I 
109TH CONGRESS 
2D SESSION 
H. R. 5641 
To promote safe and ethical clinical trials of drugs and other test articles 
on people overseas. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 20, 2006 
Mr. LANTOS (for himself and Mr. BROWN of Ohio) introduced the following 
bill; which was referred to the Committee on International Relations 
A BILL 
To promote safe and ethical clinical trials of drugs and 
other test articles on people overseas. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Overseas Human 
Testing Act’’. 
SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) Before a manufacturer of a new drug or de-
vice can market its new product, the Food and Drug 
Administration (in this section referred to as the 
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‘‘FDA’’) requires that the manufacturer conduct 
laboratory and clinical trials to ascertain the prod-
uct’s safety and effectiveness. 
(2) Federal regulations mandate that an Insti-
tutional Review Board (IRB), which is comprised of 
scientists, physicians, and lay people, review the pro-
tocol or research plan and the informed consent 
form of the proposed clinical trial to ensure, among 
other things, that the health and safety of the 
human participants are not unnecessarily endan-
gered. 
(3) Institutional Review Boards also verify that 
the manufacturer’s clinical researchers implement 
appropriate additional safeguards to protect the 
rights and welfare of potentially vulnerable popu-
lations and persons who are economically or educa-
tionally disadvantaged. 
(4) Most importantly, the IRBs help assure the 
FDA that manufacturers of new drugs and medical 
devices adequately inform human participants of the 
anticipated risks and the likelihood of projected ben-
efits derived from their participation in the clinical 
trials, and then secure the voluntary consent of the 
participants. 
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(5) For the purpose of supporting the safety 
and efficacy of the test article, the FDA, however, 
may accept the results of clinical trials with human 
participants which are conducted outside of the 
United States and do not meet United States IRB 
and ethical requirements. 
(6) Foreign clinical trials involving human par-
ticipants only need to conform to either international 
norms on clinical investigations or the laws and reg-
ulations of the country in which the research is to 
be conducted. However, neither international nor 
most host-country standards meet the stringent re-
quirements of the United States. 
(7) International and most foreign-country legal 
protections do not adequately shield participants in 
clinical investigations of a new drug or device from 
unethical, dangerous, or unscrupulous research prac-
tices. 
(8) Some researchers exploit the fragile regu-
latory systems, high illiteracy rates, and public 
health failures of developing countries to test their 
experimental drugs and devices on misinformed and 
unwilling human participants. 
(9) On April 30, 2001, the National Bioethics 
Advisory Commission (NBAC) presented to the 
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President a report, entitled ‘‘Ethical and Policy 
Issues in International Research: Clinical Trials in 
Developing Countries’’, which discussed the ethical 
issues generated by research on human participants 
in developing countries and recommended ways to 
help ensure the health and safety of these human 
participants. The NBAC highlighted the inadequate 
regulatory protections which are afforded to human 
participants in many clinical trials abroad. 
(10) In September 2001, the Office of the In-
spector General of the Department of Health and 
Human Services released the report entitled ‘‘The 
Globalization of Clinical Trials: A Growing Chal-
lenge in Protecting Human Subjects’’. In the report, 
the Inspector General acknowledged that key entities 
which oversee or study foreign research, including 
United States regulatory agencies and the World 
Health Organization, have raised concerns about the 
lack of experience and insufficient monitoring prac-
tices of many foreign IRBs. 
(11) The Inspector General also recommended, 
among other things, that the FDA collect more in-
formation on the performance of foreign IRBs and 
the growth and location of foreign clinical investiga-
tions. 
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(12) While Federal regulation should accelerate, 
whenever possible, the delivery from laboratory to 
patients of new drugs which are designed to treat 
devastating illnesses, existing law permits manufac-
turers to profit from the misery and pain of uni-
formed, misinformed, and unwilling patients in de-
veloping countries. 
(13) On June 10, 2004, the FDA issued a pro-
posed rule that would, among other things, replace 
the existing requirement that foreign clinical studies 
be conducted in accordance with the ethical prin-
ciples which are contained in the Declaration of Hel-
sinki (described in section 312.120(c) of title 21, 
Code of Federal Regulations), with a requirement 
that such studies comply with good clinical practice 
(GCP). 
(14) 
Although 
pharmaceutical 
and 
bio-
technology companies and their lobbyists, in sub-
mitted public comment, generally support the pro-
posed rule, other organizations, such as the AIDS 
Vaccine Advocacy Coalition and Public Citizen, have 
objected to the proposed deletion of the Declaration 
of Helsinki from applicable regulations because the 
removal may result in the use of placebos or other 
drugs which are less effective than established treat-
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