POLS
632 – Biotechnology and Political Structures
Fall
2010
Andrea
Bonnicksen, Zulauf Hall 401, 753-7059, albcorn@niu.edu
Office
hours: T
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.
REQUIRED
Francis
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-
44 (2004).
R.
Halsted and Diana B. Dutton, “A Case for Public Participation in Science Policy
Formation and Practice.”
David
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
Erika
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,
pp.
1-21.
Paul
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).
S.H.
Katsanis et al., “A Case Study of Personalized Medicine.” Science 320:53-54 (
Personalized
medicine
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
2, 2007).
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
Gene
therapy
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
Smart.”
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
Erik
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
Michael
Rodemeyer, “New Life, Old Bottles: First-Generation Products of Synthetic
Biology.”
Presidential Commission for the Study of
Bioethical Issues. Selected transcripts
of hearings on synthetic biology,
NOVEMBER
4 FORENSICS AND DNA
DATA BANKS
J.
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.
www.ornl.gov/sci/techresources/Human_Genome/elsi/forensics.shtml
NOVEMBER
11, 18 PRIVACY AND
DISCRIMINATION ISSUES
Is
genetic information exceptional?
George
J. Annas, “Genetic Privacy: There Ought to be a Law.”
Politics
4(1):9-15 (1999).
Mark
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
Privacy.”
23 (1999).
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.”
Russell
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.”
(http://www.genome.gov/PolicyEthics/LegDatabase/pubsearch.cfm)
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)
Genetic
GRADES
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
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
SEMINAR
PAPERS
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:
John W.
Kingdon, Agendas, Alternatives, and
Public Policies.
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
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:
EXAMS
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
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?
SAFE
ASSIGN
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