Discussion Group Reports
Blue Group Transparency Notes:
[unidentified group]: have some strong opinions, [laughter] [inaudible],
and as I said, there really have been some, a lot of thought already,
into what informed consent is, and there is a legal definition in place,
and that if we all really [went with?], [followed it?], we would be a lot
better off [coming out?]. And within that, that means that just taking
the population, it doesn't mean [inaudible]. If we involve them,
ideally, as [inaudible], with the whole process and design of it, then
we are [inaudible] from them, without having to deal with some of these
issues. The collective risks and potential benefits, [inaudible]
to tell them all. And another thought that came from that was to
involve the community in determining and letting the researchers know what
they perceive as the potential risks and benefits. Another thought
that came out was while you're doing these [tests?] in the community, why
not ask the community what their real health concerns are. [inaudible]
agenda or whatever, and they may have a completely different one, or one
that is their most [central?] core issue in their community, and we could
help them, we could help them network, [inaudible].
Adhere and enforce the legal definition in
a. Educate the population about the research
b. Realistic and full disclosure of benefit
c. Community assessment of risk and benefits
d. Community input into research goals
e. No open-ended consents or research
f. Realistic ways to minimize risks
As far as the sample size, or sample, there shouldn't be any open-ended
consent for research, that there's too much unknown [inaudible].
And take the initiative to try and minimize the risks that you do identify.
If you're able to identify them, [inaudible].
We didn't really talk about [education?] issues. I think that
the only thing I can think of is make sure you put a disclaimer in here,
that you're not speaking for the entire group, that this is only who want
it and [inaudible] individuals and [inaudible] that would be [inaudible]
highest goal, but [inaudible], and maybe ask for input from the community,
any adverse effects they might [inaudible], try to take responsibility
Traditional rights. That was difficult and [we talked about it
before?] the belief that for people that wouldn't want to help probably
[easily be able?] to identify [internally?] if they are being, participating,
in the community internally, there would be a private [inaudible] setting,
and you don't know if they had the blood taken out or not. That's
helpful if the community [supports] the research, but if they oppose the
research and you want them, [inaudible]
Black Group Transparency Notes:
Black: I guess we sort of began our discussion with point number
three, number three on this chart, that disease studies and population
studies really are different, and yet the [inaudible] overlap in some ways,
so [inaudible], analytically the same but in terms of the actual issues,
there might be some overlap there. We did talk about the ex-patriate
issue, and the question of who should be consulted for the [approval of?]
research, and the discussion was [inaudible]. Somebody said
that the question of who do you consult depends on the type of risks that
the research involves, maybe the geographic and the political distance
between the groups you're thinking of working with, and some other [inaudible],
for example, for the Hmong, [inaudible]. Hmong groups are [inaudible],
and it may not make sense to [inaudible] risks issues and have to [inaudible]
discuss with a [dissenting?] population in Cambodia, or even one band of
one tribe in what's called [inaudible] now, kind of being required to talk
to another band. So ex-patriate or [inaudible] communities is not
an issue which is not [inaudible] to answer.
Re: Expatriate issue: who shoudl be consulted? Risk and benefits,
if high risk, geographic distance.
Are protocols even possible? Type of study, type of population.
Difference between disease study vs. population study
Practicing is outstripping policy. Improvisation. Public vs. private
Need for group input re: origins and overall goal of research, possible
benefits (reciprocity and human rights issues).
And that leads to question two: are general protocols even possible?
And the protocol you may need might depend on the type of study.
It might depend on population, it might depend on the particular risk-benefit
calculus [inaudible] The first notion that general protocols are
even possible, and indeed will help. We made the point also that
-- in fact, we should practice [inaudible], that practice of [inaudible]
you're doing is [inaudible] policy, and there's a fair amount of improvisation,
[inaudible] as one goes along, which is inevitable,but it should be remembered.
Moreover, there are different positions to take on this, conclusions to
take, and the results of this fact. One would be the call for a moratorium
on this research, and there are compelling reasons for that. There
are also compelling reasons not to have a moratorium, because a moratorium
would only affect [inaudible], a moratorium that could be enforceable in
public funding, would not affect private funding, so for all purposes can
go on in the private sector, [inaudible] by drug companies, which would
be equally problematic, if you let them [out of your?] control.
And finally, some of the points [inaudible] thought of, also quite broad,
stressed the need for group input from the beginning of the research.
[inaudible] regard a research plan as, of course, an academic priority
[inaudible], but according to the interests of the community, the overall
goal of the research should be [inaudible] as well as the particular [inaudible]
of consent, [inaudible] the research, and then we ended with a reminder
that reciprocity of the moral principle of [human rights?], and that [our
own part?] in the discussion is sometimes ruled out by [or questioned by?]
Yellow Group Transparency notes:
Yellow: I wrote [inaudible] into the wrong direction -- whoa! Okay.
We discussed mainly issues related to [research that has been done?] and
has really important researchers who think hard and try to speculate on
what all the risks and benefits are, realizing that there are risks and
benefits within groups and individuals, as well as in the research, that
what's going on, it's all three of those. And the important thing
that we thought of was being upfront, because there are many risks and
benefits that are unknown to us; but tell people that they are unknown,
that the known [inaudible] and unforeseen, well, we can't foresee all of
them. But let them know that, and really stress that, so they realize
that there are things going on. Try to be as open as possible, be
upfront about the risks and benefits.
The specificity of risks and benefits is difficult
to determine. Researchers should think hard to present those that
apply, speculate on others and be "upfront" with those risks and benefits
that are known, but many that are unknown.
When does group or collective consent trump individual
What overrides the choice and authority of the
And the other issue, we basically came up with or what we [inaudible],
we discussed about when does the group or collective's consent issue "trump"
individual consent? And we had a discussion on it, and it was difficult
to determine what would override, and would it override if it was something
related to a culture, was it the culture, the religion of the culture,
that would be a factor? What would be the factor that you would use,
and just [inaudible] identifying all those aspects, and how to [inaudible].
That's it for yellow!
Red Group Transparency Notes:
We are skeptical about true informed
Red: The red group had a very fantastic conversation, but it was so good
actually that we didn't have time to really write down all the stuff, and
so I'll just present what we did finally write down before the [inaudible]
time was up. And that was that we were really skeptical that there's
such a thing as true informed consent. We were sort of not agreeing
that there is such a thing, that that even exists -- that is, the present
and attainable goal. But we think that to sort of approach true informed
consent is going to take a lot of trust and a lot of respect, and that's
a very time-dependent sort of variable. So it's going to take a lot
of time for us to get close enough to a population to understand and to
gain their trust and to know where they're coming from. We can't
do this sort of research if we're going to -- if they don't understand
what we're doing, we don't understand what their position is until we actually
go in there and get to know them. And I think it's just important
that it's all time-dependent, and that it is not [going to happen?] overnight.
It's a lot of -- I think the way that best describes it is that we have
to develop a history with these people, with any people that we're studying,
and until we develop a positive history, which we haven't done in the past,
we're not going to get anywhere. So we have to be careful of what
steps we take and how we [talk to these?] people, so that our history remains
positive. That's all.
Green Group Transparency Notes:
Green: The green group also talked about the conflicts between individual
and group decision-making. One thing we talked about was the example
of the group veto, and we came up with many, many other examples where
this potential conflict may come into play. But we also talked about
the conflict here not just in terms of subtle, coercive pressures upon
the individual, but also in terms of the informational standards associated
with informed consent; whether or not individuals would ask you a
question because the group had already evaluated the research proposal.
Individual - group conflicts (truly informed),
gx research and other types of research, stigmatizing
conditinos, other 'communities e.g. advocacy groups
pop-history research/disease-susceptibility dichotomy,
different, not necessarily "riskier," benefits of pop-history research
(disease mechanisms, protective roles), documentation on risks of pop-history
We also talked about how our discussion here is focused almost exclusively
on genetic research, but at the same time, these same sorts of issues are
also going to come up in connection with all sorts of other research, particularly
research on potentially stigmatizing conditions. And we also talked
about how the discussion here has been limited primarily to localized street
communities, but hasn't been talking about different types of communities,
for instance, advocacy organizations -- the deaf community, to give another
Finally, we talked about the population history/disease susceptibility
dichotomy that Morris was developing this morning; and regrettably, almost
all of us in the group -- myself included, incidentally, Morris -- disagreed
with the sharpness of the dichotomy that you were drawing there.
We suggested that perhaps it would be better to frame this as different
risks associated with the two types of disease -- or the two types of research,
but not necessarily that one is riskier than the other, or vice versa.
We also talked about the benefits, the potential benefits, of population
history research; mainly, that it may help to elucidate disease mechanisms
by understanding the origins of certain populations; that certain alleles
may be there because they play a protective role. There are other
selective pressures at work responsible for the existence of that allele
in a population, and that knowing that may help us to better understand
other issues. And lastly, we mentioned that there's a need for additional
documentation, empirical evidence, with regard to the actual risks of population
history research, and that simply saying that these risks exist really
isn't enough, and we need to document that.
Greely: One footnote from the chair before the last group. You've
reminded me of a really interesting paper, I can't remember where it came
out, but it tried to apply group consent ideas to research on sexual preference,
and whether gay and lesbian communities should be consulted about research
on sexual preference. I think the orange group was last.
Orange Group Transparency Notes:
Orange: It'll be fast. We just, we had a very engaging conversation;
we strayed considerably from the points [inaudible], but anyway...
Regarding the informed consent, the group and the individual, one concern
we talked about was the [inaudible] of the individuals in [inaudible],
would be very important to [inaudible] for the population. Regarding
risks and benefits, we felt that it was necessary to stress the individual
[inaudible] of that [inaudible] are likely to [inaudible lengthy phrase].
Then for the third point here, consultation, our effectiveness in securing
[inaudible rest of phrase]. Then the other thing regarding ex-patriate
communities, we felt that it was important to contact groups that would
be [inaudible] by studying these ex-patriate communities, and let the ex-patriate
communities know that other people will be [affected?] by that research
[inaudible rest of phrase].
Who should get to set the research questions about
groups? Scientists or the groups themselves?
The research questions should come first -- then
worry about the best sample (group) and sampling strategy
American Indian tribes hae a unique legal status
requiring specific negotiations with each tribe
Anonymity not a powerful protection
Greely: I think that's all six groups. Are you going to get this?
Turner: We can continue discussion over lunch...