A Review of Current Events in Human Subjects Protection

Abstract

Bioethics is a subject that has been gaining increased attention through the last few years. Factors such as globalization of research, genetic medicine, and tragic events in clinical trials have drawn attention to the importance of protecting human participants in medical research. The October 2000 revision of the Declaration of Helsinki and the release of two reports by the National Bioethics Advisory Commission are just a few examples of the recent efforts by policymaking bodies to modernize bioethical standards. This review provides an introduction to several of the groups that are participating in the reshaping of bioethical policy in the United States and around the globe. Although there are multiple bioethical issues currently being debated, three specific topics are discussed: the use of placebo controls in clinical trials, posttrial access to medicines, and financial conflicts of interest.

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Correspondence to Laura Coleman PharmD.

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Coleman, L., Holdsworth, S. A Review of Current Events in Human Subjects Protection. Ther Innov Regul Sci 36, 261–267 (2002). https://doi.org/10.1177/009286150203600204

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Key Words

  • Bioethics
  • Human subjects protection
  • Declaration of Helsinki
  • Informed consent
  • Financial conflicts of interest
  • Placebo control