Classic Readings in Bioethics

The Classic Readings in Bioethics seminar series is co-sponsored by CIRGE and the Stanford Center for Biomedical Ethics. The seminar focuses on discussing a different classic bioethics article, topic, or case, and its relevance to a more recent article or case. Anyone in the Stanford community is welcome to attend.

Classic Readings in Bioethics seminar topics are below, and the full seminar syllabus from past seminars, including readings for each topic, can be found here.

Session 1 - Grimes vs. Kennedy Krieger Institute

  • Mastroianni, A. C., & Kahn, J. P. (2002). Risk and responsibility: ethics, Grimes v Kennedy Krieger, and public health research involving children. American Journal of Public Health 92(7):1073-1076.
  • Buchanan, D. R., & Miller, F. G. (2006). Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions. American Journal of Public Health 96(5): 781-787.
  • Grimes vs. Kennedy Krieger Institute

Session 2 - Vulnerable Subjects

  • Kipnis, K., P. King, N. M., & Nelson, R. M. (2006). Response to Open Peer Commentaries on “An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial”: The Emergency Exception and Unproven/Unsatisfactory Treatment. The American Journal of Bioethics, 6(3), W49-W50.
  • Levine, C., Faden, R., Grady, C., Hammerschmidt, D., Eckenwiler, L., & Sugarman, J. (2004). The limitations of “vulnerability” as a protection for human research participants. The American Journal of Bioethics, 4(3), 44-49.

Session 3 - Emergency Research

  • Watters, D., Sayre, M. R., & Silbergleit, R. (2005). Research conditions that qualify for emergency exception from informed consent. Academic emergency medicine, 12(11), 1040-1044.
  • C. Holloway, K. F. (2006). Accidental communities: Race, emergency medicine, and the problem of PolyHeme®. The American Journal of Bioethics, 6(3), 7-17.
  • Kipnis, K., King, N. M., & Nelson, R. M. (2006). An open letter to institutional review boards considering Northfield Laboratories' PolyHeme® trial. The American Journal of Bioethics, 6(3), 18-21.
  • Magnus, David. (2006). Blood, Sweat and Tears. The American Journal of Bioethics, 6(3), 1-2.
  • Optional: Mann, H. (2006). How Confidential Trial Negotiations and Agreements between the Food and Drug Administration and Sponsors Marginalize Local Institutional Review Boards, and What to Do About It. The American Journal of Bioethics, 6(3), 22-24.

Session 4 - Conflicts of Interest

Session 5 – Tuskegee

  • Jones, J. H. (2008). The Tuskegee syphilis experiment. The Oxford textbook of clinical research ethics, 1681.
  • Brandt, A. M. (1978). Racism and research: the case of the Tuskegee syphilis study. Hastings Center Report, 8(6), 21-29.
  • Pence, G. E. (2007). “Chapter 9: Human Subjects: The Tuskegee Syphilis Study” in Medical ethics: Accounts of the cases that shaped and define medical ethics.

Session 6 - Moore vs. Regents of UC

  • Moore vs. Regents of UC. (1990).
  • Lavoie, J. (1989). Ownership of human tissue: Life after Moore v. Regents of the University of California. Virginia Law Review, 1363-1396.
  • Charo, R. A. (2006). Body of research—ownership and use of human tissue. New England journal of medicine, 355(15), 1517-1519.

Session 7 - Placebo Controls

  • Hill, A. B. (1994). The continuing unethical use of placebo controls. N Engl J Med, 331, 394-398.
  • Emanuel, E. (2001). THE ETHICS OF PLACEBO-CONTROLLED TRIALS—AMiddle GROUND. N Engl J Med, 345(12).
  • Beecher, H.K. (1966). Ethics and clinical research. N Engl J Med, 274: 1354–1360.

Session 8 - 45 CFR 46

  • 45 CFR 46.
  • Moreno, J., Caplan, A. L., & Wolpe, P. R. (1998). Updating protections for human subjects involved in research. JAMA: the journal of the American Medical Association, 280(22), 1951-1958.
    Beecher, H. K. (1966). Consent in clinical experimentation: myth and reality. JAMA: the journal of the American Medical Association, 195(1), 34-35.
  • Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical?. JAMA: the journal of the American Medical Association, 283(20), 2701-2711.

Session 9 - Tarasoff vs. Regents of UC

  • Tarasoff vs. Regents of UC.
  • Appelbaum, P. S. (1985). Tarasoff and the clinician: Problems in fulfilling the duty to protect. The American journal of psychiatry.
  • Appelbaum, P. S., & Rosenbaum, A. (1989). Tarasoff and the researcher. American Psychologist, 44, 219-228.

Session 10 – Autoexperimentation

  • Jonas, H. (1969). Philosophical reflections on experimenting with human subjects. Daedalus, 98(2), 219-247.
  • Caplan, A. L. (1984). Is there a duty to serve as a subject in biomedical research?. IRB: Ethics and Human Research, 6(5), 1-5.

Session 11 - Innovative Research

  • McKneally, M. F., & Daar, A. S. (2003). Introducing new technologies: protecting subjects of surgical innovation and research. World journal of surgery, 27(8), 930-934.
  • Eaton, M. L., & Kennedy, D. (2007). Innovation in medical technology: Ethical issues and challenges. JHU Press.

Session 12 - Undue Inducement

Session 13 - Therapeutic Misconception

  • Appelbaum, P. S., Roth, L. H., & Lidz, C. (1982). The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry, 5(3-4), 319-329.
  • Henderson, G. E., Churchill, L. R., Davis, A. M., Easter, M. M., Grady, C., et al. (2007). Clinical trials and medical care: defining the therapeutic misconception. PLoS medicine, 4(11), e324.

Session 14 - Gelsinger v. University of Pennsylvania

  • Steinbrook, R. (2008). The Gelsinger case. The Oxford Textbook of Clinical Research Ethics, 110-120.
  • Walters, L. (2000). The oversight of human gene transfer research. Kennedy Institute of Ethics Journal, 10(2), 171-174.

Session 15 - Incidental Findings

  • Ravitsky, V., & Wilfond, B. S. (2006). Disclosing individual genetic results to research participants. The American Journal of Bioethics, 6(6), 8-17.
  • Wolf, S. M., Lawrenz, F. P., Nelson, C. A., Kahn, J. P., Cho, M. K., Clayton, E. W. et al. (2008). Managing incidental findings in human subjects research: analysis and recommendations. The Journal of law, medicine & ethics, 36(2), 219-248.

Session 16 – Equipoise

  • Freedman, B. (1987). Equipoise and the ethics of clinical research. Massachusetts Medical Society.
  • Miller, F. G., & Brody, H. (2003). A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials. Hastings Center Report, 33(3), 19-28.

Session 17 - Informed Consent

  • Faden, R. R., Beauchamp, T. L., & King, N. M. (1986). A history and theory of informed consent. Oxford University Press on Demand.
  • Robinson III, S. W. (1988). Opinion in Canterbury v. Spence. US Court of Appeals, District of Columbia Circuit, 464.

Session 18 - Declaration of Helsinki

  • Declaration of Helsinki.
  • Kimmelman, J., Weijer, C., & Meslin, E. M. (2009). Helsinki discords: FDA, ethics, and international drug trials. The Lancet, 373(9657), 13-14.
  • Rid, A., & Schmidt, H. (2010). The 2008 Declaration of Helsinki—First among Equals in Research Ethics?. The Journal of Law, Medicine & Ethics, 38(1), 143-148.

Session 19 - Forensics

  • Greely, H. T., Riordan, D. P., Garrison, N. A., & Mountain, J. L. (2006). Family ties: the use of DNA offender databases to catch offenders' kin. The Journal Of Law, Medicine & Ethics, 34(2), 248-262
  • Cho, M. K., & Sankar, P. (2004). Forensic genetics and ethical, legal and social implications beyond the clinic. Nature genetics, 36, S8-S12.
  • Ossorio, P., & Duster, T. (2005). Race and genetics: controversies in biomedical, behavioral, and forensic sciences. American Psychologist, 60(1), 115.

Session 20 – Part 1: US Dept of Energy Radiation Experiments

Advisory Committee on Human Radiation Experiments Final Report, (1995).

Part 2: Willowbrook State School Hepatitis Studies

  • Stephen Goldby, Saul Krugman, M. H. Pappworth, and Geoffrey Edsall. 1971. “The Willowbrook Letters.” The Lancet.
  • Robinson, W. M., & Unruh, B. T. (2008). The Hepatitis Experiments at the Willowbrook State School. The Oxford Textbook of Clinical Research Ethics, 80.