POLS 632 – Biotechnology and Political Structures

Fall 2010

Andrea Bonnicksen, Zulauf Hall 401, 753-7059, albcorn@niu.edu

Office hours:  T 1:00 - 1:50; T 3:30 – 4:30; W 1:15 – 2:15; 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.

 

REQUIRED READINGS

Francis S. Collins. The Language of Life: DNA and the Revolution in Personalized Medicine. New York: HarperCollinsPublishers, 2010.

 

Matt Ridley, Nature Via Nurture: Genes, Experience, and What Makes Us Human. New

York: HarperCollins Publishers, 2003.

 

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.” Southern California Law Review 51:1505-34 (1978).

 

David H. Guston, “Innovation Policy: Not Just a Jumbo Shrimp.” Nature 454:940-41 (August 21, 2008).

 

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

(November 4, 2005).

 

Helpful websites to browse:

National Human Genome Research Institute (www.genome.gov)

            University of Utah. http://gslc.genetics.utah.edu/units/basics/tour/

 

Human Genome Project

Robert Cook-Deegan, The Gene Wars: Science, Politics, and the Human Genome. New

York: W.W. Norton and Co., 1994, pp. 13-47

 

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

Spring Harbor Laboratory Press, 2004, pp. 1-7.

 

Erika Cule, “Birthday Surprises.” Nature 456:420 (November 20, 2008) (fiction).

 

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. Bell.” New York University Law Review 60:30-62 (1985).

 

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 United States.”

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 (April 4, 2008).

 

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. Princeton University, 2007,  pp. 59-71

 

Nelson A. Wivel and LeRoy Walters, “Germ-Line Gene Modification and Disease

Prevention: Some Medical and Ethical Perspectives.” Science 262:533-38

(October 22, 1993).

 

Germ-line genetic alterations

John Harris, Enhancing Evolution. Princeton University, 2007,  pp. 1-7, 72-85

 

Jonah Lehrer, “Small, Furry . . . and Smart.” Nature 461:862-64 (October 15, 2009).

 

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 (May 18, 2001).

 

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. Baltimore: JHU Press, 2003, pp. 275-95.

 

Preimplantation genetic diagnosis

Human Fertilisation & Embryology Authority, United Kingdom. “Choices and Boundaries.”

 

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.” Woodrow Wilson International Center for Scholars. June 2009.

 

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.” Woodrow Wilson International Center for Scholars. March 2009.

 

Presidential Commission for the Study of Bioethical Issues. Selected transcripts of hearings on synthetic biology, July 8-9, 2010. www.bioethics.gov [Readings TBA]

 

NOVEMBER 4                     FORENSICS AND DNA DATA BANKS                        

           

J. Watson, DNA: Secret of Life. New York: Alfred A. Knopf, 2006, pp. 261-91.

 

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.

 

U.S. Department of Energy Genome Projects, “DNA Forensics.” Browse

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.” Texas Review of Law &

Politics 4(1):9-15 (1999).

 

Mark A. Rothstein, “Why Treating Genetic Information Separately is a Bad Idea.” Texas

Review of Law & Politics 4(1):33-37 (1999).

 

Mark A. Rothstein, “Genetic Exceptionalism and Legislative Pragmatism.” Hastings

Center Report 35(4):27-33 (2005).

 

Douglas H. Ginsburg, “Genetics and Privacy.” Texas Review of Law & Politics 4(1):17-

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.” New England Journal of Medicine 358(25):2661-63 (June 19, 2008).

 

Russell Korobkin and Rahul Rajkumar, “The Genetic Information Nondiscrimination Act: A Half-Step toward Risk Sharing.” New England Journal of Medicine 359(4):335-7 (July 14, 2008).

 

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 Science Learning Center, Univ. of Utah. http://gslc.genetics.utah.edu/units/basics/tour/

 

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 6:30 p.m. 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

 

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. Boston: Little Brown 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

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:

 

  1. Title and 3-4 paragraph summary that addresses these questions: what is your research question, why is it important, how will you examine it, and what is your working hypothesis (what you expect to find)? The research question should be narrow enough to be manageable.
  2. A list of 6-8 scholarly sources that you have already found. These sources should include primary as well as secondary sources and at least some articles from referred scholarly journals. For policy papers, primary documents include bills, public laws, executive orders, and administrative regulations. They can be found, among other places, at www.access.gpo.gov and http://thomas.loc.gov
  3. These sources should be carefully cited. If you take something from the internet, include a detailed enough citation (author, title, URL) so your reader can find it easily.
  4. An outline

 

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