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Overcoming barriers to Hispanic participation in clinical trials
It’s more than language; trust, finances, practical issues all come into play
In the past few years, Hispanics have become the largest minority group in the United States, numbering nearly 41.3 million in the most recent U.S. Census estimates.
But they still make up a relatively small portion of the participants in clinical research. That gap is important and troubling, since diseases such as diabetes, hypertension, and heart disease are more prevalent among Hispanics and minorities in general than in the population as a whole.
The barriers that stand between Hispanics and research are varied and require a multifaceted approach to overcome, say those who work to improve minority participation in human subjects research.
At the University of Michigan (UM), an outreach program that seeks to involve minorities of varied ethnic backgrounds in research has begun to make progress in winning the trust of the Latino community and to overcome logistical barriers to Hispanic participation in clinical trials. But there are no quick fixes, warns Louise Hahn, BSN, MSA, research subject advocate for the university’s General Clinical Research Center (GCRC) in Ann Arbor.
"We believe that if we’re successful, it will be many years before our accrual numbers are as high as we’d like them to be," she says. "We don’t expect to have a three-year program and have high numbers of participants. We really expect this will be slow. We want the community to know that we’re here, we’re interested, we’re reliable."
Providers need to be ready with the basics
Hahn says institutions that want to beef up Hispanic participation need to be ready with the basics, particularly providing translators to decipher informed consent documents and to speak with potential participants. But they also must educate themselves about the cultures in their community and how to ensure the views of different ethnic groups are represented.
"If you have a population that’s diverse, then your IRB should be, too," she says.
While lack of proficiency in English comes to mind immediately as a barrier to participation in research, it’s not the only problem encountered by researchers in recruiting the Hispanic population.
Amelie G. Ramirez, DrPH, a cancer researcher and deputy director of the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine in San Antonio, says Hispanics are severely underrepresented on available registries.
And once patients have been identified, many are ineligible for studies because of existing comorbidities.
"Some of them may have diabetes or other health problems that may keep them from being able to participate in a clinical trial," Ramirez says. "The numbers get really small — by the time you go through all these different steps, the population that could potentially be accrued becomes much, much smaller."
David Gordon, MD, associate dean for diversity and career development at the UM Medical School, heads up the school’s Minority Health Research Program.
He says he sees difficulty in identifying a cohesive Latino population — that Hispanics more often organize themselves into groups such as Mexican Americans or Puerto Ricans.
"That makes it administratively harder to identify who the key people are who have a sense of the Latino community that we can appeal to," Gordon explains.
Undocumented Hispanics often harbor mistrust
He also notes the difficulty in getting Hispanics to trust a government entity such as a university, particularly when they may be in the country without proper documentation.
"When we say we’re looking for Latino/Latina individuals to participate in research, there’s the barrier of: What is this institution? Is it part of the police? What are you really looking for?" Gordon asks.
"Particularly when you’re doing something like signing people up for registries, where you’re asking people to identify by name, you find more concern from Hispanic individuals feeling comfortable with that. Don’t get me wrong, African-Americans don’t feel comfortable about it, either," says Gordon, who is African American. "But I can see this being accentuated a bit with certain groups, particularly with the issue of immigration or citizenship status."
Other barriers can be financial or logistical, such as the cost of transportation to the research site or finding a baby sitter to care for children, he says.
And Gordon and Ramirez both note that Hispanics raise the same trust issues that many other research participants do: Am I being used as a guinea pig? Why are you trying out this drug on me? Both say participants need to get basic information about clinical trials, emphasizing the amount of research that’s already been done on the treatment, and noting that patients will receive the best standard care in addition to experimental treatment.
Strategies for success
Joel Escobedo, a third-year UM medical student, recently conducted interviews with elderly residents of a Hispanic community in Chicago to discern their attitudes about participating in research.
Despite lower education levels (most had only completed elementary school), most of the elders he interviewed knew about clinical research and believed it to be valuable.
The barriers most identified to participating in studies were logistical rather than cultural or psychosocial, says Cathy C. Lee, MD, assistant professor of internal medicine, with a focus on geriatrics, at the UM Medical School.
The participants said they would be more willing to participate if clinical research studies were conducted on weekends. While it was important to most that the researchers spoke Spanish, their ethnicity was not as important to these seniors. And nearly all said they would be more willing to participate if there was personal benefit or benefit to the Hispanic community as a whole.
Hector M. Gonzalez, PhD, assistant research scientist in epidemiology at UM, currently is conducting research among elderly Latino residents of both California’s Central Valley and southwest Detroit.
"We’re quick to point out whenever we talk to community groups that we hope the information we collect would be of benefit to them, but would also serve as a legacy to their family and their community, to better the health of the community and their family," he says.
Gonzalez says that providing bilingual services — everything from the consent forms to the support staff — is essential for recruitment and retention of participants whose first language may not be English. For example, the group he’s following in a longitudinal cohort study in California is older than 60 years old, and more than 60% prefer speaking Spanish.
"Many of them have lived in the country for 40-odd years, and they can communicate in English," he says. "But we want to ensure, starting with the informed consent, that they fully understand the relationship they’re engaging in as a partner in research."
Going beyond the trial
In addition to fluency in Spanish, Gonzalez says staff need to be people-oriented and attentive to the needs of the participants — for example, being able to help put people in touch with other health care services as needed.
That kind of "giving back" can help researchers gain and keep the trust of the Latino community, especially in an atmosphere where contact with the government isn’t always seen as welcome.
Gonzalez notes that when he began his work in California, the state had just been through a series of propositions that were seen as anti-immigrant, and community leaders were concerned that people wouldn’t be interested in volunteering for research through a state university.
"There was concern that participants would be fearful that we were working for the government and turning in people with questionable immigration status," he says.
Gonzalez says he dealt with the issue simply by not asking about a participant’s immigration status. "I think from an ethical perspective, it wasn’t really relevant," he notes.
And while participation in the research did require people to give his staff a lot of personal identifiable information, staff always explained the purpose of the questions and tests.
"We had an all, or almost all-Latino staff, and I think it helps in getting away from that kind of barrier," Gonzalez says. "I think it’s important to have people from the community, people they can relate to. We’ve had the same study nurse since day one, and she’s developed these very good working relationships with the participants."
Community advisory boards
As part of its effort to increase diversity in clinical research, UM’s Minority Health Research Program set up a small extension program at a health center in Ypsilanti, MI, which has a more diverse population, Hahn says. It also set up a community advisory board with representatives from various community, religious, and other groups in the Ypsilanti area.
Protocols accepted by the GCRC also are reviewed for suitability by the board; if the advisory board approves them, patients can be recruited at the Ypsilanti site.
Nancy Lowenbergh, BSN, RN, a community research nurse for the Ypsilanti Health Center, says she extends the university’s reach into Ypsilanti’s various minority communities. She speaks at churches and health fairs, and passes out multilingual brochures at festivals and other community events.
"It’s very hard to touch our Latino community," Lowenbergh says. "That’s why I’ve been so active with [a local Latino festival], advising them on their health tent, so I can get to be known. Now, enough people have told other people, Yes, you can trust her,’ and they’ll talk to me now."
Lowenbergh says there’s a grocery store in town where it has taken two years for her to be given permission to post notices on a community bulletin board.
She and Hahn are adamantly opposed to so-called "helicopter" studies — where a researcher descends on a community, does a study, and disappears without ever coming back to let participants know the results of the work.
"These people are used to being used; therefore, they have no trust," Lowenbergh says. "And one of the things I’m doing is proving to them that I’m here to stay, and I’m not going anywhere."