Political Science 631—Seminar in Biomedical Policy

Fall 2009

Andrea Bonnicksen (Zulauf 401; 753-7059; albcorn@niu.edu)

 

How can biomedical and biotechnological innovations best be managed in a time of rapidly changing science? In this seminar we will look at innovation in various areas of biomedical inquiry, including stem cell research, protection of participants in biomedical research, nanotechnology, and synthetic biology. Issues will be explored from multiple perspectives found in the literature of bioethics and biomedical policy. In the seminar we will aim to (1) identify relevant policy communities and their role in shaping public debate,  (2) understand the values that underlie support for and opposition to emerging technologies, (3) consider models for analyzing public policy, and (4) think critically about the societal implications of changing biomedical technologies. A recurring question involves how participatory democracy can best be achieved in decision making in the context of scientific discovery. 

 

READINGS:

Eaton, Margaret L., and Donald Kennedy. Innovation in Medical Technology. Baltimore:

            Johns Hopkins University Press, 2007.

Monroe, Kristen Renwick, Ronald B. Miller, and Jerome S. Tobis. Fundamentals of the

            Stem Cell Debate: The Scientific, Religious, Ethical, and Political Issues.

            Berkeley: University of California Press, 2008.

Bonnicksen, Andrea. Chimeras, Hybrids, and Interspecies Research: Politics and

            Policymaking. Washington DC: Georgetown University Press, 2010. Available in

            November. OPTIONAL

 

Readings with an ER below are on electronic reserve. The link to these readings is found on Blackboard (eReserves), and the readings are listed by date they are covered in the seminar. Note that some readings need not be printed in their entirety and others are optional. Depending on discussion and interest, we may spend slightly more or less time on individual topics than indicated below.

 

AUGUST 27, SEPTEMBER 3        BIOPOLICY AND PUBLIC PARTICIPATION

National bioethics commissions are one way of inviting public participation in biomedical policymaking. In recent years Bill Clinton formed the National Bioethics Advisory Commission and George W. Bush set up the President’s Council on Bioethics. President Obama has announced he will form a new bioethics commission. What has been the history of bioethics commissions in the U.S.? What role should they play in policymaking? What type of commission should the president form? The readings below explore the ethical and political dimensions of bioethics and biopolicy.

 

Role of national commissions

Johnson, Summer. “Welcome to the Bioethics Presidency.” American Journal of

            Bioethics 9(2):1-2 (February 2009). ER

 

 

Gutmann, Amy, and Dennis Thompson, “Deliberating About Bioethics.” Hastings Center

            Report 27:38-41 (May/June 1997). ER

 

“Former Bioethics Commissions.” 4 pages. Available at

            http://bioethicsprint.bioethics.gov/reports/past_commissions/index.html ER

 

Dzur, Albert W., and Daniel Levin, “The ‘Nation’s Conscience’: Assessing Bioethics

            Commissions as Public Forums.” Kennedy Institute of Ethics Journal 14(4):333-

            360 (2004). ER

 

Kass, Leon. “Reflections on Public Bioethics: A View from the Trenches.” Kennedy

            Institute of Ethics Journal 15(3):221-50 (2005). ER

 

Meslin, Eric M. “The President’s Council: Fair and Balanced?” Hastings Center Report

 34(2):6-8 (March-April 2004). ER

 

“Executive Order 12975 of October 3, 1995: Protection of Human Research Subjects and

            Creation of National Bioethics Advisory Commission.” Federal Register

            60(193):52063-65. ER OPTIONAL

 

“Executive Order 13237: Creation of the President’s Council on Bioethics.” Federal

            Register 66(231):59849-53. November 30, 2001. ER  OPTIONAL

 

Politics and bioethics

Brown, Mark B. “Three Ways to Politicize Bioethics.” American Journal of Bioethics

            9(2):43-54 (2009). ER

 

DiSilvestro, Russell. “Small-r-republicans, Big-R-Republicans, and Government

            Bioethics Councils.” American Journal of Bioethics 9(2):57-58 (2009). ER

 

Brian, Jenny Dyck, and Adam Briggle. “Bioethics and Politics: Rules of Engagement.”

            American Journal of Bioethics 9(2):59-61 (2009). ER

 

Berger, Sam. “Politics By Another Name.” American Journal of Bioethics 9(2):61-63

            (2009). ER

 

SEPTEMBER 10, 17                        STEM CELL RESEARCH, ETHICS, AND POLICY

Few issues capture as many conflicting values and have as powerful a political impact as research on human embryonic stem (ES) cells. Chapters in the book by Monroe shed light on the scientific, ethical, and policy dimensions of stem cell research. Additional readings update policy changes underway as stem cell research moves from the laboratory to clinical application.  

 

Science, ethics, and politics 

Science and vision: Monroe, Fundamentals of the Stem Cell Debate, pp. 10-36, 37-61

Ethical issues: Monroe, pp. 62-78

Religious issues: Monroe, pp. 79-94

Political issues: Monroe, pp. 95-107, 108-33,134-45

Research issues: Monroe, pp. 146-96

Observations: Monroe, pp. 197-201 

 

Moving toward clinical trials

Winslow, Ron, and Alicia Mundy, “First Embryonic Stem-Cell Trial Gets Approval from

            the FDA.” Wall Street Journal, January 23, 2009. ER

 

Couzin, Jennifer, “Celebration and Concern over U.S. Trial of Embryonic Stem Cells.”

            Science 323:568 (January 30, 2009). ER

 

“National Institutes of Health Guidelines on Human Stem Cell Research.”

            http://stemcells.nih.gov/policy/2009guidelines.htm ER

 

Majumder, Mary A., and Cynthia B. Cohen. “The NIH Draft Guidelines on Human Stem

            Cell Research.” Science 324:1648-49 (June 26, 2009). ER

 

Kiatpongsan, Sorapop, and Douglas Sipp. “Monitoring and Regulating Offshore Stem

            Cell Clinics.” Science 323:1564-5 (March 20, 2009). ER

 

Useful websites

http://stemcells.nih.gov/index.asp

http://www.stemcells.wisc.edu

http://hinxtongroup.org/wp.html

 

SEPTEMBER 24, OCTOBER 1     PROTECTIONS IN CLINICAL RESEARCH 

Although policy designed to protect human participants in medical research is well-developed in the U.S., it is still in transition. One question revolves around the blurred line between medical research and medical practice. When do medical advances move from mere innovations to systematic research warranting the protections accorded research participants? The readings below explore this question, and they illuminate policy history in the process.

 

Background on research process

National Commission for the Protection of Human Subjects of Biomedical and

            Behavioral Research. “The Belmont Report OPPR Reports.” 8 pages.

            http://sdatc.eastarnet.com/gcp/readings/belmont.pdf  ER

 

“How Does Clinical Research Work?” http://clinicalresearch.nih.gov/how.html ER

 

“Who Participates in Clinical Research?” http://clinicalresearch.nih.gov/who.html ER

 

“What Do I Need to Know if I am Thinking of Participating?”

            http://clinicalresearch.nih.gov/what1.html ER

 

When are medical innovations research and when are they clinical practice?  

Introduction: Eaton and Kennedy, Innovation in Medical Technology, pp. vii-xii, 1-22

Distinguishing innovation from research: pp. 23-36

History of research ethics: pp. 37-46, 119-29

Off-label drug use: pp. 38-56

Innovative surgery: pp. 57-71

Assisted reproduction and innovation: pp. 72-83

Neuroimaging: pp. 84-93

Conclusions and policy: pp. 94-117

 

Regulatory issues in clinical research

Shamoo, Adil E., and Jack Schwartz. “Universal and Uniform Protections of Human

            Subjects in Research.” American Journal of Bioethics 8(11):3-5 (2008). ER

 

Gilbert, Susan. “Trials and Tribulations.” Hastings Center Report 38(2):14-18 (2008).

            ER

 

Joffe, Steven, and Franklin G. Miller. “Bench to Bedside.” Hastings Center Report

            38(2):30-42 (2008). ER

 

Useful websites

www.cancertrials.gov

http://www.orc.niu.edu/orc/human_research/index.shtml

 

OCTOBER 8                         ISSUES IN NANOMEDICINE

Nanotechnology involves the manipulation of matter at very small levels (a nanometer, for example, is “one-billionth of a meter”).  Nanomedicine is a variation of nanotechnology that in theory, will, among other things, use tiny sensors and devices to detect and treat damaged cells and tissues. It has attracted the attention of government agencies, including the National Institutes of Health, which has set up Nanomedicine Development Centers across the country. Observers are asking whether nanotechnology poses new ethical and policy challenges. The readings below explore this question.

 

Blackwelder, Brent. “Nanotechnology Jumps the Gun: Nanoparticles in Consumer

            Products.” In Nigel M. de S. Cameron and M. Ellen Mitchell, eds. Nanoscale:

            Issues and Perspectives for the Nano Century. New York: Wiley-Interscience,

            2007, pp. 71-82.  ER

 

Heller, Jacob, and Christine Peterson. “Nanotechnology: Maximizing Benefits,

            Minimizing Downsides.” In Nigel M. de S. Cameron and M. Ellen Mitchell, eds.

            Nanoscale: Issues and Perspectives for the Nano Century. New York: Wiley-

            Interscience, 2007, pp. 83-96.  ER

 

Cheshire, William P. “Doing Small Things Well: Translating Nanotechnology into

            Nanomedicine.” In Nigel M. de S. Cameron and M. Ellen Mitchell, eds.

            Nanoscale: Issues and Perspectives for the Nano Century. New York: Wiley-

            Interscience, 2007, pp. 315-36.  ER

 

Cameron, Nigel M. de S. “Nanotechnology and the Global Future: Points to Consider for

            Policymakers.” In Nigel M. de S. Cameron and M. Ellen Mitchell, eds.

            Nanoscale: Issues and Perspectives for the Nano Century. New York: Wiley-

            Interscience, 2007, pp. 425-38 ER

 

Keiper, Adam, “Nanoethics as a Discipline?” The New Atlantis, Spring 2007. ER

 

Useful websites

http://nihroadmap.nih.gov/nanomedicine

http://cns.asu.edu/index.htm

 

OCTOBER 8                         TAKE-HOME MIDTERM EXAMS DISTRIBUTED

 

OCTOBER 15                       TAKE-HOME MIDTERM EXAMS DUE

 

OCTOBER 15, 22                 SYNTHETIC BIOLOGY, ETHICS, AND POLICY 

Synthetic biology involves the creation of living organisms using engineering principles. The ability to create systems that never would have existed naturally bids us to think about whether something qualitatively different is at stake that raises unique bioethical and biopolicy questions. The readings below explore these matters. For example, the reading by Parens et al. proposes a framework that would apply to all emerging technologies and that would avoid the start up of new sub-fields (synbio ethics, nanoethics) in response to new developments.

 

Parens, Erik et al. “Ethical Issues in Synthetic Biology.” Woodrow Wilson International

            Center for Scholars, 2009.      http://www.synbioproject.org/process/assets/files/6334/synbio3.pdf ER

 

Bedau, Mark A., and Mark Triant. “Social and Ethical Implications of Creating Artificial

            Cells.” In Mark A. Bedau and Emily C. Parke, eds. The Ethics of Protocells.

            Cambridge MA: MIT Press, 2009, pp. 31-48.

 

Boldt, Joachim, and Oliver Muller. “Newtons of the Leaves of Grass.” Nature

            Biotechnology 26(4):387-89 (2008). ER

 

Balmer, Andrew, and Paul Martin. “Synthetic Biology: Social and Ethical Challenges.”

            Institute for Science and Society, University of Nottingham. 2008. ER

 

Tucker, Jonathan B., and Raymond A. Zilinskas, “The Promise and Perils of Synthetic

            Biology.” New Atlantis (Spring 2006), pp. 16. ER

 

Parke, Emily C., and Mark A. Bedau. “The Precautionary Principle and its Critics.” In

            Mark A. Bedau and Emily C. Parke, eds. The Ethics of Protocells. Cambridge

            MA: MIT Press, 2009, pp. 69-87.

 

Garfinkel, Michele S., et al. Synthetic Genomics: Options for Governance. J. Craig

            Venter Institute, Center for Strategic and International Studies, MIT Department

            of Biological Engineering. COPIES PROVIDED IN CLASS.

 

ETC Group. “Extreme Genetic Engineering: An Introduction to Synthetic Biology.” ETC

            Group: Ottawa, 2007. PRINT ONLY pp. 1-22, 45-51 (OPTIONAL) ER

 

OCTOBER 29               ISSUES IN INTERSPECIES RESEARCH

With stem cell research in particular, concern has been directed to research techniques that combine human and nonhuman cells at the embryonic stages for basic research. A number of countries have preemptively barred various kinds of human/nonhuman interspecies research. What are the challenges of making policy for sensitive research that can easily become sensationalized?

 

Bonnicksen, Andrea. Chimeras, Hybrids, and Interspecies Research: Politics and

            Policymaking. Washington DC: Georgetown University Press, 2010 (available in

            November).  If the book is not available, alternative readings will be substituted. 

 

NOVEMBER 5, 12               USE OF PRIMATES IN RESEARCH

A topic that goes hand in hand with the management of innovation is the use of animals in research, particularly non-human primates. Although alternatives to animal models are emerging, biomedical discoveries in neuroscience, among other areas, add to the demand for research on primates. The readings explore the ethics and policy related to the use of primates in stem cell studies and in investigations into strokes. 

 

Primates and stem cell research

Greene, Mark, et al., “Moral Issues of Human-Non-Human Primate Neural Grafting.”

            Science 309(5733):385-86 (July 15, 2005). ER

 

Primates and stroke research

Michael E. Sughrue, et al. “Bioethical Considerations in Translational Research: Primate

            Stroke.” American Journal of Bioethics 9(5):3-12 (2009). ER

 

Fox, Marie. “The Legal Regulation of Primate Research.” American Journal of Bioethics

            9(5):13-15 (2009). ER

 

Lunstroth, John. “Aping Political Science.” American Journal of Bioethics 9(5):15-17

            (2009). ER

 

Hurst, Samia, and Alex Mauron. “Articulating the Balance of Interests Between Humans

            and other Animals.” American Journal of Bioethics 9(5):17-19 (2009). ER

 

Wilkinson, Dominic. “Trade-Offs in Suffering and Wellbeing: Utilitarian Argument for

            Primate Stroke Research.” American Journal of Bioethics 9(5):19-21 (2009). ER

 

Gerrek, Monica L. “Primate Stroke Research: Still Not Interested.” American Journal of

            Bioethics 9(5):29-30 (2009). ER

 

NOVEMBER 19                                           ALL PAPERS DUE

 

NOVEMBER 19, DECEMBER 3              PAPER PRESENTATIONS

 

DECEMBER 3                     TAKE-HOME FINAL EXAMS DISTRIBUTED

 

DECEMBER 10                   TAKE-HOME FINAL EXAMS DUE

 

OF USE THROUGHOUT THE SEMESTER   

Anderson, James E. Public Policymaking. 6th edition. Boston: Houghton Mifflin, 2006,

            pp. 1-31, 46-73. ER

 

Kingdon, John. Agendas, Alternatives and Public Policies. Boston: Little, Brown and

            Company, 1984, pp. 122-151, 205-218. ER

 

Nisbet, Matthew C., and Chris Mooney.”Framing Science.” Science 316:56 (April 6,

            2007). ER

 

Chong, Dennis, and James N. Druckman. “Framing Theory.” Annual Review of

            Political Science 10:103-26 (2007). ER

 

GRADES

Grades will be based upon a seminar paper, midterm exam, final exam, and participation.

The midterm take-home exam is due October 15 and the final take-home exam is due at 6:30 p.m. December 10. 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                         10 points                     October 1

            Midterm exam                         60 points                     October 15

            Final exam                               60 points                     December 10

            Paper                                      100 points                    November 19

            Participation                            20 points

                                                                     

A = 225 - 250; B = 200 – 224; C = 175 – 199; D = 150 – 174

 

SEMINAR PAPERS

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; New England Journal of Medicine; JAMA; Journal of Law, Medicine & Ethics; Journal of Health Politics, Policy and Law, and American Journal of Bioethics. Recent articles in law journals (available in law library) provide up-to-date law/policy summaries and sources for specific areas of biomedical policy. 

           

When deciding on your topic, select a 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. 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.       

           

The papers should be 15-20 double-spaced, typed pages. You should have a clear theme that can be stated in 2-3 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, meticulous documentation, and the raising and addressing of counter-arguments. Minimize unsubstantiated opinion. Oral presentations will be scheduled for November 19 and December 3, but all written papers are due in HARD COPY on the same day – November 19.

 

PAPER PROPOSALS

Paper proposals are worth l0 points. The proposal is an important road map for your research. You should 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
  2. 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.
  3. 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. 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
  4. 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.
  5. An outline

 

Sample abstracts of published papers will be given in class to help guide the preparation of a proposal. Members of the seminar will also read one another’s draft proposals and provide comments.

 

EXAMS

The midterm and final 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.

 

SAFE ASSIGN

All exams and papers must be uploaded to Safe Assign (found on Blackboard). The NIU undergraduate catalogue defines plagiarism as follows: “The attempt of any student to present as his or her own work that which he or she has not produced is regarded by the faculty and administration as a serious offense. Students are considered to have cheated if they copy the work or another during an examination or turn in a paper or an assignment written, in whole or in part, by someone else. Students are guilty of plagiarism, intentional or not, if 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.”

 

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, around 2-4 individuals will present articles from the readings each week (one each). This involves everyone in the 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. Instead summarize the article or chapter and engage the rest of us with the article. What is the author’s purpose? What were his/her main arguments? What are the conclusions? What are the strengths and weaknesses of the article? How does it advance our knowledge? If you want, you may distribute a page with your main points on it through Blackboard early in the afternoon on the day of class.

 

PLAGIARISM -- “The attempt of any student to present as his or her own work that which he or she has not produced is regarded by the faculty and administration as a serious offense. Students are considered to have cheated if they copy the work or another during an examination or turn in a paper or an assignment written, in whole or in part, by someone else. Students are guilty of plagiarism, intentional or not, if 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.” Northern Illinois University Undergraduate Catalog, Here are useful links: http://lrs.tvu.ac.uk/find/Plagiarism_tutorial/index.html

http://polisci.niu.edu/polisci/audience/plagiarism.shtm

This abstract accompanies an article by Francoise Baylis in Kennedy Institute of Ethics Journal 19(1):41-62 (2009).