E-drug: U.S. National Bioethics Advisory Commission draft report
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November 14, 2000
This brief note is to encourage you to submit comments to the U.S.
National Bioethics Advisory Commission (NBAC) in response to its
report Ethical and Policy Issues in International Research. The
report can be viewed at http://bioethics.gov/report.html
Comments should be submitted as follows:
By email: nbac@od.nih.gov
NBAC Website: Comments
By Mail: 6705 Rockledge Drive, Suite 700, Bethesda, MD 20892-7979
By Fax: 1-301-480-6900
The deadline for comments was November 13, 2000, but we understand
that late comments will be accepted until the end of this week. We
strongly suggest that you submit comments as soon as possible for
them to get optimal attention.
You can view Public Citizen's comments on the draft report at:
http://www.citizen.org/hrg/PUBLICATIONS/1545.htm
While the report contains several useful contributions, it provides
significant loopholes that would allow researchers to elude any
requirement to optimally treat patients during the trial or provide
effective interventions to the community after the trial. Too often,
procedural "solutions" take the place of making tough ethical
decisions. Moreover, useful data collected by the Commission's
consultants have, for the most part, been relegated to a second
volume which is not generally available for review.
Again, we urge you to submit comments and to post this message
widely. Please cc us on any comments you submit. We believe that
comments submitted on the Declaration of Helsinki from around the
world helped improve the document. We hope that the same will be
true here. The NBAC document was prepared by a U.S. Presidential
advisory commission without any systematic interviews of research
participants in developing countries, and so it is particularly
important for developing country representatives to write in.
Information on the revision of the Council for International
Organizations of Medical Sciences (CIOMS) document remains sparse.
Our understanding is that there is a drafting committee which will
meet in January 2001 and produce a draft in the Spring (northern
hemisphere) of the same year. The final version is slated to be
ready in November 2001. The previous CIOMS drafts have not been
circulated for public comment, so it is difficult to know in what
direction the revision is headed. We will keep you informed as more
information becomes available.
Yours sincerely,
Peter Lurie
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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