ETHICS AND INTEGRITY: US and International Issues
Hygiene Bldg. W3030
Nancy Kass, ScD, Instructor
Andrea Ruff, MD, Instructor
Jason Flikier, Head Teaching Assistant
Jennifer Manganello, Teaching Assistant
Jennifer Wolff, Teaching Assistant
The purpose of this course is to acquaint
students with an introduction to ethical theory and principles,
and for students to become familiar with ethics requirements when
conducting research with human subjects in the U.S. and/or developing
countries. Through lectures and small group case discussion, the
following topics will be covered: ethical theory and principles,
informed consent in research; Institutional Review Boards; the just
selection of research participants; cultural relativism; ethical
issues in vaccine research; ethics and human rights; appropriate
use of placebos; what is owed to research participants, communities,
and countries after research is completed; the use of animals in
research; and scientific and academic integrity. For small group
case discussions and for assignments, students will have the choice
of working through research examples either from the U.S. setting
or a developing country setting. Student evaluation is based on
classroom participation, an in-class exercise, a consent assignment,
individual and group case analysis work, and a final exam. This
course satisfies the NIH's and the School's requirement for training
in the responsible conduct of research.
A reading packet may be purchased from the
Matthews Medical Bookstore. Readings also are on reserve at the
Lilienfeld Library, 9th floor of Hampton House and the
Lilienfeld satellite library on the 2nd floor of Hygiene.
Please note that in the syllabus, a reading with an asterisk (*)
next to it is a reading that is available on-line.
- Participation: You are required to attend class,
keep up with the reading, and participate in class. Attendance
sheets will be distributed during each class session. It is YOUR
responsibility to sign one of these during each class session.
Anyone who misses more than four class sessions will be required
to complete an extra assignment, namely, a summary of some articles
that had been assigned for the sessions you missed.
If you miss class, it is your responsibility to go to the course
website (described below) to get any handouts that were distributed
- In-class exercises: There will be several in-class
exercises distributed throughout the quarter, in which you are
required to participate. These include serving on a "mock
IRB" and analyzing cases. In-class exercises will be ungraded,
and you may work with other students on these exercises.
- Consent assignment: You will be provided with
a choice of two research projects (one from the U.S.; one international)
and are required to write a consent form for the selected
study, and also to draft a one-paragraph description of the consent
process that ought to occur for that project. More extensive
instructions will be distributed with the assignment. This assignment
will be graded, and it must be done on your own; that
is, you should not work with other students on this assignment.
The consent form assignment will be distributed in class on Thursday,
January 31st , and will be due on Thursday, February 7th.
One point will be deducted for every day the assignment is
late, if no prior arrangements were made.
- Case analysis assignment: You are required
to write two, short case analyses (approximately 1-2 pages each,
for a total of about 3 pages, double spaced, 12 font). You will
be asked to apply the skills learned in class to write the analyses.
This assignment must be done on your own; that is, you
should not work with other students. The cases will be distributed
in class on Thursday, February 14th, and are due
on Tuesday, February 26th. One point will
be deducted for every day the assignment is late, if no prior
arrangements were made.
- Final exam: A final exam will be held during
class on Thursday, March 14th. Any
conflicts with this date must be discussed in advance
with the instructor. The final exam is a closed-book exam. It
is comprehensive and will ask you questions about the range of
topics covered in class and in the readings. Some of the questions
are short answer/multiple choice; some of the questions ask you
to write 2-3 sentences defining or describing a topic; some of
the questions ask you to write 1/3 to ½ a page responding
to a short case description or a research ethics dilemma.
Your final grade for this class is based
on the total number of points you accumulate out of a possible total
of 100 points.
- 1. You receive 5 points for showing up;
- You receive 5 points for participating;
- The consent assignment is worth 20 points;
- The case analysis assignment is worth 30 points;
- The final exam is worth 40 points.
Late assignments: One
point will be deducted for every day an assignment is late,
if no prior arrangements were made.
Dr. Kass can be reached by email at firstname.lastname@example.org
or by phone at 955-0310. Appointments can be made through Dr. Kass'
assistant, Shawn Storer, HH 348, at 614-1235.
Dr. Andrea Ruff can be reached by email
at email@example.com or by phone
at 955-1633. Dr. Ruff's office is Hygiene 5515. Appointments can
be made directly through Dr. Ruff.
Jason Flikier can be reached by email at
will hold office hours on Thursdays from 3-4 pm in Hampton House
Jennifer Manganello can be reached by email
at firstname.lastname@example.org. Her
office hours will be Thursdays from 11-12 in Hampton House 349.
Jennifer Wolff can be reached by email
at email@example.com. Her office
hours will be Tuesdays from 3-4 pm in Hampton House 447.
Please address e-mail inquiries concerning
the class too all of the above, when possible, so that the first
available person can answer your questions.
A web supplement site has been developed
for this course. The web site includes the syllabus, course description,
and links to other sites of interest. The site will be updated after
every class to include hand-outs and assignments, as relevant. Please
go to the web site to get the hand outs if you ever need to miss
class. To access the web site,
1.1 go to: http://www.jhsph.edu/~distance/
1.2 click: Online Courses
1.3 click: supplements to on-site courses
1.4 click: Research Ethics and Integrity under Department of Health
Policy and Management
1.5 Password is: ResEth
RESEARCH ETHICS AND INTEGRITY:
U.S. and International Issues
- TUESDAY, JANUARY 22: ETHICAL THEORY, PRINCIPLES
OF BIOETHICS, AND FORMAL CODES OF RESEARCH ETHICS, DR. NANCY KASS
- Beauchamp TL and Walters L. Contemporary Issues in Bioethics,
5th edition. Belmont, California: Wadsworth Publishing
Company, 1999, Chapter 1, "Ethical Theory and Bioethics",
References: Appendix A
- "The Nuremberg Code" (1949)
- World Medical Association, "Declaration of Helsinki"
- The National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research, “The Belmont
- Council for International Organizations of Medical Sciences
(CIOMS), in collaboration with the World Health Organization
(WHO), (Z. Bankowski and R.J. Levine, eds.) Ethics
and Research on Human Subjects: International Guidelines,
“International Ethical Guidelines for Biomedical Research
Involving Human Subjects”, Geneva: CIOMS, 1993.
- United Nations General Assembly Resolution 217 (1). Universal
Declaration of Human Rights. December 10, 1948.
- Table: Comparison of Regulations/Guidelines Governing Research
with Human Subjects
- Table: Chronology of guidelines concerned with biomedical
research from Nuffield Report.
- THURSDAY, JANUARY 24: AUTONOMY-BASED CONCERNS:
RESPECT FOR PERSONS AND INFORMED CONSENT, DR. NANCY KASS
- Reich WT, (ed.). Encyclopedia of Bioethics, Volume 3, revised
ed. New York: Simon & Schuster, 1995, pp. 1232-1241.
- Gostin L. (1995). Informed consent, cultural sensitivity,
and respect for persons. Journal of American Medical Association,
- Tangwa, G. (2000). The traditional African perception of
a person: Some implications for bioethics. Hastings Center
Report 30(5): 39-43.
- TUESDAY, JANUARY 29: BENEFICENCE-BASED CONCERNS:
THE WELFARE OF RESEARCH PARTICIPANTS, DR. NANCY KASS
- Levine RJ. Ethics and Regulation of Clinical Research,
New Haven: Yale University Press, 1988, Chapter 3, “Balance
of Harms and Benefits”, pp. 37-65.
- Emanuel EJ, Wendler D, Grady C. (2000). What makes clinical
research ethical? JAMA 283(20): 2701-11.*
CASE DISCUSSION: Hopkins/Kennedy-Krieger Institute
- THURSDAY, JANUARY 31: JUSTICE-BASED CONCERNS:
VULNERABLE POPULATIONS, HOLLY TAYLOR, PHD, MPH, ASSISTANT RESEARCH
PROFESSOR, BIOETHICS INSTITUTE AND DEPARTMENT OF HEALTH POLICY
- Anna Mastroianni, Ruth Faden, and Daniel Federmen (eds.)
Women and Health Research, Vol I, Washington, D.C:
National Academy Press, 1994, Chapter 3, “Justice in
Clinical Studies: Guiding Principles,” pp. 75-83.
- Mastrioianni A, Kahn J. (2001). Swinging on the Pendulum:
Shifting Views of Justice in Human Subjects Research. Hastings
Center Report 31(3): 21-28.
Articles on special populations – choose to read ONE
of the following:
- National Bioethics Advisory Commission. (1998). Chapter
1: An Overview of the Issues. In Volume 1 Report and Recommendations:
Research Involving Persons with Mental Disorders that May
Affect Decisionmaking Capacity, pp. 1-15.
- Grodin M and Alpert J. (1998). Children as participants
in medical research. The Pediatric Clinics of North America,
- TUESDAY, FEBRUARY 5: “MOCK IRB”:
INTRODUCTION TO THE INSTITUTIONAL REVIEW BOARD, AND IN CLASS EXERCISE
U.S.: Privacy and confidentiality experiences
of persons with genetic and other chronic conditions
International: Rotavirus case
- Edgar H and Rothman D. (1995). The Institutional Review
Board and Beyond: Future Challenges to the Ethics of Human
Experimentation. The Milbank Quarterly, 73(4): 489-506.
- JHU Committee On Human Research Checklist for Reviewers
(to be distributed in class)
References: Appendix B
- Department of Health and Human Services, National Institutes
of Health, Office for Protection from Research Risks, Code
of Federal Regulations, Title 45, Part 46 “Protection
of Human Subjects.”
- THURSDAY, FEBRUARY 7: THE TUSKEGEE SYPHILIS
STUDY (VIDEO IN CLASS)
- King PA. (1992). The Dangers of Difference. Hastings
Center Report 22: 35-38.
- Jones JH. (1992). The Tuskegee Legacy: AIDS and the Black
Community. Hastings Center Report 22: 38-40.
- Northington-Gamble V. (1997). Under the Shadow of Tuskegee:
African Americans and Health Care. American Journal of
Public Health 8(11):1773-1778.*
- TUESDAY, FEBRUARY 12: ETHICAL ISSUES IN STUDY
DESIGN. STEVEN GOODMAN, M.D., PH.D, ASSOCIATE PROFESSOR, DEPARTMENTS
OF ONCOLOGY, BIOSTATISTICS AND EPIDEMIOLOGY
- Hellman S and Hellman D. (1991). Of mice but not men: problems
of the randomized clinical trial. NEJM 324: 1585-9.
- Passamani E. (1991). Clinical trials- Are they ethical?
NEJM 324: 1589-1592.
- Lurie P and Wolfe S. (1997). Unethical trials of interventions
to reduce perinatal transmission of the human immunodeficiency
virus in developing countries. NEJM, 337(12): 853-856.*
- Varmus H and Satcher D. (1997). Ethical complexities of
conducting research in developing countries. NEJM,
- THURSDAY, FEBRUARY 14: DISTINGUISHING RESEARCH
FROM PRACTICE: HEALTH PROGRAM EVALUATION, HEALTH SERVICES RESEARCH,
AND OPERATIONS RESEARCH, DR. NANCY KASS
- CDC Guidance Document on Distinguishing Research from non-Research.
- Institute of Medicine. Protecting Data Privacy in Health
Services Research, Executive Summary. National Academy
Press, Washington, D.C.
CASE DISCUSSION: U.S.: Managed
care case; International: "What is research?"
- TUESDAY, FEBRUARY 19: CLINICAL RESEARCH,, DR.
CHARLES FLEXNER, ASSOCIATE PROFESSOR OF CLINICAL PHARMACOLOGY,
SCHOOL OF MEDICINE,
- Winerip M. (1998). Fighting for Jacob. New York Times Sunday
Magazine (December 6): 1-15.
- THURSDAY, FEBRUARY 21: HOST COUNTRY PRIORITIES,
DR. ANDREA RUFF, ASSOC. PROFESSOR, DEPT. OF INTERNATIONAL HEALTH;
INTERNATIONAL CASE STUDY, HIV/AIDS VACCINE TRIAL
- UNAIDS, Draft Scenario of Hypothetical HIV Vaccine Study
- UNAIDS Guidance Document. (2000). Ethical considerations
in HIV preventive vaccine research (to be distributed
- Macklin R, “International Research and Ethical Imperialism,”
Chapter 8 in Against Relativism: Cultural Diversity and
the Search for Ethical Universals in Medicine, New York:
Oxford University Press, 1999, pp. 188-217.
- Edejer T. (1999). North-South Research partnerships: the
ethics of carrying out research in developing countries. BMJ
- TUESDAY, FEBRUARY 26: PROFESSIONAL ETHICS:
ROLE RESPONSIBILITIES, AUTHORSHIP, AND ACADEMIC INTEGRITY, DR.
- Institute of Medicine, National Academy of Sciences, Responsible
Science: Ensuring the Integrity of the Research Process,
Washington, D.C.: National Academy Press, 1992, “Introduction,”
- Rennie D, Yank V, Emanuel L. (1997). When authorship fails:
A proposal to make contributors accountable. JAMA 278(7):
- THURSDAY, FEBRUARY 28: ETHICAL ISSUES IN ANIMAL
RESEARCH, ALAN GOLDBERG, PHD, PROFESSOR OF ENVIRONMENTAL HEALTH
SCIENCES; DIRECTOR, CENTER FOR ALTERNATIVES TO ANIMAL TESTING
- Russell WMS and Burch RL. The Principles of Humane Experimental
Technique. Read Chapter 2, “The Concept of Inhumanity”,
and scan the rest of the book at your discretion. Full-text
version available on-line at: @ltweb
References: Appendix C
U.S. Department of Health and Human Services, Public Health
Services. Instructions for PHS 398, Sections pertaining
to research on animals.
- TUESDAY, MARCH 5: HUMAN RIGHTS AND RESEARCH
ETHICS, DR. CHRIS BEYRER, ASSOCIATE RESEARCH PROFESSOR, DEPARTMENT
- Beyrer C and Kass N. Human rights, politics, and research
ethics review. DRAFT manuscript.
- Beyrer C. (1998). Burma and Cambodia: Human rights, social
disruption, and the spread of HIV/AIDS. Health and Human
Rights 2(4): 84-97. FINANCIAL AND OTHER
- THURSDAY, MARCH 7: CONFLICT OF INTEREST, DR.
ANDREA RUFF, ASSOC. PROFESSOR, DEPT. OF INTERNATIONAL HEALTH
- Davidoff F. (1997). Where’s the Bias? Annals
of Internal Medicine 126: 986-8.*
- Press E and Washburn J. (2000). The Kept University. Atlantic
Monthly (March): 39-54.
- TUESDAY, MARCH 12: PRIVACY AND CONFIDENTIALITY
OF RESEARCH DATA, DR. MICHAEL SWEAT, ASSISTANT PROFESSOR, INTERNATIONAL
- A. Macklin R. (1999). Chapter 1: Cultural and Ethical Relativism.
In: Against Relativism: Cultural Diversity and the Search
for Ethical Universals in Medicine. Oxford University
Press: New York, pp. 1-23.
- B. Levine RJ, Ethics and Regulation of Clinical Research.
New Haven: Yale University Press, 1988, Chapter 7: “Privacy
and Confidentiality,” pp. 163-181.
- THURSDAY, MARCH 14: FINAL EXAM IN CLASS