DISCUSSION OF COMMUNITY CONSULTATION
                         BERNARD LO, M.D.
     DR. LO:  Okay.  Thanks, Tom. 
     The next section is going to try and deal with these
difficult controversial issues of community that we were starting
to touch on before the break.
     And I just want to start by saying that this is an issue
that comes up in a lot of research, but it seems to me has
particular importance for genetic research because learning
genetic information on an individual also gives you some
information about larger groups like relatives and families.
     There is actually an interesting sort of example of concerns
about the impact of research on the community, even when
individuals might not be identifiable, and that is clinical
research on HIV and AIDS, where very early on in the AIDS
epidemic it was clear that this was an epidemic that
disproportionately affected communities, in some sort of loose
sense of the term, first predominantly gay men, homosexual men,
and then, later in the epidemic, both geographical and ethnically
targeted communities in the inner city.
     The risks were clear.  Early on, there were risks of both
stigma and very real discrimination in terms of loss of jobs,
housing, education, and the like.  And very large concerns that
individuals who were identified as being members of that group
might have other characteristics ascribed to them; the thought
that they might be infectious, contagious, or whatever.
     We touched on a number of issues before the break:
     Who is the community;
     What do you do if the community in New York disagrees with
the community in San Francisco;
     What do you do within San Francisco when this part of the
city disagrees with that part of the city;
     Who are the leaders; and,
     If you wanted to talk to community members, how do you
actually do it?
     One thing that I think is important to keep in mind is that
the kinds of studies that we are talking about in HIV tend to be
prospective clinical trials, where you are testing a new drug or
combination of drugs.  And I think what has happened is that the
real power of the community is in talking about the design of the
trial sort of before it is initiated.  And kind of the power is
not whether they give formal approval to the protocol or not, but
it is their ability to sway public opinion.
     So if respected voices in the community say that they have
serious reservations of a trial, that will really cut down on the
willingness of individuals to enroll in the trial so, even though
they may not formally sign-off or consent--I guess in Larry's
terms--they actually have a sort of I wouldn't say de facto veto
but something getting close to that.
     Over the last decade there has been a lot of energy put into
community consultation collaboration with representatives of the
community in the actual planning and design of clinical trials in
AIDS.  It has not been an easy process.  Early on, I think it was
extremely time consuming and emotionally grueling.  Lots of name-calling, shouting, vegetables thrown at people at meetings, and
the like.
     But I think in that--  And no one could have predicted at
the onset how you would design it.  I think it was something that
evolved over time as people tried to deal with one study and then
another study and began to get a feel for who the other players
were.  And, I must say, I think a lot of the AIDS activists got
very well informed on some of the technical details of the
science.
     We are very fortunate today to have Jack Killen, who is the
Director of the Division of AIDS at the NIAID.  
     His group has oversight over the AIDS Clinical Trials Group
and the community consortium that do carry out the large publicly
funded cooperative collaborative AIDS trials.  And their group
has had a lot of experience with community consultation and
trying to both understand community's concerns and address them
in the design of the study.  
     So I asked Jack, and he was gracious enough to come to share
his experience in terms of how this is done, what works, what
doesn't, what some of the pitfalls are, what some of the benefits
are, and then I think we should have a pretty interesting
discussion afterwards.  
     Jack, we are delighted that you could come.