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EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS: History and Ethical Principles

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Title: EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS: History and Ethical Principles


1
EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS
History and Ethical Principles
  • Daniel Nelson
  • Director, Office of Human Research Studies
    Associate Professor of Social Medicine
  • and Pediatrics
  • University of North Carolina-Chapel Hill

2
PROTECTING HUMAN RESEARCH SUBJECTS
  • History
  • Ethical Principles
  • Current Issues
  • QA

3
WHY SO MUCH TIME ON HISTORY?
  • How did we arrive at this point?
  • Human nature being what it is
  • The 3 Rs Rationalization, Reaction,
    Regulation
  • History places ethics in perspective
  • Those who fail to study history are condemned to
    repeat it

4
It is not cruel to inflict on a few criminals
sufferings which may benefit multitudes of
innocent people through all centuries.
Celsus, 1st century AD
5
Informed consent contract used by Maj. Walter
Reed for experiments that resulted in yellow
fever infection in Cuba, signed 26 Nov
1900 (duplicate in Spanish)
Courtesy of Col. Arthur Anderson, U.S. Army
6
Berlin Code of 1900
  • medical interventions for purposes other than
    diagnosis, therapy, and immunization are
    absolutely prohibited if
  • 1. human subject is a minor or not competent
  • 2. human subject has not given unequivocal
    consent
  • 3. consent is not preceded by proper explanation
    of possible adverse consequences of intervention

Directive to medical directors of all hospitals
from the Royal Prussian Minister of Religious,
Educational and Medical Affairs, Berlin City
Council, Dec 1900
7
German Government Directive of 1931
  • Medical science must advance, but individual
    physician has special duty and major
    responsibility for life and health of
    patient-subject
  • Risks proportionate to anticipated benefits
  • Tested in advance on animals
  • Unambiguous consent
  • Special caution if minors
  • Exploitation of social hardship is unethical
  • Academic training should stress special
    obligations when conducting research or publishing

Regulations on New Therapy and Human
Experimentation from the Reich Minister of the
Interior, Feb 1931
8
Nazi Medical Experiments in WWII Concentration
Camps
9
High Altitude Test Chamber at Dachau
10
Twin Studies in Auschwitz
Dr. Josef Mengele
11
Romanian Gypsy in Potable Seawater Experiments at
Dachau
12
Deliberate Phosphorous Burn to Test Medications
at Buchenwald
13
Hypothermia Experiments at Dachau
14
Dr. Leo Alexander with Survivor of Experiments at
Ravensbrueck
15
Case No. 1 of the Nuremberg Military Tribunal
U.S.A. vs. Karl Brandt et al.Dec 9, 1946 - Aug
20, 1947
16
Defendants and Defense Counsel
15 of 23 guilty, 7 hanged, 5 life sentences
17
NUREMBERG CODE
  • Voluntary consent of the subject is absolutely
    essential
  • Research must be for benefit of society
  • Research should build on animal experiments and
    previous knowledge
  • Procedures must avoid unnecessary mental and
    physical suffering, and include provisions to
    avoid risk of injury and death

18
NUREMBERG CODE(continued)
  • Degree of risk must not exceed the importance of
    the problem
  • Adequate facilities and qualified investigators
  • Subject must be free to stop at any time
  • Investigator must be prepared to stop if there is
    risk of injury, disability or death

19
Before IRBs, the only consent required was that
of a researcher's department head. The Nuremberg
Code was ignored in practice. As I look back on
it, the interpretation of these codes was that
they were necessary for barbarians, but not for
fine upstanding people... In this prestigious
unit we had a very strong obligation to behave in
a civilized manner.
Dr. William Silverman, Columbia pediatrician, on
the postwar mentality
20
Willowbrook State School Staten Island, 1956-1963
  • Institutionalized children
  • Deliberate infection with hepatitis A
  • Coercive recruitment after admission closed due
    to overcrowding

21
Birth Defects from Thalidomide during Pregnancy
Revised Food and Drug Administration (FDA)
requirements, 1962
22
Thalidomide Finally Approved by FDA in 1998
23
(No Transcript)
24
Staged Experiments on Obedience to AuthorityYale
University, 1960s
FakeLearner
Experimenter
Subject - Teacher
25
  • I observed a mature and initially poised
    businessman enter the lab smiling and confident.
    Within 20 min he was reduced to a twitching
    stuttering wreck rapidly approaching a point of
    nervous collapse. He pulled on his earlobe,
    twisted his hands, and at one point pushed his
    fist into his forehead and muttered Oh, God,
    lets stop it. And yet he continued to respond
    to every word of the experimenter, and obeyed to
    the end.

Stanley Milgram, 1963
26
Tearoom Trade Study
  • Sociological study of homosexual encounters
  • Several stages involving deception...
  • Observation in public restrooms
  • Obtaining name and address through license plates
  • In-home interview

27
Jewish Chronic Disease Hospital Brooklyn, 1963
  • Elderly debilitated patients injected with live
    cancer cells to study immunologic response (per
    transplant rejection)
  • Patients not informed of cancer cells
  • investigators did not wish to frighten
    unnecessarily
  • a priori hypothesis that cells would be readily
    rejected

28
the judgment of the investigator is not
sufficient as a basis for reaching a conclusion
concerning the ethical... set of questions."
NIH panel that investigated studies at Jewish
Chronic Disease Hospital
The investigator's judgment must be subject to
prior peer review to ensure an independent
determination of risks and benefits and
...voluntary informed consent."
NIH Director James Shannon, endorsed by Surgeon
General William Steward, Feb 1966
29
DECLARATION of HELSINKI World Medical
Association, 1964
  • Consent should be in writing
  • Research should build on previous work
  • Research must follow written protocol
  • Review by an independent committee
  • Caution if subject is in dependent relationship
    with investigator
  • Subjects must receive best proven diagnostic and
    therapeutic methods
  • studies in sub-Saharan Africa on perinatal
    transmission of HIV

revised 1975, 1983, 1989, 1996, 2000
30
Landmark Article on U.S. Abuses
Henry Beecher, NEJM, 1966
31
Birth Control ClinicSan Antonio, 1971
  • Impoverished Mexican-American women with multiple
    pregnancies
  • Placebo-crossover trial
  • Without knowledge/consent
  • 10/76 became pregnant on placebo

32
Untreated Syphilis in the Male Negro Macon
County, Alabama1932-1972
Tuskegee Syphilis Study
33
In beginning the study, schedules of the
blood-drawing clinics throughout the county were
announced through every available source,
including churches, schools, and community
stores. The people responded willingly, and 600
patients were selected for the study--400 who had
syphilis and, for controls, 200 who did not. The
patients who had syphilis were all in the latent
stage any acute cases requiring treatment were
carefully screened out for standard therapy.
From Twenty Years of Followup Experience in a
Long-Range Medical Study, Rivers et al, Public
Health Reports, 69391-5, 1953
34
Bad Blood
35
Spinal Tap, 1933
36
Nurse Rivers and the Government Doctors in the
early 1950s
37
NOW can we give him pencillin?
Philadelphia Inquirer, 1972
38
US National Research Act1974
  • Established National Commission for Protection of
    Human Subjects
  • The Belmont Report, 1979
  • Code of Federal Regulations, 1974, 1981
  • Institutional Review Boards (IRBs)
  • Informed consent
  • Common Rule, 1991

39
THE BELMONT REPORTEthical 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
40
RESPECT FOR PERSONS
  • Treat individuals as autonomous agents
  • Fundamental right to be left alone
  • Dont use people as a means to an end
  • Extra protections for those with diminished
    autonomy
  • Practical application informed consent, respect
    for privacy
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