POLS 632 – Biotechnology and Political Structures
Andrea Bonnicksen, Zulauf Hall 401, 753-7059, email@example.com
Office hours: T ; T ; W ; and by arrangement
Knowledge gained from the human genome project is likely to expand considerably in the 21st century in ways that affect daily life. Among other things, genetic studies will allow physicians to target drug therapies to the genotypes of individual patients; genetic testing will enable individuals to learn about their predispositions to a growing array of diseases and conditions; and DNA data banks will present new uses for criminal prosecutions. Although genetic information holds promise, it has also generated spirited debate about its ethical and policy dimensions. This seminar will focus on selected ethical and policy issues raised by medical genetics. The aims of the seminar are to build expertise of medical genetics as a policy area; look critically at how, if at all, genetic information is different from other medical information for policy purposes; and examine to what extent genetic advances warrant new oversight and legislation. Members of the seminar will have the opportunity to explore particular areas of interest by writing a paper related to genetics and public policy. By the end of the semester you should be adept at recognizing key policy areas associated with genetic research and application, be aware of and be able to argue ethical positions related to genetic applications, and identify policy patterns that reflect various models of the policy process. A background in genetics or the biological sciences is not required for this course.
S. Collins. The Language of Life: DNA and
the Revolution in Personalized Medicine.
Matt Ridley, Nature Via Nurture: Genes, Experience, and What Makes Us Human. New
The readings below (except Collins and Ridley) are available on electronic reserves. You can get access to them by going to POLS 632 in NIU Blackboard and clicking on the eReserves link on the left side. Note that some of the websites are for your browsing and are not required reading.
AUGUST 26 INTRODUCTION
Public participation in genetic policy
Bruce Jennings, “Genetic Literacy and Citizenship: Possibilities for Deliberative
Democratic Policymaking in Science and Medicine.” The Good Society 13(1):38-
R. Halsted and Diana B. Dutton, “A Case for Public Participation in Science Policy
Formation and Practice.”
H. Guston, “Innovation Policy: Not Just a Jumbo Shrimp.” Nature 454:940-41 (
Models of policy change
Organizational Research Services. “Pathways for Change: 6 Theories about How Policy Change Happens.” www.organizationalresearchservices/pathways_for_change_6_theories_about_how_policy_change_happens.pdf
SEPTEMBER 2, 9 GENETICS AND SOCIETY: TODAY AND YESTERDAY
Principles of genetics
Francis Collins, Introduction, Chapter 1, Chapter 2, Appendices A, B, C
Yudhijit Bhattacharjee, “Friendly Faces and Unusual Minds.” Science 310:802-4
Helpful websites to browse:
National Human Genome Research Institute (www.genome.gov)
Human Genome Project
Robert Cook-Deegan, The Gene Wars: Science, Politics, and the Human Genome. New
Browse National Human Genome Research Institute.“All About the Human Genome Project.” http://www.genome.gov/10001772
Examples of genetics in popular culture
Suzanne Anker and Dorothy Nelkin, Molecular Gaze: Art in the Genetic Age. Cold
Cule, “Birthday Surprises.” Nature 456:420 (
Historical misuse and misunderstanding of genetic ideas
Diane Paul, Controlling Human Heredity: 1865 to the Present. Humanities Press, 1995,
A. Lombardo, “Three Generations, No Imbeciles: New Light on Buck v.
Browse “Eugenics Archive” (www.eugenicsarchive.org/eugenics)
SEPTEMBER 16, 23 ISSUES IN GENETICS AND MEDICINE
Regulating and evaluating genetic tests
Francis Collins, Chapter 3, Appendix E
“ASHG Statement on
Direct-to-Consumer Genetic Testing in the
American Journal of Human Genetics 81:635-37 (September 2007).
Katsanis et al., “A Case Study of Personalized Medicine.” Science 320:53-54 (
Francis Collins, Chapter 4, Chapter 9, Appendix D
Karen Peterson-Iyer, “Pharmacogenomics, Ethics, and Public Policy.” Kennedy Institute
of Ethics Journal 18(1):35-56 (March 2008).
Race and ethnicity
Francis Collins, Chapter 5
Jennifer Couzin, “Probing the Roots of Race and Cancer.” Science 315:592-94 (February
Lundy Braun, “Race, Ethnicity, and Health.” Perspectives in Biology and Medicine 45(2):159-74 (Spring 2002).
Genetics and research
Leslie E. Wolf et al., “Genetic Research with Stored Biological Materials: Ethics and Practice.” IRB 32(2):7-18 (2010).
“Informed Consent for Genomics Research.” National Human Genome Research Institute (http://genome.gov/27026588)
SEPTEMBER 30 EMERGING AREAS OF RESEARCH
Human Microbiome Project
Francis Collins, Chapter 6
The NIH Common Fund, http://nihroadmap.nih.gov/hmp
National Human Genome Research Institute, “NIH Human Microbiome Project Researchers Publish First Genomic Collection of Human Microbes.” http://genome.gov/27539301
Genes and behavior
Francis Collins, Chapter 7
Matt Ridley pp. 1-6, 98-124.
OCTOBER 7, 14 GENETICS, THERAPY, AND ENHANCEMENT
Francis Collins, Chapter 8
Amanda Griscom, “Take these Genes and Call Me in the Morning.” http://www.wired.com/wired/archive/10.09/gvaccines_pr.html
John Harris, Enhancing Evolution.
Nelson A. Wivel and LeRoy Walters, “Germ-Line Gene Modification and Disease
Prevention: Some Medical and Ethical Perspectives.” Science 262:533-38
Germ-line genetic alterations
John Harris, Enhancing Evolution.
Jonah Lehrer, “Small, Furry . . . and
Nature 461:862-64 (
Michael J. Sandel. “The Case Against Perfection.” Atlantic Monthly 293:3 (51-62 (April 2004).
Jon W. Gordon, “Genetic Enhancement in Humans.” Science 283:2023-24 (March 26, 1999).
Mark S. Frankel and Audrey Chapman,
“Facing Inheritable Genetic Modifications.” Science 292:1303 (
Ori Lev et al., “The Ethics of Research on Enhancement Interventions.” Kennedy Institute of Ethics Journal 20(2):101-13 (2010).
G.K.D. Crozier and Christopher Hajzler, “Market Stimulus and Genomic Justice: Evaluating the Effects of Market Access to Human Germ-Line Enhancement.” Kennedy Institute of Ethics Journal 20(2):161-79 (2010).
Julie Gage Palmer and Robert Cook-Deegan, “National Policies to Oversee Inheritable
Genetic Modifications Research.” In Audrey R. Chapman and Mark S. Frankel, eds. Designing Our Descendants.
Preimplantation genetic diagnosis
Human Fertilisation & Embryology
Kathy L. Hudson, “Preimplantation Genetic Diagnosis: Public Policy and Public
Attitudes. Fertility and Sterility 85(6):1638-45 (June 2006).
OCTOBER 21, 28 BUILDING SYNTHETIC GENOMES
Discussion of ethics
Parens et al., “Ethical Issues in Synthetic Biology.”
Gregory E. Kaebnick, “Should Moral Objections to Synthetic Biology Affect Public Policy”? Nature Biotechnology 27(12):1106-8 (December 2009).
Discussion of policy and regulation
Rodemeyer, “New Life, Old Bottles: First-Generation Products of Synthetic
Presidential Commission for the Study of
Bioethical Issues. Selected transcripts
of hearings on synthetic biology,
NOVEMBER 4 FORENSICS AND DNA DATA BANKS
Watson, DNA: Secret of Life.
National Conference of State Legislatures. “State Laws on DNA Data Banks.” www.ncsl.org/IssuesResearch/CivilandCriminalJustice/StateLawsonDNADataBanks
B. Steinhardt, “Privacy and Forensic DNA Data Banks.” In D. Lazer, ed., DNA and the Criminal Justice System: The Technology of Justice. MIT Press, 2004, pp. 173-96.
Sheila Jasanoff, “DNA’s Identity Crisis.” In David Lazer, ed., DNA and the Criminal
Justice System: The Technology of Justice. MIT Press, 2004, pp. 337-55.
NOVEMBER 11, 18 PRIVACY AND DISCRIMINATION ISSUES
Is genetic information exceptional?
J. Annas, “Genetic Privacy: There Ought to be a Law.”
Politics 4(1):9-15 (1999).
A. Rothstein, “Why Treating Genetic Information Separately is a Bad Idea.”
Review of Law & Politics 4(1):33-37 (1999).
Mark A. Rothstein, “Genetic
Exceptionalism and Legislative Pragmatism.”
Center Report 35(4):27-33 (2005).
Douglas H. Ginsburg, “Genetics and
Matt Ridley, pp. 7-37, 38-68, 69-97, 151-76, 249-75.
Genetic Information Nondiscrimination Act
Kathy L. Hudson, et al., “Keeping Pace with the Times – The Genetic Information
Nondiscrimination Act of 2008.”
Korobkin and Rahul Rajkumar, “The Genetic Information Nondiscrimination Act: A
Half-Step toward Risk Sharing.”
National Human Genome Research Institute “Policy and Legislation Data Base.”
NOVEMBER 18, DECEMBER 2 PAPERS PRESENTED
Selected websites to browse
National Human Genome Research Institute (www.genome.gov)
National Human Genome Research Institute. “About ELSI.” www.genome.gov/10001754
Genetics and Public Policy Center (www.DNApolicy.org)
Office of Biotechnology Activities (Office of Science Policy, National Institutes of Health) (http://oba.od.nih.gov/oba/index.html)
Grades will be based upon a seminar paper, midterm exam, final exam, and participation.
The midterm take-home exam is due October 14 and the final take-home exam is due at December 2. Late papers and exams will be penalized l/2 grade per day late. A total of 240 points is possible:
ITEM POINTS DATE DUE
Paper proposal -- October 7
Midterm exam 60 points October 14
Final exam 60 points December 2
Paper 100 points November 18
Participation 20 points
A = 216 - 240; B = 192 – 215; C = 168 – 191; D = 144 – 167
The research paper is an opportunity to develop your expertise in a particular area of genetics and public policy. Many of the readings in this syllabus give ideas about topics to be explored. An additional way to gather ideas is to look through websites or recent issues of scholarly journals, including Hastings Center Report; New England Journal of Medicine; Journal of Law, Medicine & Ethics; Journal of Health Politics, Policy and Law; and American Journal of Bioethics. When deciding on your topic, select an intriguing but manageable research question about which you are genuinely quizzical. Pose the question in such a way that your conclusions could go either way, depending on the findings from your research.
Here are sample general topic areas:
Regulation of direct-to-consumer gene tests
Backlog of DNA samples in criminal data banks
Oversight of pharmacogenomic clinical trials
Federal policy and the Human Microbiome Project
Role of the Recombinant DNA Advisory Committee in science policy
Regulation of synthetic biology
Variation in newborn genetic screening laws across states
You may want to look at the policy process (e.g., getting an issue on the public agenda) or the political process (e.g., the politics of the Genetic Information Nondiscrimination Act). Or, you could conduct an analysis of the ethics of an emerging application of biotechnology. It might help to look at books that describe different models for studying public policy, such as:
Kingdon, Agendas, Alternatives, and
Company 1984 (a second edition is also available).
Paul A. Sabatier, Theories of the Policy Process. Westview Press, 2007.
The paper should be 15-20 double-spaced, typed pages. You should have a clear theme that can be stated in 1-2 sentences. I will be glad to read a draft version of the paper and make suggestions. In the papers, strive for cautious conclusions reached on the basis of thoughtful evidence, careful documentation, and the raising and addressing of counter-arguments. Minimize unsubstantiated opinion. Oral presentations will be scheduled for November 18 and December 2, but all written papers are due in HARD COPY on November 18. Each person should limit prepared comments to 15-20 minutes, and we will have 10-15 minutes for questions and answers (a total of 30 minutes for each presenter). Please make separate notes for the presentation (do not read from the paper). You are advised to practice before hand to make sure your presentation fits within the 15-20 minutes.
Paper proposals are important road maps for your research. Please work on it carefully; a well-formulated proposal will make the research and writing easier. Proposals often have the following problems: too general, no clear research question, conclusions already reached, sources not found or read, sources inadequately cited, signs of having been written with great haste. To avoid these problems, please write a proposal of approximately 2 pages that includes the following:
The exams will be distributed one week before their due dates. It is expected that you will integrate (with APA-style citation) at least 3 different class readings into each essay. To prepare, you are encouraged to take notes on the readings. Exams must be submitted in HARD COPY.
Participation will be based on attendance (with special attention to the days the papers are presented) and a demonstration that you have read the material. In addition, 2-4 individuals will present articles or chapters from the readings each week. This invites broad discussion and it gives experience in synthesizing and articulating observations orally. Each presentation should be 10 minutes or less and we will then discuss the material. When you present, assume we have all read the material so you do not need to go into great detail summarizing the content. Instead, pose analytical questions and comments. What is the author’s purpose? What were his/her conclusions? What are the implications of the article/book/chapter for genetics and public policy? What are substantive contributions to everyday knowledge? What are theoretical contributions? What counterarguments would you make to the authors?
All exams and papers must be uploaded to Safe Assign (found on Blackboard). According to the NIU undergraduate catalogue, a student is considered to have committed plagiarism if, among other things, they “copy material from books, magazine, or other sources or if they paraphrase ideas from such sources without acknowledging them. Students guilty of, or assisting others in, either cheating or plagiarism on an assignment, quiz, or examination may receive a grade of F for the course involved and may be suspended or dismissed from the university.” Here is a useful link: http://lrs.tvu.ac.uk/find/Plagiarism_tutorial/index.html