This book is a
result of the European Commission funded research project, TRUST, under the
Horizon 2020 program. It contains a collection of case studies that are
supposed to illustrate what the authors call “Ethics Dumping”. It is not clear
exactly what the authors mean by this. According to a footnote in the book
The term was introduced by the Science with and for
Society Unit of the European Commission: ‘Due to the progressive globalisation
of research activities, the risk is higher that research with sensitive ethical
issues is conducted by European organisations outside the EU in a way that
would not be accepted in Europe from an ethical point of view. This exportation
of these non-compliant research practices is called ethics dumping’ (European
Commission nd).
The central phrase
here is “export of non-compliant or unethical research practices”, although it
is not exactly clear what is meant by “export” in this context. It seems that
the consortium would want to include all research they identify as “unethical”
in a low- or middle income country where researchers, sponsors or funders from
high-income countries are involved. Typically, though, “dumping” is associated
with activities that confer some advantage on the agent that carries out the
“dumping”. In the research context this would be research that is for the primary
benefit of people in rich countries, but is done in low- and middle-income
countries because it is easier to do there. The problem is that many of the
examples in the book are about research that is done for the benefit of people in low-income countries. Another major
problem is that no attempt is made to acknowledge that the ethics judgments the
authors make are controversial and highly contested. This would not be a
problem if it was simply a report by the project group. After all, participants
in a research project are free to reach any conclusion they feel is justified
by their research. The project has, however, also developed a Global Code of Conduct to counter ethics
dumping that is going to be used in the evaluation of research projects funded
by the Commission, according to a press release:
The European
Commission’s Ethics and Research Integrity Sector in the Directorate-General
for Research and Innovation intends to propose the code as a reference document
for future research projects seeking funding under the EU’s Framework
Programmes for research and innovation.
The cases in the
book are supposed to illustrate what practices the Code of Conduct should
prevent. If the Code and the accompanying cases will be used to make decisions
about what projects the European Commission will fund, we’d better be sure that
there is general agreement about the recommendations, and that they continue to
promote research that will improve health conditions of people in low-and
middle income countries. The problem is that this is not the case. Let me
illustrate this with one example from the book.
One chapter deals with three
randomized controlled clinical trials to establish which screening program for
cervical cancer was most suitable for India. The trials compared traditional
cytology (“Pap-smears”), visual inspection after application of acetic acid
(VIA), and testing for the presence of HPV. The trials also included a non-intervention
arm. The trials were carried out in the 2000s and were funded by the US
National Institutes of Health and the Bill and Melinda Gates Foundation. The
criticism of the trials by the authors of the chapter is based on two premises.
First, is the claim that the
“international standard of screening is cytology” (p.35). Second, is the claim
that researchers have an “ethical obligation to provide <the
international> standard care to participants in the control arm, as they are
under their direct care during the course of research” (p. 44). It is the
second premise that is contentious. Let me explain why.
There is no doubt that the “international
standard” (Pap-smears) is effective at preventing cervical cancer and deaths.
However, the test is not perfect. It has low sensitivity and specificity,
requires highly trained personnel and qualified laboratories. The only way that
this test can be a reasonable predictor of cancer is for it to be done
regularly every few years. Even if the test misses a cancer once, repeating it
will increase the likelihood that it will catch the cancer before it is too
late. Given the low specificity the test also will give a high number of false
positives requiring follow up procedures. For these reasons it has been
generally agreed that a nationwide implementation of a screening program in
India using this test was not feasible when the trials started, and is still
not feasible. The infrastructure is not in place for an effective population
screening program. However, the test has been available for people in India who
want it and can pay for it themselves, or through their insurance. This means
that it is effectively available only for a small proportion of Indian women.
VIA was proposed as an alternative
to Pap-smears. In the early 2000s studies comparing these two methods had shown
that they had similar sensitivity, but VIA had lower specificity. This has led
Ruth Macklin to conclude that the effectiveness of VIA as a screening method
had already been established in 2002, but this is simply a mistake. The same source that professor Macklin quotes to support her claim that VIA is
effective, goes on to say that
Further research is required to improve its
specificity without compromising sensitivity. Information from ongoing studies
regarding its longitudinally-derived sensitivity, efficacy in reducing
incidence/mortality from cervical cancer, its cost-effectiveness and safety
will be useful in formulating public health policies to guide the organization
of VIA-based mass population-based screening programmes in developing countries
(p. 36)
In this paragraph
there is a call for research that will establish its “longitudinally-derived
sensitivity, efficacy in reducing incidence/mortality from cervical cancer, cost-effectiveness
and safety”. This is quite important, because the critics, including Ruth
Macklin, claim that all of this has already been established in 2002. For them,
the only open research question is whether VIA as a screening method is
implementable in a low income country such as India. But this clearly was not
the prevailing expert opinion. The experts believed that it was still an open
question whether VIA is effective as a screening program in low-income
countries. This, of course, was precisely what the three trials that started in
India was trying to address, thus meeting the call for research by the WHO
consultation.
In order to justify these trials one
still needs to establish that it was necessary to include a non-treatment arm. Obviously,
a large number of experts believed that it was. I believe that a non-treatment
arm was necessary, but will not argue for that here (will follow later).
To sum up the argument so far: There
was general agreement among experts that further research into the
effectiveness of alternative methods for cervical cancer screening was
necessary, and at least a substantial number of experts believed that a
non-treatment arm was necessary. To complete the argument that these trials
were justified, a final point needs to be established: Is it justified to
withhold a known, effective intervention in the control group even though it is
necessary for scientific reasons? The TRUST project participants believe that
it is never justified to do so when the research deals with a major health
endpoint such as cancer, or survival. Again, I shall not address the substance
of the argument here, as this is also not addressed in the TRUST book. Basically they point to agreement in international
guidance documents as their main argument for their position on this issue.
They claim that
Ethical guidelines governing the use of placebo in
research severely restrict the use of placebo or “no intervention” if an
effective treatment or test already exists for the disease being studied. This
is to ensure that research participants in the control arm do not receive a
lower standard of care than is already known to be effective, and are not
therefore disadvantaged by their participation in the study.
The severe
restriction they refer to is that no-treatment is allowed only if this would
case non-serious harm. The problem with this view is that it is not a fair
description of the content of international guidance documents. One should at
least acknowledge that major guidelines such as both the current and last
version of the CIOMS guidelines (see commentary to Guideline 5) recognize that there may be circumstances where
research ethics committees may allow for exceptions to this rule. Basically,
these exceptions deal with circumstances where the aim of the research is to
produce knowledge that may be relevant in the local context, precisely the
context of these three trials of cervical cancer screening programs in India.
And here is the
problem. If the European Commission is going to use the Code of Conduct
developed in the TRUST research program, with the accompanying case studies
that illustrate how the Code is to be applied, as a basis for funding decisions
of their research program for poverty related diseases, the Commission will use
a misleading and controversial moral analysis as a basis for their decisions.
There are, of course, some people who think that is good and agree. But there
are also reasonable people who will disagree, and point out that the effect
will be that some beneficial research to alleviate poverty-related diseases will
not be funded. The TRUST project has reached their conclusion with regard to
the moral issues involved, and the Commission is of course free to adopt their
recommendations as a basis for their funding decisions. But at least one hopes
that they recognize the controversial nature of the TRUST recommendations.
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