Helsinki discords: FDA, ethics, and international drug trials

  title={Helsinki discords: FDA, ethics, and international drug trials},
  author={J. Kimmelman and C. Weijer and E. Meslin},
  journal={The Lancet},
A Review and Critique of International Ethical Principles
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Challenges Working with Presidential Bioethics Commissions.
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  • 2017
I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments and as senior consultant to the National Bioethics Advisory Commission for its report on multinational research. Expand


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  • Molecular therapy : the journal of the American Society of Gene Therapy
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Because the methods and codes that define scientifically and ethically acceptable approaches to clinical human research are a cornerstone of the ASGT's activities, it is vital for the Society to respond to events and issues that may pose important new challenges to those tenets. Expand
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This study is unaware of any recent Medline-indexed publications quantifying the globalization of biopharmaceutical clinical trials (BCTs; defined as trials assessing small-molecule pharmaceuticals and adjuvants, biologics and vaccines) based on publicly accessible data. Expand
The Declaration of Helsinki
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In April 2002 the Nuffield Council on Bioethics published the Report The Ethics of Research Related to . It provides an ethical framework for those designing or conducting healthcarerelatedExpand