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Community boards help build local awareness
CABs are experts on local attitudes
For many clinical trials developing a community advisory board (CAB) is the right thing to do for the local community and for eventual participants. But it's also the right strategy for investigators, who otherwise might miss cues about problems with their protocol design and participant education.
CABs are particularly indispensable in foreign cultures and countries where U.S.-based investigators might be unaware of beliefs that make biospecimen collection more complicated than it is in the United States.
Community boards work best when they serve as an advisory body that informs researchers, as well as assists in educating the community about clinical trials, says Kathleen MacQueen, PhD, MPH, a senior social scientist and coordinator of interdisciplinary research ethics at Family Health International in Research Triangle Park, NC.
Without a CAB or similar mechanism, researchers might not learn of major obstacles to biospecimen collection and storage until a trial is underway. But if a CAB has been informing investigators of local culture and beliefs, these obstacles could be handled before misunderstandings arise.
For example, some cultures believe that every part of a person's body must be buried after death, so even biospecimens from the person must be retrieved and buried or the person's soul will be restless.1
So if a CAB has alerted investigators to this belief, then issues related to the long-term storage of biospecimens can be addressed up front and resolved at the time of trial enrollment.
HIV biomedical prevention researchers have learned the importance of being fully informed by a local community board through trial and error.
"Several years ago, we'd heard anecdotal reports about concerns [participants] had about blood draws and tissue samples and what happens to them," MacQueen says.
"People had some interesting ideas about why we would want to collect blood and what would be done with it," she adds. "We heard about rumors of witchcraft and vampirism or using samples to do genetic engineering that would make people in the United States rich, but leave people in the developing world poor."
All of this was anecdotal, so at an HIV prevention trial network meeting, HIV researchers and experts held a special session to discuss these reports.
"We had about 80 researchers and community educators and CAB members from Asia, Latin America, Africa, and the U.S. there to discuss this," MacQueen says. "We broke into roundtable discussions."
Prior to the meeting, attendees were asked to answer a list of questions about their local communities' concerns and experience with biospecimen issues, and many people had conducted a little research in their own localities, she notes.
"So when they came to the meeting, they said, 'Here's what I am being told,'" MacQueen says. "We learned a lot and published the results of our tabletop discussion in IRB: Ethics & Human Research."
The big take-home message was that if researchers don't fully explain what they're doing and why they're doing it in a way that participants can fully understand, then participants will jump to their own conclusions based on their own life and culture experiences, she explains.
"If they don't understand what a laboratory is and how you would use blood to understand the disease, and if they only understand the use of blood in the context of witchcraft, then that's the model they'll use," MacQueen says.
In another example of cultural misunderstanding, clinical trial professionals would tell participants that they will collect two vials of blood, which is a couple of tablespoons of blood. The CT staff thought they were describing how small the blood amount would be by using a local term for "vial," MacQueen says.
But participants in one culture didn't have a good translation for the word "vial," so it was translated as "bottle." To these participants the world bottle evoked an image of a Coca Cola bottle, and to them it appeared that researchers wanted to take two Coke bottles worth of their blood, she adds.
"So if you don't really talk to people and listen to them and understand what they think, then all of your best intentions can go haywire," MacQueen says.
After learning of this misunderstanding, clinical trial staff found a very simple solution: they showed participants a liter jug and explained that the blood in the human body could fill four or five of these jugs, MacQueen explains.
"Then they showed them a vial and said, 'We use this to collect a small amount of your blood,'" she adds. "Then they also explain that their bodies are constantly making more blood."
CAB members can help to anticipate and clear up these communication issues.
"I'm an anthropologist and I have a PhD that helps me figure out how to understand a new community," MacQueen says. "But every time I go into a new community, I start at ground zero, and I'm there to learn from the experts -- the community members."
Researchers should approach communication during the informed consent process the same way.
"You don't want people signing up if they don't understand what's required in the clinical trial," MacQueen says.
"Our informed consent process can take a half day or more since some HIV trials are so complex with screening, informed consent, and behavioral interviews," she adds. "We accept that as the way it is."
So HIV biomedical prevention investigators will give participants very detailed information booklets and sheets before they enroll and have them take these home to discuss with their families.
The point is to let them think about how difficult it might be for them to take pills each day or use a microbicide gel each time they have sexual intercourse and to come back to the clinic every month for an HIV test, for example.
"If someone feels this is too much for them then you don't want them in the trial because it's not about enrollment numbers, but about retention numbers, taking time to talk with the person and building a relationship," MacQueen says.
"Laying the groundwork in the community can be very important to that process," she adds. "If there's a buzz in the community that this is an important study then even if a person is not in the trial, he'll be supportive of people who are enrolled."