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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