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3 Conducting Research in Developing Countries
Pages 15-20

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From page 15... ... 3 Conducting Research in Developing Countries This session was designed to explore three specific questions:  What issues, cultural and otherwise, arise when researchers from de‐ veloping and developed countries collaborate?  What are the unique governance and regulatory challenges that influ‐ ence research in developing countries? Read the entire page →
From page 16... ... 16 Culture Matters: International Research Collaboration in a Changing World 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 de‐ veloped and developing countries is not an illustrious one, with very few excep‐ tions. In the early 20th century, most research collaborations with developing countries were designed to address a U.S. need, such as studying diseases af‐ fecting 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 ad‐ vantage of the ethical vulnerabilities arising from a lack of experienced inde‐ pendent review boards and the fact that low‐income populations are more susceptible to financial incentives to participate in a research study. The as‐ sessment 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 im‐ pede 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) Read the entire page →
From page 17... ... Conducting Research in Developing Countries 17 that is acceptable internationally and that holds to the tenets of the many dec‐ larations, 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 de‐ veloping nation. This is a long process that involves recruitment, training, certifi‐ cation 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 bioeth‐ ics. "It's not just waiting until the developing country somehow acquires a gen‐ eration 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 organiza‐ tions that have basic accountability principles in place. Also, there needs to be the potential for capacity building and two‐way learning opportunities. "Even‐ tually, 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‐ Read the entire page →
From page 18... ... 18 Culture Matters: International Research Collaboration in a Changing World try remains less developed, said Ames Dhai. "Is there a culture of lack of re‐ sponsibility? " asked Dhai. "Is there adequate political will within these coun‐ tries to ensure progress and development? Read the entire page →
From page 19... ... Conducting Research in Developing Countries 19 fits of research are distributed among the collaborators and how decision mak‐ ing 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 corpo‐ rate partners is to engage with stakeholders from both the developed and de‐ veloping world and to understand how corporate social responsibility is struc‐ tured 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 im‐ provements in labor conditions or for socially responsibility products of re‐ search 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, open‐ ness, and integrity, is also critical, and Dhai said that when trust and trustwor‐ thiness 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 interna‐ tional research is paired with a history of exploitation of developing countries. On the other hand, developing countries are plagued by corruption, inefficien‐ cies, 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 re‐ search are transparency, accountability, and enforcement. "We need active citizen participation to ensure transparency, collaboration, accountability, and Read the entire page →
From page 20... ... 20 Culture Matters: International Research Collaboration in a Changing World 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) Read the entire page →

From page 15...

... 3 Conducting Research in Developing Countries This session was designed to explore three specific questions:  What issues, cultural and otherwise, arise when researchers from de‐ veloping and developed countries collaborate?  What are the unique governance and regulatory challenges that influ‐ ence research in developing countries?

Read the entire page →

From page 16...

... 16 Culture Matters: International Research Collaboration in a Changing World 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 de‐ veloped and developing countries is not an illustrious one, with very few excep‐ tions. In the early 20th century, most research collaborations with developing countries were designed to address a U.S. need, such as studying diseases af‐ fecting 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 ad‐ vantage of the ethical vulnerabilities arising from a lack of experienced inde‐ pendent review boards and the fact that low‐income populations are more susceptible to financial incentives to participate in a research study. The as‐ sessment 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 im‐ pede 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)

Read the entire page →

From page 17...

... Conducting Research in Developing Countries 17 that is acceptable internationally and that holds to the tenets of the many dec‐ larations, 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 de‐ veloping nation. This is a long process that involves recruitment, training, certifi‐ cation 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 bioeth‐ ics. "It's not just waiting until the developing country somehow acquires a gen‐ eration 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 organiza‐ tions that have basic accountability principles in place. Also, there needs to be the potential for capacity building and two‐way learning opportunities. "Even‐ tually, 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‐

Read the entire page →

From page 18...

... 18 Culture Matters: International Research Collaboration in a Changing World try remains less developed, said Ames Dhai. "Is there a culture of lack of re‐ sponsibility? " asked Dhai. "Is there adequate political will within these coun‐ tries to ensure progress and development?

Read the entire page →

From page 19...

... Conducting Research in Developing Countries 19 fits of research are distributed among the collaborators and how decision mak‐ ing 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 corpo‐ rate partners is to engage with stakeholders from both the developed and de‐ veloping world and to understand how corporate social responsibility is struc‐ tured 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 im‐ provements in labor conditions or for socially responsibility products of re‐ search 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, open‐ ness, and integrity, is also critical, and Dhai said that when trust and trustwor‐ thiness 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 interna‐ tional research is paired with a history of exploitation of developing countries. On the other hand, developing countries are plagued by corruption, inefficien‐ cies, 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 re‐ search are transparency, accountability, and enforcement. "We need active citizen participation to ensure transparency, collaboration, accountability, and

Read the entire page →

From page 20...

... 20 Culture Matters: International Research Collaboration in a Changing World 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)

Read the entire page →

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3 Conducting Research in Developing Countries Pages 15-20

3 Conducting Research in Developing Countries
Pages 15-20