Study finds participation despite fears of exploitation
It's an accepted truism among many in biomedical research: Blacks won't participate at the same rates as other ethnic groups, because of fear of being exploited, thanks to the legacy of the infamous Tuskegee Syphilis Study.
But the truth is more complex, says Ralph V. Katz, DMD, MPH, PhD, a professor of epidemiology and health promotion at the New York University College of Dentistry, New York.
Katz is part of a team of researchers on the Tuskegee Legacy Project, a long-term project to understand and address issues related to recruitment and retention of blacks and other minorities in biomedical research.
After administering an extensive questionnaire to 900 people of different races in four American cities, Katz says his group learned a more subtle lesson — that while blacks are more likely to raise concerns about participation in research, they are just about as willing to volunteer as whites.
"One headline summed it up by saying: 'Blacks: Wary, but willing,' and I think that's a wonderful summation of what we found," Katz says. "I think the African-American community would be very smart to be wary and reflective of history, but I think they participate in American life, they always have, as fully as they're allowed to in very positive ways."
And he believes the study carries a special message for researchers who struggle to achieve minority representation in their studies — and the IRBs who review them.
"I think people should have the confidence to actually hold the investigators' feet to the fire to come up with creative, active plans to recruit the diversity of population that we need scientific health answers on," Katz says. "In other words, don't cut them slack because you think it's an impossible task."
Katz's study was published in the November 2006 issue of the Journal of Health Care for the Poor and Underserved.1
Conference spurred interest
Katz's introduction to the issue came at a 1994 conference he attended about the Tuskegee study, which ran from 1932 to 1972 in Macon County, AL. As part of a U.S. Public Health Service study on the effects of syphilis, nearly 400 poor black men were watched for years without being adequately treated for the disease, even after penicillin was established as the drug of choice for syphilis in 1947, according to the Centers for Disease Control.
The study was revealed by public health workers in 1972, to a huge public outcry. In 1973, the National Association for the Advancement of Colored People filed a class-action lawsuit, resulting in a more than $9 million settlement for those who had survived the experiment. In 1997, President Clinton delivered a formal apology on behalf of the nation to the survivors and the families of the men who died in the study.
Katz says the 1994 symposium featured a number of speakers reflecting on the Tuskegee study and its legacy in health care research. Their message was a familiar one — that knowledge of the abuses of that study had soured African-Americans on participating in biomedical research.
"On the 12-hour train ride back, it just struck me that I didn't think academics could talk all day and not cite a reference — and there wasn't one reference cited" to back up the central premise that African-Americans were less likely to volunteer for research because of Tuskegee, Katz says.
At the time, Katz was director of the Northeastern Minority Health Research Center, which was conducting research into such conditions as oral cancer, pediatric AIDS and baby bottle caries.
"We had all African-American cases, as it turned out, in New York, because we were based with the dental school there," he says. "I said, if we have this problem in the community we're trying to recruit, we've got to make sure they understand we're not operating that way. I decided to quickly make up a questionnaire and find out if that was in fact the story, that [blacks] were afraid of coming into studies."
As it turned out, that questionnaire took three years to develop, and became the Tuskegee Legacy Project (TLP), an attempt to quantify issues of recruitment and retention among minorities.
The 60-question TLP questionnaire asked subjects — white, black and Hispanic — about their knowledge of research abuses, including Tuskegee, and their willingness to consider participating in research, based on a number of factors.
Subjects were asked whether they might be more or less inclined to volunteer based on who was running the study — the subject's own doctor, a university medical school, the government, a nonprofit foundation, a tobacco company, a drug company or an insurance company.
They were asked how their decision might be influenced by what the study required — a blood draw, an IV injection, exercise, personal interviews, telephone interviews, dietary restrictions, oral medication or major or minor surgery.
Subjects also were asked about fears that might hinder them from participating, including fear of being a "guinea pig" or lack of trust in research.
The subjects were asked three times during the questionnaire about their knowledge of Tuskegee, including an open-ended probe asking about abuses in medical research, and two questions that identified the Tuskegee study by name, Katz says.
The telephone questionnaire first was administered to 900 adults in four cities: Birmingham, AL, Hartford, CT, San Antonio, TX, and Tuskegee, AL.
Katz says Birmingham was chosen because it was the closest city to Tuskegee that had a major medical center, and Hartford was chosen because of its comparable size and demographic similarities to Birmingham. San Antonio was selected in order to provide a sizable number of Mexican-American subjects, to balance Hartford's Puerto Rican population.
As for the fourth location, "I couldn't give up the epicenter of Tuskegee, even though it's a much more rural area and not likely to be invited to participate in studies," he says.
Study circumstances affect results
The results from the basic question on willingness to participate in biomedical studies showed that 20.6 percent of blacks were considered "likely" to participate, compared to 31.2 percent of whites. However, the authors note that when the question is broken down by who administers the study and what is asked of participants, the picture changes.
Blacks were only slightly more influenced than whites by who was running the study, and in fact reported being more likely to participate than whites in a few instances. On the question of what a subject would be willing to do in a study, there were fewer differences between the racial and ethnic groups.
Hispanics' responses were found to hover between the blacks' and whites' responses to the major questions studied.
"The in general differences between racial and ethnic groups . . . disappeared when subjects were given specific study circumstances as to who was conducting the study or what subjects were asked to do within the study," the authors write.
"Based on these study findings, the recruitment of Black and Hispanic minorities for biomedical studies appears to be a fully attainable goal for most types of biomedical studies, in addition to being highly desirable for ensuring diversity within study populations in biomedical research."
A few years later, the same questionnaire was administered to 1,100 adults in New York City, Baltimore and San Juan, Puerto Rico.
"Not only did we find the same direction of findings, but almost the same exact measurement level, and it was separated by three years in the field and different cities," Katz says. "It gives a hint that this is a stable phenomenon and we may have a reliable instrument that can replicate it."
The authors write that while some previous studies have linked unwillingness to participate in research on specific knowledge of the Tuskegee study, they have not shown a more general effect on the black population as a whole.
And they note that more recent studies have shown that minorities do enroll, proportionally, in biomedical research at expected rates when researchers make an effort to recruit them. The article cites the national Women's Health Initiative, which achieved 93 percent of its targeted minority goal and reported that recruitment yields for black and Hispanic groups surpassed those of white women.
Katz says many of the studies that achieved this success came after the 1994 National Institutes of Health Guidelines for the Inclusion of Women and Minorities in clinical studies, which required that researchers do more to achieve diversity in their studies.
"Putting up notices just on posts in medical centers doesn't necessarily attract everybody," he says. "But if you work through medical centers, and you work through churches and community leaders and community organizations, you'll get a full participation, as these studies are finding out.
"They meet their quotas, although it does take a little more planning and effort, and that's what the 1994 legislation asks for," he says.
Katz says his group is only beginning to sift through the large quantity of data collected through the TLP questionnaire.
"We have 18 manuscripts designed to be published that we can think of now, and we'll find more as we get into it," he says.
But he says the story that's emerging about blacks' attitudes toward research seems strong.
"I think I see a very solid and sane and understandable message here: Wary but willing, and the wary is understandable, and the willing is evidenced by the recent studies that have assessed participation in studies and have gone one step further to make sure that the community knows they're welcome and in fact vital to the success of the [research] project."
Reference
- Katz RV, et al. The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research. Journal of Health Care for the Poor and Underserved. 2006;17:698-715.
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