BIOETHICS LAW AND POLICY (LAW 715)
SPRING 2016
“The law is America’s greatest strength, but sometimes also its greatest curse, when
it gets in the vicinity of ethics … It may be the best institution we have, but it is a poor
substitute for moral consensus and public debate on ethics.”
Daniel Callahan, Escaping from Legalism
Tuesdays, 2:00 – 4:00 PM
Corboy Law Center, Room 1104
Prof. Nadia Sawicki
Office: Room 725
Phone: 312.915.8555
Email: nsawicki@luc.edu
COURSE GOALS
Medical innovations since the 20th century have necessitated public discussion about ethical
norms in medical research and clinical practice, and the role that the law should play in
responding to these ethical norms. In this course, students will learn how the law’s regulatory
powers can be used to set boundaries in medicine, and, in turn, how theories of medical ethics
and practice might be used to inform modern policy developments.
COURSE REQUIREMENTS
Class Participation: The success of this course is dependent on each student’s interest and
active involvement. Seminar participants are expected to come to each class prepared and ready
to contribute to group discussion.
Attendance: Your are expected to attend every class and arrive on time. Absences and
tardiness will affect your class participation grade.
Respectful Discussion: Given the sensitive nature of the material we will be studying, it
is particularly important that students maintain a professional and respectful manner
during class discussions. Our shared goal in this classroom is to learn from each other and this can be done only in an atmosphere of honesty, trust, and mutual respect. If you
have any questions or concerns on this subject, please do not hesitate to speak with me.
Technology: Inappropriate use of technology in class is disruptive to your professors and
fellow students. Laptops may be used in the classroom only to take notes and access
course readings on TWEN. Cell phones must be off.
Reading Assignments: The reading assignments for each week (generally between 40 and 75
pages) will be posted on the course TWEN page. The purpose of these readings is not to serve as
comprehensive accounts of black-letter law or ethical theory, but rather to introduce seminar
participants to new perspectives and to spark discussion of the challenges facing stakeholders at
the intersection of law and bioethics.
Critical Response Papers: By March 29, each student must complete two critical response
papers addressing the weekly readings. Response papers must be uploaded to TWEN by
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midnight on the Monday before class. For example: If writing a response paper on research
compensation (to be discussed in class on Tuesday, Jan. 26), it should be uploaded to TWEN by
midnight on Monday, Jan. 25. These short (2 to 3 single-spaced pages) argument-based response
papers are intended to give you an opportunity to explore issues that particularly spark your
interest, surprise you, offend you, or otherwise challenge your intuitions. In each paper, you
should take a position and defend it by reference to arguments grounded in law, policy, history,
religion, philosophy, science, or the like. You are welcome to express your personal opinion or
play “devil’s advocate” – the goal here is to work on building a clear and coherent argument
rather than relying on mere rhetoric or unsupported opinion.
Policy Proposal and Class Leadership: The last four weeks of the semester will be devoted to
developing issues in law and bioethics, the details of which will be determined by student
interest. Groups of 3 students will each take responsibility for researching one “hot issue” of
their choosing. Each group must (1) prepare a written policy proposal (approximately 10 to 15
double-spaced pages) recommending action on the issue; and (2) lead a 50-minute class on the
issue, presenting a brief overview of the issue and directing class discussion using questions and
case studies, incorporating the policy proposal as appropriate. Please keep in mind the following
schedule as your group begins this project:
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Week of March 14: Meet with Prof. Sawicki to discuss planning.
Two weeks before class: Select relevant reading assignments; e-mail them to Prof.
Sawicki for review.
One week before class: Post reading assignments and draft policy proposal on TWEN.
Tues. May 10: Submit final policy proposal (and 1-page group memo) to Prof. Sawicki.
GRADING
Your final grade in this course will be based on class participation (20%), critical response
papers (20%); and policy proposals and presentations (60%). All grading is final.
While each course requirement is considered independently, the following should serve a general
guide as to how student work will be evaluated:
A/A-: The student demonstrates an exceptional understanding of the subject matter, is
able to thoroughly describe and explain themes raised in the readings, and presents a
sophisticated, creative, consistent, and comprehensively researched argument of his own
creation that stands up against equally well-reasoned criticism.
B+/B: The student demonstrates a strong understanding of the subject matter, is able to
clearly describe and explain themes raised in the readings, and presents a reasonable, consistent,
and well-researched argument of his own creation that stands up against reasonable objections.
B-/C+/C: The student demonstrates a basic understanding of the subject matter, is able
to accurately describe the themes raised in the readings, and presents a reasonable argument of
his own creation that demonstrates basic research skills and awareness of reasonable objections.
C-/D/F: The student demonstrates a substandard understanding of the subject matter, is
not able to accurately describe ideas and principles raised in the readings, or presents an
argument that demonstrates substandard research skills, logical inconsistencies, factual errors,
or an inability to identify reasonable objections.
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PRELIMINARY SCHEDULE
Recommended Pre-Semester Readings
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General overview of ethical theories: Steinbock, Arras, & London, Moral Reasoning in
the Medical Context (esp. pp. 8-35)
On emotions, cognitive biases, and how they impact discussion of bioethical issues:
Alberto Giublini, Don’t Mind the Gap: Intuitions, Emotions, and Reasons in the
Enhancement Debate
Jan. 19
Human Subjects Research: Abuse, Consent, and Vulnerability
What legal requirements should exist to ensure that clinical research is
conducted in an ethical manner?
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Jan. 26
Harriet Washington, A Notoriously Syphilis-Soaked Race: What Really
Happened at Tuskegee (Chapter 7), in MEDICAL APARTHEID (2008)
Belmont Report, 44(76) FR 23192 (April 18, 1979)
HHS Policy for the Protection of Human Subjects, §46.111 and §46.116
Pp. 88-96 of MORAL SCIENCE: PROTECTING PARTICIPANTS IN HUMAN
SUBJECTS RESEARCH (Presidential Commission, 2011)
Charles Lidz and Paul Appelbaum, The Therapeutic Misconception: Problems
and Solutions (Med. Care 2002)
Franklin Miller and Howard Brody, What Makes Placebo-Controlled Trials
Unethical? (Am. J. Bioethics 2002)
Human Subjects Research: Compensation for Research-Related Injury
Should research subjects have a right to recover for research-related injuries?
If so, what legal mechanisms should be used to compensate them?
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Pp. 56-69 of MORAL SCIENCE: PROTECTING PARTICIPANTS IN HUMAN
SUBJECTS RESEARCH (Presidential Commission, 2011)
Leslie Meltzer Henry, Moral Gridlock: Conceptual Barriers to No-Fault
Compensation for Injured Research Subjects (J. L. Med. & Ethics 2013)
Pages 166-179 of Holly Fernandez Lynch, Human Research Subjects as
Human Research Workers (2014)
University of Washington Human Subjects Assistance Program Fact Sheets
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Feb. 2
Consent and Compensation: Research on Human Tissue
What property rights do people have in their bodily “stuff”? Should there be
any legal limitations on the use of human tissue for research purposes?
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Feb. 9
Rebecca Skloot, Taking the Least of You (NYT 2006)
Charlotte Harrison, Neither Moore nor the Market: Alternative Models for
Compensating Contributors of Human Tissue (Am. J. Law & Med. 2002)
Greenberg v. Miami Children’s Hospital Research Institute, 264 F. Supp. 2d
1064 (S.D. Fla. 2003)
National Cancer Institute, Providing Your Tissue for Research: What You
Need to Know
Various materials, Minnesota blood spot controversy
Consent and Compensation: Organ Transplantation
Should the U.S. abandon its prohibition on the sale of organs? Are there other
non-market mechanisms for incentivizing organ donation?
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Feb. 16
National Organ Transplantation Act, Prohibition of organ purchases, 42
U.S.C.A. § 274e
Kevin Sack, 60 Lives, 30 Kidneys, All Linked (NYT 2012)
Henry Hansmann, The Economics and Ethics of Markets for Human Organs
(1989)
Renee Fox and Judisth Swazey, Organ Transplantation as Gift Exchange, in
SPARE PARTS: ORGAN REPLACEMENT IN AMERICAN SOCIETY (1992), pp. 31-42
Creating New Life: Limiting the Right to Reproduce
Should there be any legal limitations on how those who wish to procreate may
do so? Should the law recognize the right not to be a genetic parent?
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John Robertson, Assisting Reproduction, Choosing Genes, and the Scope of
Reproductive Freedom (Geo. Wash. L. Rev. 2008)
Stephanie Saul, Building a Baby, With Few Ground Rules (NYT 2009)
Elizabeth Anderson, Why Commercial Surrogate Motherhood Unethically
Commodifies Women and Children (Health Care Analysis 2000)
Szafranski v. Dunston, 993 N.E.2d 502 (Ill. App. 2013)
S. Ory, The American Octuplet Experience: A Transformative Event (Fertil.
and Steril. 2010)
Amy Klein, Twins: The Fetal Paradox (Newsweek 2014)
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Feb. 23
Creating New Life: Genetic Engineering and Human Enhancement
Should there be any legal limitations on germline gene therapy or genetic
enhancement?
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Mar. 1
Kim Tingley, The Brave New World of Three-Parent IVF (NYT 2014)
Genetics and Public Policy Center, Human Germline Genetic Modification:
Issues and Options for Policymakers (2005): pp. 11-14 (basic science), pp 3942 (Oversight), and 43-46 (Options and Considerations for Policymakers)
President’s Council on Bioethics, Beyond Therapy (2003): pp. xv-xvii (Letter
to President) and 286-301 (Essential Sources of Concern)
Julian Savulescu, Genetic Interventions and the Ethics of Enhancement
Death and Dying: Defining Death
Should the U.S. consider changing the legal definition of death? If so, on what
grounds?
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Uniform Determination of Death Act materials
N.J. Stat. Ann. 26:6A-2 through 6A-5, “Declaration of Death”
10 N.Y. ADC 400.16, “Determination of Death”
In re TACP, 609 So.2d 588 (Fla. 1992)
Various materials, McMath and Munoz cases
David Magnus et al, Accepting Brain Death (NEJM 2014)
Seema Shah et al, Death and Legal Fictions (J. Med. Ethics 2011)
Mar. 8
NO CLASS (Spring Break)
Mar. 15
Death and Dying: Resolving Futility Disputes
What legal rules (and institutional policies) would be most effective in avoiding
and/or resolving futility disputes?
 Causey v. St. Francis Medical Center, 719 S. 2d. 1072 (1998)
 Excerpts, Nancy Jecker and Lawrence Schneiderman, WRONG MEDICINE (pp.
8-22)
 Robert Truog et al, The Problem With Futility (NEJM 992)
 Excerpts,Thad Pope, Medical Futility Statutes (Tenn. L. Rev. 2007) (pp. 4281)
 Texas Medical Futility Law: Texas Stat. Code Ann. §166.045 and .046
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Mar. 22
Duties to the State: Public Health Emergencies
What can medical professionals be required/asked to do in furtherance of
public health goals?
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Mar. 29
Heidi Malm et al, Ethics, Pandemics and the Duty to Treat (Am. J. Bioethics
2008)
Alexandra Stewart, Mandatory Vaccination of Health Care Workers (NEJM
2009)
Bernard Lo and Mitchell Katz, Clinical Decision Making During Public
Health Emergencies (Annals Int. Med. 2005)
Daniel Fox, From TB to AIDS: Value Conflicts in Reporting Disease
(Hastings Ctr. Rep. 1986)
Middlebrooks v. State Board of Health, 710 So.2d 891 (Ala. 1998)
Duties to the State: Lethal Injection and Torture
What obligations do medical professionals owe to the state? Should the
appropriate scope of medical practice be defined by the medical profession, or
by policymakers?
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Arthur Isak Applbaum, Doctor, Schmoctor: Practice Positivism and Its
Complications, in ETHICS FOR ADVERSARIES (1999)
AMA Statement on Physician Participation in Capital Punishment (1993)
Atul Gawande, When Law and Ethics Collide: Why Physicians Participate in
Executions (NEJM 2006)
David Waisel, Physician Participation in Capital Punishment (Mayo Clin.
Proc. 2007)
Jane Mayer, The Experiment (New Yorker 2005)
Gregg Bloche and Jonathan Marks, When Doctors Go to War (NEJM 2005)
Apr. 5
[TBD]
Apr. 12
[TBD]
Apr. 19
[TBD]
Apr. 26
[TBD]
May 10
Final Policy Proposals Due
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