by Jacqueline M. Duda Volume 59, Number 5
Recruiting minority and ethnic populations into clinical research is a complex and evolving issue that transforms the way researchers think about recruitment and clinical trial design. Current studies that investigate the willingness, or unwillingness, of minority participation remain unclear as to whether or not past research abuses, such as the inarguably infamous U.S. Public Health Service (USPHS) Syphilis Study, leave the most resounding impact. And assuming that minorities are simply unwilling to participate at all in research completely misses the mark. Physicians and researchers who work in the trenches of community and public health care argue that an overall lack of recruitment attempts and appropriate outreach strategies, as well as logistical, financial, cultural and other related barriers, are often overlooked. “It concerns the way persons of color have been treated for years predating the Syphilis Study, being treated as second-class citizens and that notion being institutionalized within the medical community,” explains Vivian L. Carter, assistant director for Community Partnership at the Tuskegee University National Center for Bioethics in Research and Health Care. The issues reach deep into the antebellum South, back to a time when it was common for slaves to be purchased for the singular purpose of horrific medical experiments and other inhumane practices that resonated throughout medical history.
Human relations in research
“It’s not that the USPHS Syphilis Study isn’t important. It is very important,” says Dr. Vanessa Northington Gamble, former director of the Tuskegee University National Center for Bioethics in Research and Health Care and chair of the Tuskegee Legacy Committee, “but there are other factors that influence people’s attitudes.” A lack of respect could be one issue, or a breach of trust in a community. It is simply not correct to attribute everything to the Syphilis Study. It’s much more complicated and requires the examination of other issues. The mistrust of medicine and public health is much broader than the focus on African-Americans and other people of color, explains Gamble, who is now university professor of medical humanities and professor of health policy and American studies at George Washington University. Other groups, some white middle-class parents for instance, clearly fear vaccines, but it’s not viewed as a racial issue, she says. Furthermore, “mistrust puts the onus on the patients. Trustworthiness puts the onus on medicine and public health to earn that trust.”
Even the name “Tuskegee” can be misread without much consideration for the enormous contribution the institution has made to medicine and science and the pride its legendary faculty invoke. The fact that the study occurred in Tuskegee at what was then called the Tuskegee Institute, the name “Tuskegee Study” was adopted in books and articles as shorthand for the original name—“The United States Public Health Service Study of Untreated Syphilis in the Male Negro,” Carter explains. Using the term “Tuskegee Study” implies that the university conducted the study. Personnel from the Tuskegee Institute were involved in the investigation, but the federal government ran and conducted the study, says Gamble. In addition to the Tuskegee Bioethics Center’s community and national outreach regarding informed consent and other bioethical educational projects, the center is engaged in a major campaign to educate the public regarding the name of the study. “We adjusted a great deal of correspondence and we instruct people to use either the ‘Syphilis Study’ or the officially documented title,” says Carter.
Engaging communication
“When speaking to the idea that African-Americans are unwilling to participate in research, I respond by asking, ‘How many times have you tried to actually recruit them?” says Carter, “And what has been your approach? What has been the relationship between the institution and the community? You can’t just come up with a research idea and go out and recruit people and expect them to respond with open arms. You start years before by getting to know the people and allowing them to get to know you.” Recruitment is a process of relationship building and mutual respect.
Anna Nápoles, an associate professor in the Department of Medicine at the University of California, San Francisco, and the author of several studies on recruitment and participation of minorities and the elderly in clinical research, says, “Minorities are willing. But there are certain rules of engagement: respect, cultural appropriateness, and addressing any issues or concerns they may have about past studies, such as the Syphilis Study.” The research project, Nápoles insists, has to be formed as an ongoing relationship with the academic institution, not just a drop-in to the communities to start the research. Researchers can foster this at the community level with community health care providers, and build on that level of trustworthiness and transparency, and explaining informed consent, unlike what had happened in the past.
“The men in the Syphilis Study were deceived,” says Susan M. Reverby, McLean Professor in the History of Ideas and Professor of Women’s and Gender Studies at Wellesley College, and author and editor of books that examine the Syphilis Study. “There were only 16 doctors in Macon County at the time, and you had to have money to access them,” Reverby explains. “The men were told that the aspirins and tonics and procedures were to treat their ‘bad blood.’” They signed up because they thought they were going to receive good care [that they couldn’t otherwise afford]. The men had no idea that the researchers were withholding treatment, she says. “And it didn’t end in 1972. Those men had families, their children,” says Carter, “the entanglement of the name, it’s still here…it’s evolving. People may not know the study by name but they know that something happened and that human beings were abused, that people were being wrongfully used in a study.” In Nápoles’ work, while the subject of the Syphilis Study arose as a concern for some, the accompanying concerns were just as pervasive. The experience of African-American communities as a whole, the discrimination and the racism, and how they had been previously treated in health care, also influenced their willingness to participate in research. “There needs to be an intensive effort to design studies that are culturally and linguistically appropriate, and toward inviting these communities to participate,” says Nápoles.
Clinical trial enrollment is a problem across the board. “Frequently, cancer studies must close because they can’t recruit enough people,” says Aisha T. Langford, director of community outreach at the University of Michigan Comprehensive Cancer Center and a doctoral student at the university’s School of Public Health, Health Behavior and Health Education. Langford adds that a common reaction among investigators has been to think the minority patients harbor mistrust against the medical profession. It’s more than that, she insists.
“You can’t assume that your patients will be paranoid because of the Syphilis Study. Researchers and physicians need to take the time to listen and elicit what their concerns are,” says Reverby. “It’s about becoming trustworthy. Physicians need to prove themselves. Don’t immediately assume, however, that [the patients] will not trust you.”
Langford says that one of the bigger issues at hand is patient–provider communication about clinical trials, which hasn’t always been the best. It’s critical, she says, to dialogue with the community about the purpose of the research, how the process works, and how research is connected to innovations in medicine. “When I work in the community,” Langford explains, “patients often mention that studies have been done but they never hear anything else. No letter, no phone call, no follow-up. Researchers need to be mindful of this. Patients want follow-up.” Informed consent must be thoroughly explained and transparent. “Minorities are willing to sign up if they have enough information to make a good decision,” says Langford.
Ultimately, says Nápoles, research has to give back some tangible benefit to the community, and it’s critical for researchers to do follow-up and provide the findings to the participants. “They want the results back, even if it didn’t benefit them directly,” she adds.
Moving forward toward improving the system
The Syphilis Study is a byproduct of the medical profession’s institutionalized insensitivity in their training and in engaging persons of color, along with the history of abuse and insensitivity that has been imposed on persons of color through the very denial of care, says Carter. The Bioethics Center works with the Human Genome Project at Howard University, the University of Tennessee Health Science Center, the University of Michigan, Georgetown University’s Bioethics Center and many others to provide more insight into the voices of minorities and of women, and to help train health care professionals to become more aware of the ethics of their actions. “We support the human relations aspect,” says Carter. “The translational component is more than clinical. It focuses on community. If we can cure AIDS in the laboratory, it means nothing in the lab. We have to get it into the community. That’s where the real impact is made.” Carter applauds clinical researchers. “My work wouldn’t mean anything without them,” she says, “but the clinical aspect means nothing if people can’t, or won’t, make use of it.”
“It’s imperative that medical school students learn about the USPHS Syphilis Study in terms of human and professional behaviors,” Gamble urges. For example, the study was reported in several medical and public health journals, and it was well known to the medical community at the time, but the study continued even after the Nuremberg Code was established. Which begs the question—why did it go on for so long before it was stopped? “We talk about U.S. history in terms of health care—the idea that this enigma during that time existed at Tuskegee is an integral part of U.S. history,” says Carter. “We need to educate others in regards to public health ethics…. These are really social justice issues. We look at this through a bioethical lens. We have to consider these issues as we engage communities and address the issues of transparency in research. Not just—is it legal, but is it just? Is it fair? Is it right?”
Jacqueline M. Duda is a health writer based in Washington, D.C.