Informed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad

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dc.contributor.author Lee, Stacey B.
dc.date.accessioned 2009-11-04T18:30:43Z
dc.date.available 2009-11-04T18:30:43Z
dc.date.issued 2009-11
dc.identifier.uri http://jhir.library.jhu.edu/handle/1774.2/33526
dc.description.abstract The past several years have seen an evolution in the obligations of pharmaceutical companies conducting clinical trials abroad. Key players, such as international human rights organizations, the United States government and courts, and the media have played a significant role in defining those obligations. This article examines the evolution of those obligations through the lens of past, present, and future recommendations for informed consent protections. In doing so, this article suggests that, no matter how robust these obligations become on their face, they will continue to fall short of providing meaningful protection until they are accompanied by a substantive enforcement mechanism that holds multinational pharmaceutical companies accountable for their conduct. Issues of national sovereignty, particularly in the United States, will continue to prevent meaningful enforcement from an international tribunal or from one universally adopted code of ethics. Rather than continuing to pursue an untenable international approach, this article argues that a viable enforcement mechanism lies in application of the Alien Torts Statute (ATS). Recent federal appellate court precedent interpreting the ATS provides the mechanism for granting victim redress and enforcing sponsor accountability for informed consent misconduct. A vital component in ensuring the world population’s “right to health” includes substantive human rights protections. This article concludes that by building on the federal appellate court’s ATS analysis, which grants foreign trial participants the right to pursue claims of human rights violations in the United States, a mechanism for enforcing not only substantive informed consent, but also human rights protections can be created. en
dc.description.provenance Submitted by Rashawna Sydnor (rsydnor@jhu.edu) on 2009-11-04T18:30:43Z No. of bitstreams: 1 Stacey Lee - Informed Consent - Pharmaceutical Obligations (2).pdf: 115666 bytes, checksum: 6b8470198c010ad8155ba3b4c25661c7 (MD5) en
dc.description.provenance Made available in DSpace on 2009-11-04T18:30:43Z (GMT). No. of bitstreams: 1 Stacey Lee - Informed Consent - Pharmaceutical Obligations (2).pdf: 115666 bytes, checksum: 6b8470198c010ad8155ba3b4c25661c7 (MD5) Previous issue date: 2009-11 en
dc.language.iso en_US en
dc.publisher Carey Business School, Johns Hopkins University en
dc.relation.ispartofseries The Johns Hopkins Carey Business School Working Paper Series;09-11-001
dc.subject K33 - International Law en
dc.subject K32 - Environmental, Health, and Safety Law en
dc.title Informed Consent: Enforcing Pharmaceutical Companies' Obligations Abroad en
dc.type Working Paper en

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