America Living With AIDS

AM E R I C A Living With

HIV disease but will also contribute to
a better understanding of how certain
experimental drugs will actually work
outside a scientifically controlled environment.
The Commission believes controlled clinical trials are an essential
part of any comprehensive clinical
research program. Placebo controls
are warranted in clinical research
when no other effective
therapy exists, but where
effective therapies do
strategy exist, comparison of new
threefold: therapies to those proven
lications of effective are considered
ortunistic appropriate. The realities
asms; direct of HIV disease demand
py; and that creativity and flexie successful, bility in designing and
diminished implementing the trials
e, which, are equally essential.
nagine, Input from representat is really tives of affected commulex. nities at the earliest stage
of study design can miniCI, M.D. mize misunderstandings
0 and improve participation in trials. The importance of autonomy and
patient choice, long a
central theme of discourse about the
ethics of human subjects research,
should be underscored. People with
HIV disease have sought and disseminated information in order to make
informed choices about whether they
wish to assume the risk of participation in research. People with HIV disease have also sought greater involvement on research-related advisory

councils. This involvement is now
reflected by the participation of people
with HIV disease on many decisionmaking councils of the National Institutes of Health, the Food and Drug
Administration, the Institute of
Medicine, Institutional Review Boards,
and other such bodies. The Commission believes the involvement of people
with HIV disease on all of these councils and advisory bodies has and will
continue to enhance HIV-related
research programs. The Commission
particularly encourages the involvement of people of color on these bodies and advisory councils.
The National Institutes of Health,
in particular the National Institute on
Allergy and Infectious Diseases
(NIAID), sponsors most of the clinical
research on HIV. The AIDS Clinical
Trials Group (ACTG) is a national
program administered by NIAID
which sponsors HIV-related clinical
trials in academic institutions around
the country. Included in this national
program is an "ACTG-without-walls
concept" that specifically conducts
clinical studies for people with
hemophilia.
The ACTG Program has received
considerable scrutiny and criticism
over the past few years from a number
of individuals and organizations
including ACT-UP, the People with
AIDS Coalition, members of
Congress, the Institute of Medicine,
and advocates for women, children,
and prisoners, among others. In its
Third Interim Report to the President
and the Congress, the National Commission on AIDS also expressed a
great deal of concern about the ACTG

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