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RESEARCH ETHICS AND INTEGRITY: US and International Issues

HPM 306.665
Tuesday/Thursday 1:30-3:00PM
Hygiene Bldg. W3030

Nancy Kass, ScD, Instructor
Andrea Ruff, MD, Instructor
Jason Flikier, Head Teaching Assistant
Jennifer Manganello, Teaching Assistant
Jennifer Wolff, Teaching Assistant

COURSE OBJECTIVE:

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.

REQUIRED READINGS:

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.

COURSE REQUIREMENTS and ASSIGNMENTS:

  1. 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 that day.


  2. 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.


  3. 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.


  4. 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.


  5. 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.

GRADING POLICY:

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. 1. You receive 5 points for showing up;
  2. You receive 5 points for participating;
  3. The consent assignment is worth 20 points;
  4. The case analysis assignment is worth 30 points;
  5. 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.

COMMUNICATION WITH COURSE INSTRUCTORS:

Dr. Kass can be reached by email at nkass@jhsph.edu 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 aruff@jhsph.edu 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 jflikier@jhsph.edu. Jason will hold office hours on Thursdays from 3-4 pm in Hampton House 349.

Jennifer Manganello can be reached by email at jmangane@jhsph.edu. Her office hours will be Thursdays from 11-12 in Hampton House 349.

Jennifer Wolff can be reached by email at jwolff@jhsph.edu. 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.

WEBSITE

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

306.665: RESEARCH ETHICS AND INTEGRITY:

U.S. and International Issues
2002
SYLLABUS

  1. TUESDAY, JANUARY 22: ETHICAL THEORY, PRINCIPLES OF BIOETHICS, AND FORMAL CODES OF RESEARCH ETHICS, DR. NANCY KASS
    1. Beauchamp TL and Walters L. Contemporary Issues in Bioethics, 5th edition. Belmont, California: Wadsworth Publishing Company, 1999, Chapter 1, "Ethical Theory and Bioethics", pp. 10-30.

    References: Appendix A

    1. "The Nuremberg Code" (1949)
    2. World Medical Association, "Declaration of Helsinki"
    3. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report” (1979)
    4. 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.
    5. United Nations General Assembly Resolution 217 (1). Universal Declaration of Human Rights. December 10, 1948.
    6. Table: Comparison of Regulations/Guidelines Governing Research with Human Subjects
    7. Table: Chronology of guidelines concerned with biomedical research from Nuffield Report.
  2. THURSDAY, JANUARY 24: AUTONOMY-BASED CONCERNS: RESPECT FOR PERSONS AND INFORMED CONSENT, DR. NANCY KASS
    1. Reich WT, (ed.). Encyclopedia of Bioethics, Volume 3, revised ed. New York: Simon & Schuster, 1995, pp. 1232-1241.
    2. Gostin L. (1995). Informed consent, cultural sensitivity, and respect for persons. Journal of American Medical Association, 274(10): 844-45.*
    3. Tangwa, G. (2000). The traditional African perception of a person: Some implications for bioethics. Hastings Center Report 30(5): 39-43.
  3. TUESDAY, JANUARY 29: BENEFICENCE-BASED CONCERNS: THE WELFARE OF RESEARCH PARTICIPANTS, DR. NANCY KASS
    1. Levine RJ. Ethics and Regulation of Clinical Research, New Haven: Yale University Press, 1988, Chapter 3, “Balance of Harms and Benefits”, pp. 37-65.
    2. Emanuel EJ, Wendler D, Grady C. (2000). What makes clinical research ethical? JAMA 283(20): 2701-11.*

    CASE DISCUSSION: Hopkins/Kennedy-Krieger Institute lead study

  4. THURSDAY, JANUARY 31: JUSTICE-BASED CONCERNS: VULNERABLE POPULATIONS, HOLLY TAYLOR, PHD, MPH, ASSISTANT RESEARCH PROFESSOR, BIOETHICS INSTITUTE AND DEPARTMENT OF HEALTH POLICY AND MANAGEMENT
    1. 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.
    2. 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:

    1. 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.

      2. OR

    2. Grodin M and Alpert J. (1998). Children as participants in medical research. The Pediatric Clinics of North America, 25(6): 1389-1401.*
  5. 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

    1. 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.
    2. JHU Committee On Human Research Checklist for Reviewers (to be distributed in class)

    References: Appendix B

    1. 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.”
  6. THURSDAY, FEBRUARY 7: THE TUSKEGEE SYPHILIS STUDY (VIDEO IN CLASS)
    1. King PA. (1992). The Dangers of Difference. Hastings Center Report 22: 35-38.
    2. Jones JH. (1992). The Tuskegee Legacy: AIDS and the Black Community. Hastings Center Report 22: 38-40.
    3. Northington-Gamble V. (1997). Under the Shadow of Tuskegee: African Americans and Health Care. American Journal of Public Health 8(11):1773-1778.*
  7. TUESDAY, FEBRUARY 12: ETHICAL ISSUES IN STUDY DESIGN. STEVEN GOODMAN, M.D., PH.D, ASSOCIATE PROFESSOR, DEPARTMENTS OF ONCOLOGY, BIOSTATISTICS AND EPIDEMIOLOGY
    1. Hellman S and Hellman D. (1991). Of mice but not men: problems of the randomized clinical trial. NEJM 324: 1585-9.
    2. Passamani E. (1991). Clinical trials- Are they ethical? NEJM 324: 1589-1592.
    3. 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.*
    4. Varmus H and Satcher D. (1997). Ethical complexities of conducting research in developing countries. NEJM, 337(14): 1003-1005.*
  8. THURSDAY, FEBRUARY 14: DISTINGUISHING RESEARCH FROM PRACTICE: HEALTH PROGRAM EVALUATION, HEALTH SERVICES RESEARCH, AND OPERATIONS RESEARCH, DR. NANCY KASS
    1. CDC Guidance Document on Distinguishing Research from non-Research.
    2. 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?" case

  9. TUESDAY, FEBRUARY 19: CLINICAL RESEARCH,, DR. CHARLES FLEXNER, ASSOCIATE PROFESSOR OF CLINICAL PHARMACOLOGY, SCHOOL OF MEDICINE,
    1. Winerip M. (1998). Fighting for Jacob. New York Times Sunday Magazine (December 6): 1-15.
  10. THURSDAY, FEBRUARY 21: HOST COUNTRY PRIORITIES, DR. ANDREA RUFF, ASSOC. PROFESSOR, DEPT. OF INTERNATIONAL HEALTH; INTERNATIONAL CASE STUDY, HIV/AIDS VACCINE TRIAL
    1. UNAIDS, Draft Scenario of Hypothetical HIV Vaccine Study Proposal.
    2. UNAIDS Guidance Document. (2000). Ethical considerations in HIV preventive vaccine research (to be distributed in class).
    3. 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.
    4. Edejer T. (1999). North-South Research partnerships: the ethics of carrying out research in developing countries. BMJ 319: 438-441.*
  11. TUESDAY, FEBRUARY 26: PROFESSIONAL ETHICS: ROLE RESPONSIBILITIES, AUTHORSHIP, AND ACADEMIC INTEGRITY, DR. NANCY KASS
    1. Institute of Medicine, National Academy of Sciences, Responsible Science: Ensuring the Integrity of the Research Process, Washington, D.C.: National Academy Press, 1992, “Introduction,” pp. 17-35.
    2. Rennie D, Yank V, Emanuel L. (1997). When authorship fails: A proposal to make contributors accountable. JAMA 278(7): 579-585.
  12. THURSDAY, FEBRUARY 28: ETHICAL ISSUES IN ANIMAL RESEARCH, ALAN GOLDBERG, PHD, PROFESSOR OF ENVIRONMENTAL HEALTH SCIENCES; DIRECTOR, CENTER FOR ALTERNATIVES TO ANIMAL TESTING
    1. 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.

  13. TUESDAY, MARCH 5: HUMAN RIGHTS AND RESEARCH ETHICS, DR. CHRIS BEYRER, ASSOCIATE RESEARCH PROFESSOR, DEPARTMENT OF EPIDEMIOLOGY
    1. Beyrer C and Kass N. Human rights, politics, and research ethics review. DRAFT manuscript.
    2. 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
  14. THURSDAY, MARCH 7: CONFLICT OF INTEREST, DR. ANDREA RUFF, ASSOC. PROFESSOR, DEPT. OF INTERNATIONAL HEALTH
    1. Davidoff F. (1997). Where’s the Bias? Annals of Internal Medicine 126: 986-8.*
    2. Press E and Washburn J. (2000). The Kept University. Atlantic Monthly (March): 39-54.
  15. TUESDAY, MARCH 12: PRIVACY AND CONFIDENTIALITY OF RESEARCH DATA, DR. MICHAEL SWEAT, ASSISTANT PROFESSOR, INTERNATIONAL HEALTH
    1. 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.
    2. B. Levine RJ, Ethics and Regulation of Clinical Research. New Haven: Yale University Press, 1988, Chapter 7: “Privacy and Confidentiality,” pp. 163-181.
  16. THURSDAY, MARCH 14: FINAL EXAM IN CLASS

Last Updated: 11/25/02

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