Amidst the ongoing scramble to conduct COVID-19 clinical and vaccine trials, there are concerns that marginalized communities are underrepresented in these trials, despite being the groups most affected by COVID-19. This lack of diversity in clinical trials stems from a combination of both past and present failures from the United States in equitably protecting BIPOC, including a history of unethical research practices.
“It’s been harder to recruit individuals who may be identified as minorities because of some of the historical events that have happened, as it pertains to studies in those groups,” Dr. Sharmon Osae, a clinical assistant professor at the University of Georgia, said. “A very prominent and a very well known example includes the Tuskegee experiment.”
Beginning in 1932, the “Tuskegee Study of Untreated Syphilis in the Negro Male” involved 600 Black men, 399 of which had syphilis, without their informed consent. Going one step further than consent, informed consent confirms that patients fully understand the possible risks and consequences of their participation in a study so that they can make an informed decision about their participation.
In the Tuskegee Study, the men were told that they would receive treatment and free medical exams, but in reality the men with syphilis were not provided proper treatment, even after penicillin became available as a treatment in around 1945. While the Tuskegee Study is the most well known example of unethical research practices, there is a long history of research malpractice against African Americans and other POC that has led to overall medical distrust.
“Thankfully, there have been some changes in our federal policy regarding how research is conducted, including the introduction of the Belmont Report,” Dr. Stephaun Wallace from the COVID-19 Prevention Network said. “One of the main hallmarks of that report was the mandate of a process called informed consent.”
In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed. They created guidelines of the basic ethical principles for research involving human subjects, which are summarized in the Belmont Report. There are three ethical principles outlined by the Belmont Report: respect for persons, beneficence, and justice.
Respect for persons is the recognition of autonomy and protection of those who have diminished autonomy, from illness or disability for example. Similarly, the principle of justice condemns the use of prisoners or otherwise disadvantaged groups when it is not applicable to the research. Lastly, beneficence is the concept that researchers should maximize benefits and minimize harms to study participants, with there ideally being no harm done. In practice, these principles are fulfilled through informed consent, as well as an assessment of any risks and of the participants involved.
“Now in the present, there are large groups of people who have medical distrust,” Osae said. “It’s a combination of what’s happened in the past, and the failure of the scientific community to really inform individuals in a more appropriate way about how they are being protected and why it’s important for them to participate.”
“It’s a combination of what’s happened in the past, and the failure of the scientific community to really inform individuals in a more appropriate way about how they are being protected and why it’s important for them to participate.”
— Dr. Sharmon Osae
The principles outlined in the Belmont Report were put in place to prevent unethical studies like the Tuskegee Study from ever happening again, but without the proper communication, the distrust from historically unethical practices is lasting. Today, there are still accessibility issues inhibiting certain communities from participating in medical trials.
“[For] our Hispanic communities, they might have a hard time navigating our healthcare system, they might have a little bit harder time understanding English,” Dr. Andres Martinez, a professor from the University of Colorado Denver Medical Campus, said. “We do need doctors that are African American, we do need more doctors that are Hispanic — that way the cultural or language barrier is decreased.”
People from marginalized communities tend to lack medical or scientific literacy, which is the ability to comprehend the concepts that a doctor or researcher is explaining to them. This gap in scientific knowledge is likely due to the disproportionately poorer education for marginalized communities, as well as underrepresentation in science and medical higher education.
Without a doctor that can effectively communicate with these groups, it’s hard to overcome distrust and convey the importance of participation in medical trials. Martinez expressed feeling a responsibility, as a healthcare provider, to facilitate this communication.
“There needs to be a concerted effort on the part of the industry, including pharmaceutical companies, to support projects that increase health and scientific literacy in communities, so that communities are more armed with information that can empower them and support their advocacy for their own health and well being,” Wallace said.
“There needs to be a concerted effort on the part of the industry, including pharmaceutical companies, to support projects that increase health and scientific literacy in communities, so that communities are more armed with information that can empower them and support their advocacy for their own health and well being.”
— Dr. Stephaun Wallace
In addition to any communication barriers, it may be a financial burden to commit to participating in a medical trial.
“If you’re working 80 hours a week to make ends meet, you can’t go to the different appointments, you can’t take the different phone calls,” Osae explained. “It’s a burden that a lot of individuals may not have the opportunity to, or the ability to participate in [these trials].”
Black and Latinx people are more likely to have lower incomes, higher unemployment rates, and are more likely to be single parents than white people — all of which would make it hard to find the time to participate in a trial, when they instead need to focus on working or childcare. It is important, however, for researchers to find ways for them to participate, because diverse study groups allow researchers to understand any possible side effects and to accurately measure the effectiveness of treatment.
“Genetics has a big part and plays a big role in how patients metabolize medications and how medications work in everyone’s body,” Osae explained. “If, for instance, say only women were recruited for a study, we wouldn’t have the information available to identify whether or not whatever our intervention was works in men.”
It is especially important to include a diverse group of patients in COVID-19 trials because COVID-19 has disproportionately affected Black and Latinx communities.
“If you see the demographics of patients affected with the COVID-19 disease, you’re gonna start to see a lot of minority groups affected by this,” Martinez said. “[Many Latinx people] have outdoor jobs, or jobs in which they have to have frequent encounters with other people.”
For the health of these communities, it is critical that any vaccines and treatments are effective for them also. Wallace mentioned that a diverse group of people participating in a trial will increase willingness to use the product after it is approved, which is especially important for marginalized communities who have lower levels of health literacy and are most affected by COVID-19.
While the implications of poor health literacy and lack of diverse trial groups are especially evident during the COVID-19 pandemic, the systemic issues in education and healthcare that led to this point must be addressed to improve the quality of healthcare for marginalized communities in the future.
“This isn’t something that’s going to be fixed overnight, and it’s certainly not even something that can be fixed in a year or two. This is going to take systemic change,” Osae said. “It’s really working on our healthcare system as a whole, [and] working on our country as a whole.”
Last updated 10/12/20
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