10/17/05
G504 - INTRODUCTION TO RESEARCH ETHICS
Section: Course Director:
Kimberly A. Quaid, Ph.D.
Time: Tuesday 3-4:40 p.m.
Place: Room 242 in the
Nursing School Building
Office Phone: 274-2390
(Medical Genetics) / 278-4039 (Bioethics)
Email: kquaid@iupui.edu
Office hours: By appointment
call 274-2390 (Genetics) or 278-4039 (Bioethics)
Background: Beginning
in 1990, the National Institutes of Health (NIH) required all pre-doctoral and
postdoctoral trainees supported by training grants (T-32 grants) to receive
formal training in the responsible conduct of research. This course was developed and offered
for the first time in the fall of 1996 in order to meet the federal requirements
for these trainees. Since that time,
a number of schools and departments at IUPUI have chosen to require their
graduate students to take this course.
In December of 2000, the Office of Research Integrity (ORI) announced a
new federal policy that all research staff on NIH-supported grants would be
required to document formal training in research ethics. The original deadline was October 2003
for all research staff to have received a program of instruction. On February 5, 2001, the Bush
Administration suspended the implementation policy. Implementation is now occurring on a piecemeal basis, (e.g.
the current requirement for all key personnel on projects involving research
with human subjects to document training in human subjects research). However, there is a high likelihood
that the policy will be implemented at some point in the future.
The course covers historical and contemporary issues
related to scientific integrity and the responsible conduct of research
including policies and procedures related to scientific misconduct, authorship
and peer review, conflicts of interest, the use of humans and animals in
biomedical research, the ownership of data, intellectual property,
international research and ethical issues related to genetic technology.
Purpose: One
definition of the word ěethicalî is ěconforming to accepted standards,
especially professional standards, of conduct.î The purpose of this class is not to inculcate virtue, nor to
determine whether or not you are ethical; rather, the purpose is to inform you
about the rules and the accepted standards of behavior and to help you develop
skills for dealing with hard problems on your own. This is important because all too often there are no hard
and fast rules for determining what is the proper thing to do. Standards of conduct may vary from
community to community, or even from discipline to discipline. While students often find this fact
frustrating, it also means that one must learn to think through these issues
for oneself in order to develop a plan of action that is defensible to oneself
in the event that one may have to explain it to others.
About the Course Director: I
organized the course in 1995 and have taught in and directed the course since
that time. I was the Executive
Secretary for the Chair of the IUPUI Committee on Ethics in Research from
1995-1998 and was Chair of the Committee from 1998-2002. I am a psychologist by training and am
currently a tenured Professor in the Department of Medical and Molecular
Genetics. I am also a Core Faculty
member of the IU Center for Bioethics established in 2001.
Course Goals: The
goals are that at the end of this course, students will be able to:
Course Objective: The
primary objective of this course is to provide graduate students, postdoctoral
students, and faculty with skills and resources valuable for survival. The primary goals of this course are:
Texts:
Macrina FL (Ed.) Scientific
Integrity: An Introductory Text with Cases.
Washington, D.C., ASM Press, Second Edition, 2000.
The following readings
will be handed out in class.
Bebeau MJ Developing a
well-reasoned response to a moral problem in scientific research in Moral
Reasoning in Scientific Research: Cases for Teaching and Assessment developed by MJ Bebeau, KD Pimple, KMT Muskavitch, SL
Borden, and DH Smith, 1995.
Grading:
This
course may be taken either for a grade or Pass/Fail. If you wish to take the course Pass/Fail, you will need to
register for this option with the registrar when you sign up for the course or
during the first few weeks in class.
The deadline for choosing the Pass/Fail option is September 13,
2005. If you do not register for this option, you will
receive a grade.
In
order to meet the needs of the various constituents on campus, this course can
be taken for variable credit ranging from 2-3 credits. The expectations for each of these
credit options are explained below.
Attendance will be taken.
1. Two Credits
Students
who are taking this class for two credits are expected to attend and to
participate actively in all sessions.
In addition there will be two written case analyses and a final
examination. For those of you who
wish to take the course for a grade, the grading for the course is as follows:
Attendance/Class Participation 10%
Written Assignments 30%
Final Examination 60%
2. Three Credits
Students
who are taking this class for three credits are expected to attend and to
participate actively in all sessions.
In addition to two written assignments and a final examination, there
will be an 8-10 page paper. Paper
topics must be approved by me by mid-semester. For those of you who wish to take the course for a
grade, the grading for the course is as follows:
Attendance/Class Participation 10%
Written Assignments (Cases) 20%
Paper 20%
Final Examination 50%
Case Analysis: One way
to learn to think through these issues is through case analysis. We will be discussing various cases in
class. Most will be short cases
from your book and are listed as cases for discussion for that day. For some days, the last part of the
class will consist of a discussion of cases related to the topic of the
day. You will occasionally be
asked to break into groups to discuss the cases amongst yourselves and then
present your conclusions to the class in an organized manner. When we break into groups, I
suggest that each group choose one presenter to present the case to the rest of
the class and one recorder to take notes of the discussion.
You
will be given a monograph: Bebeau MJ Developing a well-reasoned response to a moral
problem in scientific research in Moral Reasoning in Scientific Research:
Cases for Teaching and Assessment
developed by MJ Bebeau, KD Pimple, KMT Muskavitch, SL Borden, and DH Smith,
1995. Please read through this
carefully. This monograph is to be
used as a guide for discussing cases and for writing up the cases.
Each
case will be evaluated on the basis of the following criteria:
1. Identification of issues and points of conflict presented in
the case.
2. Identification of interested parties
3. Identification of possible actions and consequences
4. Identification of obligations of interested parties
5. Conclusion and rationale: In other words, you must come to a
conclusion regarding what is the proper thing to do and justify your
conclusion. This justification
should refer to specific moral principles (Dr. Eberlís lecture should be
helpful), should be logical, and should flow from your conclusion.
Written Assignments: All
written assignments must be typed and must be handed in as a paper copy on the
day of class that the assignment is due.
If there is a problem handing in a paper on time, I must be informed of
this fact prior to the due date for the paper. I know that you are all busy and I try my best to be
flexible.
Analysis
of ethical issues
For this paper, I would like you to present and
analyze an ethical issue in an area of scientific activity that is of
particular interest to you in your own work. Examples might include ethical issues in public health,
research with cognitively impaired subjects, research with children, research
with human biological materials, genetic research on autopsy specimens,
research with animals etc. The
focus should be on the issues in professional ethics for scientists or health
care professionals.
For this assignment, I would like you to write and
analyze a scenario that poses a problem in one of the topics in research ethics
covered in this class. Scenarios
should be similar in length and format to those presented in your textbook at
the end of each chapter, but should be your own work and, preferably, reflect
some of your own experience. The
scenarios should be suitable for discussion in class and if they are based in
fact, should contain no identifying information. Your analysis can follow that presented in the Bebeau
monograph handed out in class or you may wish to ask questions that arise from
your scenario and then answer the questions. Papers should be 4-5 pages (at least 1000 words) in length
excluding any references.
The final exam will be a take-home open book final
that is handed out on the last day of class. You should complete the final on your own. That is to say that the final is not a
group effort. A word to the wise:
It is not a good thing to plagiarize answers to a final exam for a class in
research ethics. In fact, you
would all be advised to give the citation for your answers on the final. The final should be typed and handed in
to me at my Genetics office, IB130, Room 159.
For those taking the class for three credits, a final
paper is expected. You may look
through the text for a particular topic in research ethics that interests you
and may be especially relevant to your particular specialty or you may analyze
a case that has been in the media.
The paper should be 8-10 pages in length excluding references.
Please discuss the paper topic you have chosen with me
prior to embarking on writing the paper.
The paper is due any time before the last day of class.
Section I: Introduction and Background
Week 1: 8/30/05 - General Orientation to Course
Speaker: Kimberly A. Quaid, Ph.D.
Professor,
Departments of Medical and Molecular Genetics, Psychiatry and Medicine
Core
Faculty, Indiana University Center for Bioethics
Also,
if you want to understand why anyone really cares about this stuff, I suggest
the following: Go to: http://www.healtoronto.com/gallodocs.html
Readings:
Read the Executive Summary. Robert Gallo is the scientist who claimed to have
discovered the AIDS virus. As you
might imagine, this was a really big deal in the science world. Gallo was accused of stealing the virus
from a group of French scientists. Believe me, it is fascinating reading.
Walter Stewart and Ned Feder are the Click and Clack
of research integrity. Drs.
Stewart and Feder were NIH employees who took it as their sacred mission to
ferret out research misconduct. In
the process, they made many enemies and they were eventually ordered to cease
these activities by NIH.
Week 2: 9/6/05 - Introduction to Ethical Theory
Speaker: Jason Eberl, Ph.D.
Assistant
Professor, Department of Philosophy
Readings:
1.
Fuchs BA and Macrina FL,
Chapter 2: Ethics and the Scientist in Scientific Integrity pages 17-27.
Week 3: 9/13/05 - History of Science and
Misconduct
Speaker: William Schneider, Ph.D.
Professor,
Department of History
Core
Faculty, Indiana University Center for Bioethics
Readings:
1. ěThe
Establishment of Institutional Review Boards in the U.S.: Background Historyî http://www.iupui.edu/~histwhs/G504.dir/irbhist.html
Week 4: 9/20/05 - Scientific Misconduct: Current Definitions, Policies and
Procedures
Speaker: Kimberly A. Quaid, Ph.D.
Professor,
Department of Medical and Molecular Genetics
Core
Faculty, Indiana University Center for Bioethics
Readings:
1. Macrina
F. Chapter 1: Methods, Manners and Mandates. In Scientific Integrity pages 1-16.
2. Guidelines
for the Conduct of Research at the National Institutes of Health. In Scientific Integrity, pgs. 289-295.
3. Go
to: http://www.indiana.edu/~policies/. Go to Research Policies for the Office
of Research and University Graduate School. Click on IU Policies and Procedures. Go to Research Compliance and click.
Print out Indianapolis policy for Research Misconduct and bring to class.
For
discussion: To be handed out
week before.
Hilts PJ. The Science Mob: The David Baltimore Case
– And
Its Lessons. In Research Ethics: A reader. D Elliot
and JE Stern (eds.) University Press of New England: Hanover, N.H, 1997. Pages
43-51.
Roberts L. Misconduct: Caltechís
Trial by Fire in Research Ethics: A reader. D Elliot and JE Stern (eds.)
University Press of New England: Hanover, N.H, 1997. Pages 60-68.
Section
II: General Topics
Week 5: 9/27/05 - Authorship, Collaboration,
Publication and Reviewing Practices
Speaker: Kimberly A. Quaid, Ph.D.
Professor,
Departments of Medical and Molecular Genetics, Psychiatry and Medicine
Core
Faculty, Indiana University Center for Bioethics
Readings:
1.
Macrina FL Chapter
4: Authorship and Peer Review. In Scientific
Integrity pages 49-66.
2.
Macrina FL, Chapter 8:
Collaborative Research in Scientific Integrity pages 157-170.
3.
Go to: http://www.onlineethics.org. Scroll down to Research Ethics and
click. Scroll down to educational resources and click. Scroll down and click on Responsible
Authorship. Scroll down to
Readings for Biomedical Research. Read Uniform Requirements for Manuscripts
Submitted to Biomedical Journals- Updated May 2000 by International Committee
of Medical Journal Editors (ICMJE)
4.
ORI Working Definition
of Plagiarism – Go to: http://ori.dhhs.gov
5.
Go to the ORI newsletter
for December 1994, Vol.3, No.1, page 5.
For
discussion:
Case: 4.5, p.67 and 4.9, p 68 in Scientific
Integrity
Week 6: 10/04/05 - Animal Rights and Animal Welfare
Speaker:
Lisa Pompos, DVM
Assistant Director, Laboratory Animal Resource Center
Readings:
1. Fuchs
BA. Chapter 6: Use of animals in biomedical experimentation. In Scientific
Integrity pages 101-121.
2. Go
to: http://www.iupui.edu/~resgrad/ Click on Research and Sponsored
Programs. Click on Research
Compliance. Find Animal Care and
Welfare (IACUC) and click on Policy on Research Involving Animals. Print and bring
to class.
3. Read
case: 6.4 p. 122 for discussion
Week 7: 10/11/05 - Implications of HIPAA for
Research
Speaker: Marcia Gonzalez, J.D.
Compliance
Office and Privacy Officer
Indiana
University School of Medicine
Readings:
1.
Go to: http://www.iupui.edu/~resgrad/ Click on HIPAA information. Print
Glossary. Bring to class.
Topic Oriented Paper Due TODAY!!!!!!!!!
Week 8: 10/18/05 - History of Research with
Human Subjects
Speaker: William Schneider, Ph.D.
Professor,
Department of History
Core
Faculty, Indiana University Center for Bioethics
Readings: Will be handed out the week before.
1. Brandt
AM (1978) Racism and Research: The case of the Tuskegee Syphilis Study. The
Hastings Center 8:21-29.
2.Ý Rothman DJ (1982) Were Tuskegee and Willowbrook "Studies in Nature"? The Hastings Center 12:5-7.
3.Ý The Hastings Center
12:5-7.
4.ÝÝ Vonderlehr RA, Clark T,
Wenger OC and Heller JR (1936) Untreated syphilis in the male negro. Venereal Disease Information
17:260-265.
5.ÝÝ Pesare PJ, Bauer TJ,
Gleeson GA (1950) Untreated syphilis in the male negro: Observation of abnormalities
over sixteen years. American Journal of Syphilis, Gonorrhea, and Venereal
Diseases. 34:201-213.
Click here for a copy of the visual presentation in class
You may also want to
browse the following:
1. Go
to: http://www.med.virginia.edu/hs-library/historical/apology/whouse.html
Read Report on Tuskegee and President Clinton's
apology.
2. The
Nuremberg Code for Research with Human Subjects:
http://ohsr.od.nih.gov/guidelines/nuremberg.html
3. World
Medical Association. Declaration of Helsinki
"Ethical Principles for Medical Research Involving Human Subjects"
(1964, revised through 2002) at: http://www.wma.net/e/policy/b3.htm
4. Go to the Belmont Report: http://ohsr.od.nih.gov/guidelines/belmont.html.
Week 9: 10/25/05 – Film: Miss Evers Boys
I
will be showing the film, ěMiss Evers Boys,î a fictionalized account of the
Tuskegee Syphilis Study.
Week 10: 11/01/05
- Research with Human Subjects: Governmental
Regulations and The Role of the IRB
Speaker: Shelley Bizila
Director,
Research Compliance Administration, IUPUI
Readings:
1. Swerdlow
PS. Chapter 5: Use of Humans in Biomedical Experimentation. In Scientific
Integrity pages 73-90.
2. National
Bioethics Advisory Commission Go to: http://www.georgetown.edu/research/nrcbl/nbac/ Go to REPORTS,
Go to: Ethical and Policy Issues in Research Involving Human Participants. Read Final Recommendations, August 2001.
Activity:
Think you know everything about Human Subjects?
Log on to: http://www.iupui.edu/~resgrad. Click on Research and Sponsored Programs, then click on Human Subjects
Certification. Read:
IU Important Notice 00-5. Click on
Test and take it.
For
discussion:
Case 5.9, p 92, Scientific Integrity
Case 5.12, p 93-94, Scientific Integrity
Case 5.2, p 90, Scientific Integrity
Week 11: 11/08/05 - Ownership of Data, Intellectual Property and Copyright
Speaker: Kenneth Crews
Copyright
Management Center
Readings:
1.
Mays TD Chapter 9:
Ownership of data and intellectual property. In Scientific Integrity pages 179-200.
2.
Read in detail: http://www.umi.com/dissertations/copyright/
3. Take
a general look at the website for the Office of Copyright Management at http://www.copyright.iupui.edu
The only 15 letter word that can be spelled without
replicating a letter is:
UNCOPYRIGHTABLE
Week 12: 11/15/05 - International Research
Ethics
Speaker: Eric M. Meslin, Ph.D.
Director,
Indiana University Center for Bioethics
Professor
of Medicine, Medical and Molecular Genetics, and Philosophy
Readings:
1. Ruth Macklin, Double Standards in Medical Research in Developing Countries, Cambridge: Cambridge University Press, 2004, pp. 1-35.
Speaker: Rose F. Fife, M.D.
Associate
Dean for Research
Barbara
F. Kampen Professor of Womenís Health
Professor
of Medicine, Biochemistry and Molecular Biology
Chair,
Conflict of Interest Committee
Readings:
1. Bradley
SG Chapter 7: Managing Conflicting Interests in Scientific Integrity pages 131-151.
2. Go
to: http://www.iupui.edu/~resgrad/ Click on Research and Sponsored
Programs. Click on Policies. Click on ěPolicies on Conflict of
Interestî. Print and bring to
class.
Week 14: 11/29/05
- Genetic Technology and Research on Human Specimens
Speaker: Kimberly A. Quaid, Ph.D.
Professor,
Departments of Medical and Molecular Genetics, Psychiatry and Medicine
Core
Faculty, Indiana University Center for Bioethics
Readings:
1. Munro
CL Chapter 10: Genetic technology
and scientific integrity. In Scientific Integrity pages 211-223.
2.
National Bioethics
Advisory Commission, Research Involving Human Biological Materials: Ethical
Issues and Policy Guidance
http://www.georgetown.edu/research/nrcbl/nbac/ [Read the Executive Summary]
Case Analysis Paper Due
Week 15: 12/6/05 - Case Presentations & Handout Final Examination
On-Line Resources on Research
Ethics
http://www.lemoyne.edu/OTRP/otrpresources/otrp_sci-misc.html
http://www.indiana.edu/~poynter/tre-onln.html#syllabi
http://www.research.umn.edu/ethics/