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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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29 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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31 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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33 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.