Last Week in Review

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Last Week in Review
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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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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

• 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

• 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 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