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For two decades, Duke has gained a reputation as an international leader in global health research, with the mission of reducing health inequities around the world. Conducting global health research comes with ethical and regulatory challenges that are overcome through collaborations, ongoing communication and flexibility across partners. Global health researchers and institutional leaders shared best practices and key regulatory considerations for conducting successful research to advance global health and wellbeing among the world's local communities. “What an expert group assembled for this topic. I am excited to learn from them,” said Dr. Monica Lemmon, MD, Associate Dean for Scientific Integrity at the Duke School of Medicine and the moderator of the town hall hosted by the Duke Office of Scientific Integrity on May 22, 2023.

Adam King, MSP, represented the International Research Support Team which serves all Duke teams conducting research internationally. “We are here to help you throughout the entire project cycle, from pre-award stage to implementation and close out with all the international agreements and expense related questions. Remember that you are not alone. Duke brought you here to do impactful work and brought us here to be the expert group for you,” King said. He mentioned the many tools and services his unit has for the global research community and encouraged the audience to reach out. He said the key words for managing challenges related to successful international projects are communicate, disclose and adapt. “It is important to have an ongoing dialogue during the project,” King continued. To exemplify the importance of communication, he shared some stories about projects in which his team was able to respond effectively to regulatory and implementation challenges. Often, working internationally requires travel for meetings with community members; this raises issues about costs for vehicles, insurance, and the allowability of these expenses. “A faculty member was working in Malawi and they had to do a lot of travel during the rainy season. It was important to see the project as a whole in its own context, and realize that a car wash in Malawi could be an allowable expense, even though a car wash in Durham would not,” King recounted.

 

Lindsey Spangler, JD, Associate Dean for Research Integrity at the Duke School of Medicine, presented research security considerations. “This is a newer concept,” she said. In 2018 Francis Collins, the Director of NIH, wrote a letter to grantees to warn about the “threats to integrity” in the context of international research, related to diversion of intellectual property, sharing of confidential information with foreign entities and failure to disclose resources from foreign governments. In the almost 5 years since then, the concept has shifted. Lindsey Spangler added: “The current definition of research security is safeguarding the research enterprise against the misappropriation of research and development to the detriment of national or economic security, related violations of research integrity, and foreign government interference.” The biggest consideration for investigators, Spangler said, is disclosure requirements, at the person, project and program level.

Associate Dean Spangler emphasized the importance of foreign components disclosures and the many nuances of these processes. “While ‘foreign component’ is an NIH term, she said, “other federal sponsors have requirements for disclosure and even prohibitions on certain work occurring outside the United States.” An example which may be less obvious is a collaboration with investigators at a foreign site anticipated to result in co-authorship. “Read the FOA and NOA to make sure you are in compliance with all reporting obligations.” She pointed to newer requirements related to biosketch and Current and Pending/Other Support (such as supporting visiting scholars), as well as providing supporting documentation related to any foreign appointments.

Marlee Krieger, Executive Director of Center for Global Women’s Health Technologies presented on behalf of Nimmi Ramanujam, PhD, the founding director of the GWHT Center and the Robert W. Carr, Jr., Distinguished Professor of Biomedical Engineering, Professor of Pharmacology and Global Health. The key for impactful global health research is to never stop listening to community partners, Krieger said, and to overcome the many local stigmas related to women’s health. “Cervical cancer is a disparity that can benefit from human design. Mortality still continues to rise even if this disease is completely treatable. Fifty percent of the women diagnosed with cervical cancer die and more than 60% of women are unscreened. With early screening we can prevent these deaths. According to the World Health Organization, cervical cancer deaths can be reduced by 30% in 10 years with appropriate technology. “Cervical cancer prevention is one of four best buys in global public health with a return of investment of $26 for every $1 spent,” Marlee Krieger said. The Center screened over 1000 women and provided tools to eight countries. She emphasized the importance of engaging the end users of global research projects – in this case, local women who provided insights about barriers and supported the public campaigns to overcome the stigma placed on women’s anatomy.

Osondu Ogbuoji, MBBS, MPH, ScD, Assistant Research Professor at Duke Global Health Institute and Deputy Director of the Center for Policy Impact in Global Health, unveiled the many truths behind health indicators. “It is important to understand why health indicators are better in some areas and worse in others. Intra-country disparities are worse in Nigeria, China and India than cross-country disparities around the world. This is because of the wealthy elites who have access to benefits and programs before the poor,” said Dr. Ogbuoji. Persistent inequality is a “wicked problem”, he added, referring to J. Conklin’s article “Dialogue mapping: Building shared understanding of wicked problems” (2005): sometimes the problems are understood after a solution is already provided, or other times problems are symptoms of other, deeper problems with no easy solutions, especially in places where public health is chronically underfunded.

“But it is important to keep in mind that there are things that can be done,” Dr. Ogbuoji said. He talked about the importance of engaging people closest to the problem in solution design. He added: “it is also critical to recognize that context is key - universal or global solutions do not exist.” He also showed the importance of transdisciplinary approaches and of being aware that solutions may lead to other problems. Therefore, second-order thinking – if we do this what we do next – it is important for managing expectations.

Catherine Staton, MD, Associate Professor in Emergency Medicine, Neurosurgery & Global Health, Director of the GEMINI Research Center and Vice Chair of Research Strategy & Faculty Development for the Department of Duke Emergency Medicine, presented some of the best practices for grant writing in global health research. A key factor for obtaining federal funding is showing why a global location is important for your project. “As an emergency medicine researcher, studying a unique population, in an area where it takes many days to go to a hospital, helps us understand best practices and unique challenges for health delivery systems,” explained Dr. Staton. Global research provides the opportunity to study untouched populations. Dr. Staton added: “In Tanzania, for example, mothers think that alcohol is beneficial for their children and has nutritional value. Think about what an alcohol harm reduction campaign can do there”.  Global research also provides the opportunity to study really complex situations and health systems gaps or strengths that could not be studied domestically. “Brazil, for example, has a very unique health system. Healthcare is free, but services are not equitably dispersed because the country is big. With this huge data, we can understand how access to healthcare works in countries with huge gaps,” said Dr. Staton. She invited researchers to be culturally sensitive, and reach for the “low hanging fruit” - choose countries where conducting research is not only important, but also feasible.