Ethics in Research

1st and Foremost: The Hippocratic Oath

I swear by Apollo Physician and Asclepius and Hygieia and Panaceia and all the gods and goddesses, making them my witnesses, that I will fulfil according to my ability and judgment this oath and this covenant: To hold him who has taught me this art as equal to my parents and to live my life in partnership with him, and if he is in need of money to give him a share of mine, and to regard his offspring as equal to my brothers in male lineage and to teach them this art - if they desire to learn it - without fee and covenant; to give a share of precepts and oral instruction and all the other learning to my sons and to the sons of him who has instructed me and to pupils who have signed the covenant and have taken an oath according to the medical law, but no one else. I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.

I will neither give a deadly drug to anybody who asked for it, nor will I make a suggestion to this effect. Similarly I will not give to a woman an abortive remedy. In purity and holiness I will guard my life and my art. I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work. Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves. What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.

If I fulfill this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot

Modern (1964 – present) I swear to fulfill, to the best of my ability and judgment, this covenant: I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow. I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of overtreatment and therapeutic nihilism. I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery. I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God. I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure. I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm. If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.

Horrifying violations of Ethics in Research Nazi Doctors Tuskgee Stanley Milgrim Philip Zimbardo

Nazis Dr. Horst Schummann's attempted to invent a injectable method of sterilization (Auschwitz) He injected an unknown substance directly into the ovaries of an unknown number of women. The substance caused fevers, inflammation of the ovaries and severe pain. Much is still unknown, as all of his patients perished at Auschwitz and Birkenau

Ravensbruck Dr. Karl Gechardt ‘experimented’ with bone-transplantation between women – often summarily killing the donor before beginning the procedure.

Mengele Twins at Auschwitz – known experiments include: injecting unknown substances into their eyes in an attempt to change their eye color; purposefully infecting one twin with a fatal disease, and then, after the death of the infected twin, killing the other and comparing their anatomy through autopsy; performing 'postmortems' on living subjects; sewing two twins together to 'study' blood flow

Citations Accounts from Martin Gilbert, The Holocaust: A History of the Jews of Europe during the Second World War, p. 687-689 and 718-722. Yehuda Bauer, A History of the Holocaust, p. 219 For more information: http://www.auschwitz.dk/Mengele1.htm http://www.ushmm.org/research/doctors/index.html http://auschwitz.dk/Mengele/ http://www.vhf.org/

In Response The Nuremberg Principles

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, over-reaching, 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 the 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 an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. 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 probably 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.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably 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.

Declaration of Helsinki Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004

Tuskegee 1932, 600 African-American males from Tuskegee were 'recruited' by the US Government's Center for Disease Control with the promise of free healthcare. 399 of them had previously been infected with Syphilis, 201 had not. Those who tested positive were not told. Rather than provide the free health care promised, the CDC gave all the men placebos, and their degenerating health recorded. The study continued until 1972 — more than twenty years after the discovery that a simple penicillin shot cured syphilis. The experimenters went so far as to follow one subject to Birmingham, AL to make sure he did not get the life-saving penicillin shot!

1974: The Belmont Report Distinction between medical practice and medical research: “The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)”

Stanley Milgrim Subjects recruited for a ‘memory experiment’. S is the subject the ‘teacher’, A is a confederate (actor) the ‘learner’ E is the experimenter. S’s control panel is marked with increasing voltages 0-450 V with a big sign that says “Do not go past this point” at 300 V.

Stanley Milgrim As A continues to get answers wrong, E instructs S to shock A, which results in screams of pain and, between questions, pleading to stop, complaints of a heart condition, and reminders that too much voltage is fatal. A stops speaking after 300V.

Stanley Milgrim 65% of Subjects administered the complete 450V before stopping – even if the confederate A falls silent! No subjects stopped at 300V.

Philip Zimbardo…

Major flaw in both: Less-than-honest about the hypothesis being tested. Others?

Virtual Ethics Board An environmental psychologist sits in a crowded library and keeps detailed records of seating patterns.

An environmental psychologist takes videotapes of seating patterns in the library. These tapes are maintained indefinitely, and library patrons do not know they are being filmed.

An experimental psychologist tells students that he is interested in their reading comprehension when in reality he is recording the speed of their responses rather than their comprehension.

A social psychologist is studying bystander intervention in a liquor store. Permission has been obtained from the store manager, In clear view of a patron, an experimenter “steals” a bottle of liquor. A second experimenter approaches the patron and asks, “Did you see him steal that bottle?”

A social psychologist connects surface electrodes to male participants with their prior approval. These participants are told that the electrodes are connected to a meter in front of them that measures sexual arousal. In reality, the meter is controlled by the experimenter. Participants are then shown slide of nude males and females. Prior questioning has revealed the stated sexual preference of the participants. The meter gives high readings for pictures of the sex opposite to the participant’s sexual preference.