Earning respect, trust in international settings
PIs must put more time in to building trust
No one can predict yet whether or not the growing infamy of the Guatemalan syphilis study results in enrollment problems for researchers engaged in international research. It certainly will not help. Regardless, at least one expert believes that even with the protections and regulations put in place in the 21st century, international trial investigators need to do more to earn the trust of the communities they study.
"What I'm trying to understand is what makes community engagement effective at an operational level and what should we be doing at an ethical level," says James Lavery, MSc, PhD, research scientist at St. Michael's Hospital in Toronto, Canada.
"Fundamentally, this is the whole notion of humanizing trials," Lavery says.
If researchers walk into a Guatemalan village with the mindset that this person is a mother and daughter then it would be hard to treat her as the subjects were treated in the Guatemalan syphilis study of the mid-1940s, he adds.
In those trials, vulnerable populations in Guatemala were intentionally infected with sexually-transmitted diseases (STDs) without their knowledge or consent.
"It must be inevitable when these stories come to light that there is a deep suspicion that the people doing research do not care enough about the well-being of the people they're engaging," Lavery says.
Investigators and the research ethics community need to move beyond the rhetoric of conducting informed consent in language and literacy-appropriate ways and instead try to meet study subjects on their own terms, learning what it is to them to be respected by researchers, Lavery suggests.
"Maybe this means going more slowly forward with the research project or giving [subjects] opportunities to have meaningful input or even to change what we do," he adds.
Lavery and co-investigators have developed a framework for community engagement in global research that lists 12 points to consider for effective community engagement. These include ensuring the research project's goals are made clear to the community and understanding the community's attitudes and perceptions of the proposed research project.1
"What I'm trying to accomplish with this work is to bring it up to the surface and bring it into the open so investigators are not caught napping," Lavery says.
Lavery lists these potential issues in engaging communities in global research:
How do you represent the community?
"I've seen many different mechanisms for how communities are represented, and there are a lot of difficult problems there," Lavery says. "Conceptually, how do you represent a community?"
It might be that three people out of a population of 35,000 are chosen to speak on behalf of the entire community. Typically they'll be part of a community advisory board.
"But what does that mean?" Lavery says. "It's easy for investigators, but most people in the community do not know the board exists."
One key is to spend time in the community before the research project begins and get to know people who could be impacted by the study, he suggests.
Another strategy is to purposely look for dissenting opinions and include these people in the community advisory board.1
"One thing we believe in that investigators virtually never do is actively seek different views rather than seek people who will agree with everything you do," Lavery says. "There's a moral obligation to seek out people who may not agree with your practices in the overall trial."
Give these people an opportunity to express their views even if it will take time and make investigators uncomfortable, he adds.
"We think that's a requirement of respect and being a good host," he says. "Try to listen and understand people who may oppose the research."
If this strategy were applied at various time points in human subjects research history, then it's easy to imagine that the Guatemalan and Tuskegee study abuses would never have occurred.
"Imagine if you had to as an investigator talk to people in Guatemala and ask them if they thought it was a good practice to infect people without their knowledge?" he says.
What do members of the community feel about trial procedures?
It's better to find out how the community might react to controversial or slightly risky procedures before the trial begins. Although this might take time and result in complaints by researchers, it's preferable to the worst-case scenario of the community expressing its views after the study is underway.
"People stop complaining when trials shut down because communities say, 'We've had enough,'" Lavery says.
This has happened in international HIV research where well-developed activism has had an impact on clinical trials, he notes.
"You have hundreds of millions of dollars in these trials, and if they fail or if you have to go to new sites and start over, it can take years," Lavery says. "There are hardship costs on the side of investigators and funders, but the communities have some power, and we want to avoid those kinds of problems."
For example, if a study requires blood draws and exporting blood samples to another country, then investigators should do extensive ground work to find out how this will be perceived by a community's populous.
"What might happen is the community says, 'I'm not sure we're happy with your exporting our blood samples to another country,'" Lavery says.
Investigators should think about what it means to be a good guest in these communities and demonstrate why these blood samples are important.
"It's fundamentally about respect," Lavery says. "How confident are we that we have really learned how to be respectful of the communities we're engaging?"
International researchers do a good job overall, but there are ethical gaps that need to be resolved, and this is what Lavery and other researchers are trying to address with the global health research framework project.
The project, funded by the Bill and Melinda Gates Foundation, looks at what makes community engagement effective.
"We have done nine case studies in seven countries where we look at in-depth details to reveal insights into what kinds of practices contribute to effectiveness," Lavery says. "We focus on what people do, the operational level, and what are the practices and mechanisms and what is gained on the ethical side by each of these practices with a strong emphasis on community."
Reference
- Lavery JV, Tinadana PO, Scott TW, et al. Towards a framework for community engagement in global health research. Trends in Parasitol. 2010;26:279-283.
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