International research requires lengthy capacity building

Don't just parachute in and fly out

International HIV vaccine trials underway in resource-poor settings provide good examples of how clinical research (CR) can be done in both ethical and culturally-sensitive ways despite a wide variety of obstacles.

Even without recent reminders of past callous behavior by researchers, such as the recent news of U.S. public health investigators intentionally infecting Guatemalans with sexually transmitted diseases (STDs), there have been rumors and tall tales of immoral research behavior circulating among some international populations.

For instance, some people in sub-Saharan Africa still believe that AIDS was a creation of white people to eradicate blacks.

HIV researchers working in these international settings continue to do their work as carefully and sensitively as they can in hopes of dispelling these rumors and false beliefs.

"Those who are engaged in the day-to-day combat against AIDS are facing rumors and misconceptions all the time, and they have mixed success," says Robert J. Levine, MD, professor of medicine and lecturer in pharmacology at Yale University School of Medicine in New Haven, CT. Levine also is a senior fellow in bioethics and was co-founder of the Yale Interdisciplinary Center for Bioethics at Yale.

One success involves the increased use of condoms in Africa, despite some regions' cultural bias against condom use, he notes.

"There is increasing cooperation with clinical trials, but there's even more cooperation with treatment regimens," Levine says.

International documents, including those that address the ethics of international vaccine research, have a strong expectation for capacity building in countries hosting research.

"It's my view that capacity building is most important when you have as prolonged interaction with the people of a country as you do in a vaccine development program," Levine says. "You don't just parachute in and do research and leave."

Vaccine research is an especially long-term investment since it can take seven to 10 years or longer.

"This is not a transient contract," Levine says. "It's most important to do capacity building when you have this long of an engagement."

While HIV vaccine research is fairly prominent on the international scene now, building capacity in an international setting is important for any type of research, including influenza vaccine studies and others, he notes.

The best way to build this capacity is through continued contact with the community after and between trials.

"This is one reason why vaccine trials have been so popular in Uganda and Thailand," Levine says. "The United States has been collaborating with people in the major cities of those countries for many years, so a new study is not a big thing."

When an international community has no context or past history with researchers, then capacity building is resource intensive and time-consuming, often taking years to build the trust and relationships necessary for a successful trial, he adds.

Until this foundation of trust is solid, it would be difficult to have ethical and practical debates with research communities about the responsibilities of investigators and sponsors after the study ends.

For instance, in HIV vaccine research, it's expected that some people will be infected with HIV because the vaccine or control substance doesn't work and they haven't followed the researchers' instructions to follow safe sex practices. So what happens to these people?

Is it the responsibility of the study sponsor to provide them with lifelong antiretroviral therapy?

"In the United States, if you are exposed to the HIV virus or anthrax virus you immediately are given post-exposure treatment," Levine says. "Do we owe that level of care to people in other countries?"

Or should the sponsor make antiretroviral treatment available and affordable to study volunteers?

There are a number of ways these can be handled, and research projects have had no consistent answer to these questions, so it's a debate that has to be made at the community level after investigators have done the groundwork necessary to build capacity and trust.