Letter to the National Bioethics Advisory Commission (NBAC)
on draft report, "Ethical and Policy Issues in International
Research"
November 20, 2000
Harold T. Shapiro, Ph.D., Chair
Eric M. Meslin, Ph.D., Executive Director
National Bioethics Advisory Commission
6705 Rockledge Drive, Suite 700
Bethesda, MD 20892-7979
Dear Drs. Shapiro and Meslin:
The Association of American Medical Colleges (AAMC) appreciates
this opportunity to comment on the National Bioethics Advisory
Commission (NBAC) draft report, "Ethical and Policy Issues
in International Research." The AAMC represents all 125
accredited U.S. medical schools, more than 400 major teaching
hospitals, 91 academic and professional societies consisting
of 75,000 faculty members, and the nation's medical students
and residents. This report is of particular interest to us
since a significant number of biomedical researchers conducting
studies abroad are faculty members of the institutions that
we represent.
The AAMC firmly believes that researchers, Institutional
Review Boards (IRBs), and sponsors must carefully consider
the ethical requirements, irrespective of the location, of
any research protocol. We also concur that the nature and
understanding of these requirements differ based on the particular
locale or culture, and we commend the NBAC for offering a
forum to discuss the ethical, legal, and policy issues that
arise when research is sponsored or conducted in other countries.
In general, the AAMC finds the report to be well researched
and pertinent. However, we believe that many of the recommendations
are poorly framed, impractical, and may result in the unintended
consequence of preventing important research on major health
problems in developing countries. In some cases, these recommendations
would place responsibilities on researchers, institutions,
and their IRBs that are beyond their purview and expertise.
Although the AAMC appreciates the need for researchers and
IRBs to consider local cultural norms in the design of research
and the informed consent process, we believe that it may not
be feasible in some cultures to involve the direct participation
by community members in addressing these issues. Researchers
and IRBs should be encouraged to find effective ways to obtain
advice on local cultural norms that are more relevant than
arbitrary prescriptive recommendations. Indeed some scientists
and scholars in the developing world regard the application
of prescriptive recommendations based on Western standards
to be a form of "ethical imperialism." However accomplished,
the AAMC agrees that the goal should be to conduct research
in a manner that is culturally sensitive.
The other major problematic recommendation in the report
concerns the provision of successful interventions to local
populations once the research protocol is finished. At the
start of a trial, it will not be known which intervention
will prove most effective, and thus what systems and resources
will be necessary. In addition, the recommendation provides
no guidance on how large a population should be involved or
for what length of time the intervention should be provided
(an especially difficult question for chronic diseases). During
the course of the trial, the AAMC believes there is no question
that there is an obligation to provide necessary health care
to all trial subjects. But to place requirements on researchers
that are indefinite with regard to population and time would
make trials so expensive that they could never be offered
to international populations, depriving them of findings that
respond to their health needs.
Finally, the AAMC would like to offer one editorial suggestion.
The Commission should include an executive summary, which
would be very helpful in conveying the overarching principles
that helped to form the specific recommendations.
In summary, the AAMC strongly encourages the NBAC to carefully
reconsider those recommendations that place impractical requirements
on researchers in community involvement and post-trial benefits.
At a time of increasing pleas to the scientific community
to heed the staggering tolls of endemic diseases in under-The
AAMC believes that the result of yourdeveloped countries,
it is imperative that any promulgation of new ethical guidelines
for international research be informed by sensitivity and
a careful balancing of individual and societal benefits. The
AAMC is concerned that the NBAC’s proposed recommendations
do not reach that balance, and that the result will be to
discourage research thatmay potentially benefitcould benefit
enormously not only the local health needs of the host country.
country, but more broadly, of the region. To maximize the
benefits of research for all nations, it is imperative that
worthy and ethically sound international research projects
continue to flourish.
The AAMC thanks NBAC for the opportunity to comment on its
draft report. Please do not hesitate to call upon us if we
can be of any help in the future.
Sincerely,
Jordan J. Cohen, M.D.
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