RESEARCH ON HUMAN SUBJECTS

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RESEARCH ON HUMAN SUBJECTS

• Edward J.Mahoney
• Saint Michaels College

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RESEARCH ON HUMAN SUBJECTS

• Historical
• Medical
• Ethical
• Perspectives

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Research on Human Subjects

• Historical Foundations

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Research on Human Subjects

• Historical Foundations
• Nuremberg Trials (1946)

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Research on Human Subjects

• Historical Foundations
• Nuremberg Trials (1946)
• Nuremberg Code

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Research on Human Subjects

• Historical Foundations
• Nuremberg Trials (1946)
• Nuremberg Code
• Voluntary Informed Consent

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Research on Human Subjects

• Historical Foundations
• Nuremberg Trials (1946)
• Nuremberg Code
• Voluntary Informed Consent
• Scientifically Valid Research

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Research on Human Subjects

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

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Research on Human Subjects

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

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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

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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

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Research on Human Subjects

• Historical Foundations (Continued)
• World Medical Society (1964)

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Research on Human Subjects

• Historical Foundations (Continued)
• World Medical Society (1964)
• Guidelines that are Broader in Scope

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Research on Human Subjects

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

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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

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Research on Human Subjects

• Historical Foundations (Continued)
• Events of the 1970s

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Research on Human Subjects

• Historical Foundations (Continued)
• Events of the 1970s
• The Tuskegee Studies

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Research on Human Subjects

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

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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

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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)

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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)

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Research on Human Subjects

• Historical Foundations (Continued)
• Radiation Studies

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Research on Human Subjects

• Historical Foundations (Continued)
• Radiation Studies
• Amelia Jackson (1966)

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Research on Human Subjects

• Historical Foundations (Continued)
• Radiation Studies
• Amelia Jackson (1966)
• Vanderbilt University (1940s)

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Research on Human Subjects

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

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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)

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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)

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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)

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Research on Human Subjects
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Research on Human Subjects
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Research on Human Subjects
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Research on Human Subjects
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Research on Human Subjects
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Research on Human Subjects
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Research on Human Subjects
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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))

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Research on Human Subjects

• Historical Foundations (Continued)
• Radiation Studies
• Public Disclosure (1993)
• Plutonium Injection Experiments

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Research on Human Subjects

• Historical Foundations (Continued)
• Radiation Studies
• Public Disclosure (1993)
• Plutonium Injection Experiments
• Radioisotope Distribution Tests

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Research on Human Subjects

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

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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

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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

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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

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Research on Human Subjects

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

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Research on Human Subjects

• Belmont Report of 1979

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Accepted Practice

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Accepted Practice
• Therapeutic

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Accepted Practice
• Therapeutic
• Standard in the Field

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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

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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

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Research

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Research
• Experimental

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Research
• Experimental
• Untested

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Research on Human Subjects

• Belmont Report of 1979
• Boundaries Practice and Research
• Research
• Experimental
• Untested
• Designed to Determine Safety

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Research on Human Subjects

• Belmont Report of 1979

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Research on Human Subjects

• Ethical Principles

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Research on Human Subjects

• Ethical Principles
• Respect for Persons

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Research on Human Subjects

• Ethical Principles
• Respect for Persons
• Autonomous Subjects

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Research on Human Subjects

• Ethical Principles
• Respect for Persons
• Autonomous Subjects
• Protection of Persons Lacking Capacity

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Research on Human Subjects

• Ethical Principles
• Secure the Well-Being of Patients

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Research on Human Subjects

• Ethical Principles
• Secure the Well-Being of Patients
• Do No Harm

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Research on Human Subjects

• Ethical Principles
• Secure the Well-Being of Patients
• Do No Harm
• Maximize Possible Benefits

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Research on Human Subjects

• Ethical Principles
• Secure the Well-Being of Patients
• Do No Harm
• Maximize Possible Benefits
• Minimize Possible Harms

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Research on Human Subjects

• Ethical Principles
• Serve the Demands of Justice

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Research on Human Subjects

• Ethical Principles
• Serve the Demands of Justice
• Who Ought to Receive Benefits of Research

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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

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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

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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

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Research on Human Subjects

• Applications

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Research on Human Subjects

• Applications
• Informed Consent

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Research on Human Subjects

• Applications
• Informed Consent
• Information

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Research on Human Subjects

• Applications
• Informed Consent
• Information
• Clear and Cogent

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Research on Human Subjects

• Applications
• Informed Consent
• Information
• Clear and Cogent
• Can be Understood by the Subject

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Research on Human Subjects

• Applications
• Informed Consent
• Consent

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Research on Human Subjects

• Applications
• Informed Consent
• Consent
• Voluntariness

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Research on Human Subjects

• Applications
• Informed Consent
• Consent
• Voluntariness
• Free of Coercion and Undue Influence

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Risk Harm That May Occur

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Risk Harm That May Occur
• Probability (Chance of Harm)

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Risk Harm That May Occur
• Probability (Chance of Harm)
• Magnitude (severity of Harm)

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Benefits

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Benefits
• Positive Value That May Result

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Research on Human Subjects

• Applications
• The Assessment of Risks and Benefits
• Benefits
• Positive Value That May Result
• Positive Value for Others

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Research on Human Subjects

• Medical Research and Medical Therapy
• Therapy Aimed at the Relief of Suffering and
  Restoring People to health

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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

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Research on Human Subjects

• Medical Research
• Therapeutic

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Research on Human Subjects

• Medical Research
• Therapeutic
• Possibility of Direct Immediate Benefit

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Research on Human Subjects

• Medical Research
• Therapeutic
• Possibility of Direct Immediate Benefit
• Non-Therapeutic

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Research on Human Subjects

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

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Research on Human Subjects

• Medical Research
• Research Involving Children

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Research on Human Subjects

• Medical Research
• Research Involving Children Problems
• The Willowbrook Project

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Research on Human Subjects

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

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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?

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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

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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

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Research on Human Subjects

• Medical Research
• Research Involving Children Benefits

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Research on Human Subjects

• Medical Research
• Research Involving Children Benefits
• Children are not Little Adults

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Research on Human Subjects

• Medical Research
• Research Involving Children Benefits
• Children are not Little Adults
• Childrens Bodies Function Differently

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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

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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

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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

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Research on Human Subjects

• Medical Research
• Research Involving Children Criteria
• Who is Considered a Child?

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Research on Human Subjects

• Medical Research
• Research Involving Children Criteria
• Who is Considered a Child?
• Informed Assent?

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Research on Human Subjects

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

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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?

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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

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Research on Human Subjects

• Medical Research
• Research Involving Prisoners

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Research on Human Subjects

• Medical Research
• Research Involving Prisoners
• Historical Caution

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Research on Human Subjects

• Medical Research
• Research Involving Prisoners
• Historical Caution
• Reduction in Sentence Duress?

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Research on Human Subjects

• Medical Research
• Research Involving Prisoners
• Historical Caution
• Reduction in Sentence Duress?
• Avoiding Undue Influence

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Research on Human Subjects

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

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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

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Research on Human Subjects

• Medical Research
• Research Involving The Poor

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Research on Human Subjects

• Medical Research
• Research Involving The Poor
• Tuskegee Study

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Research on Human Subjects

• Medical Research
• Research Involving The Poor
• Tuskegee Study
• Use of Public and Municipal Hospitals

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Research on Human Subjects

• Medical Research
• Research Involving The Terminally Ill

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Research on Human Subjects

• Medical Research
• Research Involving The Terminally Ill
• Informed Consent?

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Research on Human Subjects

• Medical Research
• Research Involving The Terminally Ill
• Informed Consent?
• Feelings of Despair

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Research on Human Subjects

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

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Research on Human Subjects

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

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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?

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Research on Human Subjects

• Medical Research
• Research Involving Cognitively Impaired Subjects

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Research on Human Subjects

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

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Research on Human Subjects

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

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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?

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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.

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RESEARCH ON HUMAN SUBJECTS

• Comments
• Questions
• Discussion