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.
Bonnicksen,
Andrea. Chimeras, Hybrids, and
Interspecies Research: Politics and
Policymaking.
November.
OPTIONAL
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
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.”
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
Meslin,
Eric M. “The President’s Council: Fair and Balanced?”
34(2):6-8 (March-April 2004). ER
“Executive
Order 12975 of
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.
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
Ethical
issues:
Religious
issues:
Political
issues:
Research
issues:
Observations:
Moving
toward clinical trials
Winslow,
Ron, and Alicia Mundy, “First Embryonic Stem-Cell Trial Gets Approval from
the FDA.” Wall Street Journal,
Couzin,
Jennifer, “Celebration and Concern over
Science
323:568 (
“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 (
Kiatpongsan,
Sorapop, and Douglas Sipp. “Monitoring and Regulating Offshore Stem
Cell Clinics.” Science 323:1564-5 (
http://stemcells.nih.gov/index.asp
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
Background
on research process
National
Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research. “The
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.”
ER
Joffe,
Steven, and Franklin G. Miller. “Bench to Bedside.”
38(2):30-42 (2008). ER
Useful
websites
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.
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.
Interscience, 2007, pp. 83-96. ER
Nanomedicine.” In Nigel M. de S. Cameron
and M. Ellen Mitchell, eds.
Nanoscale:
Issues and Perspectives for the Nano Century.
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.
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
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.
Boldt,
Joachim, and Oliver Muller. “
Biotechnology
26(4):387-89 (2008). ER
Balmer,
Andrew, and Paul Martin. “Synthetic Biology: Social and Ethical Challenges.”
Institute for Science and Society,
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.
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:
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.
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 (
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
OF USE
THROUGHOUT THE SEMESTER
Anderson,
James E. Public Policymaking. 6th
edition.
pp. 1-31, 46-73. ER
Kingdon,
John. Agendas, Alternatives and Public
Policies.
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
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
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:
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).