E-drug: NBAC: American research without a requirement for American IRB review
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December 1, 2000
We are writing to urge you to write to the U.S. National Bioethics
Advisory Commission (NBAC) immediately to comment on a new twist in
the current draft of NBAC's report on the ethics of international
research. Please submit your comments before the next NBAC meeting
on December 7 and 8, with a cc to us.
At the last meeting on November 22, the NBAC for the first time
circulated a draft recommendation that would permit U.S. researchers
to conduct research in foreign countries without having to receive
approval from a U.S. Institutional Review Board (IRB). The new
recommendation reads as follows:
"Clinical trials conducted in developing countries and subject to
U.S. research regulations must, as a minimum, be given prior approval
by an independent ethics review committee in the country where the
research will take place. Researchers should include in the research
protocol plans for facilitating communication between or among IRBs
in the United States and with ethics review committees in the
collaborating countries."
Importantly, the first sentence used to read: "Clinical trials * must
meet prior approval by an independent ethics review committee in the
country where the research will take place AS WELL AS BY A U.S. IRB
(emphasis added)." The capitalized part of the sentence has now been
omitted, meaning that developing country IRB approval alone would
suffice.
The NBAC is in effect proposing that U.S. researchers from
universities, government or the pharmaceutical industry could conduct
research in developing countries without any U.S. approval. The
entire onus of participant protection would be shifted to the
developing world, where the ethical review infrastructure, as the
NBAC documents clearly in its report, is grossly inadequate. Yet it
is to this infrastructure that the NBAC would entrust participant
protection, even though it is seen as so inadequate that the NBAC
report recommends the need for capacity building. Can we really
expect countries with no IRBs or IRBs with little experience to turn
down research, particularly with the prospect of millions of dollars
of hard currency in the offing? Even the U.S. IRBs have been heavily
criticized by the government's own Inspector General for inadequately
protecting participants.
The NBAC proposal is illegal, unethical and bad policy. What the
NBAC is proposing is illegal under U.S. law, which requires review
both in the U.S. and abroad. There is a similar requirement in the
Council for International Organizations of Medical Sciences (CIOMS)
ethics document. And it is certainly terrible policy to permit U.S.
taxpayer funds to be expended without review in the U.S. Once again,
the NBAC is proposing standards lower than those accepted
internationally.
While some U.S. institutions will not exploit this loophole, some
will and it likely to prove irresistible to many pharmaceutical
companies who are already shifting their research operations to the
under-regulated developing world.
It is outrageous that such an objectionable change should be
introduced into the document at so late a stage in the document
revision process, particularly because the meeting at which this
change was made public was illegally constituted under the Federal
Advisory Committee Act - a fact, that when we brought it to the
attention of the NBAC resulted in the cancellation of the official
meeting. Nonetheless, the NBAC continued to meet as if there was no
cancellation. The meeting was scheduled for the day before the
four-day weekend of the major U.S. holiday Thanksgiving, ensuring
poor attendance from both the public (we were the only people who
provided testimony) and even from the commissioners themselves (only
two of the 21 commissioners were present in person). Our comments on
the draft NBAC document prior to this can be found at:
http://www.citizen.org/hrg/PUBLICATIONS/1545.htm
Please take the time to write to the NBAC expressing your opposition
to this last-minute change and cc a copy to us. We can then
incorporate your comments into our testimony at the next NBAC meeting
(December 7 and 8 in Washington, D.C.), which is itself illegal under
the Federal Advisory Committee Act, because it, too, was not
announced to the public properly. It is especially important to have
statements from developing country researchers and those sitting on
IRBs in industrialized countries. The contacts for mailing comments,
which should be received as early as possible prior to the December 7
meeting, are:
Email: nbac@od.nih.gov
NBAC Website: Comments
Mail: 6705 Rockledge Drive, Suite 700, Bethesda, MD 20892-7979
Fax: (301) 480-6900
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Web address: http://www.citizen.org
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