Political Science 531—Seminar in Biomedical Policy
Andrea Bonnicksen (Zulauf 401; 753-7059; email@example.com)
In this seminar we will examine ethical and policy issues relating to six areas of biomedicine: assisted reproductive technologies, embryonic stem cells, somatic cell nuclear transfer, medical research, organ procurement, and end-of-life decision making. The readings are aimed first broadly to introduce each topic and then to examine challenges posed by the efforts to develop policy. Policy is defined broadly to include both private and public decision makers representing multiple disciplines, including science, law, medicine, and philosophy. The goals of the seminar are for members to (l) develop an understanding of issues raised by changing medical technologies , (2) identify recurring themes in these issues, (3) recognize and evaluate the incremental nature of policy, (4) understand the interplay between private and public policy and between bioethics and biopolicy, (5) become aware of career opportunities related to this field, and (6) develop policy skills through work with primary documents.
Readings for the seminar are on 2-hour library reserve in Founders’ Library. They are organized by topic and are unbound for easier photocopying. Additional material from the internet will occasionally be recommended.
Roger B. Dworkin, Limits: The Role of the Law in Bioethical Decision Making.
Bloomington: Indiana University Press, 1-18, 164-171 (1996).
Thomas A. Birkland, An Introduction to the Policy Process: Theories, Concepts, and
Models of Public Policy Making. Armonk NY: M.E. Sharpe, 2001, pp. 19-23, 38-
43, 194-229 (excerpts).
Amy Gutmann and Dennis Thompson, “Deliberating About Bioethics.” Hastings Center
Report 27:38-41 (May/June 1997).
Daniel Callahan, “Bioethics.” Encyclopedia of Bioethics 1:247-255 (1995).
Peter Shorett, Paul Rabinow, and Paul Billings, “The Changing Norms of the Life
Sciences.” Nature Biotechnology 21:123-125 (February 2003).
SEPTEMBER 2, 9 ASSISTED REPRODUCTIVE TECHNOLOGIES
John A. Robertson, “Embryos, Families, and Procreative Liberty: The Legal Structure of
the New Reproduction,” Southern California Law Review 59:939-957, 1039-41
Washington: Georgetown University Press, 1998, pp. 369-374.
Technology.” In DeJonge and Barratt, eds., pp. 320-325.
Susan M. Avery and Peter R. Brinsden, “Cryopreservation of Gametes and Embryos:
Legal and Ethical Aspects.” In DeJonge and Barratt, eds., pp. 407-414.
Lori B. Andrews, “The Sperminator,” New York Times Magazine, March 28, 1999.
Arnold M. Belker, et al., “Live Birth After Sperm Retrieval from a Moribund Man,”
Fertility and Sterility 76:841-843 (October 2001).
Rebecca Dresser, “Protecting Posthumous Children,” Hastings Center Report 32:8-9
National Institutes of Health, “Pluripotent Stem Cells: A Primer,” pp. 1-8.
Gene Outka, “The Ethics of Human Stem Cell Research.” Kennedy Institute of Ethics
Journal 12:175-182 (June 2002) (excerpt).
John A. Robertson, “Ethics and Policy in Embryonic Stem Cell Research.” Kennedy
Institute of Ethics Journal 9:109-136 (June 1999).
Richard M. Doerflinger, “The Ethics of Funding Embryonic Stem Cell Research: A
Catholic Viewpoint.” Kennedy Institute of Ethics Journal 9:137-150 (June 1999).
National Bioethics Advisory Commission, “Ethical Issues in Human Stem Cell Research:
Executive Summary.” Rockville MD, 1999, pp. 1-11.
Noelle Lenoir, “Europe Confronts the Embryonic Stem Cell Research Challenge.”
Science 287:1425-1427 (February 25, 2000).
Browse nih.gov (click “stem cell information”)
Gretchen Vogel, “Bush Squeezes Between the Lines on Stem Cells.” Science 293:1242-
45 (August 27, 2001).
United States Conference of Catholic Bishops, “President Bush’s Stem Cell Decision.”
Constance Holden and Gretchen Vogel, “’Show Us the Cells,’ U.S. Researchers Say.”
Science 297:923-925 (August 9, 2002).
Donald Kennedy, “Stem Cells: Still Here, Still Waiting.” Science 300:865 (May 9, 2003).
Gretchen Vogel, “Stem Cells Lose Market Luster.” Science 299:1830-31 (March 21,
Elias Zerhouni, “Stem Cell Programs.” Science 300:911-912 (May 9, 2003).
“Disease Insights From Stem Cells,” Nature 422:787 (April 24, 2003).
Office of Nancy Reagan. Letter to Orrin Hatch, January 29, 2003.
“Do No Harm Position Statement on Human Cloning.”
H.R. 534; S. 303
Margaret R. McLean, “Red Light, Green Light: The California Cloning and Stem Cell
Laws,” Hastings Center Report 32:7 (November-December 2002).
SEPTEMBER 30 PAPER PROPOSALS DUE
Ian Wilmut, et al., The Second Creation. New York: Farrar, Straus and Giroux 2000, pp.
National Bioethics Advisory Commission. Cloning Human Beings. Executive Summary.
President’s Council on Bioethics, “Human Cloning and Human Dignity: Executive
Summary, 2002” www.bioethics.gov/reports/cloningreprot/execsummary.html
Daniel Callahan, “Cloning, Then and Now” in Arlene Judith Klotzko, The Cloning
Sourcebook. New York: Oxford University Press, 2001, pp.104-108
Lori Andrews, “Mom, Dad, Clone.” In Klotzko, pp. 245-262.
Raanan Gillon, “Human Reproductive Cloning.” In Klotzko, pp. 184-202
Lee Silver, “Thinking Twice, or Thrice, about Cloning.” In Klotzko, pp. 61-69
Yitzchok Breitowitz, “What’s So Bad About Human Cloning?”
Kennedy Institute of Ethics Journal 12:325-341 (December 2002).
Martha C. Nussbaum, “Little C.” In Martha C. Nussbaum and Cass R. Sunstein, eds.,
Clones and Clones. New York: W.W. Norton & Company, 1998, pp. 338-346.
David Magnus, “Cloning and the Regulative Dilemma,” In Klotzko, pp. 237-44
Mary Warnock, “The Regulation of Biotechnology.” In Klotzko, pp. 233-36
Stephen S. Hall, “Eve Redux: The Public Confusion over Cloning.” Hastings Center
Report 33:11-15 (May/June 2003).
George J. Annas, “Cloning and the U.S. Congress,” NEJM 346:1599-1602.
Constance Holden, “Hatch Signs on to Pro-Research Bill,” Science 296:997 (May 10,
Rebecca Dresser, “Human Cloning and the FDA.” Hastings Center Report 33:7-8
National Conference of State Legislatures, “State Human Cloning Laws: Updated
OCTOBER 7 MIDTERM TAKE-HOME EXAMS DISTRIBUTED
OCTOBER 14 MIDTERM TAKE-HOME EXAMS DUE
OCTOBER 7, 14 PROTECTION OF SUBJECTS IN MEDICAL RESEARCH
David J. Rothman, “Research, Human: Historical Aspects.” Encyclopedia of Bioethics
4:2251-56 (1995) (excerpts).
Charles R. McCarthy, “Research Policy: General Guidelines.” Encyclopedia of Bioethics
4:2285-2289 (1995) (excerpts).
“Federal Regulations Regarding the Protection of Human Subjects of Research,” in
Jonsen et al., pp. 62-75.
“What is a Clinical Trial?” www.clinicaltrials.gov
NIU Office of Research Compliance, p. 1.
45 CFR 46 updated = http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
Institute of Medicine, “Responsible Research: A Systems Approach to Protecting
Research Participants,” pp. 1-8. www.nap.edu
Tom L. Beauchamp, “IOM Report on the System for Protecting Human Research
Participants,” Kennedy Institute of Ethics Journal 12:389-90 (December 2002).
Franklin G. Miller and Donald L. Rosenstein, “The Therapeutic Orientation to Clinical
Trials.” NEJM 348:1383-86 (April 3, 2002).
Sharmon Sollitto, et al., “Intrinsic Conflicts of Interest in Clinical Research: A Need for
Disclosure.” Kennedy Institute of Ethics Journal 13:83-91 (June 2003).
Thomas B. Freeman, et al., “Use of Placebo Surgery in Controlled Trials of a Cellular-
Based Therapy for Parkinson’s Disease.” NEJM 341:988-991 (Sept. 23, 1999).
Ruth Macklin, “The Ethical Problems with Sham Surgery in Clinical Research.” NEJM
341:992-995 (Sept. 23, 1999).
Charles Weijer, “I Need a Placebo Like I Need a Hole in the Head,” Journal of Law,
Medicine & Ethics 30:69-72 (2002).
Sam Horg and Franklin G. Miller, “Is Placebo Surgery Unethical?” NEJM 347:137-139
(July 11, 2002).
Robert Steinbrook, “Protecting Research Subjects – The Crisis at Johns Hopkins,” NEJM
346:716-720 (February 28, 2002).
Robert Steinbrook, “Testing Medications in Children.” NEJM 347:1462-70 (October 31,
Jason H.T. Karlawish, “Research Involving Cognitively Impaired Adults,” NEJM
348:1389-92 (April 3, 2003).
Arthur L. Caplan and Pamela Sankar, “Human Subjects in Weapons Research.” Science
298:923 (November 1, 2002).
Daniel W. Fitzgerald, Angela Wasunna, and Jean William Pape, “Ten Questions
Institutional Review Boards Should Ask When Reviewing International Clinical
Research Protocols.” IRB 25:14-18 (March-April 2003)
“Fair Benefits for Research in Developing Countries.” Science 298:2133-34 (December
Greg Koski and Stuart Nightingale, “Research Involving Human Subjects in Developing
Countries.” New England Journal of Medicine 345(2):136-38 (July 12, 2001).
Harold Shapiro and Eric Meslin, “Ethical Issues in the Design and Conduct of Clinical
Trials in Developing Countries.” New England Journal of Medicine 345(2):139-
42 (July 12, 2001).
OCTOBER 21, 28 ORGAN PROCUREMENT
Jeffrey Protas, “Organ and Tissue Procurement: Medical and Organizational Aspects.”
Encyclopedia of Bioethics 4:1852-56 (1995).
Anthony J. Langone and J. Harold Helderman, “Disparity Between Solid-Organ Supply
and Demand,” NEJM 349:704-706.
Ellen Sheehy, et al., “Estimating the Number of Potential Organ Donors in the United
States,” NEJM 349:667-674.
Alexander S. Curtis, “Congress Considers Incentives for Organ Procurement.” Kennedy
Institute of Ethics Journal 13:51-52 (March 2003).
Francis L. Delmonico, et al., “Ethical Incentives – Not Payment – for Organ Donation,”
NEJM 346:2002-2005 (June 20, 2002).
Donald Joralemon and Phil Cox, “Body Values: The Case Against Compensating for
Transplant Organs.” Hastings Center Report 33:27-33 (January-February 2003).
Robert M. Veatch, “Why Liberals Should Accept Financial Incentives for Organ
Procurement.” Kennedy Institute of Ethics Journal 13:19-36 (March 2003).
Amitai Etzioni, “Organ Donation: A Communitarian Approach.” Kennedy Institute of
Ethics Journal 13:1-18 (March 2003).
Clifford Earle Bartz, “Operation Blue, ULTRA:DION—The Donation Inmate Organ
Network.” Kennedy Institute of Ethics Journal 13:37-43 (March 2003).
David C. Cronin et al., “Transplantation of Liver Grafts from Living Donors into
Adults—Too Much, Too Soon.” New England Journal of Medicine
Lainie Friedman Ross, “Solid Organ Donation Between Strangers,” Journal of Law,
Medicine & Ethics 30:440-445 (2002).
Jeffrey Kahn, “Commentary: Making the Most of Strangers’ Altruism,” Journal of Law,
Medicine & Ethics 30:446-447 (2002).
Lainie Friedman Ross, “All Donations Should Not Be Treated Equally: A Response to
Jeffrey Kahn’s Commentary,” Journal of Law, Medicine & Ethics 30:448-451
Robert Pear, “F.D.A. Delays Regulation of Tissue Transplants,” New York Times, May
5, 2003, p. A18.
Sheryl Gay Stolberg, “Could This Pig Save Your Life?” New York Times Magazine.
October 3, 1999, p. 46+.
NOVEMBER 4, 11 END OF LIFE DECISION MAKING
Ronald E. Cranford, “I. Criteria for Death.” In Encyclopedia of Bioethics 1:529-
Alexander Morgan Capron, “II. Legal Issues in Pronouncing Death.” In Encyclopedia of
Bioethics 1:534-540 (1995).
Alexander Morgan Capron, “Brain Death – Well Settled Yet Still Unresolved,” NEJM
344:1244-46 (April 19, 2001).
Alexander M. Capron, “Brain Death—Well Settled Yet Still Unresolved.” New England
Journal of Medicine 344(16):1244-46. (check)
Thomas A. Mappes, “Persistent Vegetative State, Prospective Thinking, and Advance
Directives.” Kennedy Institute of Ethics Journal 13:119-139 (June 2003).
The Support Principal Investigators, “A Controlled Trial to Improve Care for Seriously
Ill Hospitalized Patients.” JAMA 274:1591-98 (November 22/29, 1995).
Bernard Lo, “Improving Care Near the End of Life: Why Is It So Hard?” JAMA
274:1634-36 (November 22/29, 1995).
Case Study, “But Is It Assisted Suicide?” Hastings Center Report 25:24-25 (May-June
David M. Eddy, “A Conversation With My Mother.” JAMA 272:179-181 (July 20,
Timothy E. Quill, et al., “Palliative Options of Last Resort.” JAMA 278:2099-2104
(December 17, 1997).
Don Marquis, “The Weakness of the Case for Legalizing Physician-Assisted Suicide.” In
Margaret P. Battin, et al., Physician Assisted Suicide. New York: Routledge,
1998, pp. 267-278.
Margaret P. Battin, “Physician-Assisted Suicide: Safe, Legal, Rare?” In Battin et al., pp.
Leon R. Kass, “Suicide Made Easy: The Evil of ‘Rational’ Humaneness.” Commentary
20:19-24 (December 1991).
Katrina Hedberg et al., “Five Years of Legal Physician-Assisted Suicide in Oregon,”
NEJM 348:961-964 (March 6, 2003).
Ezekiel J. Emanuel, et al., “What Are the Potential Cost Savings from Legalizing
Physician-Assisted Suicide?” NEJM 339:167-172 (July 16, 1998).
Ben Rich, “Oregon v. Ashcroft: The Battle Over the Soul of Medicine,” Cambridge
Rebecca D. Pentz, et al., “Revisiting Ethical Guidelines for Research with Terminal
Wean and Brain-Dead Participants.” Hastings Center Report 33:20-26 (January-
Robert D. Truog, “Dying Patients as Research Subjects,” Hastings Center Report 33:3
Jessica Couzin, “Crossing a Frontier: Research on the Dead,” Science 299:29-30 (January
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 6:00 p.m. DECEMBER 9. Late papers and exams will be penalized l/2 grade per day late. A total of 260 points is possible:
Paper proposal September 30 10 points
Midterm exam October 14 70 points
Final exam December 9 70 points
Paper November 25 90 points
Participation 20 points
A = 234 – 260; B = 208 – 233; C = 182 – 207; D = 156 - 181
Many of the readings listed in this syllabus give ideas about topics to be explored. An additional way to gather ideas is to look through recent issues of scholarly journals, including Hastings Center Report, NEJM, JAMA, Journal of Law, Medicine & Ethics, or Journal of Health Politics, Policy and Law. Indexes to law journals are available across from the reference desk in the Law Library. Recent law review articles provide up-to-date law/policy summaries and sources for specific areas of biomedical policy, such as assisted suicide or assisted reproductive technologies.
When deciding on your topic, select a research question about which you (and others) are genuinely quizzical. Pose the question in such a way that your conclusions could go either way, depending on your research. The paper will be more manageable if it revolves around a specific policy question. Papers may, for example, evaluate an existing or a proposed policy, assess the political feasibility of a proposed policy, or trace the legislative history of an attempted policy change. Primary as well as secondary sources are to be used. Primary documents (bills, administrative decisions, laws, executive orders, etc.) are available at www.access.gpo.gov........ ... and http://thomas.loc.gov
Here are sample general topics:
Policy governing protection of human subjects in weapons research
Policy on xenotransplantation
FDA and regulation of tissue transplantation
Comparative analysis of NBAC and President’s Council on Bioethics
Models for allocating smallpox vaccines
Evaluation of new liver allocation policy
Cross-national analysis of ES cell policies
Political feasibility of bills to extend protections to all research
participants regardless of funding source
Evaluation of ES cell funding policy initiated in 2001
Analysis of embryo freezing court cases
Paper proposals are due SEPTEMBER 30 and are worth l0 points. They should be 1-2 pages in length and divided into parts:
2. a) Specific description of the research problem and scholarly question that needs to be addressed, b) statement of reasons this is important, c) statement of your working hypothesis (expected outcome), and d) statement of your methodology.
3. A list of 8-l0 scholarly sources that you have already found. These should be properly cited and should include primary as well as secondary documents. Examples of primary documents are legislative bills, public laws, judicial decisions, Executive Orders, and administrative regulations.
Most proposals will be returned with requests for clarification and a narrowing of the research question. These rewritten proposals will be due OCTOBER 7.
The papers themselves should be 15-20 double-spaced, typed pages. You should have a clear theme that can be stated in 2-3 sentences. You are strongly encouraged to write a draft for me to read. In the papers, strive for cautious conclusions reached on the basis of thoughtful evidence, meticulous documentation, and the raising and addressing of counter-arguments. Minimize unsubstantiated opinion. The written papers are due NOVEMBER 25. Oral presentations will be scheduled for November 18, 25, and December 2.
The midterm and final exams will be distributed one week before their due dates. They and the term papers will be marked l/2 grade down per day late.
Participation will be based on attendance (with special attention to the days the papers are presented) and a demonstration that you have read the readings and have synthesized and analyzed them. When you present an article in class, develop notes in which you summarize the article and engage the author(s).