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Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop (2014)

Chapter: 3 Conducting Research in Developing Countries

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Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
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3

Conducting Research in Developing Countries

This session was designed to explore three specific questions:

  • What issues, cultural and otherwise, arise when researchers from developing and developed countries collaborate?
  • What are the unique governance and regulatory challenges that influence research in developing countries?
  • What are the ethical principles to consider when engaging in cross-cultural research collaborations?

Two speakers addressed these questions in a session moderated by Patrick Schlesinger, Assistant Vice Chancellor at the University of California, Berkeley. Benjamin Caballero, Professor of International Health in the Bloomberg School of Public Health and Professor of Pediatrics in the School of Medicine at Johns Hopkins University, discussed how to move from paternalism to partnership in research collaborations involving investigators in developing countries. Ames Dhai, Director and Head of the Steve Biko Centre for Bioethics at the University of the Witwatersrand, spoke about the role of ethics in making decisions regarding research collaborations in developing countries of varying economic status.

3.1 UNIVERSITY PERSPECTIVES ON INTERNATIONAL RESEARCH AGREEMENTS

Presenter: Benjamin Caballero, Professor of International Health in the Bloomberg School of Public Health and Professor of Pediatrics in the School of Medicine at Johns Hopkins University

Speaking from his perspective as a pediatrician conducting research on childhood obesity in developing countries, Benjamin Caballero took the posi-

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×

tion that “in many cases, we are in a pre-cultural stage.” By this he meant that in many countries, the main challenges relate to ethical and regulatory issues regarding the use of humans as experimental subjects. “Culture and language barriers are not a main concern if experiments are conducted without consent or with fake consent.” In most developing countries, a lack of resources and expertise results in weak regulatory frameworks and an increasing reliance on private sector support that does not necessarily follow the same academic framework that most researchers from the developed world are accustomed to following.

Caballero noted that the history of research collaborations between developed and developing countries is not an illustrious one, with very few exceptions. In the early 20th century, most research collaborations with developing countries were designed to address a U.S. need, such as studying diseases affecting the productivity of U.S. companies or performing studies that were deemed too risky for U.S. subjects. In some cases, U.S. investigators took advantage of the ethical vulnerabilities arising from a lack of experienced independent review boards and the fact that low-income populations are more susceptible to financial incentives to participate in a research study. The assessment of risk is subjective for people living in a high-risk environment; risks that would be unacceptable in American culture would be routine for those living in developing countries. In addition, said Caballero, low literacy may impede truly independent informed consent procedures.

The U.S. Public Health Service Sexually Transmitted Disease Inoculation Study, conducted in Guatemala from 1946-1948, is one of the most egregious examples of a project that took advantage of these factors (CDC, 2010). This study, approved by the National Institutes of Health (NIH), the U.S. Surgeon General, the Pan American Health Organization, and Guatemala’s Ministry of Health, involved inoculating healthy people and sex workers with syphilis to study transmission of the disease. More recently, a major pharmaceutical company was charged with falsifying parental authorizations so that infants could participate in a vaccine trial in which fourteen babies died, while another was accused of bribing subjects to participate in clinical trials in order to speed up enrollment. “This problem continues in many countries,” said Caballero. “It is what I characterized as a pre-cultural problem—we don’t bridge the barriers, we circumvent the barriers of culture and language.”

In his view, there are five principles of collaboration that need to be addressed. The first and most important is that any study designed to be conducted in a developing country has to be relevant for the local population, local scientists, and for the national Ministry of Health. “It cannot be just for convenience, cost, or expediency,” said Caballero. Second, any collaboration needs to share risks, either by using a combined population or a protocol designed to minimize risk. The third principle is that there must be a regulatory framework

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×

that is acceptable internationally and that holds to the tenets of the many declarations, such as the Helsinki and Belmont Declarations, that state that there are ethical principles in conducting experiments on humans that go beyond culture. The last two principles hold that there should be strong local ethical expertise and there should be unbiased funding that is driven by the size of the study and not by the operations or convenience.

Some of these principles, said Caballero, have been implemented by NIH as well as by various non-governmental organizations and foundations. “There is general progress,” he said, “and while we are still learning how to do it better, there is deliberate and strong intention to do it right.” Doing it right also means that the majority of research funds should be controlled by local institutions and local principal investigators and that research protocols are approved by local, independent, internationally registered research ethics committees (RECs). In his experience, many countries lack RECs, and so creating an independent, reliable REC is often the first task in establishing a collaborative research effort in a developing nation. This is a long process that involves recruitment, training, certification by an international organization, and demonstrating expertise that must be reevaluated by NIH every two years

Research projects must also include capacity building in research bioethics. “It’s not just waiting until the developing country somehow acquires a generation of people who are savvy on ethical issues.” Toward that end, the NIH Office of Global Health is funding eight centers of excellence in developing countries and these centers include ethical capacity building as part of their mission.

In his final remarks, Caballero summarized the key conditions that are needed to establish an effective research collaboration with a strong ethical foundation. To start, there needs to be political and social support for science in the partner country and there should be defined strategic goals for research. The best collaborations take place with strong, reliable counterpart organizations that have basic accountability principles in place. Also, there needs to be the potential for capacity building and two-way learning opportunities. “Eventually, with time, there will be a true partnership in which we both contribute something original to improve the research and improve the quality of life of everyone involved,” said Caballero.

3.2 USING ETHICS IN DECISION MAKING

Presenter: Ames Dhai, Director and Head of the Steve Biko Centre for Bioethics at the University of the Witwatersrand

In thinking about the differences between wealthy and poor developing nations, it is important to understand the context and ask why a wealthy coun-

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×

try remains less developed, said Ames Dhai. “Is there a culture of lack of responsibility?” asked Dhai. “Is there adequate political will within these countries to ensure progress and development?” The bottom line, she said, is that there is no one-size-fits-all solution, but that ethics can support decision-making across cultural and wealth/poverty divides. She also noted that the huge gaps between the haves and the have-nots cannot be fully understood through the over-simplified division of the world into the global rich and the global poor. “In fact, the reality is that 20 percent of the largest fortunes in the world are in the so-called poor countries, and even within these countries we find dramatic and drastic health differences that are closely linked to social disadvantage, not cultural divide,” she said. “I think it is also important to remember that it is the power differentials between and amongst classes in these countries and the influence over the state that are at the root cause of poverty. Again, it is not culture, but it is class differences and the power differentials.”

Addressing the subject of governance, Dhai said that it is often absent in developing countries, and when it is present the standards differ markedly across countries. In addition, even when governance and regulatory frameworks do exist, implementing them is a problem given the general lack of financial support for such initiatives. She raised the possibility of creating a global minimum standard for regulatory activities that both parties in a research collaboration would have to meet before a project could begin and that both parties can sustain throughout the project.

Dhai commented on Caballero’s idea of helping developing nations create research ethics committees by noting that these are often created from a Western philosophical perspective. “Very little consideration is given to local philosophies and local cultures,” said Dhai, and when there are differences in what a local ethics committee decides compared to the decisions made by its developed country collaborators, these decisions are often looked upon negatively, a phenomenon she called ethical imperialism. When her institution finds itself in such a situation, where its decision making is questioned, she requests a conference call with the partner institution to see how the two partners can develop a combined decision making process. “Some respect this request, and others don’t want to talk to us,” she said.

Ethical issues do not end with a project’s approval, said Dhai; it is important to look at what happens after the project is reviewed and approved. Her institution uses both passive and active post-approval monitoring. Passive monitoring involves reviewing reports from the sponsor’s monitoring agents and data from safety monitoring boards, while active monitoring involves site visits. There have been instances, she said, where active monitoring identified problems that required fixing before enrollment could continue.

For Dhai, one of the dominant ethical principles that must be part of any collaboration is justice or fairness, both in terms of how the burdens and bene-

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×

fits of research are distributed among the collaborators and how decision making occurs. South Africa uses the principle of justice to assist health research priority setting activities by considering the burden of disease in the country and the cost-effectiveness of the interventions being planned. An important part of justice, she added, is social responsibility, and the challenge for corporate partners is to engage with stakeholders from both the developed and developing world and to understand how corporate social responsibility is structured in the context of a specific developing nation. “The priority for most in the developing world is to secure a livelihood, and therefore demands for improvements in labor conditions or for socially responsibility products of research are often of secondary concern,” said Dhai. She wondered if industry, which is increasingly global in the way it runs human clinical trials, has different standards for social responsibility that it holds its partners to in the developing and developed parts of the world.

She also noted the importance of looking at trust and trustworthiness when creating collaborations. “Trust is so essential to all relationships,” Dhai said. “There is no single variable that so thoroughly influences interpersonal and group behavior.” As a result, she believes that trust should be considered a public good that is essential for maintaining cooperation in society. The first characteristic of trust is that it involves at least two actors, one who trusts and one who is trusted. A second characteristic is that the trusting actor willingly makes him or herself vulnerable to the trusted actor in circumstances in which the trusted actor could actually benefit from taking advantage of the trusting actor. Finally, the trusting actor must make himself or herself vulnerable in the belief or expectation that the trusted actor will behave in a trustworthy way that does not exploit the trusting actor’s vulnerability.

Trustworthiness, which is characterized by ability, benevolence, openness, and integrity, is also critical, and Dhai said that when trust and trustworthiness are well matched the result is an interdependence between the trusting and trusted actors. “Most enterprises and initiatives are very successful when there is a high level of interdependence,” she said. But in most developing countries there is a culture of mistrust and suspicion, especially in collaborative contexts, which she believes is not surprising given that the history of international research is paired with a history of exploitation of developing countries. On the other hand, developing countries are plagued by corruption, inefficiencies, and mismanagement, making it difficult for developed world sponsors to trust that money will be put into creating capacity and actually doing research.

Dhai ended her presentation by discussing Lawrence Gostin’s recently published framework for creating a transformative agenda for global health justice (Gostin, 2013). The most important aspects of this framework for research are transparency, accountability, and enforcement. “We need active citizen participation to ensure transparency, collaboration, accountability, and

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×

better resource mobilization for socially responsive research in the developing world,” said Dhai. “There has got to be increased stakeholder accountability and education initiatives to ensure a well-informed civil society to strengthen political accountability. We cannot confuse political accountability with culture. It is dangerous to do so.”

REFERENCES

Center for Disease Control. 2010. Findings from a CDC Report on the 1946-1948 U.S. Public Health Service Sexually Transmitted Disease (STD) Inoculation Study. Washington DC: U.S. Department of Health and Human Services. Available at http://www.hhs.gov/1946inoculationstudy/findings.html (accessed 7/24/2014).

Lawrence O. Gostin. 2013. Towards a Framework Convention on Global Health: A Trans-formative Agenda for Global Health Justice. Yale Journal of Health Policy, Law, and Ethics 13(1):Article 1. Available at http://digitalcommons.law.yale.edu/cgi/viewcontent.cgi?article=1201&context=yjhple (accessed 3/25/2014).

Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
Page 15
Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
Page 16
Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
Page 17
Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
Page 18
Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
Page 19
Suggested Citation:"3 Conducting Research in Developing Countries." National Academy of Sciences, National Academy of Engineering, and Institute of Medicine. 2014. Culture Matters: International Research Collaboration in a Changing World: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/18849.
×
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In an increasingly interconnected world, science and technology research often transects international boundaries and involves researchers from multiple nations. This paradigm provides both new opportunities and new challenges. As science and technology capabilities grow around the world, United States-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. At the same time, enhancing international collaboration requires recognition of differences in culture, legitimate national security needs, and critical needs in education and training.

Culture Matters is the summary of a workshop convened by the Government-University-Industry Research Roundtable (GUIRR) in July 2013 to address how culture and cultural perception influence and impact the process by which research agreements are made and negotiated across international boundaries. In this workshop, "Culture Matters: An Approach to International Research Agreements", representatives from around the world and from GUIRR's three constituent sectors - government, university, and industry - gathered to provide input into four specific meeting tracks or domains. The tracks focused on research and agreements affecting or involving people/human subjects; environmental and natural resources; science, engineering, and manufacturing; and agriculture and animal issues. This report examines each of these domains and the role that culture and cultural expectations may have in the forging and implementation of international research agreements.

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