issues relating to genetic information uses, a directory of scholars working on privacy aspects of genetic data applications, and a set of selected and classified abstracts of major social science works dealing with privacy aspects of genetic data uses.
A comprehensive bibliographic database and collection of publications related to the ethical, legal, and social implications (ELSI) of the Human Genome Project have been developed at the General Law Library of Los Alamos National Laboratory (LANL). Over 5600 books and articles have been catalogued, and copies of most of these materials have been obtained for the library collection.
Yesley and his staff have also prepared a second printed edition of ELSI Bibliography: Ethical Legal and Social Implications of the Human Genome Project, extracted from the computer database. This edition has been distributed to several thousand interested individuals and medical libraries. It provides a current and comprehensive resource for identifying publications on 17 major topics, e.g., counseling, discrimination, eugenics, DNA fingerprinting, patents, privacy, reproduction, screening, and therapy. This is not a complete inventory of the topics (keywords) that can be searched in the underlying computer database. Yesley will provide custom searches of the database to researchers interested in other topics. Also, the database may be made accessible online, enabling researchers to perform their own searches.
The ELSI bibliography is drawn from the computer database, which can be searched and sorted on a variety of parameters and combinations of parameters. For example, a search can be limited to any topic or name, sorted chronologically or alphabetically by author, or limited to certain periods or publications. The results of custom searches can be sent by e-mail, fax, or U.S. mail to the requestors. Researchers are also invited to use the extensive collection of ELSI books and articles at the LANL General Law Library.
The George Washington University Center for Health Policy Research is conducting a 12-month research and education project in genetic science to assist federal and state courts in adjudicating lawsuits involving genetic testing and gene therapy. The project's goal is to produce a desk book to assist judges' management of such information under the rubric "novel scientific evidence." To aid in desk book production, a midproject workshop will brief judges and other court-affiliated personnel about basic science and research horizons related to the Human Genome Project and will produce two documents. The National Conference of Metropolitan Courts; National Association of Court Managers; State Justice Institute; National Institute of Justice, SEARCH, Inc.; Federal Bureau of Investigation; and Association of Academic Health Centers will collaborate in the project.
"The Secret of Life"
Predicting Future Disease: Issues in the Development, Application, and Use of Tests for Genetic Disorders
Human Genetics Education for Middle and Secondary Science Teachers
Pathways to Genetic Screening: Patient Knowledge--Patient Practices
Studies of Genetic Discrimination
"Medicine at the Crossroads"
Impact of Technology Derived from the Human Genome Project on Genetic Testing, Screening, and Counseling: Cultural, Ethical, and Legal Issues
Genome Technology and Its Implications: A Hands-On Workshop for Educators
Diane Baker and Paula Gregory(1)
Human Genome Center; University of Michigan; Ann Arbor, MI 48109-0674
313/747-2738, Fax: /764-4133
(1)National Center for Human Genome Research; Bethesda, MDHUGO International Yearbook: Genetics, Ethics, Law, and Society (GELS)
Alex Capron and Bartha Knoppers(1)
Pacific Center for Health Policy and Ethics; University of Southern California; Los Angeles, CA 90089-0071
213/740-2557, Fax: -5502, Internet: acapron@law.usc.edu
(1)Faculty of Law; University of Montreal; Quebec, Canada H3C 3JFThe Human Genome: Science and the Social Consequences; Interactive Exhibits and Programs on Genetics and the Human Genome
Charles C. Carlson
The Exploratorium; San Francisco, CA 94123
415/563-7337, Fax: /561-0307, Internet: charliec@exploratorium.eduThe Human Genome Project: Information Management, Access, and Regulation--Educational Materials for High School Biology
Joseph D. McInerney and Lynda Micikas
Biological Sciences Curriculum Study; Colorado College; Colorado Springs, CO 80903
719/578-1136, Fax -9126, Internet: jmcinerney@cc.colorado.eduPilot Senior Research Fellowship Program: Bioethical Issues in Molecular Genetics
Declan Murphy and Claudette Cyr Friedman
Library of Congress; Washington, DC 20540
Friedman: 202/707-1513, Fax: -1714DNA Banking and DNA Data Banking: Legal, Ethical, and Public Policy Issues
Philip R. Reilly
Shriver Center; Waltham, MA 02254
617/642-0230, Fax: /893-5340
Social Science Concepts and Studies of Privacy: A Comprehensive Inventory and Analysis for Considering Privacy, Confidentiality, and Access Issues in the Use of Genetic Tests and Applications of Genetic Data
Alan F. Westin
Center for Social and Legal Research; Hackensack, NJ 07601
201/996-1154, Fax: -1883, America Online: alanrp@aø1.comResources on the Ethical, Legal, and Social Implications of the Human Genome Project
Michael S. Yesley
Los Alamos National Laboratory; Los Alamos, NM 87545
505/667-3766, Fax: /665-4424, Internet: msy@lanl.govAdjudicating Genetic Testing and Gene Therapy Litigation: Factors Influencing the Privacy Law and Bioethics Attitudes and Opinions of Trial and Appellate Judges Managing Lawsuits Related to Scientific and Technological Advances Emanating from the Human Genome Project
Franklin M. Zweig
Center for Health Policy Research; George Washington University; Washington, DC 20052
202/296-6922, Fax: -0025 or /785-01141993 Conferences
Maximizing the Return From Genome Research: A Conference Concerning the Effect of Patent Scope on Commercial Incentives
May 20-23, 1993, at Concord, New Hampshire
Thomas G. Field; Franklin Pierce Law Center; University of New Hampshire; Concord, NH; 603/228-1541, Fax: /224-3342
Teaching Ethics in the Biomedical and Biological Sciences: A Workshop for Research Faculty
June 12-16, 1993, at Bar Harbor, Maine
Ed Golub; Pacific Center for Ethics and Applied Biology; San Diego, CA;
619/625-0734, Fax: /793-3632Between Design and Choice: The Social Shaping of Genetic and Reproductive Technologies
April 2-4, 1993, at Ithaca, New York
Sheila Jasanoff; Cornell University; Ithaca, NY;
607/255-6049, Fax: -6044Projects Continuing into FY 1993
Paula Apsell and Graham Chedd
WGBH Educational Foundation; Boston, MA 02134
Chedd: 617/492-2777 Ext 4352, Fax: /787-5781
Ruth E. Bulger and Jane E. Fullarton
National Academy of Sciences; Institute of Medicine; Washington, DC 20418
Fullarton: 202/334-3913, Fax: -2031
Debra L. Collins, R. Neil Schimke, and Linda Segebrecht(1)
Department of Medical Genetics; University of Kansas Medical Center; Kansas City, KS 66160-7318
913/588-6043, Fax: -3995, Internet: ukanvm.cc.ukans.edu
(1)Science Pioneers; Kansas City, MO 64110
Troy Duster and Diane Beeson(1)
Institute for the Study of Social Change; University of California; Berkeley, CA 94720
510/642-0813, Fax: -8674
(1)Department of Sociology; California State University; Hayward, CA 94542
Marvin Natowicz
Division of Medical Genetics; Shriver Center; Waltham, MA 02254
617/642-0176, Fax: /894-9968
George Page and Stefan Moore
WNET/Thirteen; New York, NY 10019
212/560-2767, Fax: /582-3297
Ralph W. Trottier, Lee A. Crandall,(1) David Phoenix,(2) Mwalimu Imara,(2) and Ray E. Moseley(1)
Department of Pharmacology and Toxicology and (2)Department of Community Health and Preventive Medicine; Morehouse School of Medicine; Atlanta, GA 30310
404/752-1711, Fax: /755-7318
(1)Department of Community Health and Family Medicine; University of Florida; Gainesville, FL 32610