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4
Ethics
“The ethics panel stands between the culture panel and the re-
search integrity panel in the sense that ethics are informed by culture
and govern behavioral choices in the conduct of research. This panel
will explore issues related to the ethics of safeguarding privacy, security,
and confidentiality; bioethical issues related to human subjects research
as well as other activities with bioethical implications, all from both a
domestic U.S. and a global perspective.” (Workshop Agenda)
4.1 ETHICAL ISSUES IN INTERNATIONAL INDUSTRY-
UNIVERSITY RESEARCH COLLABORATION1
Dr. Susan Butts, Senior R&D Director (retired) at Dow Chemical
Company, provided perspectives from her extensive industry experience with
international and cross-sectoral collaborations. Her roles included negotiating
research agreements and coaching Dow researchers in their interactions with
external collaborators. Her group was responsible for overseeing collabora-
tions with over 150 universities located around the world, including interven-
tion and problem resolution. If ethics and integrity are not addressed when
the collaboration is formed, problems—real or perceived—can arise down the
road. Sometimes perceived ethical lapses can cause significant problems.
In this section and other sections summarizing presentations, views and opinions are
1
attributed to the presenter unless stated otherwise.
27
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28 CORE ELEMENTS OF INTERNATIONAL RESEARCH COLLABORATION
Rather than focus on researchers that are not behaving ethically,
Dr. Butts focused on those who are behaving ethically but run into prob-
lems because of differences in cultural expectations or context issues such as
the source of funding. For example, expectations about the ultimate goals
of the research, sharing of results, and other issues can differ depending on
whether a project is supported by a profit-making company or a govern-
ment agency.
Companies often seek out collaborations with universities because
university researchers are perceived to be neutral and so the results will have
more credibility. This premise only holds if the public believes that they
can trust university researchers. Some people question whether industry
funding taints university research. Both companies and universities have
a significant stake in ensuring that this is not the case. Two specific issues
that arise in this context are the right to publish and the integrity of results.
Misunderstandings and problems sometimes arise from differences
in how government, industry, and universities relate to each other in the
United States compared to other countries. In some countries, government
takes a much more active role than the United States does in promoting
their industries. Universities in some countries may be more willing than
those in the United States to enter “work for hire” agreements with indus-
try, where the sponsoring company exercises significant control over the
project. Companies also need to be attentive to faculty expectations about
continued funding beyond the original research program, being clear that
research without commercial potential will not receive continued funding
even if the science is interesting.
Dr. Butts stated that it is important to avoid value judgments in inter-
national collaborations. Some common practices overseas might not be
typical in the United States, which does not mean they are wrong. It is
also important to ask questions, clarify the goals and expectations of all the
partners, and establish how the project will be managed during the initial
negotiations. Sometimes the parties will find that research collaboration will
not work because of divergent goals or for other reasons.
4.2 ETHICAL CONSIDERATIONS AFFECTING
CLINICAL RESEARCH INVOLVING CHILDREN
IN THE DEVELOPING WORLD
Lisa Bero, Professor of Clinical Pharmacy at the University of Cali-
fornia, San Francisco, discussed her work over the past several decades with
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ETHICS
the Better Medicines for Children Project, which is undertaken by the World
Health Organization (WHO) Department of Pharmaceutical Policy and
Essential Medicines. WHO has had an Essential Medicines List (EML) since
1977, but in 2002 the list became much more rigorously evidenced-based.
Medicines get on the list based on health care need and data on their efficacy
and safety. The list is used by many countries to help them procure medicines
at favorable prices and then launch an essential medicines program.
The Better Medicines for Children Program was launched in 2007.
The program raises many of the issues discussed at the workshop thus far.
There is a persistent need for more research on medicines for children, since
many of the top causes of death among children under five can be cured or
ameliorated by medicine. Wider availability of essential medicines would
help make a big dent in childhood mortality. The WHO launched the first
Essential Medicines List for Children in 2007. Even with the existence of
the list, there can still be problems with regard to the supply chain and
misuse. In addition, many medicines actually prescribed to children are
not effective at all.
According to Dr. Bero, zinc sulfate, which is used to treat diarrhea,
illustrates some of the barriers to getting medicines to children in develop-
ing countries. In addition to having an EML that includes zinc sulfate, the
appropriate dosage form must be available. For low income settings, this
would need to be a dissolvable tablet. At this time there is only one manu-
facturer of this form of the medicine. The medicine has to be registered in
the country, which may involve local research (not necessarily local clinical
trials). It must be procurable at a reasonable cost. There must be clini-
cal guidelines and an implementation strategy. Parents must be willing to
use the medicine and children must be willing to take it. Zinc does not taste
good, and taste formulation can be culture specific.
From the above, it is clear that there is a real need for research in devel-
oping countries related to medicines for children. The EML for Children
Committee’s recommendations put a high priority on pharmacokinetics
studies (research on what the body does to the drug), particularly in neo-
nates (newborn infants). Examples include research on the effects of malnu-
trition on pharmacokinetics, dosage, and the timing of drug administration
in relation to food intake. According to Dr Bero, there is not a good research
base in these areas today.
One of the projects within the WHO Better Medicines for Children
Program is to develop reporting standards for clinical trials in children and
regulatory standards for new drugs and formulations. Part of this involved
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30 CORE ELEMENTS OF INTERNATIONAL RESEARCH COLLABORATION
a review of ethical guidelines to identify gaps and inconsistencies in the
ethical guidelines of different countries related to conducting research in
children. Regulatory authorities from 82 countries are involved.
The focus of the effort is on Africa and India, where implementation
is being supported by the Bill & Melinda Gates Foundation. Some existing
ethical guidelines do not mention children, while a few state that children
should be included in research studies. The defined age for a child differs,
with some defining the upper age limit as 12 years old and some as high
as 21. The EML uses a cutoff of 12. Neonates are hardly mentioned. All the
guidelines that mention children recommend special safeguards for consent
and assent, specify that research should be relevant to the health needs of
the child, and that appropriate care be provided.
Dr. Bero explained that existing ethical guidelines diverge in signifi-
cant ways. For example, should less risk be tolerated in children, or should
more benefit be demanded to make a trial in children acceptable? Some of
the guidelines state that no risk can ever be tolerated even if the benefit is
potentially great. Even a child with a fatal condition might not be allowed
to get an experimental treatment in some cases. Other guidelines that
allow variations are often unclear. There are also differences on the issue
of whether healthy children may be included in research. Participation
by healthy children is very useful for pharmacokinetic studies and dosage
studies. Some ethical guidelines state that studies in children should only
be carried out after phase III clinical trials have been carried out on adults,
which does not make sense from a pharmacological standpoint because
children are not just little adults.
Payment for participants in clinical research is another important issue.
As a practical matter, payment for participants is necessary in low resource
settings, but some of the guidelines are not clear on this point. Note that
participants are often compensated in developed country clinical research.
Efforts are ongoing to review existing evidence and work on developing
appropriate standards and the capacity to conduct clinical trials involving
children, with the ultimate goal being to increase the availability of essential
medicines.
4.3 ETHICAL CONSIDERATIONS IN SCIENCE AND
ENGINEERING PRACTICE
Stephanie Bird, Co-Editor-in-Chief, Science and Engineering
Ethics, provided perspectives from engineering ethics that can be general-
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ETHICS
ized to address science, technology, and engineering research more broadly.
She drew on the work of several engineering ethicists.
One of Eugene Schlossberger’s (1997) points is that beyond being
competent, engineers are responsible for considering the foreseeable impacts
of technology, including the long-term effects of social change that are
associated with their particular projects. These include economic change,
safety considerations, environmental impacts and cultural disruption. As an
example, Schlossberger considers engineers working with the government
as part of a team to build a dam in a lesser developed nation. When choos-
ing the site, a given location may be appropriate for building the dam, but
might have broader, problematic implications for the local population. The
purpose of the dam is to facilitate movement of the region from subsistence
farming to cash crops in order to improve the economy of the whole coun-
try. Yet the dam might involve displacement of villages and peoples. It might
lead to safety concerns due to the use of pesticides, including products that
are banned in the United States. Environmental damage might result from
runoff. Finally, cultural disruption might result from displacing traditional
ways of life.
While negotiations are clearly a matter for the engineering firm and the
government of the country that has asked the engineering firm to design
and build a dam, Schlossberger says that the participating engineers them-
selves need to consider the larger impacts and ethical implications of what
they are doing. This is consistent with an elaboration of the Paramountcy
Requirement that is essentially universal among engineering codes of ethics,
which says that “engineers should hold paramount, the safety, health and
welfare of the public in the performance of professional duties.” This ex-
tends to the public no matter where the work is carried out.
Michael Davis (1991) and Ed Harris (1998) have identified the public
relevant to the Paramountcy Principle as “any person or group vulnerable
to the effects of the tasks through lack of political or financial power, infor-
mation, technical training or time for deliberation.” This includes anyone
who is not able to understand what is involved. One can ask whether
those who bear the risks actually receive the benefits, whether those who
bear the risks do so voluntarily, and whether those who bear the risks are
aware of the full extent of the risks that they are bearing. Clearly, individuals
in some settings, in a particular region, in a particular economy, may not be
in a position to speak up for their own concerns.
Dr. Bird stated that for international collaborations, the primary ethical
concern is to explicitly address and avoid exploitation. The potential trap
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32 CORE ELEMENTS OF INTERNATIONAL RESEARCH COLLABORATION
is paternalism, which may arise when collaborations involve groups with
different economic conditions and different cultural values, and where the
power differential is substantial. The challenge is to achieve a partnership
between and among different collaborators.
In order to get deeper perspectives on international differences in
values, foreign post-doctoral trainees and graduate students are potentially a
valuable resource because they are confronted with the differences in values
and style between the United States and their native national homelands.
Dr. Bird discussed work done at Children’s Hospital of Philadelphia, which
surveyed its many foreign national post-doctoral trainees (Alexander and
Williams, 2004). The trainees commented on the corporate feel of at least
some U.S. laboratories compared with the less formal, sharing atmosphere
in research settings abroad. Alexander and Williams found that trainees
experienced “some difficulty reconciling their interest in science and the
advancement of humankind with the need for restrictions in sharing (tech
transfer), limitations on collaborations, the politics of funding (especially
in hot fields), and the hassles of negotiating system hierarchies.” Of course,
these issues would likely be raised by U.S. citizens as well.
They further found that “intellectual property and data ownership
stimulated lively discussion about the tension between science and com-
merce, and about the potential for infringement of academic freedoms.”
The foreign trainees also raised concerns about “the export of Western
values to international collaborators.”
Dr. Bird also talked about her own work at the Massachusetts Institute
of Technology teaching the responsible conduct of research and heading
up the ethics domain in health science technology, teaching many gradu-
ate students from other countries. These students are often sensitive to
the circumstance that their top-flight education would help to develop
products (e.g., auditory and optical implants) to serve a relatively small,
privileged population. They may have originally been motivated by the
desire to improve the mobility of, say, individuals who had lost their limbs
to landmines.
Clearly, the students themselves notice some disconnect between what
they were experiencing in their education and what it was that they saw as a
focus of their education. In this sense, science and technology collaboration
can be a double edged sword. Foreign students and collaborators with social
concerns may be put off by the competitiveness of the research environment
at many U.S. institutions. Dr. Bird urged that care be taken in addressing
the ethical issues that arise in collaboration and to not get too caught up on
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ETHICS
compliance. Checking the appropriate boxes on forms may involve settling
for the minimum. What is the bigger picture? Why is the policy there in the
first place? To borrow from Greg Koski, formerly with the U.S. Department
of Health and Human Services (DHHS) heading the Office of Human
Research Protections, how can we foster a culture of conscience rather than
a culture of compliance?
4.4 SAMPLE PERSPECTIVES FROM THE
BREAKOUT SESSION ON ETHICS
The Ethics breakout session organized its discussion around what
one might put in a primer on how to undertake international research
collaborations.
Individual participants made a number of points during the discussion.
This is a non-exhaustive list, and is not intended to represent consensus
views of the workshop or the breakout session:
· Ethics is relevant to all aspects of international agreements from
conceptualizing the idea, to working the idea into a concrete plan,
to developing a set of agreements, and all the way through the
implementation. It is important to consider that the collaboration
is a process, not a one-time event. Conversations about the ethical
implications of provisions or actions are going to happen at every
step of the process. Perspectives may change over time, but the ear-
lier the ethics discussion begins, the better.
· Ethical issues can be difficult to talk about and cultural implications
may be an impediment to straightforward discussion. This makes
it all the more important to develop a context and setting in which
that conversation can be held. This is a function of several factors,
such as the availability of support for workshops and the develop-
ment of networks. It is easier to have these conversations with those
one knows and with whom one has developed some trust.
· There is value in articulating the general ethical principles in the
agreement. The group discussed a possible list of principles (e.g.,
transparency, fairness), and collaborators might similarly agree to the
important parameters and how to apply them in a systematic way.
· This is not just an abstract discussion. It is important that ethical
principles are reflected in the details of business practices and how
the partnership will function.
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34 CORE ELEMENTS OF INTERNATIONAL RESEARCH COLLABORATION
· International partnerships may encounter some issues that are quite
distinct from domestic partnerships. On the other hand, there are
issues that are going to be relevant across the board. Cultural dif-
ferences may be clearer when accompanied by ethnic, national, or
linguistic differences. Cultural differences between organizations
and sectors in the same country may be less apparent but perhaps
no less real.
· As these principles are operationalized, some clearly bad practices
or actions might be forbidden. In addition, there could be actions
that are okay, actions that are recommended, and actions that are
required. Doing a systematic analysis within the setting of the part-
nership and taking into account the legal and regulatory frameworks
may help in coming up with a clear approach.
· There are several tools that might be developed for a primer on
international research collaborations. For example, it might be use-
ful to have a list of frequently asked questions, covering issues that
may be confusing. Also, case studies and vignettes could be very
valuable.
REFERENCES
Alexander, Madeline and Wendy Reed Williams. 2004. A Guidebook for Teaching Selected
Responsible Conduct of Research Topics to a Culturally Diverse Trainee Group . The
Children’s Hospital of Philadelphia.
Davis, Michael. 1991. Thinking Like an Engineer. Philosophy and Public Affairs (Spring) 20
(2): 164-165.
Harris, Charles E., Jr. 1998. Engineering Responsibilities in Lesser-Developed Nations: The
Welfare Requirement. Science and Engineering Ethics 4 (3): 321-331.
Schlossberger, Eugene. 1997. The Responsibility of Engineers, Appropriate Technology, and
Lesser Developed Nations. Science and Engineering Ethics 3 (3): 317-326.
