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24 Health Law. 1 (2011-2012)

handle is hein.journals/healaw24 and id is 1 raw text is: IN THIS ISSUE After Guatemala and Nigeria: The Future of International Clinical Research Regulation..... 1 State of the ABA Health Law Section Letter................ 3 CO-OPs: A Little Known Provision of the Health Reform Law........................ 21 Healthcare Employers With Unaffordable Pension Plans: A Non-Bankruptcy Solution.... 26 Two Steps Forward, One Step Back: HHS Invests in Health IT Infrastructure, but Admits to Failures in Security Enforcement........................ 34 AMERICAN BAR ASSOCIATION Health Law Section Volume 24, Number 1 October 2011 THE ABA HEALTH LAW SECTION ::H EALTH AFTER GUATEMALA AND NIGERIA: THE FUTURE OF INTERNATIONAL CLINICAL RESEARCH REGULATION Steven W. Postal Associate and Post-Graduate Fellow Office of the Maryland Attorney General Baltimore, MD Robyn Whipple Diaz Associate General Counsel St. Jude Children's Research Hospital Memphis, TN* The globalization of clinical research is the new reality; in 2009, 50 million people were enrolled in clini- cal trials worldwide.' A June 2010 report by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) confirmed that 80 percent of approved marketing applications for drugs and biologics con- tained data from trials conducted overseas, and more than 50 percent of clinical trial subjects and sites were located overseas.2 The percentage of clinical trials registered by the Food and Drug Administration (FDA) con- ducted outside of the United States and Western Europe went from five percent in 1997 to 29 percent in 2007. A major driver for the outsourcing of clinical research is financial: while it costs approximately $20,000 to track a single subject in an American clinical study, it only costs $2,000 per subject in India.4 Despite the existence of inter- nationally recognized protections for participants in human subjects research, in the drive toward medical advancement some study sponsors and investigators have failed to provide participants abroad with the rights afforded to research participants in the United States. The sheer number of studies conducted abroad has led to a lack of regulatory oversight, putting some of the world's most vulnerable populations at risk. This article ana- lyzes two particularly egregious studies in which internationally accepted human research subjects protections were not available to foreign partic- ipants in studies conducted by U.S.-based sponsors and investigators. One such study took place in the 1940s but was just recently unearthed from long-forgotten archives; the other, from the 1990s, has been the subject of battles in U.S. courts for the last ten years. This article will discuss these studies, as well as the tools that will likely be used in the future to bet- ter protect human research subjects abroad, including lawsuits in U.S. courts under the Alien Tort Statute. continued on page 7 VAV

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