Linda M. Woolf, Ph.D.
Research methods and ethics are an integral component of psychological science. While psychology texts usually present an extensive discussion of methodology, only a cursory discussion of research ethics is often included. Teachers of psychology who want students to learn rather than simply memorize the ethical principles are left to supplement the text through lecture, additional readings, or other classroom activities. Various methods have been suggested to reinforce students understanding of research ethics ranging from analyses of controversial psychological research (Korn, 1984) to the presentation of simulated case studies (McMinn, 1988). While these methods may sensitize the student to the difficulties associated with ethical decision making in a research context, they may not sensitize the student to the human rights concerns of research subjects. An understanding of these underlying human rights concerns related to the use of human subjects in research is imperative as students engage in research both as experimenter and as participant.
This poster provides information concerning a course designed to teaching ethics grounded in discussion of the historical context out of which basic ethical research principles were defined and refined. In this course, students examine studies conducted by Nazi doctors and the Japanese military during World War II (e.g., the Dachau hypothermia/high altitude experiments and the Unit 731 field/laboratory biological warfare experiments, respectively). The role of these atrocities in the development of the 1947 Nuremberg Code as well as their relationship to the Universal Declaration of Human Rights is evaluated.
The evolution of further guidelines such as the Declarations of Helsinki is traced. Human rights violations that occurred in the U.S. in the name of science as well as current ethical dilemmas such as those associated with psychiatric research, AIDS, and Alzheimers disease research are presented and evaluated. Finally, ethical questions concerning the use of unethically obtained data are discussed. While the information presented in this poster is for a semester long course, this material is easily adapted for individual lectures within other courses while discussing research ethics.Recommended Resources
Nazi Medical Experimentation & Ethics:
Annas, G., & Grodin, M. (Ed.)(1992). The Nazi doctors and the Nuremberg Code: Human rights in human experimentation. Oxford: Oxford University Press.
Bleich, J. D. (1991). Utilization of Scientific Data Obtained through Immoral Experimentation. Tradition, 26, 65-76.
Michalczyk, J. J. (1994). Medicine, ethics, and the Third Reich: Historical and Contemporary Issues. Kansas City, Missouri: Sheed & Ward
Pross, C. (1991). Breaking Through the Postwar Coverup of Nazi Doctors in Germany. Journal of Medical Ethics, 17,13-16.
Steinfels, P. (1986). Biomedical Ethics and the Shadow of Nazism: A Conference on the Proper Use of Nazi Analogy in Ethical Debate. The Hastings Center Report, 6, 1-19.
Nazi Medical Experimentation - Specific Studies
Angell, M. (1990). The Nazi Hypothermia Experiments and Unethical Research Today. New England Journal of Medicine, 322, 1462-1464.
Berger, R. L. (1990). Nazi Science: The Dachau Hypothermia Experiments. New England Journal of Medicine, 322, 1435-1440.
Lagnado, L. M. and Dekel, S. C. (1991) Children of the Flames: Dr. Josef Mengele and the Untold Story of the Twins of Auschwitz. New York: William Morrow.
Japanese Medical Experimentation - WWII
Harris, S. (1994) Factories of death: Japanese biological warfare, 1932-45, and the American cover-Up. London: Routledge.
Tanaka, Y. (1998). Hidden Horrors: Japanese War Crimes in World War II. Boulder, Colorado: Westview Press.
Nazi Medical Experimentation - General
Aly, G., Chroust, P., & Pross, C. (1994). Cleansing the Fatherland: Nazi medicine and racial hygiene. Baltimore: John Hopkins University Press.
Biaglioli, M. (1992). Science, Modernity and the 'Final Solution' in S. Friedlander (ed.) Probing the Limits of Representation. Cambridge: Harvard University Press.
Burleigh, M. (1994). Death and deliverance: "Euthanasia" in Germany c. 1900-1945. Cambridge: Cambridge University Press.
Caplan, A. L. (1992). When Medicine Went Mad: Bioethics and the Holocaust. Totowa, NJ: Humana Press.
Friedlander, H. (1995). The origins of Nazi genocide: From euthanasia to the final solution. Chapel Hill, NC: University of North Carolina Press.
Gutman, Y. & Berenbaum, M. (Eds.) (1994). Anatomy of the Auschwitz death camp. Bloomington, Indiana: Indiana University Press.
Hackett, D. A. (Ed.) (1995). The Buchenwald report. Boulder, Colorado: Westview Press.
Hoedeman, P. (1991). Hitler or Hippocrates: Medical Experiments and Euthanasia in the Third Reich. Sussex, England: Book Guild.
Lerner, B. H. and Rothman, D. J. (1995). Medicine and the Holocaust: Learning More of the Lessons. Annals of Internal Medicine, 122, 793-794.
Lifton, R. J. (1986). The Nazi doctors: Medical killing and the psychology of genocide. New York: Basic Books.
Proctor, R. (1988). Racial hygiene: Medicine under the Nazis. Cambridge: Harvard University Press.
Proctor, R. (1999). The Nazi war on cancer. Princeton, NJ: Princeton University Press.
Pross, C. & Aly, G. (1991). The Value of the Human Being: Medicine in Germany, 1918-1945. Berlin: Ortzekammer Berlin.
The Nuremberg Code
The Nuremberg Code arose as part of the trial of the United States v. Karl Brandt. Karl Brandt and others were tried at Nuremburg for crimes against humanity committed in their roles as the Nazi high command. The code has ten requirements:
1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent: should be so situated as to be able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and their effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur, except perhaps, in those experiments where the experimental physicians also serve as subject.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill, and careful judgment required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
Nuremberg Code, Trials of War Criminals before the Nuremberg Tribunals under Control Council Law No. 10.
Human Experimentation vs. Human Rights
Instructor: Dr. Linda M. Woolf
These atrocities will be evaluated within the context of necessary fundamental human rights using the 1948 Universal Declaration of Human Rights, the 1947 Nuremberg Code, the Declarations of Helsinki, the American Psychological Association's Ethical Principles in the Conduct of Research With Human Participants, and other documents pertaining to human rights and human experimentation. We will also examine:
Topic & Readings
|Week||One|| Introduction to class|
What are Human Rights?
What is the Relationship between Human Rights and Human Experimentation?
The Universal Declaration of Human Rights
The Nuremberg Code
The Declarations of Helsinki
The Nuremberg Code: An International Overview by Sharon Perley, Sev Fluss, Zbigniew Bankowski, and Francoise Simon in The Nazi Doctors and the Nuremberg Code edited by G. Annas and M. Grodin
The Nuremberg Principles in International Law by Robert Drinan in The Nazi Doctors and the Nuremberg Code edited by G. Annas and M. Grodin
|Week||Two||Laying the Groundwork|
The Relevance of the Holocaust to Current Bio-Medical Issues by Arthur Caplan in Medical Ethics and the Third Reich (METR)
The Healing-Killing Paradox by Peter Haas in METR
|Week||Three||Nazi Medicine: From Racial Hygiene Theories to Euthanasia and Sterilization |
Human Genetics in Nazi Germany by Benno Muller-Hill in METR
Racial Hygiene: The Collaboration of Medicine and Nazism by Robert Proctor in METR
Nazi Doctors, German Medicine, and Historical Truth by Christian Pross in The Nazi Doctors and the Nuremberg Code edited by G. Annas and M. Grodin
|Week||Four||Nazi Medicine's Role in the Holocaust|
Sterilization, Euthanasia, and the Holocaust - The Brutal Chain by Daniel Nadav in METR
The Destruction of "Lives Not Worth Living" by Robert Proctor in Racial Hygiene: Medicine under the Nazis by R. Proctor
|Week||Five||Nazi Medicine's Role in the Holocaust continued|
|Week||Six||Human Experimentation - Dachau|
Nazi Science - The Dachau Hypthermia Experiments by Robert Berger in METR
Malaria Experiments in Dachau by Helmut Ableiter in The Buchenwald Report edited by D. Hackett
Dachau High Altitude Medical Experiments from the Nizkor Project
|Week||Seven||Human Experimentation - Auschwitz|
Nazi Doctors by Robert Jay Lifton and Amy Hackett in Anatomy of the Auschwitz Death Camp edited by Y. Gutman and M. Berenbaum
The Crimes of Josef Mengele by Helena Kubica in Anatomy of the Auschwitz Death Camp edited by Y. Gutman and M. Berenbaum
The Personal, Public, and Political Dimensions of Being a Mengele Guinea Pig by Eva Kor in METR
|Week||Eight||Human Experimentation - Auschwitz continued|
Human Experimentation - Buchenwald
Selected Readings from The Buchenwald Report edited by D. Hackett
|Week||Nine||Human Experimentation - Buchenwald continued|
Human Experimentation - Ravensbruck
The Stations of the Cross by Vera Laska in METR
|Week||Ten||Human Experimentation continued|
|Week||Eleven||Human Experiments conducted by the Japanese - WWII|
Concentration Camp Experiments: Their Relevance for Contemporary Research with Human Beings by Jay Katz in METR
Human Experiments: "Secret of Secrets" in Factories of Death: Japanese Biological Warfare, 1932-45, and the American Cover-up by S. Harris
|Week||Twelve||Evaluation of research|
The Changing Landscape of Human Experimentation: Nuremberg, Helsinki, and Beyond by George Annas in METR
|Week||Thirteen||Jewish Doctors in the Shadow of the Reich|
Creativity in the Face of Disaster: Medicine in the Warsaw Ghetto in METR
Historical Origins of the Nuremberg Code by Michael Grodin in METR
|Week||Fourteen||Into the Future|
Relevance of Nazi Medical Behavior to the Health Profession Today by Michael Franzblau in METR
Medicine and Human Rights: A Proposal for International Action by Michael Grodin, George Annas, and Leonard Glantz in METR
The Ethics of Using Scientific Data Obtained by Immoral Means by F. Rosner, et. al. in The New York State Journal of Medicine, 91, pp. 54-59.
Should the Nazi Research Data be Cited? by Kristine Moe in The Hasting Center Report, December 1984, 5-7.
Lessons We Have Learned by Lisa Sowle Cahill in METR
|Week||Sixteen||FINAL EXAM (10:30 - 12:30)|
Increasingly, universities and other research institutions are coming under fire for failure to protect human subjects. Sanctions for such failures have ranged from the employment termination of the principal investigators to the forced suspension of federally funded research projects (e.g. Duke University, University of Oklahoma, University of Miami). This past June, Health and Human Services Secretary Donna Shalala announced several new initiatives to strengthen protection for participants in research. One of the initiatives includes fines upwards of one million dollars for failure to comply with federal ethical guidelines concerning research participants particularly in relation to protection from harm and informed consent. Thus, students need to learn and follow the guidelines established through history and exemplified in the American Psychological Associations Ethical Principles in the Conduct of Research with Human Participants as a means to protect themselves and their institutions.
However, it is imperative that students develop a deeper understanding of the underlying human rights concerns associated with these guidelines so as to not simply structure their research protocols to fit the "letter of the law". Teaching the ethical guidelines associated with the use of human participants stressing the value of research ethics grounded in human rights analyses and history will assist students as they move from simple knowledge of the rules to a deep understanding of the ethical principles.
January 18, 1999
Blood Trials Done Without Consent
CHICAGO (AP) - Twenty-four critically ill patients died after being given a blood substitute without their informed consent, according to federal officials.
Baxter International Inc. (NYSE:BAX - news) was able to test the substitute known as HemAssist without consent because of a 1996 change in U.S. Food and Drug Administration regulations.
The change, which broke with a 50-year standard that required informed consent for nearly all experiments on humans, was designed to facilitate research in emergency medicine that could not happen if doctors were forced to take the time to get patient consent.
Baxter officials halted their clinical trial of HemAssist last spring after reviewing data on the first 100 trauma patients enrolled in the nationwide study.
Of the 52 critically ill patients given the substitute, 24 died, representing a 46.2 percent mortality rate. The suburban Deerfield, Ill.-based company had projected 42.6 percent mortality for critically ill patients seeking emergency treatment.
December 15, 2000, Friday
Parents 'misled' in consent for baby trials
Doctors are failing to get fully informed consent from parents for research involving their babies, a study carried out across Europe has shown.
Fewer than one in three of the parents of 200 babies involved in trials were given all the information they needed in the right way, said Su Mason, of Leeds University, and Peter Allmark, of Sheffield University.
August 29, 2000
Safety fears stop inmate research
Federal investigators cease research at Miami and Texas universities and criticize two others for patient safety lapses.
Four universities have come under fire for medical research on prisoners after federal investigators found holes in the safety net designed to protect them.
Although much of the criticism was directed at research projects involving people in prison or under state supervision, federal investigators also found problems with studies outside the justice system.
For example, they questioned whether the University of Miami had followed proper procedure when it did not obtain informed consent forms from non-inmates enrolled in a trauma study that was comparing pelvic-fracture treatments.
U.S. Halts Cancer Tests In Oklahoma; Patient Protections Ignored, Agency Says
March 29, 1999
VA Not Alone in Ethical Shortcomings; Hospitals Failure to Give Research Subjects Adequate Information is Surprisingly Common
The federal orders last week to suspend research at the West Los Angeles Veterans Affairs Medical Center were unprecedented, but they trace back to an ethics problem that appears to be surprisingly common in U.S. clinical studies: failure to provide research subjects with adequate informed consent.