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RESEARCH ON HUMAN SUBJECTS

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World Medical Society (1964) Research on Human Subjects. Historical Foundations (Continued) ... Medical Research. Therapeutic. Possibility of Direct Immediate Benefit ... – PowerPoint PPT presentation

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Title: RESEARCH ON HUMAN SUBJECTS


1
RESEARCH ON HUMAN SUBJECTS
  • Edward J.Mahoney
  • Saint Michaels College

2
RESEARCH ON HUMAN SUBJECTS
  • Historical
  • Medical
  • Ethical
  • Perspectives

3
Research on Human Subjects
  • Historical Foundations

4
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)

5
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code

6
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent

7
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent
  • Scientifically Valid Research

8
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent
  • Scientifically Valid Research
  • United Nations Charter

9
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent
  • Scientifically Valid Research
  • United Nations Charter
  • NIH Policies of 1953

10
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent
  • Scientifically Valid Research
  • United Nations Charter
  • NIH Policies of 1953
  • Research in the 1960s

11
Research on Human Subjects
  • Historical Foundations
  • Nuremberg Trials (1946)
  • Nuremberg Code
  • Voluntary Informed Consent
  • Scientifically Valid Research
  • United Nations Charter
  • NIH Policies of 1953
  • Research in the 1960s
  • Injecting Elderly Indigent People

12
Research on Human Subjects
  • Historical Foundations (Continued)
  • World Medical Society (1964)

13
Research on Human Subjects
  • Historical Foundations (Continued)
  • World Medical Society (1964)
  • Guidelines that are Broader in Scope

14
Research on Human Subjects
  • Historical Foundations (Continued)
  • World Medical Society (1964)
  • Guidelines that are Broader in Scope
  • Public Health Service Policy (1966)

15
Research on Human Subjects
  • Historical Foundations (Continued)
  • World Medical Society (1964)
  • Guidelines that are Broader in Scope
  • Public Health Service Policy (1966)
  • Covers All Human Subject Research

16
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s

17
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s
  • The Tuskegee Studies

18
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s
  • The Tuskegee Studies
  • National Research Act of 1974

19
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s
  • The Tuskegee Studies
  • National Research Act of 1974
  • National Commission for the Protection of Human
    Subjects in Biomedical Research

20
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s
  • The Tuskegee Studies
  • National Research Act of 1974
  • National Commission for the Protection of Human
    Subjects in Biomedical Research
  • Code of Federal Regulations (1981)

21
Research on Human Subjects
  • Historical Foundations (Continued)
  • Events of the 1970s
  • The Tuskegee Studies
  • National Research Act of 1974
  • National Commission for the Protection of Human
    Subjects in Biomedical Research
  • Code of Federal Regulations (1981)
  • Revised CFR (1991)

22
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies

23
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)

24
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)

25
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)
  • Oak Ridge Laboratories (1950-1974)

26
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)
  • Oak Ridge Laboratories (1950-1974)
  • Oregon State Prison (1963-1971)

27
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)
  • Oak Ridge Laboratories (1950-1974)
  • Oregon State Prison (1963-1971)
  • Columbia University (1950s)

28
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)
  • Oak Ridge Laboratories (1950-1974)
  • Oregon State Prison (1963-1971)
  • Columbia University (1950s)
  • Fernald, MA Residential School (1946-1956)

29
Research on Human Subjects
30
Research on Human Subjects
31
Research on Human Subjects
32
Research on Human Subjects
33
Research on Human Subjects
34
Research on Human Subjects
35
Research on Human Subjects
36
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Amelia Jackson (1966)
  • Vanderbilt University (1940s)
  • Oak Ridge Laboratories (1950-1974)
  • Oregon State Prison (1963-1971)
  • Columbia University (1950s)
  • Fernald, MA Residential School (1946-1956)
  • Public Disclosure (1993))

37
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments

38
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments
  • Radioisotope Distribution Tests

39
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments
  • Radioisotope Distribution Tests
  • Nontherapeutic Experiments with Children

40
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments
  • Radioisotope Distribution Tests
  • Nontherapeutic Experiments on Children
  • Total-Body Irradiation

41
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments
  • Radioisotope Distribution Tests
  • Nontherapeutic Experiments on Children
  • Total-Body Irradiation
  • Atomic Veterans Experiments

42
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Plutonium Injection Experiments
  • Radioisotope Distribution Tests
  • Nontherapeutic Experiments on Children
  • Total-Body Irradiation
  • Atomic Veterans Experiments
  • Intentional Releases of Radiation in Secret

43
Research on Human Subjects
  • Historical Foundations (Continued)
  • Radiation Studies
  • Public Disclosure (1993)
  • Advisory Committee on Human Radiation Experiments
    (1996)

44
Research on Human Subjects
  • Belmont Report of 1979

45
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research

46
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Accepted Practice

47
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Accepted Practice
  • Therapeutic

48
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Accepted Practice
  • Therapeutic
  • Standard in the Field

49
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Accepted Practice
  • Therapeutic
  • Standard in the Field
  • For the Well-Being of the Patient

50
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Accepted Practice
  • Therapeutic
  • Standard in the Field
  • For the Well-Being of the Patient
  • Reasonable Hope of Success

51
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Research

52
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Research
  • Experimental

53
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Research
  • Experimental
  • Untested

54
Research on Human Subjects
  • Belmont Report of 1979
  • Boundaries Practice and Research
  • Research
  • Experimental
  • Untested
  • Designed to Determine Safety

55
Research on Human Subjects
  • Belmont Report of 1979

56
Research on Human Subjects
  • Ethical Principles

57
Research on Human Subjects
  • Ethical Principles
  • Respect for Persons

58
Research on Human Subjects
  • Ethical Principles
  • Respect for Persons
  • Autonomous Subjects

59
Research on Human Subjects
  • Ethical Principles
  • Respect for Persons
  • Autonomous Subjects
  • Protection of Persons Lacking Capacity

60
Research on Human Subjects
  • Ethical Principles
  • Secure the Well-Being of Patients

61
Research on Human Subjects
  • Ethical Principles
  • Secure the Well-Being of Patients
  • Do No Harm

62
Research on Human Subjects
  • Ethical Principles
  • Secure the Well-Being of Patients
  • Do No Harm
  • Maximize Possible Benefits

63
Research on Human Subjects
  • Ethical Principles
  • Secure the Well-Being of Patients
  • Do No Harm
  • Maximize Possible Benefits
  • Minimize Possible Harms

64
Research on Human Subjects
  • Ethical Principles
  • Serve the Demands of Justice

65
Research on Human Subjects
  • Ethical Principles
  • Serve the Demands of Justice
  • Who Ought to Receive Benefits of Research

66
Research on Human Subjects
  • Ethical Principles
  • Serve the Demands of Justice
  • Who Ought to Receive Benefits of Research
  • Who Ought to Bear the Burdens of Research

67
Research on Human Subjects
  • Ethical Principles
  • Serve the Demands of Justice
  • Who Ought to Receive Benefits of Research
  • Who Ought to Bear the Burdens of Research
  • Determining What is Ones Due

68
Research on Human Subjects
  • Ethical Principles
  • Serve the Demands of Justice
  • Who Ought to Receive Benefits of Research
  • Who Ought to Bear the Burdens of Research
  • Determining What is Ones Due
  • Fairness in Distribution

69
Research on Human Subjects
  • Applications

70
Research on Human Subjects
  • Applications
  • Informed Consent

71
Research on Human Subjects
  • Applications
  • Informed Consent
  • Information

72
Research on Human Subjects
  • Applications
  • Informed Consent
  • Information
  • Clear and Cogent

73
Research on Human Subjects
  • Applications
  • Informed Consent
  • Information
  • Clear and Cogent
  • Can be Understood by the Subject

74
Research on Human Subjects
  • Applications
  • Informed Consent
  • Consent

75
Research on Human Subjects
  • Applications
  • Informed Consent
  • Consent
  • Voluntariness

76
Research on Human Subjects
  • Applications
  • Informed Consent
  • Consent
  • Voluntariness
  • Free of Coercion and Undue Influence

77
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits

78
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Risk Harm That May Occur

79
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Risk Harm That May Occur
  • Probability (Chance of Harm)

80
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Risk Harm That May Occur
  • Probability (Chance of Harm)
  • Magnitude (severity of Harm)

81
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Benefits

82
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Benefits
  • Positive Value That May Result

83
Research on Human Subjects
  • Applications
  • The Assessment of Risks and Benefits
  • Benefits
  • Positive Value That May Result
  • Positive Value for Others

84
Research on Human Subjects
  • Medical Research and Medical Therapy
  • Therapy Aimed at the Relief of Suffering and
    Restoring People to health

85
Research on Human Subjects
  • Medical Research and Medical Therapy
  • Therapy Aimed at the Relief of Suffering and
    Restoring People to health
  • Research To Acquire a Better Understanding of
    the Chemical and Physiological Processes of Human
    Functioning

86
Research on Human Subjects
  • Medical Research
  • Therapeutic

87
Research on Human Subjects
  • Medical Research
  • Therapeutic
  • Possibility of Direct Immediate Benefit

88
Research on Human Subjects
  • Medical Research
  • Therapeutic
  • Possibility of Direct Immediate Benefit
  • Non-Therapeutic

89
Research on Human Subjects
  • Medical Research
  • Therapeutic
  • Possibility of Direct Immediate Benefit
  • Non-Therapeutic
  • Research May Help Others in the Future

90
Research on Human Subjects
  • Medical Research
  • Research Involving Children

91
Research on Human Subjects
  • Medical Research
  • Research Involving Children Problems
  • The Willowbrook Project

92
Research on Human Subjects
  • Medical Research
  • Research Involving Children Problems
  • The Willowbrook Project
  • Why Should Children Ever be Subjects in Research
    Trials?

93
Research on Human Subjects
  • Medical Research
  • Research Involving Children Problems
  • The Willowbrook Project
  • Why Should Children Ever be Subjects in Research
    Trials?
  • Betrayal of Trust To Allow Potential Harm?

94
Research on Human Subjects
  • Medical Research
  • Research Involving Children Problems
  • The Willowbrook Project
  • Why Should Children Ever be Subjects in Research
    Trials?
  • Betrayal of Trust To Allow Potential Harm?
  • The Lack of Informed Consent

95
Research on Human Subjects
  • Medical Research
  • Research Involving Children Problems
  • The Willowbrook Project
  • Why Should Children Ever be Subjects in Research
    Trials?
  • Betrayal of Trust To Allow Potential Harm?
  • The Lack of Informed Consent
  • Possibilities of Exploiting Children

96
Research on Human Subjects
  • Medical Research
  • Research Involving Children Benefits

97
Research on Human Subjects
  • Medical Research
  • Research Involving Children Benefits
  • Children are not Little Adults

98
Research on Human Subjects
  • Medical Research
  • Research Involving Children Benefits
  • Children are not Little Adults
  • Childrens Bodies Function Differently

99
Research on Human Subjects
  • Medical Research
  • Research Involving Children Benefits
  • Children are not Little Adults
  • Childrens Bodies Function Differently
  • Children are Prone to Certain Diseases

100
Research on Human Subjects
  • Medical Research
  • Research Involving Children Benefits
  • Children are not Little Adults
  • Childrens Bodies Function Differently
  • Children are Prone to Certain Diseases
  • Pediatric Medicine is Jeopardized

101
Research on Human Subjects
  • Medical Research
  • Research Involving Children
  • Children are not Little Adults
  • Childrens Bodies Function Differently
  • Children are Prone to Certain Diseases
  • Pediatric Medicine is Jeopardized
  • Provides Long-Term Benefit for Others

102
Research on Human Subjects
  • Medical Research
  • Research Involving Children Criteria
  • Who is Considered a Child?

103
Research on Human Subjects
  • Medical Research
  • Research Involving Children Criteria
  • Who is Considered a Child?
  • Informed Assent?

104
Research on Human Subjects
  • Medical Research
  • Research Involving Children Criteria
  • Who is Considered a Child?
  • Informed Assent?
  • What is the Duty of Parents/Guardians?

105
Research on Human Subjects
  • Medical Research
  • Research Involving Children Criteria
  • Who is Considered a Child?
  • Informed Assent?
  • What is the Duty of Parents/Guardians?
  • What About Non-Therapeutic Research?

106
Research on Human Subjects
  • Medical Research
  • Research Involving Children Criteria
  • Who is Considered a Child?
  • Informed Assent?
  • What is the Duty of Parents/Guardians?
  • What About Non-Therapeutic Research?
  • Age, Maturity and Psychological State

107
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners

108
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners
  • Historical Caution

109
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners
  • Historical Caution
  • Reduction in Sentence Duress?

110
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners
  • Historical Caution
  • Reduction in Sentence Duress?
  • Avoiding Undue Influence

111
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners
  • Historical Caution
  • Reduction in Sentence Duress?
  • Avoiding Undue Influence
  • Could Offer Personal Advantage to prisoners

112
Research on Human Subjects
  • Medical Research
  • Research Involving Prisoners
  • Historical Caution
  • Reduction in Sentence Duress?
  • Avoiding Undue Influence
  • Could Offer Personal Advantage to prisoners
  • It is an Exercise of Their Autonomy

113
Research on Human Subjects
  • Medical Research
  • Research Involving The Poor

114
Research on Human Subjects
  • Medical Research
  • Research Involving The Poor
  • Tuskegee Study

115
Research on Human Subjects
  • Medical Research
  • Research Involving The Poor
  • Tuskegee Study
  • Use of Public and Municipal Hospitals

116
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill

117
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill
  • Informed Consent?

118
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill
  • Informed Consent?
  • Feelings of Despair

119
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill
  • Informed Consent?
  • Feelings of Despair
  • Looking for Any Cure

120
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill
  • Informed Consent?
  • Feelings of Despair
  • Looking for Any Cure
  • Unreasonable Expectations

121
Research on Human Subjects
  • Medical Research
  • Research Involving The Terminally Ill
  • Informed Consent?
  • Feelings of Despair
  • Looking for Any Cure
  • Unreasonable Expectations
  • Treated as a Research Resource?

122
Research on Human Subjects
  • Medical Research
  • Research Involving Cognitively Impaired Subjects

123
Research on Human Subjects
  • Medical Research
  • Research Involving Cognitively Impaired Subjects
  • Protection Proportionate to the Risk Involved

124
Research on Human Subjects
  • Medical Research
  • Research Involving Cognitively Impaired Subjects
  • Protection Proportionate to the Risk Involved
  • Assent is Necessary but not Sufficient

125
Research on Human Subjects
  • Medical Research
  • Research Involving Cognitively Impaired Subjects
  • Protection Proportionate to the Risk Involved
  • Assent is Necessary but not Sufficient
  • Is There Ant Benefit to the Subject?

126
Research on Human Subjects
  • Medical Research
  • Research Involving Cognitively Impaired Subjects
  • Example The wife of a severely demented man, who
    never expressed a desire to be involved in
    research, is asked to give permission for her
    husband to undergo a series of PET scans solely
    for the purposes of research.

127
RESEARCH ON HUMAN SUBJECTS
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