Researchers' misconceptions often prevent enrollment of minorities
Research ethical experts offer advice
The fear of rejection due to stigma sometimes stops investigators from approaching minority communities about enrolling in research studies. This is a misconception that needs to be addressed and corrected, clinical research ethical experts say.
The attitudes and beliefs of principal investigators (PIs) and the research team are the chief problem in low minority participation in research, says Stephen Thomas, PhD, a professor of health services administration and the founding director of the Maryland Center for Health Equity at the University of Maryland in College Park, MD.
"The literature is full of examples, and the whole narrative has been built around resistance of minorities in research," Thomas says. "From Tuskegee to Henrietta Lacks, we know the distrust on the part of the [African American] community has been earned."
But this is not the chief barrier to minority clinical trial participation that many people believe, he adds.
"Our evidence suggests that African Americans and Latinos believe science and research are important, but they are not being asked to participate," he adds. "Our concern is that they're not being asked because principal investigators and staff believe they'll be rejected if they asked or that they believe this is a population that is difficult to recruit and retain or that it will hurt their accrual numbers."
A recent study about the inclusion of African Americans in genetic studies found that 71% of eligible African Americans approached in telephone screening calls agreed to participate in a smoking study; 57% of eligible European Americans participated in the study.1
Investigators found that subjects could passively avoid participation by refusing the telephone screening or declining to answer the phone. This type of passive avoidance was inversely correlated with the proportion of African Americans in the zip code. The zip codes with the highest proportion of African Americans had the lowest rates of refusing telephone screening and not answering the phone.1
"I think the take-home message is that it's important to include minorities in studies, and they want to be included in studies when they're approached," says Sarah McConnell Hartz, MD, PhD, an instructor at the Washington University School of Medicine, department of psychiatry in St. Louis, MO.
The barriers to minority participation in research appear to be related more to researchers' perceptions about how minority communities might respond more than to the communities' actual response. Research institutions can turn this trend around by educating investigators and research staff about minority recruitment.
"We just completed a random household survey, and it was amazing how the statistics of African Americans and Latino Americans showed they were not be asked to participate in studies," says Mary A. Garza, PhD, MPh, an assistant professor in the department of behavioral and community health and associate director for the Maryland Center for Health Equity, University of Maryland School of Public Health.
When African Americans and Latinos were asked to participate, they said "yes" more often than "no," Garza adds.
The survey highlights the need for better education for investigators, research staff, and the community, she notes.
"We're hoping to address this issue in a curriculum," Garza says. "We're developing two curriculum – one for researchers and one for the community."
The curriculum contains modules and will aim to educate the community about the importance of participating in research. It also will focus on skills building and contain interactive videos and activities, Garza says.
For researchers, the education will focus on the historical context of research abuses and how to access communities and build community partnerships, she adds.
Educating researchers about recruitment, and particularly about recruiting from minority communities, is fairly new.
"To what extent are researchers trained to recruit, in general?" says Sandra Crouse Quinn, PhD, associate dean for public health initiatives, school of public health and a professor of family science at the University of Maryland. "And are they trained in particular issues and strategies for recruiting from minority communities?"
Research professionals need to overcome their internal barriers and beliefs related to thinking that any particular population is more willing to participate in studies than some other population, Quinn notes.
Recruiting minorities might take extra time, as would recruitment of any new group.
"If you were going out to recruit any group what might you do beforehand: would you form focus groups, do literature searches, ask other investigators what has worked for them?" Quinn says. "People are waiting to be asked to participate, but you may have to stretch your boundaries."
Research institutions could educate research staff about how to enter a new community to build partnerships, Garza says.
"I practice community-engaged research and have partnerships with key leaders of the community," Garza says. "It's a two-way street; the key thing is that participants need to be informed and often times they're the last ones to know what's going on."
A common research approach will have investigators ending contact with the community when the study is complete. But this is a mistake, she says.
"These community relationships should be long-lasting," Garza says. "Dr. Thomas calls it the drive-by researcher; we should use the community as our greenhouse as opposed to our laboratory."
Community relationships with investigators should strengthen and grow with each study, she adds.
Another strategy would be to reach out to community partners to seek their opinion on the best ways to reach a particular audience, Quinn says.
"If you have other studies where you recruited people from this population, ask them what made them willing to participate," Quinn suggests. "Do your homework in a number of ways."
Retention of minority participants also worries investigators. Some of the same strategies used in recruitment will work with retention, but the key for retention is the informed consent process, Garza says.
"If you build respect and have a caring atmosphere in the beginning then that subject is more likely to stay with you," she says. "Stay in constant contact and provide follow-up, and keep them informed of what's going on; communication is very important."
Investigators should keep in mind that word-by-mouth marketing is powerful: research participants might spread positive words about a research team that has treated them well, and they might steer people away from researchers who do not work at building these relationships, Garza says.
Research institutions can improve minority participation in studies by building an infrastructure that supports clinical trial inclusion of minorities and women, Thomas says.
"We have successfully demonstrated how it's done by building an infrastructure called the CRAB — community research advisor board," he says. "People from common walks of life and populations we're trying to recruit from and investigators and staff sit on a research advisory board."
The CRAB reviews all study proposals that have implications for human subjects, he adds.
"The board doesn't do a thumbs up or thumbs down, but the CRAB model is a way for investigators to interact and engage with the community," Thomas says.
The community board also can assist with disseminating research results.
"Often times, the community participant just wants to understand what's going on with the study, Garza note.
Each area of research, including oncology and cardiovascular disease, could have its own CRAB.
"The problem is finding someone to maintain the CRAB if it's not tied to one disease or one grant," Thomas notes.
"There are missing infrastructure components," he explains. "When we talk about building trust, our icon is a bridge, but that bridge needs to be maintained."
Each research institution will need to make this decision, and it could differ from place to place.
"It could be the centers for minority health or a healthy equity office," Thomas suggests.
"We've developed community training and researcher training, and we're rolling out the training as we speak," he adds.
- Hartz SM, Johnson EO, Saccone NL, et al. Inclusion of African Americans in genetic studies: what is the barrier? Am J Epidemiol. 2011;174(3):336-344.