Nelson Michael, M.D., Ph.D.
Christine Grady, R.N., Ph.D.
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DR. WAGNER: In our -- thank you, Zeke. In
our next section we get to hear from a couple of our
commission members, Christine Grady and Nelson Michael.
They served along with our chair, Amy Gutmann, and John
Arras, on the international search panel, which, as
Amy noted before, was set up as a subcommittee of this
commission. On behalf of the entire commission, thanks
to the four of you for being engaged in that.
Now, Christine and Nelson will report to us on
the findings and recommendations of the subcommittee
that were drafted at the conclusion of your third
meeting, I believe, in July.
And according to the terms of reference for
the international research panel, their task was to
advise the commission in the following areas,
commissioners, and that is: the dominant norms and
competing alternatives driving ethics of medical
research and different -- in different global regions
that are outside the United States; two, conflicts, if
any, between U.S. norms and international standards,
something that Zeke was just talking about; three,
challenges facing researchers conducting U.S.-funded
research in global settings; and four, possible
strategies to address differences in regional norms for
So, with that, which of the two of
you -- Nelson, you're going to begin? Welcome, and
thanks for doing this.
DR. MICHAEL: Thank you, Dr. Wagner. So, I
thank the commission for allowing Christine and I to
speak to you today about, I think, a very, very rich
process that both of us, along with John Arras and our
committee chair, Amy Gutmann, were really privileged to
spend time with a large international group of
colleagues. And I found it unbelievably informative.
This is coming from the background of somebody who has
been doing international research all my professional
life. And I learned a lot from these colleagues, and I
found them both professionally very engaging and
helpful on this topic, and I think I've made a number
of lifelong friends, as have we all, on that commission
subcommittee. It was a very well-selected group.
So, the way this is going to occur, I am going
to talk about the first two recommendations that have
come out of the report that has been described earlier
today, and Christine will then take over from me, and
will describe the next three of the total of five
So, I don't want to do much reading, so -- but
I will just have you look at this, and I will read the
top line sentence. So, the first recommendation was
that researchers must demonstrate respect for human
subjects and their communities in all phases of
clinical trial design and implementation.
Recognizing other cultural standards and
practices through community engagement -- and that is
the buzz word -- is one concrete means of showing
respect. And here you see two sub-topics that I will
talk about briefly at the very end of my remarks, in
terms of increasing ongoing international dialogue
between U.S. and international bodies as being a
critical part to protecting human subjects, and also
touching briefly on equivalent protections, which I
think you are going to see as a theme multiple times
So, what is community engagement? That is a
very large catch term. And I think that one thing I am
hoping in the next session to get from some of the
presenters is their view on some of the more specific
aspects of what we mean by community engagement. So
this isn't just high-minded talk, it can be distilled
to implementation and meaningful evaluation to see if
this process truly does increase protection for
research volunteers, and isn't simply a salve.
So, I see this, and the panel saw this, as a
process that was additive to all of the top-down
normative body and regulatory processes that are
already in place, to -- and by that I mean scientific
review, the institutional review board, or ethical
review committee process. This is something that is
additive to what is already in place. This is a
bottom-up process to strengthen the transparency of
In that sense, it's a microphone. This
process is a microphone from the community from which
subjects are embedded to the research activities and to
the researchers themselves, but also to the related
communities in which all of us exist. This would
include -- and tangible examples of what community
engagement could be, and manifestations of those would
be -- community advisory boards, open meetings to
discuss research activities that are forming and are
ongoing, what their implications are. These would
include invitations for community representation on
study teams and to bring liaisons from the community to
normative bodies and non-governmental organizations.
An essential distillation of this process of
community engagement, which would be research is
continuously viewed and struggled with -- and I use
that term pointedly -- it's struggled with -- by the
broader number and type of partners that are engaged in
scientific and clinical research activities to ensure
that subjects and communities continue to endorse
benefit outweighing risk.
So, this addresses and respects international
diversity and ethics and practices. However, I think
it's very, very important to say, and we spent some
time talking about this as a deliberative body, that
community engagement is necessary, but it is not
sufficient, in and of itself, to strengthen bioethical
standards, and potentially one could expose
circumstances where community approaches in specific
cases are actually contrary to overall views of
bioethics or intrinsic rights that the majority of
individuals living on this planet would endorse.
And, therefore, this process may, in fact,
expose information that would lead research teams to
actually decide not to do science, not to do research
in that particular time and place, and could modify
that science, or even stop the process, all together.
So, in terms of specifics about community
engagement, the World Health Organization, UN AIDS, and
the AIDS Vaccine Advisory Coalition -- and we're very
honored today to have, in the next session, to have a
representative from AVAC, the executive director,
Mitchell Warren, who I'm sure will be talking a little
bit about good participatory practices. But this has
been -- they just released a second version of this
approach, so there is some granularity to, again, the
high-minded comments that I am making now. I think
there is a process in place to guide us to how one
would actually implement and actually evaluate this
process, and I will let -- I'm sure Mitchell will be
talking about that to some degree.
Let me just end by pointing to these two
points that are clarified here, under the first
recommendation. There needs to be an increased
dialogue between U.S. bioethical conversations and
those which occur in the international arena. And this
is, I think, most notably demonstrated by the second
point -- and this was discussed during Zeke's
conversation with us, as well, about equivalent
I think we need to embrace the protection of
subjects over the embrace of compliance with
regulations. And in that sense, I think the system
needs a little more sanity so that we can concentrate
on that which may be very well and good in an
international norm -- an example that's given in the
report is the differential application of annual
continuing review processes, which are different, as an
example, between the United States and the United
Kingdom -- and I think that we need to be reflective on
how U.S. standards and compliance to those standards
may, in fact, not truly be enhancing research
protections. And there needs to be a dialogue and a
give-and-take in that sense, so that, ultimately, the
best thing is done for research participants, either
here in the United States, or overseas.
So, let me stop there and go on to the second
recommendation. And this is one I don't think I need
to say much about, because we discussed a lot of this,
as it worked out, just in the past few minutes.
So the second recommendation was that funders
of human subjects research should support ethics
training for investigators and others, to include IRB
Now, this is not as counterculture to
discussions that we just had emphasizing protection
over compliance, because part of the discussions
involve the fact that, yes, we thought it was important
for researchers to understand that training in
bioethics isn't just a box-checking exercise, it isn't
just a requirement. It needs to be something that
truly is embraced, so that the scientific process can
be completely integrated, and not seen as just simply
an adjunct or a hurdle, in the worst case, to get over
before science can be done.
Because experienced investigators will
understand that even a single episode in their careers
of lapses in ethical execution of science has very dire
consequences, not just for individuals, but for
institutions and their -- and potentially, even the
entire field in which they are involved in. So this is
something that needs to be done in a way that is seen
as meaningful by researchers, and not simply a burden.
In that sense, ethical training needs to be
balanced, in terms of cultural differences that may
exist between what is done in one's home country and
what is done overseas, and the sense this research
needs to be done in a context where ethical training
isn't simply an onerous online series of endless
training that is seen as pro forma.
But that said, as I am a person that is
subject to a lot of that online endless box-checking
exercises, I find very little in the current training
that really has helped me to be an international
researcher, and I think that that is something that,
clearly, would be an important strengthening of ethical
training as we go on, to focus on the implications and
the differences of doing research, both in the United
States as well as overseas.
So, in that sense, I think that would be a
recommendation that we would have, that that kind of
training be more focused and have a better rationale
for the implications for doing the research overseas.
Let me just close by saying that ethical
training -- and this is something I think that probably
Dr. Glass will resonate with and maybe discuss -- I
haven't seen your slides yet, but this is something I
think that you will feel strongly about -- is I think
that we need to strengthen ethical review committees
and strengthen IRBs overseas.
When we talk about IRB training, we're not
simply talking about box-checking exercises for
individual scientists. We're talking about a way to
ensure that, as we, the world community, begins to do
research in more and more countries, that there is
equivalent strength of IRBs.
And I will tell you that, in my own
experience, the Fogarty International Center, the
European EDCDP, the WHO, and some of the WHO-associated
activities, like the African AIDS vaccine program, is
very interested in spending their resources on ethical
strengthening of ERCs and IRBs overseas.
And, importantly, that process is linked to
normative bodies and oversight by groups like the World
Health Organization so that, at the end of the day, it
isn't just a researcher talking to their IRB, their
institution, saying, "Yes, I sent a team that was
funded by the Fogarty, it went overseas, it trained
this IRB, everything is fine, everything is fine now."
It's never good enough for a researcher to say
everything is fine. Others need to look into that
So, let me stop there and hand the control
over to my colleague.
DR. GRADY: Okay. So I want to echo what
Nelson said, that it was an honor to be part of the
international panel. It was a remarkably committed,
engaged, and thoughtful group of people from around the
world. And under Amy's very capable leadership, and
the staff's indefatigable efforts, we began our work
right away and in three short days, I think,
accomplished a lot.
I am going to talk about the three
recommendations that are left. But I wanted to say
that the recommendations reflect the discussions of the
panel, and are presented to the commission now for
consideration. They are not, like, "finalized," I
guess, is the way I would think about it.
And also, that they were based on a set of
findings that the report also begins to describe, and I
just wanted to comment on a couple of those findings,
because I think they're relevant to understand the
One of those is that the panel noted that in
the decades since the Guatemala experiments, there has
been a number of rules, standards, and principles that
have been developed for protecting human subjects, both
in the United States and across the world, and that
many of these rules and standards actually agree on
some fundamental principles that do protect human
Despite that agreement, there is some
variation. There are some conflicts. And there are
differences in implementation and interpretation that
sometimes do create challenges, especially in
We also, of course, noted the increase in
international research, which comes with both benefits
and potential problems, in the sense that it's very
important for finding ways to benefit the health of
people around the world, and understanding differences,
but it also is true that different places have
different levels of experience with protecting human
subjects, and sometimes there are ways to find routes
So, to focus on the three recommendations,
this is the third one that the panel came up with:
Greater efforts are needed to enhance transparency,
monitor ongoing research, and hold researchers and
institutions responsible and accountable for violations
of applicable rules, standards, and practices. To
enhance transparency and accountability, governments
should consider requiring all greater-than-minimal risk
research to be registered, and results reported.
I think -- I don't think anyone would disagree
with transparency, or the notion of transparency. We
have heard about that throughout lots of our meetings.
And we discussed yesterday the role of lack of
transparency as a factor in the Guatemala experiments.
Certainly shining a light on research makes it
difficult to ignore the ethics, and allows people to
comment on the ethics.
Similarly, accountability. One of the members
of the panel in particular, I think, frequently said,
"It's not the fact that we lack standards and rules,
but we lack or we don't have enough enforcement of
And I think he also included, in addition to
enforcement, knowledge, that the -- as Nelson talked
about, training and education of investigators and
IRBs. Investigators and institutions can only be held
accountable for things that they know about. The rules
have to extend -- they have to be available to them,
they have to know how to apply them, and they have to
know what the consequences are of not adhering to them.
And there are a number of consequences that we could
The specific recommendation here is about
registration. And certainly it is one way of
increasing transparency. I think it's notable that in
the last decade or so there have been a lot of efforts
to have clinical trials registered around the world.
Certainly the Declaration of Helsinki says every
clinical trial must be registered in a
publicly-accessible database. The WHO says
registration of clinical trials is a scientific and
Our current U.S. law, as found in the Food and
Drug Administration Amendments Act of 2007, requires
advance registration in a public database,
clinicaltrials.gov, of applicable clinical trials,
which include mostly intervention studies that are
under FDA regulation, and does not include a bunch of
studies that one might question whether or not they
should be in there. Phase one studies, for example,
observational, epidemiological, and some others.
I think, interestingly, by the current
definitions of clinicaltrials.gov, what is applicable
-- most of the studies that were done in Guatemala, if
they were being done today, would not be registered in
It's also interesting that many other
jurisdictions around the world have similar public
registries. The European Medicines Agency has an
online registry that it's had for several years. Many
countries have established national registration
requirements. Brazil has one that's been in effect for
a long time, India, China.
The International Council of Medical Journal
Editors require, as a condition of consideration for
publication, registration in a public registry. So
there is a lot of efforts already in place.
So, I found myself thinking, as I was
preparing for today: What could the commission do that
would advance this particular area of transparency,
especially through registration? Certainly we could
endorse the policies of the Declaration of Helsinki or
the ICGAME -- JME, (sic) or FDA, or the European
Directive, et cetera. We could think about expanding
the requirements for registration, to include more
clinical trials that are -- or more clinical research
that is not currently covered, and we could also talk
about maybe other options for encouraging or enforcing
accountability and transparency beyond registration.
So, going on to --
DR. GUTMANN: Could I just quickly --
DR. GRADY: Yes?
DR. GUTMANN: You mentioned FDA, but you
didn't mention NIH, which sponsors an awful lot of
DR. GRADY: Yes. So all clinical trials that
are interventional are required to be published in
clinicaltrials.gov if they're NIH trials.
The next recommendation from the panel was the
United States should implement a system to compensate
research subjects for research-related injuries. And
we talked about one model, which I will get to in a
I think everyone knows that, in the United
States, neither sponsors nor institutions are required
to provide compensation for research injuries, or free
medical care for injuries. They are only required by
regulation to inform participants who are in
greater-than-minimal risk research what will happen to
them if they are injured. And there is a lot of debate
about how that language should be phrased in consent
forms and a lot of time spent on that.
Many European countries -- again, as many
people know -- do mandate clinical trials insurance.
And we also know that research carries risk, some
serious risk -- although serious risk and death seems
to be relatively rare. We heard from Zeke and from
others that we don't have data, we don't' really know
what the level of risk is in research.
There was an interesting study done a few
years ago by the Lewin Group which looked at 102
academic medical centers in the United States to see
what kind of policies they had for treating -- for
offering medical care for research-related injuries to
participants in their research. And well more than
half offered none. They charged for treatment for
injuries in the usual way, through insurance companies
or directly to the participants, if they didn't have
insurance. None offered compensation for anything
beyond medical care, like lost wages or of pain and
suffering, or anything like that.
Again, everybody knows in the U.S. the way to
get compensation for research injury is through the
tort system. And I think what's really interesting is
if when you go back in to look at the history, decades
of discussion have ensued about the need for a system
of compensation for research injury. And national
commissions, one after the other for 30, 40 years, have
recommended a no-fault system of some sort for
compensation for research injuries.
And interestingly, although commissions have
recommended it, and lots of moral justification has
been written about it, no such system has been
established. There are lots of interesting obstacles
that we could talk about.
Again, I think it's interesting to see what's
happened in the last decade. Many countries around the
world and some U.S. research institutions have actually
moved forward and developed compensation systems. I
think there is some interesting -- I had some examples
of problems that could occur, but I want to say more
about what the commission's -- I mean the -- sorry, the
panel's recommendation points to.
It points to the possibility of examining the
vaccine injury compensation program, which is a
U.S.-based no-fault alternative to the traditional tort
system for compensating people who are injured from
compulsory childhood vaccines. And this is a system
that is funded by a surcharge on vaccines that are
pooled and available for damages. There is a list of
eligible side-effects, acceptable time frame, and it
covers a lot of different kinds of injuries.
There are other options for no-fault
mechanisms that might be worth exploring. And I think
it's really maybe important for the commission to think
about what the other options are, as well as to find
out more about the vaccine injury compensation system.
So, again, I thought about what should the
commission do. I think, certainly, we can call for
no-fault insurance, like many previous commissions
have. We might be able to dig deeper and propose some
tangible structures for no-fault compensation systems.
Again, there are others that have been written about
and proposed besides the model based on Vaccine Injury
And the fifth recommendation from the panel
was continued efforts to harmonize and guide
interpretation of rules should be made a priority over
creating new rules.
As you know, we just heard about the proposed
rule-making from the government, in terms of changing
the Common Rule, which suggests that there is a need to
revise and continue to update rules, even if there is
not a need for more rules. But interestingly, as I was
thinking about this, if I talk about registration and
compensation for injury, if we were to attend to both
of those, both of those might end up necessitating new
I think that the panel was really in
agreement -- in heated agreement, actually -- that new
rules are not necessarily better. We don't need new
rules. But we need sound, clear, streamlined rules
that can make efficiencies and promote quality, in
terms of research.
I also think it's interesting that we
have -- we continue to talk about harmonization.
Again, nobody, I think, disagrees with the need for
harmonization. Of note, Ruth Macklin, in one of the
papers that we had received, opined that harmonization
is probably not feasible, and part of the reason is
because there are radically different interests that
the stakeholders have, in terms of research needs.
I think it's interesting to think about what
kinds of harmonization we could promote, whether we
should, as a commission, endorse streamlining,
revision, harmonization, evidence-based protection, the
promotion of a culture of responsibility using the
rules that do exist. I mean there are lots of possible
ways to go forward. But I think the goal is
efficiency, protection, and harmonization.
And that is all I was going to say.
DR. WAGNER: Christine, thank you. And
Nelson -- and Nita has a question.
DR. FARAHANY: First, thank you both. This
was incredibly informative. And thank you, all of you,
for participating in what sounds like an incredibly
I wanted to focus, Christine, on
recommendation number four about the no-fault, or
strict liability system. And you know, it strikes me
as a challenging one, particularly given the number of
past commissions that have recommended it, but also as
a person who teaches tort law, and is somewhat
committed to the tort system, it seems at odds with the
National Vaccine Act approach.
So, the National Vaccine Act is actually a
compulsory process, versus an assumption of the risk
that people undertake with engaging in human subjects
research. And so, it seems, theoretically, at least,
different to me, if you choose to engage in research.
And it seems like it dovetails with another
discussion that we have been having, which is what are
the benefits of research to individuals and to the
community. And thinking about how you balance the
benefits of research versus the risks of research that
might pose to an individual, this might be one of those
areas of benefits of research that we would think
about, which is what is the compensation for the risk,
or how do you overcome the risk.
It might be different, though, as well, right?
We might think the benefits of engaging in research,
both to the community and the individual, are
sufficient such that a strict liability system weighs
heavily against the researchers, and more in favor of
the individual. So it seems like this is a delicate
and difficult area.
So, I was hoping you could elaborate a little
bit about the rationale for a strict liability system,
and for thinking about, given that this is an
assumption of the risk -- and one of the things, of
course, that we promote is informed consent and the
need for informed consent -- how those work together.
DR. GRADY: I probably can't, but I can say a
few things that I think are maybe relevant to that
I think the panel, for example, talked very
briefly about the vaccine injury compensation program.
There has been, however, some literature that has
addressed this as a possible model for research-related
And I think, you know, there are lots of
reasons that it works okay in the vaccine world and
might not work so well in the research world. One of
them is that the -- you know, there are a limited list
of vaccines that are predictable, to some extent, in
terms of what their side-effects are. And they are
compulsory, as you suggested, in a certain way,
although some would argue with that.
The other is that, you know, research is -- I
mean we do have this system where we ask people to
accept the risks of research, and they have the choice
to not accept those risks. And some people have
argued, once you have done that, you don't need to
offer them the benefit of care for their
research-related injuries, that, you know, that's part
of what they bargained for, so to speak. But that
seems -- I don't -- that doesn't seem right to me. I
mean I have to say I think --
DR. GUTMANN: One thing. The international
panel felt strongly that it was wrong and a mistake
that the United States was an outlier in not specifying
any system for compensation for research subjects,
other than you get a lawyer and sue. And most research
subjects just -- it's just too difficult to do it.
It's much more difficult than in the case of a -- you
know, somebody hits you with a car and you -- there are
lawyers who come and, you know -- what are called
ambulance chasers, and you can do it.
The -- where -- the U.S. is an outlier here.
What -- and it doesn't mean that there aren't arguments
to be made, but the panel felt very strongly it was an
outlier on the wrong side.
What the panel did not feel strongly about is
what the right mechanism would be. It used the vaccine
example as an example of something that works in its
area and is available, but it did not specify. And in
some future meeting we will explore possibilities. But
the strong point of the panel was not to have rules
about compensation for certain kinds of injury is a bad
DR. FARAHANY: And just to clear up that, so
the strong recommendation is not that it be a strict
liability scheme, just that some scheme be developed?
DR. GUTMANN: Absolutely right. There is not
a strong recommendation about what the scheme should
be. There is a very strong recommendation that there
ought to be some understanding of having a scheme for
-- a system for compensation.
And there was also a sense that, although
previous commissions have recommended this, they have
recommended it among one among, in some cases, dozens
of recommendations, and have not highlighted this, and
have not gone into any depth, which is what the panel
is asking us to do, on what such a scheme might look
So the panel is asking us to make this a
priority among the things we look at, and look at it in
DR. WAGNER: But, Nita, you're suggesting it
as the commission -- is we incorporate this in our
recommendations going forward, we should consider
recommending against strict liability system?
DR. FARAHANY: I want to think about it more
carefully. I mean this is -- but I -- my intuition
would be that a pure strict liability scheme in a
system like this one would probably not be the
But I am open to that being something --
DR. WAGNER: It's a conversation the committee
DR. FARAHANY: It's a conversation we should
DR. ARRAS: As a fortunate member of this
team, I just want to make a comment about the framing
of this report, okay, because this report leaves out a
number of really hot-button issues in the world of
international research; issues that have drawn a lot of
heated discussion. For example, the standard of care
and the use of placebos in trials, the provision of
post-trial access to drugs, and what that should look
like, or the provision of ancillary care during a
So these are all very contentious, contested
issues, and I just think it's important to note, for
the commission and for the broader public, that, given
the limited time frame that our group was facing, we
decided to bracket those questions and focus
exclusively in our report on issues closer to the bone
of protecting subjects from risk and harm and offenses
to dignity. Right?
But, with any luck and more time, the larger
commission will hopefully address some of those other
issues, which I think are extremely important, and we
could shed light on. Thanks.
DR. WAGNER: Roger, got you. But this might
be a place to insert Joseph Millum's question. He is
at NIH, where he is a bioethicist. But he recalls
that, with regard to equivalent protections -- and I
don't know which one of you to go to on this, or anyone
from that group -- that in 2003 there was a working
group that reported a proposed method for
deliberating -- excuse me, for determining whether
foreign regulations offered equivalent protections.
And the question is are we aware of that, and
why has it not gone forward, if we are aware of it?
DR. MICHAEL: Let me defer to Christine,
because this is something that's very close to her.
DR. GRADY: Well, we are aware of that, Joe.
DR. GRADY: It hasn't been adopted by the
regulators. And, therefore, either it needs to be
adopted or revisited, and maybe more detail needs to be
put into place.
But I think Zeke's point also is very
important. You know, a lot of people over the years
have agreed that equivalent protections ought to
be -- that quote, that possibility in the regulations
ought to be utilized, but it has never been fleshed out
sufficiently to allow it to be utilized.
DR. WAGNER: So it has to be further --
DR. GRADY: Well, I think that that report
that Joe referred to, if we're going to pursue
equivalent protections, we would look at that report in
some detail and say, "What, from that report, can we
salvage and say, 'This ought to be done now,' and what
needs to be changed, since now we're in 2011, besides
-- from 2003" --
DR. GUTMANN: Could I ask a specific question
about equivalent protections? So we were given, on the
panel -- and, mind you, everything we did on the panel
we said was going to be a prologue to what the
commission did in some more -- in some cases, in some
So, we were given one example of what an
equivalent protection would be, which is in the United
Kingdom the reporting is less frequent than the
reporting requirement in this country. But otherwise,
there is no substantive difference. And that should be
seen as an equivalent set of protections. They agree
on informed consent, on all the other important things
on equivalent protections.
Is there any other example? Because we need
to -- if we're going to go down the road of equivalent
protections, we ought to -- we've got to start by
DR. GRADY: Right.
DR. GUTMANN: Of where, intuitively at least,
you would say, "Sure, that's equivalent."
DR. GRADY: Yeah.
DR. GUTMANN: Is there another example, or is
DR. GRADY: Well, I think I probably provided
that example. It was annual review, the need for
annual review. But I'm sure there are other examples.
I'm not sure I can come up with one right now, but I'm
sure there are other --
DR. GUTMANN: So one of the things we should
do as a commission is ask those who have come before to
provide us with at least a short list of equivalent
protections, and we should look at them and see whether
they strike us as equivalent. And if they do, then we
may have a recommendation to be made. But if they
don't, this may -- there may not be equivalent -- I
DR. WAGNER: Essentially, an --
DR. GUTMANN: I am totally agnostic, because
that's the only example that I have actually been
I mean another example -- no, one other
example are different ways of obtaining informed
consent, different forms for informed consent, which
are basically the same, but just are different forms.
DR. WAGNER: Formatting.
DR. GUTMANN: Yeah.
DR. GRADY: I think one of the debates has
been to what extent do procedures need to be
equivalent, the procedures for review, approval,
consent, et cetera.
DR. WAGNER: As opposed to purposes.
DR. GRADY: As opposed to principles or any
more substantive requirements.
DR. GUTMANN: Yeah, yeah. So we need -- we
just need some of the examples.
DR. WAGNER: Raju?
DR. KUCHERLAPATI: Thanks, Jim.
I have, actually, questions about many of the
recommendations. So maybe I would focus first on the
first two recommendations, Nelson. And the first
recommendation is about community engagement, and the
second recommendation is about training.
The way the recommendations are, you know,
worded right now seem to suggest that, you know, such
community engagement doesn't exist today and,
similarly, that -- it also suggests that training, you
know, the IRBs and the investigators, about -- you
know, doesn't exist. And I wanted to make sure that
that wasn't the intention. Or -- I'm not sure
that -- I would imagine that there are, indeed -- there
is community engagement today. It may not be adequate,
I don't know what the recommendation is. Can you
DR. MICHAEL: No, I think that's very helpful.
And I find -- you know, it's provocative that you would
read it that way. That certainly was not the intent.
So I think that's an important thing to hear, that you
would see it as -- in that light.
Certainly training exists, and certainly
community engagement exists, but it's differentially
applied, and it's differentially effective. And I
think that is -- really was the point, to emphasize in
both of those arenas, that community engagement,
honestly, is something that I think 10 years ago people
just shrugged their shoulders about. You know, Father
knows best. The research pushes down community
engagement as a megaphone from researchers to the
communities that tell them what researchers or health
ministries want to do. And I think the historical
record may suggest some of those activities 60 years
This is not to say that these activities don't
exist today, but they need to be strengthened and made
more transparent and more pervasive. And I think that
probably Mitchell and others maybe in the next session
will provide a little more granularity about what we
actually mean by community engagement.
But I will tell you that in my organization,
it's been a real uphill process to get hard-core
clinical investigators to want to talk about things
that sound, frankly, fuzzy and soft, but understanding
that there are significant liabilities, I would say, to
do research overseas in the absence of really embracing
the substance of both of those issues.
DR. WAGNER: We have a comment. Is it Carla
Saenz? Is that the proper pronunciation in the --
DR. GUTMANN: Carlos, could you stand up?
DR. WAGNER: Carla.
DR. GUTMANN: Oh, Carla.
DR. WAGNER: Carla, yeah.
DR. GUTMANN: Carla.
DR. WAGNER: From the Pan American Health
Organization, who offers this comment, which I think is
an important comment to take into consideration, that
their organization welcomes the recommendation to
increase training in research ethics.
They want, however, to point out that what is
needed is training that is effective -- that is, that
targets the real needs, and also in the context of the
region, even though the broad needs are the same
throughout the world -- and also training that is
efficient, that is coordinated with all other national,
international initiatives. Often, training -- her
experience is that training in Latin America is
So, we may want to incorporate these kinds of
thoughts in a recommendation going forward, not
that -- just that training exist, but are there some
ways to gauge how it is both effective and efficient,
in doing so.
We are actually probably at a good place for a
break. We ran a little long because we ran long in the
early session. It would be great to get back here at
quarter of, so we could start again. Thanks, Nelson
and Christine, for your presentation.