Ethics in Research

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Ethics in Research
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!st and Foremost

• The Hippocratic Oath

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• 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 covenantTo 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.

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• 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.

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• If I fulfil 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

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Modern (1964 present)

• I swear to fulfill, to the best of my ability and
  judgment, this covenantI 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.

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• 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.

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• 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.

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Horrifying violations of Ethics in Research

• Nazi Doctors
• Tuskgee
• Stanley Milgrim
• Philip Zimbardo

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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

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Ravensbruck

• Dr. Karl Gechardt experimented with
  bone-transplantation between women often
  summarily killing the donor before beginning the
  procedure.

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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

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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/

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In Response

• The Nuremberg Principles

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• 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.

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• 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.

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• 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.

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• 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.

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Declaration of Helsinki

• Adopted by the 18th WMA General Assembly,
  Helsinki, Finland, June 1964, and amended by
  the29th WMA General Assembly, Tokyo, Japan,
  October 197535th WMA General Assembly, Venice,
  Italy, October 198341st WMA General Assembly,
  Hong Kong, September 198948th WMA General
  Assembly, Somerset West, Republic of South
  Africa, October 1996and the 52nd WMA General
  Assembly, Edinburgh, Scotland, October 2000 Note
  of Clarification on Paragraph 29 added by the WMA
  General Assembly, Washington 2002Note of
  Clarification on Paragraph 30 added by the WMA
  General Assembly, Tokyo 2004

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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!

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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)

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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.
• Ss 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.

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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.

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Stanley Milgrim

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

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Philip Zimbardo
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Major flaw in both

• Less-than-honest about the hypothesis being
  tested.
• Others?

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Virtual Ethics Board

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

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• 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.

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• 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.

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• 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?

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• 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 participants sexual preference.