Testimony before the Subcommittee on Human Resources, Committee on Government Reform and Oversight, U.S. House of Representatives

Thank you for the opportunity to testify before the Subcommittee on these
crucial bioethical issues. Our testimony today will address two subjects:
HIV vaccine trials and a National Institutes of Health (NIH)-funded study of
needle exchange programs in Alaska. While these two areas may seem
disparate, there are several common themes that link them: 1. the difficulty
of obtaining informed consent in vulnerable populations; 2. the need to
provide research subjects with state-of-the-art medical care; and 3. the
conflict of interest between the purported needs of researchers and the clear
needs of the research subjects. We will address HIV vaccine trials first.
There is no question that the development and widespread utilization of a
vaccine that effectively prevents transmission of HIV would be a public
health triumph. With behavioral interventions currently having an important
but limited impact upon HIV transmission, an effective vaccine is our best
hope for preventing the huge burden of suffering from HIV disease both in
the U.S. and abroad. Yet enormous ethical issues complicate potential
vaccine efficacy trials. We shall mention just three.
First, because behavioral interventions such as safe sex counseling or the
provision of condoms or sterile syringes have the capacity to reduce HIV
risk behavior, it is critical to provide research subjects with state-of-the-art
behavioral interventions as part of HIV vaccine trials. Yet, to the extent that
such interventions are effective, there will be fewer new HIV infections and
the ability to demonstrate statistically significant reductions in new HIV
infections due to the vaccine will be reduced. This places the researcher in a
classic conflict of interest, and creates an incentive to not provide adequate
behavioral interventions in conjunction with these vaccine trials. The
obvious solution to this dilemma is to employ an independent group of
individuals to provide the behavioral interventions, but on several occasions
when this has been suggested in the context of HIV vaccine trials it has met
with opposition.
The remaining two issues deal with potential HIV vaccine trials in
developing countries. Worldwide, an estimated 21.8 million people are
presently living with HIV. Over 94% of these individuals live in the
developing world; residents of developing countries therefore stand to derive
the greatest benefit from such a vaccine. The need for a vaccine for a
particular country is, however, different from the need for a vaccine trial in
that country.

The Council for International Organizations of Medical Sciences' ethical
guidelines on research in developing countries state unequivocally that "the

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