Global biomedical and public health research—whether introducing genetically modified mosquitoes to fight dengue or testing new medicines to prevent HIV transmission from mother to child—is aimed at finding and implementing solutions to some of the world's most pressing health problems. That's obviously a fundamentally ethical pursuit. Isn't it?

Yes, says James Lavery, recently named the first Conrad N. Hilton Professor in Global Health Ethics. But, he adds, failure to understand the social and political context in which the work is being done, or to know and address how stakeholders perceive a project's implications, has the potential to sink even the most well-intentioned, well-funded, otherwise well-designed research study.

Lavery, who is also a faculty member in the Emory Center for Ethics, likens what he does to being an architect. He works with people who may be designing lovely and functional structures to make sure they don't build upon unstable foundations or in unsuitable locations. Consider the mosquito net program that died because the white color of the net represented death in the country where it was being tested. Or the HIV pre-exposure study that was abruptly shut down after the sex workers involved in the study, who felt their concerns had not been taken seriously, staged a protest at an international AIDS meeting. Both projects likely looked great on the blueprint but fell apart in the construction phase.

Global research is especially tricky, says Lavery, since the majority of programs are conducted in low- and middle-income countries by researchers and funding from high-income countries. Researchers face different cultures, different languages, an imbalance of power and knowledge, and, sometimes, lingering distrust and fear of exploitation. Lavery's unique community engagement program addresses those and other problems.

Many bioethicists are philosophers, largely focused on theory and concepts. Although Lavery moves comfortably in that world, his focus is unfailingly practical, based on what works and what doesn't, for scientists and for the communities involved.

Lavery works in the space where core commitments and ethical intentions of global health research are translated into action and preserved through relationships with stakeholders, beginning with the scientists and people who fund them, and extending throughout the communities touched by studies. It's a space far more active and complex than what is usually considered bioethics, he says.

In 2006, the Bill & Melinda Gates Foundation was preparing to put almost half a billion dollars into scientific and biotechnology research to help solve the enormous health problems of the developing world. Hundreds of scientists sent proposals. Creating single-dose vaccines, ones that didn't require refrigeration and could be delivered needle-free. Developing genetic and chemical strategies to deplete or incapacitate disease-transmitting insects. Improving nutrition, curing chronic infections, more accurately measuring disease and health status.

How, Lavery asked himself, would the Gates Foundation deal with the ethical issues that would inevitably arise? He and some Toronto colleagues called to ask. The answer: What do YOU think we should do? The team received a three-month contract and a two-foot stack of 46 proposals under consideration.

Reviewing them, they identified likely issues. ("We were pretty accurate," says Lavery.) They also created a proposal of their own to help deal with those issues. The Gates Foundation funded 43 of the original 46 programs and added a 44th: a $10 million grant—at the time the biggest grant ever made in bioethics—to Lavery and a colleague as principal investigators of the Ethical, Social and Cultural (ESC) Program for the Bill & Melinda Gates Foundation's Grand Challenges in Global Health initiative.

Lavery and the ESC Program moved beyond Grand Challenges to work broadly with the entire Gates portfolio of global health and development, which has culminated in the community engagement program he brought to Emory.

What IS community engagement?

The dimension of global health ethics that most interests Lavery is what he calls "human infrastructure"—the web of relationships between researchers and the diverse stakeholders who have interests in the conduct and/or outcomes of the research. Community engagement is how this infrastructure comes about—how researchers identify and manage non-obvious stakeholder interests, demonstrate respect and trustworthiness, and build legitimacy by creating opportunities for dialogue and deliberation.

"I'm not trying to introduce additional obstacles for scientists," says Lavery. Instead, he consults with them—and the people who fund them—to help plan, design, manage, and evaluate strategies for engaging with relevant stakeholders in order to make their research more successful and more ethically robust.

Again, Lavery compares the task to architecture. Creating a community engagement strategy is like imagining and creating a building, he says. Lavery sits with the scientists, discussing their vision, what they hope their "building" will accomplish and for whom. Who are the stakeholders? What are constraints of space, budget, regulations? Will it fit? Be appropriate? Accepted?

When architects design buildings, they draw on a fairly finite set of architectural elements—doors, windows, walls, staircases—and put them together in a unique way, according to specific constraints of the space. Community engagement is the same, says Lavery. "Our work has been to figure out analogous elements, such as terms of research partnerships, ethical commitments and guiding principles, methods for integrating community engagement activities with program management. We then help researchers and funders integrate these elements to develop blueprints and project management strategies."

Based on years of investigating such "buildings," including many that never got off the ground, Lavery and his team are constructing a "Learning Platform" to facilitate the process for funders and researchers. Each new building/project is completely different, completely customized.

Coming to America

Rollins Dean James W. Curran believes Lavery will "provide leadership in public health ethics across the university and serve as a resource to Emory's global ethics partners." Indeed, since Lavery arrived in November 2016, he has been making connections—and plans—with Emory colleagues and the university's rich array of global public health partners. His new office looks out on the Centers for Disease Control and Prevention. A mile away, he's welcomed by Carter Center leaders including President Carter himself. He spends time at the Task Force for Global Health, the Emory affiliate founded by global health pioneer and Rollins emeritus professor William Foege.

And then there are Lavery's ongoing connections with the Gates Foundation, colleagues at the University of Toronto, and other leading global health programs across the world. He's working to leverage those relationships to expand Emory's research and also its teaching, with visiting professors and videoconferencing. His commitment is cementing Emory's position as a leader in global health ethics.

How a classical guitarist got to the new Hilton Chair: turning points

When James Lavery was five, he and his parents emigrated from Glasgow to Toronto. Years later, he was accepted into a musical performance program but soon changed majors, thinking biology and genetics might be more practical. (He still plays classical guitar, which he calls "brutal" work.) Then, five turning points changed him from a not-so-great student to an internationally recognized expert.

First, as an undergraduate at McMaster University, he was captivated by a course in bioethics. He won a coveted slot in the University of Toronto's Institute of Medical Science and Centre for Bioethics, then and now one of the leading bioethics institutions, and went on to earn an MSc and PhD at Toronto and a postdoctoral fellowship from the Social Sciences and Humanities Research Council and Canadian Health Services Research Foundation at Queen's University.

Second, in 1989, during the young couple's honeymoon in Kashmir, new wife Susan was hospitalized with appendicitis. People were "so outrageously kind," he recalls, "reaching out to help strangers in need" when they themselves were dealing with poverty and conflict. A door opened in his mind. Whatever his ethics career became, it would include global health.

Third, still a student, he met the founders of Medecins Sans Frontieres Canada (MSF, Doctors without Borders in English). As the first editor of the MSF Canada newsletter, Lavery went to Rwanda, Burundi, and Zaire (later Democratic Republic of Congo) where he was deeply moved by the refugee camps and make-shift clinics. It strengthened his interest in marginalized populations.

Fourth, seeing firsthand the ethical problems encountered by investigators working with vulnerable populations. In 2000, Lavery became the first bioethicist at the Fogarty International Center, just beginning to develop its bioethics program, and a staff member in the National Institutes of Health's Warren G. Magnuson Clinical Center's Department of Clinical Bioethics, already one of the world's top programs.

One study in particular would dominate global bioethics discussions for a decade. U.S. studies had found giving the antiviral AZT to HIV-infected pregnant women sharply lowered risk of transmission to their babies. But the protocol was long, expensive, and complicated—not possible in poorer countries. Would a shorter, simpler course provide protection? A study began in 16 countries in Asia and Sub-Saharan Africa, where women made up over 60 percent of HIV infected people and had no access to treatment. Some women in the study would receive the drug but others would get a placebo.

When activists protested this violated the women's rights, Lavery joined in international meetings discussing revision of ethical guidelines. Then he was put in charge of a Health and Human Services working group on how the U.S. regulations work in other countries.

Fifth, Lavery and NIH colleagues did a detailed analysis of 21 case studies of international research projects, with commentaries on their success or failure by leading experts in bioethics, global health, policy, and regulation. The project was completed after Lavery returned to St. Michael's Hospital and the University of Toronto as an associate professor in the Dalla Lana School of Public Health. Ethical Issues in International Biomedical Research is widely considered one of the top books on the ethics of research involving human subjects in developing countries.

At Toronto, Lavery began to build a pioneering new program, looking for ways to be responsive to the issues he found in those studies. And that's when his long-standing relationship with the Bill & Melinda Gates Foundation began, which in turn led him to Emory.

"Jim Lavery is an international leader in global health ethics, community engagement, and the ethics of international research," says Paul Root Wolpe, director of the Center for Ethics at Emory. "I cannot think of a better scholar to enrich Emory's public health and ethics program."