human rights and bioethics: regulating global research george j. annas, jd, mph professor &...
TRANSCRIPT
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Human Rights and Bioethics: Regulating
Global Research
George J. Annas, JD, MPHProfessor & Chair
Department of Health Law, Bioethics & Human RigthsBoston University School of Public Health
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Presenter Disclosures
No financial relationship with any phramaceutical or biotechnology company, including those that will be mentioned in this talk: Pfizer, Wyeth and Genzyme.
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Informed Consent
• Health Law
• Bioethics
• Human Rights
• Synthesis?
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Nuremberg Code
• Consent: Voluntary, Competent, Informed and Understanding
• Right to withdraw at any time
• Plus 8 subject welfare provisions
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Helsinki Declaration
• Meant to Replace Nuremberg
“Therapeutic Privilege”
• Research/Treatment
• Researcher/Physician
• Subject/Patient
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Continuing Controversies
• Consent (content, doc, quality, followup)
• Benefit Sharing (responsibility, followup)
• IRBs (defective protection mechanism?)
• Research or health care? Prevent/treat?
• Universal standards and enforcement
• The relevance of the “right to health”
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