Define ethics

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Define ethics
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Why are ethics necessary in research?

• To insure the protection of human and animal
  subjects
• To insure that research outcomes are achieved
  using moral and appropriate guidelines
• For the purpose of clarifying that research
  contributes to the body of knowledge constituting
  the background of a discipline

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Three Guiding Principles of Human Subject
Protection

• Autonomy
• Beneficence
• Justice

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Autonomy - the capacity of individuals to make
their own life decisions self- determination
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Beneficence - the obligation to attend to the
well-being of individuals principle of do no
harm
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Justice - fairness in the research process
equitable distribution of benefits and burdens
subject selection performed without bias
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What are Institutional Review Boards and why do
we have them???
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A Little History (unfortunately there is lots
more)

• Tuskegee study
• Failure to treat subjects
• Failure to tell subjects they werent being
  treated
• Subjects not chosen randomly
• Failure to use successful treatments developed
  after the start of the study
• World War II and Nazi Experimentation
• subjects not allowed to choose whether to
  participate
• subject selection biased
• justice was ignored
• treatments were not valid by any stretch of
  science

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more history

• The Jewish Chronic Disease Hospital study (1963)
  where patients hospitalized for a chronic disease
  gave oral informed consent without full details
  of the study they were then injected with
  cancer cells but not told they were getting
  cancer cells
• Willowbrook study (1963-1969) children in a state
  hospital for the mentally retarded were injected
  with hepatitis virus so that researchers could
  study the natural history of the virus in this
  population. Parents consented but had been told
  the children would get the virus anyway because
  of terrible conditions in the facility

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Actions Arising from Violations of Subjects
Rights

• The Nuremburg Code of 1947
• The Declaration of Helsinki and continuing
  revisions
• The Belmont Report and continuing revisions

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The Nuremburg Code of 1947

• Occurred as a result of Nazi war crimes
• emphasized that participants in research should
  voluntarily consent to participate
• can consent only after being informed of the
  study procedures
• studies can only be performed by qualified
  individuals

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Declaration of Helsinki, 1964

• The International Code of Ethics for Biomedical
  Research
• Concept of independent review of research by
  qualified individuals not associated with the
  project
• Right to refuse publication for work not done in
  accordance with the accords

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The Belmont Report (1979)

• Finalized report on the decisions made for the
  protection of human subjects starting in 1974
• Standardizes requirements for informed consent
  and Institutional Review Board procedures
  intended to insure autonomy, beneficence, and
  justice

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IRB Membership

• Both genders must be represented
• Multiple professional groups must be represented
• One non-scientific member
• One member separate from the institution
• Committee members must be able to judge submitted
  studies

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www.uab.edu/irb
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Ethical Responsibilities of the Researcher

• Honesty and integrity in every phase of research
• To do clinical research that is meaningful
• To be competent and have expertise in the area
  under investigation
• Publication of research outcomes, being honest
  and thorough in the documentation of such
  outcomes
• To give credit to collaborators
• Conducting data analysis through procedures which
  are appropriate and to not manipulate the data to
  achieve results the investigator wants

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Control Groups

• What are they?
• Why are they necessary?

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Elements of Informed Consent
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What is included in Informed Consent?

• Patient/participant is fully informed of purpose,
  procedures, risks and discomforts, benefits, and
  alternatives
• All information is confidential and anonymous
• Consent Form written in lay language
• Researcher available to answer questions at any
  time
• Consent must be voluntary
• Special consideration for vulnerable populations
• Free to withdraw consent at any time

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What ethical violations did you find in the UAB
study on the web page?
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Violations in Dermatology Drug Study

• Conflicts of interest
• PI failed to take responsibility for the study
• Falsification of data
• Failure to tell subjects of other interventions
• Failure to tell subjects when study results
  proved false
• Falsification of information from PI to IRB
• Failure of IRB to intervene when fraud was
  discovered
• Failure of PI to insist on writing up results
  instead of letting the company do it
• Competition between overseeing agencies at the
  federal level