Outside US (OUS) Trials

TitleOutside US (OUS) Trials
Publication TypeCase Study
Year of Publication2007
AuthorsStanford Biodesign, Stanford University,
PublisherStanford Biodesign, Stanford University
Keywordsbiomedical engineering , Human Research Subjects , MEDICINE , SCIENCE
AbstractA company who designs medical devices have completed their testing in animal subjects, and feel that they are now ready to move on the human testing of devices. Because of the cost and logistical barriers in the United Sates, they decide to test their device first in India and then in European centers. What are some of the issues the company should consider, including ethical and regulatory issues, before they go forward with this plan?
OEC Unique IdentifierEthics Cases in Biodesign
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