It's always
a pleasure to, talk in this, course.
And I'm very sorry that I can't be there in person.
But greetings to everyone from Scotland.
So Robert has discussed, the issue of the standard of
care
that should be used in research studies
in resource limited settings.
One of the other key issues he introduced concerned
the types of trials that one can do in resource poor
settings.
And the associated issue of post-trial access
to treatments that are used or that are tested in those
trials.
And that's what I'm going to focus on
today.
I'm start by briefly outlining two cases.
These are based on real studies.
But I've somewhat simplified the details.
The first case concerns
access to antiretroviral therapy for patients with HIV Aids.
Millions of people around the world,
including in sub-Saharan Africa, South America and
Southeast Asia,
have access to antiretroviral therapy.
The lifespan of people who are successfully maintained
on
T is now close to that of people who don't have
HIV,
but thousands of patients end up having to move to
different types
of antiretroviral as their strain of HIV virus,
develops
resistance to the r t.
This study was carried out with patients
who, already on second line antiretrovirals
and whose second line regimens were now failing
due to resistant strains of HIV.
And the study sought to test a strategy
for optimizing alternative treatment
combinations for these patients.
It was an open label phase for prospective interventional
study,
enrolling 500 adults with HIV one
whose treatment with a second line
regimen contained a protease inhibitor
that is a particular type of antiretroviral, which
was failing.
The goal of the study was to test
a novel method
for assessing, resistance,
and assignments
then of the patient to a new treatment
regimen.
Study had sites in Brazil, India, Kenya,
Malawi, Peru, South Africa, Thailand and
Uganda.
Then all of the drugs that we used in
the trial were licensed in the US.
They weren't all licensed in the countries
where the trial was taking place.
And this meant that participants might have been put on a
lifesaving,
treatment regimen, but then they wouldn't be able
to obtain
the same combination of drugs once they left the trial.
And the researchers who designed the study,
this seemed unethical.
So that's the first case.
Second case concerns a research study
on Huntington's disease.
Huntington's disease is a hereditary brain
disease,
caused by an autosomal dominant mutation,
which means that if someone has Huntington's,
then normally
her children have a 50% chance of inheriting
the gene.
And so developing the disease as well.
Symptoms of Huntington's
usually start between, ages of 30 and 50.
Causes uncoordinated, jerky body movements
and a decline
of mental capacity and adventure.
Most Huntington's patients die
within 20 years of onset of symptoms.
There's a rural community
on Lake Maracaibo in northwest Venezuela
that has the highest concentration
of Huntington's carriers in the world.
This made it an ideal community for
carrying out research into the disease.
So in 1993, US researchers used,
samples of blood and semen from people in Maracaibo
to identify the gene that was responsible
for causing Huntington's.
As a result of that research, a genetic test was developed
that could determine whether or not
someone was a carrier of the disease.
And that test is now available in many health care systems
around the world, but it's not available
to people in Maracaibo.
And to some, that seems unfair.
So Anastrozole is,
a physician working in the community,
expressed the concern like this.
He said in the US or Europe,
whoever has the disease in their family
has the option to decide.
I want to get the test.
I don't want to know.
The people of Maracaibo don't have that option.
Even after they collaborated in the research.
That these cases illustrate two ethical issues
that are salient in research in populations
that lack access to good quality care
outside of research studies,
which includes many populations in low and middle income
countries.
It can also include
groups in high income countries who lack access to affordable
health care, including in countries like the
US.
But I'm not going to focus on those cases
today.
The first is the issue of personal access.
What care should participants receive after a
study?
So if they have a chronic condition
that still requires treatment,
are they entitled to continued treatment?
Second, the issue of reasonable availability
should host communities have access to study
interventions?
After a successful study?
So I'm going to start
by discussing, post-trial access to care for trial participants.
And note I'm going to primarily focus
on post-trial access
to the intervention that's being tested in a study.
Now, of course, that's not the only some
participants might need a trial meeting.
It has, however, been the focus of a lot of the
debate
over post-trial access.
So first, what do the guidelines
and the regulations say about this issue?
The Declaration of Helsinki is, the World
Medical Association
statement of the ethical principles
that they think should govern research.
Extremely influential document used by research ethics
committees.
These,
all around the world mentioned in regulations.
The 2024 version of the declaration states
in advance of the clinical trial,
post-trial provisions must be arranged
by sponsors and researchers to be provided by themselves,
healthcare systems or governance for all
participants
who still need the intervention identified
as beneficial and reasonably safe.
In the trial.
Exceptions to this requirement
must be approved by Research Ethics
Committee.
Okay.
At the national level, things are much less clear
cut than they are with the Declaration of
Helsinki.
Most national regulations for human
subjects research are silent on this
question.
So the common rule, for example, says nothing about post-trial
access.
Other regulations might encourage
provision,
require researchers to make efforts
to transition participants to care,
or simply require the provision of information.
There is a legal requirement to provide post-trial access
for participants in Argentina, Brazil,
Chile,
Peru, and recently India.
I've not seen much data on, how that has been implemented
in, Argentina, Chile, India and Peru.
It's pretty recent in most countries.
In Brazil, the entity
that has the legal duty to provide
post-trial access is frequently disputed.
So pharmaceutical companies end up suing the government,
and the government ends up suing pharmaceutical companies.
Finally, post-trial access to successful
interventions is also recommended by some,
national guidelines in low and middle income
countries.
So, for example, in South Africa,
in Uganda,
those sorts of recommendations are not legally binding.
But like the Declaration of Helsinki,
they might be relied upon by research ethics committees
who then have the power to disapprove
research.
Various sponsors of research, have policies that relate to
post-trial access to, I'm going to mention
just one, which is NIH
has guidance.
The NIH guidance applies very narrowly.
It's written only for the provision of,
antiretroviral treatment.
It applies only to the provision of treatment to participants
in treatment trials.
So not, for example, participants
who contract
HIV during studies of interventions
to prevent HIV transmission.
And it applies only to developing countries.
So not, for example, two studies that take place in
the US.
The guidance states
that the NIH expects investigators
or contractors
to address the provision of antiretroviral treatment
to trial participants after their completion of the
trial.
The NIH recommends that investigators
or contractors work
with host countries, authorities and other stakeholders
to identify available sources of antiretroviral treatment.
Priority may be given to sites where sources are identified.
The provision of antiretroviral treatment
following the completion
of the trial.
Okay.
So, that's what some of the guidance and
regulations say about post-trial access.
What should we make of it from
the point of view of ethics?
Well, many researchers,
trial participants, IRB members, ethicists
think that there is a duty to provide
post-trial access to effective treatment
to participants who need it.
Providing a justification for that duty has proven more
challenging.
Multiple rounds have
been suggested, and I'm going to quickly discuss
four important grants that have been raised by
bioethicists.
And I'll note some of the challenges
with using them.
I'll then say something about how post-trial access
plays out in practice.
The first justification is based on
avoiding harm to participants.
So if someone has a chronic disease
and is benefiting from the treatment
that they're on during a trial,
taking them off the treatment will harm them.
And this, it's argued, will violate the duty of normal
absence.
The case of antiretroviral therapy makes this clear.
If someone's HIV is controlled by, regimen,
taking it off that regimen will lead
to a resurgence of her disease.
And this sort of justification in terms
of harm to participants is quite common.
I think, though,
it's usually a mistaken justification.
The reason that it's mistaken
is that in many, maybe most of the cases
in which post-trial access to care
would be desirable.
Participating in the trial in the first place benefited
participants
relative to how they would otherwise have been.
So suppose, we're evaluating a proposed
trial of antihypertensive drug that's unapproved and so
unlikely
to be available soon to participants in a study.
Assume that the drug turns out to be
beneficial
and there aren't alternatives available outside the trial.
Otherwise, we wouldn't have these
ethical concerns in the first place.
In that case, if the participants were not in
the trial,
they would be without access to this beneficial treatment.
Being in the trial provided access
to that treatment for a while.
So it's plausible that they're therefore better
off
even if they don't get access after the trial.
And that implies that trial participation itself doesn't
harm them.
And so the duty of non Maleficent's is not violated.
A second and I think more plausible
justification
grounds post-trial obligations and the special relationship
between researchers
and their participants that develops
during the course of the study.
And the idea is that this is analogous
to the relationship between doctors and their
patients.
So just as a doctor has,
a special duty with regard to the well-being of a patient.
So a researcher has a special duty
with regards to the well-being of the
participant.
And that's because in any clinical
research,
participants entrust aspects of their health
to the researchers, providing information
about their condition,
receiving clinical care, and so on.
Now, clearly,
that suggests that the duty would be greater
when a study has been long and has involved lots of
clinical care.
But then that fits with how
researchers tend to feel that the participants have
developed.
The longer and deeper the relationship, the greater
the felt obligation.
And there are two related challenges
that I see in,
appealing to a special relationship
between researchers and participants
in order to ground the duty of researchers
to provide
post-trial, access to care.
One of them is that the role morality of a
researcher
might be different than that of a clinician.
After all, the primary goal of research
is to conduct rigorous science
that can generate knowledge that can benefit future
patients.
The well-being of research participants
is normally a secondary goal,
or maybe a constraint on the pursuit
of that primary goal.
By contrast,
the primary goal of clinical care
is in general to help the patient
who is currently in front of the clinician.
So, insofar as the two audience analysis,
we'd expect the special obligations
of the researcher to her participants
to be weaker than those, of the clinician,
to her patients.
The other challenge is that in any case, I'm not convinced
that clinicians have open ended obligations to their
patients,
at least in the United States.
It seems as though when someone loses their
insurance,
their primary care physician
doesn't have an obligation to continue
to provide care to them for free.
Right?
That most there's a duty not to abandon one's patient to
ensure
a transition to some other source of care.
So I think
the relationship is, a possible ground
for post-trial obligations,
of researchers, but potentially quite a weak
grand.
Third,
some ethicists cite a duty of reciprocation.
So research participants contribute
to medical knowledge when they take part
in medical experiments.
It seems plausible they deserve something
in return for the contribution they make.
But one appropriate way, to provide
this might be by providing
additional medical care to them after the trial is complete.
Now, again, I think this is a plausible
ground
for post-trial obligations.
One important challenge, though, is it's not going to
ground
open ended obligations, and it won't grant the same
obligations
in every case.
If what we're doing is,
reciprocating for the contribution of the
participants,
then the extent of the obligation
to benefit them, it's going to depend
on the extent of their contribution.
And this, we might think, would be analyzed in terms of
factors
like, the burden they took on in participating, the risks they
took on. So.
Note also
that it's not just or even mostly
the researchers
who would have this obligation, since other parties also benefit
for the contribution of research participants.
The very least sponsors of research,
like pharmaceutical companies, would share the obligation to
reciprocate.
And so might governments who make use of the products of
research,
within healthcare systems.
So this is not just going to be then an obligation
that falls on researchers.
For a duty to provide post-trial access might be
grounded
in a duty of beneficence.
That's called the duty to rescue.
That's classic case.
To, illustrate this duty is as follows.
Yeah.
Imagine I'm on my way to give a talk,
and I walk past, a large pond.
And in the pond, I notice, a child drowning.
No one else is around.
Now, I could wade into the pond
and save the child, but
I'm wearing a rather nice white suit,
so it's going to be ruined if I rescue the child.
And that is several hundred dollars.
Here's the point.
Even if it's going to ruin my suit,
I have a moral duty to wade in and rescue
the child.
The ethicist Peter
Singer provides a succinct statement of the duty
here.
He writes, if it's in our power to prevent something bad from
happening
without thereby sacrificing anything
morally significant, we ought thoroughly to do it.
So apply this, principle to the case of hand
research.
This might be in a position to give urgently needed
treatment.
So, for example, continued care might be lifesaving
and research participants may not have access
to other sources of treatment outside of the trial.
So the duty to rescue could ground post-trial
obligations.
Two challenges should be mentioned,
regarding the duty to rescue in this context.
First,
it's going to apply only in cases
where providing the intervention
is relatively low cost and the benefit it provides is
very high.
Those are going to be the rescue cases
for really expensive,
interventions or interventions that provide only marginal
benefit.
That's not going to justify a duty
to rescue.
Second,
the duty to rescue applies any time that someone
can provide a great benefit to another at low cost to
herself.
It's not specific to researchers or research subjects.
For example, if,
the researchers in a particular
country are studying heart disease,
but the local community is in desperate
need of, say, antimalarials.
The fact that the researchers
could provide those antimalarials
could mean they have a duty to rescue,
even to people who are not in that research
study. And
clinicians, NGOs, government agencies,
anyone else in a position to provide
aid can equally have a duty to rescue.
So this table
summarizes, foregrounds that have been suggested for why
there might be an ethical duty to provide
post-trauma care to participants
who wouldn't be able to access that care
otherwise.
I've suggested that, the duty to avoid harm
will normally not apply in the cases
we're interested in.
The special relationship between researchers and
participants,
and the duty of reciprocity might ground
duties of care for the researchers.
But those duties will be limited in their extent.
The duty to rescue may occasionally apply,
but it won't be limited to the urgent needs of
participants.
So some key points I'd like to emphasize
from this ethical analysis of post-trial access.
None of the justifications
that I've discussed imply an open ended obligation for
researchers.
The researchers themselves don't have an obligation to
provide
care for the next step. Yes.
Further,
none of the justifications imply that the best or the only way to
discharge
researchers post-trial obligations
is by providing the study intervention.
It might be in some cases, like with the antiretroviral
study,
but in other cases, especially, with studies where the standard
of care in
the trial is higher than the standard of care
outside it,
other care beside the experimental
intervention might be more valuable.
And finally,
this is not just a matter for the researchers.
We need to consider the duties of multiple parties,
including the researchers, but also sponsors and national
governments
who are responsible for providing care to the
citizens.
Current practice with regard to,
providing post-trial access to effective experimental
products
is highly variable.
Many research sites,
the focus is on transitioning
participants who still need cat other sources
of care.
So these might be national health systems.
They might be other studies for which participants are now
eligible.
Research sites in these cases, may
then provide short term
care during a transition period, but not for extended periods of
time.
Some companies have ensured continued access to beneficial
treatments
for serious conditions by running, open label extension
studies.
And again, this is not a consistent
practice
in high income countries.
It's more likely participants will get access, to
continue treatment through expanded
access programs or in the US,
compassionate use programs until drugs get licensed.
Finally.
Perceived obligations
to ensure post-trial access have also led, in some cases,
public and private sponsors, to avoid carrying out research
in contexts
where patients don't have access to effective care outside of the
trial.
I don't want to flag this because I think
it's a potentially unfortunate effect
of demanding that researchers and sponsors
provide post-trial care.
You're getting into this,
I think also in the end of the question
period in the last session.
So there's potential for people who already lack access to care
to be
penalized, again by not getting access
to care through research.
So pushing for post-trial access cuts
both ways.
Let me return now to the case with which we began.
The drugs in question were made by multiple private companies,
and those companies agreed to provide the drugs
that were not licensed in country for free.
They didn't want to be involved with the distribution of the
drugs.
That would have to be done by the research team.
The sponsor, on the other hand,
was not allowed to provide clinical care outside of a
research study.
So after considerable negotiation,
the following arrangement was reached.
The researchers designed an extension study,
which would provide the manufacturers
drugs with the goal of testing
whether the participants remain virally suppressed for two
further years.
And the thought was that two years
should be enough time for the drugs
to be licensed in country and provided
to patients through national programs.
I'll leave you to decide whether you think
that was a sufficient arrangement.
Okay, so I'm not going to leave behind
the issue
of what carries out to participants
who leave a trial still in need of care.
And I'm going to turn to the issue
of what's owed
to the communities that host research.
To a large extent, this discussion is focused on
the issue
of making, again, study interventions
available
to host communities.
Now, there are fewer
guidelines and regulations that speak to this issue.
Two of the most important sets of international guidelines
have relevant clauses.
So the Declaration of Helsinki says that
medical research with individuals, groups
or communities in situations
of particular vulnerability is only justified
if it's responsive to the health needs and priorities,
and the individual, group or community stands to benefit
from the resulting knowledge, practices
or interventions.
The second piece of extremely influential
international guidance comes from
the Council of International Organizations
of Medical Sciences or Science.
Their 2002 guidelines set
before undertaking research in a population or community
with limited resources.
The sponsor and the investigator must make every effort to ensure
that
the research is responsive
to the health needs and the priorities
of the population, community, and which is to be carried out
and any intervention or product developed or knowledge generated
will be
made reasonably available for the benefit of that
population
or community.
Okay, so what's the ethical reasoning
behind these recommendations that the group population
communities should get access to the products of research?
I think that the underlying concern
about conducting research, where it's not expected
that the host community would get access
to the products of research, is a concern
about exploitation.
Now, what does it mean
for one party to exploit another,
or for a transaction
to be exploitative?
The standard analysis defines exploitation like this
x exploit Y when X takes unfair advantage of y situation.
So the party doing the exploiting
takes advantage of some
vulnerability of the other party in order to get more out of
them.
That is deserved.
So, for example, suppose my car gets stuck in the mud.
Phyllis is the only person with a tow truck.
I might be vulnerable because I have no other way to get out
of the mud.
I suppose it's miles to the nearest town.
I won't be able to make it there without my car.
Suppose she charges me a thousand bucks for ten
minutes.
Work.
So I might be willing to pay that much to get pulled out of
the mud.
If I'm in a desperate situation.
But she's surely treating me wrongly.
And the wrong here, I think, is that she's
exploiting me.
She takes unfair advantage of my situation
to get more out of our interaction than she should.
Now, looking at this sort of,
simple example helps us to see some key
characteristics of exploitation.
Does exploitation have to be harmful
to the person who's exploited?
No, I'm not harmed in this, case by, exploiting me.
I'm benefited.
That's why I agreed to pay the thousand
bucks.
Because it's better for me to be pulled out of the mud and
survive
than it is to be left there with my thousand bucks.
Does exploitation involve invalid consent?
Again, no.
I might understand what I'm agreeing to
and do it voluntarily, but still be exploited.
So we can have what Alan Wertheimer called
mutually advantageous consensual exploitation.
Okay, so return now to the question
of the exploitation of communities
that host research.
They'll be exploited if they receive
an unfair level of benefits
from the research relative to the burdens
of hosting the research and relative
to the gains to other parties.
So gains to other
parties might be, companies who profit
from developing a successful drug,
or maybe patients in other countries
who benefit from the drug being developed.
So we need to think about the burdens
and the benefits to those communities.
So what sort of burdens might that be?
Over and above
the risks and burdens faced by, research
participants themselves?
Well,
the research might make use of clinical services that are
scarce.
Right.
So if local health care practitioners
are hired for the research, then
it might attract them away from the public
health system and thereby contribute to,
an internal brain drain.
There's a limit to how much research
can take place at any one site.
So research that doesn't have
high social value may crowd out that more valuable
research.
There are, of course,
also benefits potentially to host communities.
And so a research study might answer questions
about local health problems that are important to the host
community.
But so answering questions
about the epidemiology of a disease
might help with local vector control,
efforts or with public information
campaigns.
The research may be, part of the process
of developing new interventions that are going to benefit the
population
rather than taking away from the
facilities
and the trained clinicians, that will be providing care.
It's possible that the infrastructure
that's used for the research could expand
local facilities, and local health care
workers might get additional training.
Now, think
back to the reasonable availability requirement
requiring that research,
only be conducted when the products of research
will be made reasonably available
for patients and host communities.
Avoids exploitation by ensuring that
the benefits
those communities are fair given the benefits that other parties
receive.
Given the burdens that have taken
on hosting the research.
The idea, I take it, is that the benefits
of getting access to new interventions
that are important for the health
of people in the community is normally
thought to be a sufficient benefit
to avoid
exploitation.
However.
The requirement of reasonable
availability has come in for some criticism.
For one, it's not going to be relevant
to some research, right?
For example, it's not going to apply
to phase one, trials, since normally
the products that make it through phase
one of not yet shown efficacy.
Is going to apply to epidemiological studies
because they have no associated product.
Sometimes there are no benefits to be provided, right?
If the study doesn't show an intervention to be effective,
then there's no beneficial intervention to provide
further.
The requirement, has been criticized
for putting an excessive burden on researchers and sponsors.
It's not their job.
It's argued
to provide drugs to everyone in the
population who would benefit from them.
Nor is it their job to ensure that the, local
health care system provides the drugs.
And finally,
the reasonable availability, requirement
has been criticized for taking a view
of the benefits that count that's too narrow
according to the amount of exploitation
we're working with.
Whether or not someone is exploited
by a transaction depends on the amount
to which she benefits
relative to her contribution, benefits
to others, and so on.
Nothing in the account
relies on the benefits to her being of a particular type,
and insisting that the benefits be in the form of providing
experimental interventions.
That leads to the problems with research that doesn't,
produce a product.
Now, some of these objections have been addressed
in the most recent revisions to the CMS guidelines, which
clarify
the reasonable availability requirement, say
as part of their obligation, sponsors
researchers must also make every effort
in cooperation with government and other relevant stakeholders
to make available as soon as possible,
any intervention or product developed
and knowledge generated for the population
or community in which the research
is carried out, and to assist in building
local research capacity.
But this clearly doesn't deal with the objection
that what matters is the amount, not the type of benefits
on this.
There is a debate.
Some ethicists think we should allow
a much wider range of benefits
to host communities to account.
So, for example, they think exploitation
could be avoided by,
supporting a clinic to provide additional health
care to community members or improving the supply of
potable water.
Others think once we loosen
requirements on, what benefits count,
there's a risk of communities getting a raw deal.
But there are big power disparities
between the high income country
institutions and companies that, fund international
research
and the host communities in low and middle
income countries where they take place.
If we don't have a standard for what's fair,
and if research sponsors are allowed
to, shop around different communities
for a good deal, then we risk a race to the
bottom.
We risk that is the powerful sponsors of
research,
bargaining down the benefits that they provide to host
communities.
Now, there are also middle positions
between these two.
Recall that the reasonable availability
requirement was originally one
half of a two part requirement, but that research should be
responsive
to host population needs, that the products of research should
be made
reasonably available.
If you're convinced
by the criticisms of reasonable availability, but you're not
convinced,
we should allow just any benefits
to host communities to account.
Then you might turn to the first of these requirements to help
out,
no matter what else you might say,
no matter what else.
Research should be responsive to the health needs of the
population
in which the research is carried out.
Here's how I like to think about
responsiveness.
I like to think about it in terms of local social value.
So you already have learned about the social value
requirement
for research, according to which the knowledge
that,
a research study is expected to generate
should be sufficiently valuable to justify
asking the participants to take on the risks and burdens of
participation.
The idea here
is that we can also think in terms of the local social
value,
which is the value of, the knowledge that the research
generates
to the community that hosts the research.
If the value of that knowledge, whether it be from
epidemiological research or implementation
research or developing new products,
the value of that knowledge is sufficiently great.
The research won't be exploitative.
So I think it may be easier to work out
whether research has sufficient local social value than whether
a particular amount of benefits offered to a community is fair.
If that's right, that's a reason to think
that we should care about responsiveness.
On the other hand, if we think that in principle
any type of benefit should count,
but deciding whether the benefits
to a community are sufficient,
that's a
reason to be more liberal about what benefits count,
and then to try to put in place protections to,
make sure that it doesn't lead to exploitation in practice.
Now, there's much more to be said
about this discussion, but,
I should wrap up to take home points
about reasonable availability.
First, it's hard to justify requiring that researchers or
sponsors
ensure that study products that are shown
effective must be made
reasonably available to the communities
or populations that host research.
Secondly, I think it's hard to justify research that's not
relevant
to the health of host communities
in low and middle income countries.
In practice, asking the question,
what's the relevance
of this research to the population
in which it's been carried out
turns out to be a good way to avoid exploitative research,
and a good way to identify ways in which a research project
should be changed in order to give it more local social
value.
Okay, we're turning now
to the second case, with which I started this talk.
Most people in Maracaibo don't know about the
Huntington's test.
As far as I know, none of them have access to it.
At the, time, a radio program that reported on
this
said that the test was available privately in Caracas at,
a cost of about $1,000.
I don't know whether that's still the case,
that the original goal of the research,
which was finding a cure for Huntington's
disease, has not been achieved.
So the host community doesn't have a new treatment,
and it doesn't have the test that was developed for the
research
with members of the community.
On the other hand, the researcher who led
the project in Maracaibo has raised
a large amount of money about $6 million
to support the Huntington's disease
clinic there.
So one might think that this benefit
to members of the community is large
enough that we should not say
that doing the research there
was exploitative.
Okay.
To conclude,
there's widespread agreement that both participants in
clinical trials
and the communities
that host research studies should benefit
from research participation.
And I've talked about some of the ways
in which
people think they should benefit and why
there's disagreement about the type of benefit
that's got to be provided and the extent of that benefit.
So, for example, how long a sponsor should
pay for X participants to receive care?
There's also disagreement about who has the duty to provide the
benefit,
whether it's governments, whether it's
the researchers and their sponsors.
Finally,
I want to sound a cautionary note
about the ethical issues that we've been discussing this
morning.
I think conducting research in environments where many
people
lack access to affordable, quality care is ethically
challenging.
I don't think
that should put us off doing it.
As the examples that, Robert described showed,
conducting this research is also vitally
important
for improving the health of people
in low and middle income countries.
So the ethical challenges are challenges
that should be met,
not challenges that should be avoided.
Thank you.