General Requirements
Medical Devices: Applied Ethics and Public Policy (HONR 288L), Spring 2010
General Requirements
Distributive Studies
You may have chosen this course as part of your CORE Liberal Arts and Sciences Studies
Program, the general education portion of your degree program. CORE Distributive Studies
courses are designed to ensure that you will take a look at several different academic disciplines
and the way they create and analyze knowledge about the world. A faculty and student
committee approved this CORE Distributive Studies course because it will introduce you to ideas
and issues that are central to a major intellectual discipline and because it promises to involve
you actively in the learning process. Please take advantage of the opportunities this course offers
you.
Course Background
In this course you will learn about medical devices like artificial heart valves and artificial hearts.
We will discuss the government’s requirements for clinical testing, and the obligations that
physicians, manufacturers, FDA, and the Congress have to patients. We will use resources and
methods from the field of sociology (case studies, interviewing, and content analysis) to better
understand the impact of all of these requirements and obligations on society, and we will use
several ethical theories to analyze and evaluate public policy.
We will discuss case studies from my experience as a regulatory consultant and as the former
Director of the Division of Cardiovascular Devices at the FDA. Case studies will include
controversies concerning breast implants, allegations of scientific misconduct (the David
Baltimore case), artificial hearts, deaths due to mechanical heart valves, and others recommended
by the class. The case studies will show (a) how public policy affects patients, physicians,
researchers, and manufacturers; (b) how it is influenced; and (c) how individuals viewing the
same problem can come to different conclusions based on different ethical theories.
Ethics provides guidance on how people should interact. The relationships that exist between
physicians and patients, between medical device manufacturers and physicians, and between
medical device manufacturers and patients create the rights and obligations of each group. Ethics
helps us to define the role responsibilities that each of the individuals has in these relationships.
Sociology examines social life as it is influenced by social systems like the medical research
community, the medical industry, FDA, NIH, and the Congress. Research from in-depth
interviews, surveys, and content analysis provides important insight into what various social
groups understand about medical technology and how they are affected. This insight is important
for a proper ethical analysis of the policies of these social systems. It is also important to
understanding how to educate the public about new technologies (a requirement of professional
codes of ethics).
When we read about failures of medical devices in the news, it often appears that someone has
acted unethically – a scientist committed fraud, company management didn’t test the device
enough to assure that it was safe and effective, the public wasn’t notified of a problem in a timely
Rahmoeller/December 29, 2009
3
manner, or a physician didn’t give patients adequate informed consent. The problem is often
much more complex than it first appears. There is often more than one right answer or, from
other’s perspectives, no right answer. Most of us will make important, controversial decisions in
our lives – this course will give you a process by which to make those decisions.
Required Course Materials
 Readings prepared by Glenn Rahmoeller.
 Murphy, T., Case Studies In Biomedical Research Ethics, (MIT Press, 2004 – ISBN: 0262-63286-1)
Optional Course Materials
 Levine, C., Taking Sides: Clashing Views on Controversial Bioethical Issues,
(Dushkin/McGraw-Hill, 13th edition – ISBN: 978-0-07-354566-0)
Expectations and Grading
The success of this class depends on your presence and participation in each session. Learning
will come primarily from the class discussions in which you participate. If you must miss a
class, please discuss it with me as soon as possible – all of us benefit from listening to each
other’s views, so you will be missed.
I expect you to spend an average of 3-6 hours each week preparing for this course. There are
readings assigned each week. Please come prepared to discuss the material (please note: if I
believe the class is not prepared, I reserve the right to give a quiz – in which case I will use your
quiz grade as your class grade for the day). Ten percent (10%) of your grade will be based on
how well you respond during our discussion of these issues.
You will have 10 papers due during the semester. Three of these are major papers (3-4 pages)
that will show me that you can apply what you have learned – they count for 25% of your grade.
The remaining seven papers are brief response papers (1-2 pages) relating to questions about the
readings for the day or to your research paper (outline and Power-Point). I also ask that you
include a thoughtful question about the readings that we can discuss in class. These brief
response papers count for 25% of your grade.
You must write a research paper – either as part of a group or individually. If you choose to
work in a group, you will work in teams of 3-4 students to write a research paper on an issue that
is important in some area of medicine or medical technology. Each person in the group will be
responsible for a specific section(s) of the paper – (a) background (3-4 pages, plus list of
references); (b) social implications (3-4 pages, plus list of references); (c) ethical analysis (3-4
pages, plus list of references); and (d) introduction (1 page, plus list of references), discussion (23 pages, plus list of references), conclusion (1 page). The research paper will count for 15% of
your grade. Each student will receive an individual grade for his section(s) of the research paper.
For individual research papers, you may either analyze the effect of a new technology on society,
or you may write about an in depth interview to learn more about a technology and its effects.
Rahmoeller/December 29, 2009
4
Individual research papers must be 4-6 pages, excluding the list of references. The research
paper will count for 15% of your grade.
Your group, or you (if you write an individual research paper), must also present this research to
the class. For group research, I will give one grade for the presentation – and all students in the
group will receive that grade. Your presentation will be worth 5% of your grade.
The remaining 20% of your grade will come from a take-home final exam. The exam will
consist of one question that you must address in a 4-6 page paper.
In summary:
 Class participation
 3 major papers
 7 brief response papers
 Research paper
 Research presentation
 Final exam paper
10%
25%
25%
15%
5%
20%
All papers should be written for a reader who is unfamiliar with the material. Assume that
person will read your papers for the purpose of understanding what you are learning from this
class. I grade all papers based on their overall quality. I take into consideration: (a)
thoroughness, (b) accuracy, (c) organization and logical flow, (d) lack of repetition, and (e)
grammar. For ease of reading and to maintain consistency, all written assignments must be
double spaced, typed in size 12 font, with 1.5 inch margins on the right and bottom of the page
(so that I have room to write my comments).
Do Your Own Work
You may discuss any of the assignments with each other. I see this as part of the learning
experience. Nevertheless, when it comes to writing the weekly responses, papers, research paper,
and final exam, you must prepare this material independently. It is acceptable to quote from
cited references, but copying from each other or copying material from other sources without
quoting and citing the source is unacceptable and will result in severe penalties.
Academic Accommodations
If you have a documented disability, you should contact Disability Support Services 0126
Shoemaker Hall. Each semester students with documented disabilities should apply to DSS for
accommodation request forms which you can provide to your professors as proof of your
eligibility for accommodations. The rules for eligibility and the types of accommodations a
student may request can be reviewed on the DSS web site at
http://www.counseling.umd.edu/DSS/receiving_serv.html.
Religious Observances
The University System of Maryland policy provides that students should not be penalized
because of observances of their religious beliefs, students shall be given an opportunity,
whenever feasible, to make up within a reasonable time any academic assignment that is missed
Rahmoeller/December 29, 2009
5
due to individual participation in religious observances. It is the responsibility of the student to
inform the instructor of any intended absences for religious observances in advance. Notice
should be provided as soon as possible but no later than the end of the schedule adjustment
period. Faculty should further remind students that prior notification is especially important in
connection with final exams, since failure to reschedule a final exam before the conclusion of the
final examination period may result in loss of credits during the semester. The problem is
especially likely to arise when final exams are scheduled on Saturdays.
Academic Integrity
The University of Maryland has a nationally recognized Code of Academic Integrity,
administered by the Student Honor Council. This Code sets standards for academic integrity at
Maryland for all undergraduate and graduate students. As a student you are responsible for
upholding these standards for this course. It is very important for you to be aware of the
consequences of cheating, fabrication, facilitation, and plagiarism. For more information on the
Code of Academic Integrity or the Student Honor Council, please visit
http://www.studenthonorcouncil.umd.edu/whatis.html.
The University of Maryland is one of a small number of universities with a student-administered
Honors Code and an Honors Pledge, available on the web at
http://www.jpo.umd.edu/aca/honorpledge.html. The code prohibits students from cheating on
exams, plagiarizing papers, submitting the same paper for credit in two courses without
authorization, buying papers, submitting fraudulent documents, and forging signatures. The
University Senate encourages instructors to ask students to write the following signed statement
on each examination or assignment: "I pledge on my honor that I have not given or received any
unauthorized assistance on this examination (or assignment).”
Office Hours
Generally, I will be in the faculty office in Anne Arundel Hall from 12:45-1:45 on the day that
we have class. I am also available to meet with you earlier on that day or at other times if you
contact me and make an appointment.
 phone: 301-466-6160
 e-mail: rahmoell@umd.edu
 home email: rahmoeller@verizon.net
I am looking forward to teaching this class. I want to make it an enjoyable learning experience
for everyone.
Mr. Rahmoeller
Rahmoeller/December 29, 2009
6