At time of writing (late 2020), researchers around the world are racing to test vaccines for the covid-19 virus. To test the efficacy and safety fo these vaccines, studies must recruit thousands of participants and track them over time. They need to know, Do people who get the vaccine have any negative side effects? Do people who get the real vaccine have lower rates of COVID infection compared to people who get a placebo vaccine?
In this story, New York Times journalist Jan Hoffman explores one legacy of the Tuskegee study: It has led to pervasive distrust of research participation on behalf of African-Americans. This means that Black Americans may not be eager to participate in vaccine trials for covid-19.
We need to include people of all ethnicities in these clinical trials. Hoffman writes:
It is essential, public health experts say, that research reflect diverse participation not only as a matter of social justice and sound practice but, when the vaccine becomes available, to help persuade Black, Latino and Native American people to actually get it. (The participation of Asian people [in vaccine trials] is close to their share of the population.)
“Historically, we test everything in white men,” said Dr. Michael, a member of the vaccine development team at Operation Warp Speed, the public-private partnership set up by the White House. “But the disease is coming after people of color, and we need to encourage them to volunteer because they have the highest burden of disease.”
Early on in vaccine trials, African-Americans were making up only 3% of the study participants (this group is 15% of the U.S. population). Therefore, recruiters like Carla Arnold were going door to door and meeting with small community groups, trying to recruit African Americans to participate in the trials. Hoffman's article includes this exchange:
...an older woman turned the question back on Carla Arnold, ... who is well-known to people in the Heights:
“Miss Carla, would you feel comfortable allowing them to inject you?”
Ms. Arnold, 62, adjusted her seat to face them down, her eyes no-nonsense above a medical mask.
“They already did,” she replied.
[...] Ms. Arnold carefully explained to the tenants her decision to participate in the trial for the vaccine being developed by Moderna, a company that has received pledges of $1.5 billion from the Trump administration for its effort.
“I am a proud African-American woman,” she said. “As African-Americans, we always seem to get less out of things that go on. I want us at the forefront of this. I want to make sure that Black people are represented. I’m going by faith that these people won’t do to African-Americans what they did to us in Tuskegee. I’m holding them accountable.”
Questions
a) In Chapter 4 (Ethics) you read about Tuskegee Syphilis study, which violated all three ethical principles of the Belmont Report. One of these is respect for persons. How did the Tuskegee study violate this principle?
b) The second Belmont principle is beneficence. How did the Tuskegee study violate this principle?
c) The third Belmont principle is justice. How did the Tuskegee study violate this principle?
d) Which Belmont principle is most relevant to the composition of the participant pool for a vaccine trial?
The Tuskegee study isn't the only famous historical example of research that unfairly targeted Black Americans. Hoffman reminds readers of three infamous studies here:
[examples] include surgeries by Dr. J. Marion Sims, a 19th-century gynecologist, on enslaved Black women, the 40-year-long Tuskegee study, in which doctors deliberately allowed syphilis to progress in Black Alabama sharecroppers, and researchers’ taking of cells without permission from Henrietta Lacks, an African-American cancer patient, in 1951.
e) As Hoffman's article explains, African-Americans' reluctance to participate in vaccine trials probably reflects, in part, an understandable mistrust of researchers, based on these past examples (“'It’s not the science we distrust; it’s the scientists,' said Jamil Bey"). Reflect on this outcome of past unethical practice: Why
In one sense, it might seem fair that in the current trial, African-Americans are not disproportionately "bearing the burden" of the vaccine trials and its potential risks (that's the justice principle). Nevertheless, by not recruiting African-Americans in the trials, this group risks being left out of its potential benefits, too. It's an issue of ethical fairness and good practice: Access to to the vaccine (even in its trial form) needs to be equal in all communities, both now and in the future. And this is especially true because Black Americans are much more likely to be affected by the virus.
Hoffman's article ends on a positive note:
By the following week, there were signs that the outreach efforts were helping. The portion of people of color in the Pittsburgh area in the vaccine registry had risen to 8 percent, up from 3 percent. Because trial leaders can choose whom they finally enroll, they have been increasing the percentage of nonwhite subjects. Moderna reported that nationwide, as of Sept. 28, 26 percent of those enrolled were Black.
Thank you to Adam Putnam of Furman University for sharing this example with me.
