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Historical backgrounds of WHY U.S. regulations cover biomedical and social behavior. Melody Lin, Ph.D. Deputy Director, Office for Human Research Protections Director, International Activities Department of Health and Human Services Melody.Lin@hhs.gov Dec. 12, 2012. Objectives.

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historical backgrounds of why u s regulations cover biomedical and social behavior

Historical backgrounds of WHY U.S. regulations cover biomedical and social behavior

Melody Lin, Ph.D.

Deputy Director, Office for Human Research Protections

Director, International Activities

Department of Health and Human Services

Melody.Lin@hhs.gov

Dec. 12, 2012

objectives
Objectives
  • Historical cases of unethical research
  • National Research Act
  • National Commission
    • Biomedical
    • Behavioral
nuremberg
Nuremberg
  • 23 German doctors were charged with crimes against humanity
  • experiments without subject consent
the nuremberg code 1947
The Nuremberg Code (1947)

Rules for "Permissible Medical Experiments"

  • voluntary consent
  • benefits outweigh risks
  • withdraw from participation
nuremberg code
Nuremberg Code
  • Informed consent without coercion
  • Prior animal experimentation
  • Justify by anticipated scientific results
  • Qualified scientists
  • Avoid physical and mental suffering
  • No expectation of death or disabling injury
slide6
NoDid the Nuremberg Code Impact the behavior of American scientists who did research on humans?
but in america
But, in America
  • Willowbrook (1950s)

Mentally retarded children were deliberately injected with hepatitis virus to study its effects

  • Jewish Chronic Disease Hospital (1960s) Live cancer cells were injected into 22 senile patients.

… with no benefit to patients,

and no consent of kin.

the 18th world medical assembly 1964 in the declaration of helsinki
The 18th World Medical Assembly (1964), in the Declaration of Helsinki
  • Set forth additional recommendations to guide medical doctors in biomedical research involving human subjects
beecher article
Beecher Article

“Ethics and Clinical Research” Henry K. Beecher New Engl J Med 274 (1966):1354-60

  • 22 published medical studies presenting risk to subjects without their knowledge or approval
  • Published in some of the most prestigious journals and conducted at some of the most prestigious institutions
tuskegee syphilis study
Tuskegee Syphilis Study
  • PHS conducted 1932-1972
  • 400 Black American Men
  • Natural course of untreated syphilis
  • Unknowing participants
  • No treatment when drugs were available
national action
National Action

1973 - Kennedy Hearings. Tuskegee, etc., and ta search for ethical issues in social/behavioral research:

  • Stanley Milgram’s Obedience Study
  • Laud Humphreys’ Study of “tearoom trade”

1974 - National Research Act established the National Commission for Protection of Human Subjects of Biomedical & Behavioral Research

Required IRBs at institutions receiving HEW support for human subjects research.

the belmont report
The Belmont Report

Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Respect for persons

Beneficence

Justice

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979

the milgram study
The Milgram Study
  • Experiment on obedience to authority figures
  • Study on the conflict between obedience toward authority and ones personal conscious
slide15

E – Experimenter

T – Teacher (Subject)

L – Learner (Actor)

(E) orders (T) to give what the subject believes are painful electric shocks to (L).

The subjects (T) believed that for each wrong answer, the (L) was receiving actual shocks, but in reality there were no shocks.

(L) set up a tape recorder integrated with the electro-shock generator, which played pre-recorded sounds for each shock level.

the milgram study1
The Milgram Study
  • Only the "teacher" is an actual subject, i.e. unaware about the actual setup
  • The subject and the learner were told by the experimenter that they would be participating in an experiment helping his study of memory and learning in different situations
the milgram study results
The Milgram Study: Results
  • In the first set of experiments, 65 percent of the subjects administered the experiment's final massive 450-volt shock
    • many were very uncomfortable doing so;
    • some said they would refund the money they were paid for participating in the experiment
ethical issues
Ethical Issues
  • Respect for Persons: Stanley Milgram deceived his study's subjects (failure to disclose important aspects of study to allow a voluntary decision to participate)
  • Beneficence: Subjects (T) were placed under more pressure than many believe was necessary to test the study hypothesis
  • Respect for Persons: Subjects were coerced into remaining in study against their will
humphreys tearoom trade ph d dissertation sexual deviance sociologist wash u
Humphreys: Tearoom TradePh.D. dissertation (sexual) DevianceSociologist, Wash. U.
  • Laud Humphreys studied homosexual encounters in “tearooms” – public restrooms
  • Homosexuals who engage in sex in tearooms like to have a third person present, someone they call a “Watch queen”
humphreys cont d
Humphreys (cont’d)
  • As a “Watch Queen” Humphreys made observations in order to do research
  • He wrote down the license plate numbers of the men and traced their home addresses
  • A year later, he visited them at home, and conducted a follow-up survey
humphreys cont d1
Humphreys (cont’d)
  • 38% of men having tearoom sex were married
  • Most identified themselves as heterosexual
  • It turns out, most of these men were frustrated their wives
ethical issues1
Ethical issues
  • The researcher acted as a lookout, alerting participants engaged in an illegal activity
  • Unknown to the subjects, the researcher noted the license numbers of their cars
  • License numbers were traced to reveal the name and address of each car owner
  • Traced subjects were interviewed as part of a larger public health survey (true purpose of their participation not revealed)
ethical problems
Ethical Problems
  • Aiding in crime
    • Since the Missouri law forbade homosexual activity Humphreys was assisting in a crime by acting as a lookout (i.e., the “watch queen”)
ethical problems cont d
Ethical Problems (cont’d)
  • Informed consent
    • Did not seek informed consent
      • Likely they would have refused participation
  • Endangering subjects
    • Took some care here: the names in safety deposit box in another state, refusing to tell police what he was doing
      • What if name had been released?
      • Would the publication lead to a “crack down”?
laud humpheys postscript
Laud Humpheys’ Postscript
  • Because of his study, the sociology department lost federal funding, many senior faculty left
    • Sociology program later eliminated
  • Laud Humphreys (1930-1988) received his Ph.D. Career SUNY (Albany, NY)
summary
Summary
  • National Research Act. 1974
  • Federal response to harm arising from biomedical and behavioral experimentations
  • National commission for the protection of human subjects of biomedical and behavioral research
  • National commission outlined ethical principals upon which the ethics of research study are evaluated in the U.S.