COVID-19 trials protect human rights

MGN

To be safe for us, a vaccine must be tested with people like us

COVID-19 continues to spread furiously across our community. But, there’s a glimmer of hope in the fight to curb this pandemic: vaccines.

In the greater Minneapolis area, there are two COVID-19 vaccine trials that are recruiting patients. One of them is through HealthPartners, and I’m a physician-researcher who’s working on the trial. The other is through Allina Health.

I talk with people across the community, and I get a lot of questions about whether it’s safe to participate in these vaccine trials or other medical research.

It is critical to the success of the study to have Black participants involved to ensure the effectiveness and relevance of the vaccine to our community. My hope as a Black doctor is to have an honest dialog about the risks, benefits, and protections of getting involved in research.

The Black community has reasonable fears about engaging in research studies. African slaves in the United States, and many other vulnerable populations, have historically been involved in research against their will or without their consent.

Even now, the Black community has worse experiences and outcomes when seeking medical care compared to other populations. The trust of the Black community is needed now more than ever to address the global pandemic and how it’s affecting our community in greater numbers than other communities.

Overcoming the difficult past

Because of the difficult history of how medical research has impacted Black communities, we seek to address those concerns by being transparent about our research and by being culturally sensitive in our approach to this study. It is important to note that modern medical research requires that participation be voluntary and with consent. Many layers of legal protection now exist to make human research as safe as possible.

Many of these protections stem from the Tuskegee Syphilis Study, in which Black men living with syphilis were offered free medical care to participate, but were unknowingly denied treatment for their disease even after it became widely available in the 1940s because researchers wanted to see the natural course of the disease. This inhumane experiment continued until 1972 when a researcher disclosed their concerns to a reporter.

The outcry after this study was made public led to Congressional hearings and the creation of the Belmont Report, which includes three basic principles to protect human rights in research:

  1. Respect for persons—people who want to participate in research must be informed and able to make their own decisions.
  2. Doing good (“beneficence”)—a study must aim for the most benefit with the least risk, while not doing harm to study participants.
  3. Justice—the risks and benefits of research cannot be greater in one group than another.

Laws and regulations following the Belmont Report were established in 1981. This led to the creation of Institutional Review Boards (IRBs), which are independent groups of scientists or doctors within any research organization. These IRBs will review and monitor research at all stages to ensure human rights are being protected. The IRB must be consulted if a study is changed at all, or if any significant injury occurs.

Vulnerable populations, such as children or prisoners, are called out in research regulations. These populations have heavy restrictions and protections for research because they are vulnerable to being convinced to participate. All research in these populations can only occur if the research benefits those populations directly.

Modern research violations have only rarely occurred—almost always when IRB regulations were not followed—and these have had major consequences for the researchers and institutions where the research was performed. There is an IRB at HealthPartners that oversees the current vaccine study to protect human safety, and there have been no research violations in our institution to date.

Representation in research matters

Thinking about justice, this vaccine trial is aiming to include the populations most at risk. This is not a study just in or on Black people. This study is targeted at those with high-risk jobs, high-risk diseases, and races/ethnicities most affected by the disease. We want to include the same percentage of people of various populations as are represented in our community, and that includes Black people.

Most importantly, we want the Black community to be assured that when a vaccine becomes available, it has been tested with people like us. We cannot give people this assurance if our community does not participate. When people ask me what they can do to help with the pandemic, this is one way they can help. Be a representative in this study and give a voice to our needs, our bodies, and our experiences.

For more information about the COVID-19 vaccine trial at HealthPartners, visit www.HealthPartners.com/vaccinestudy.

Dr. Zeke McKinney practices clinical occupational and environmental medicine (OEM) for HealthPartners in St. Paul and St. Louis Park, MN, and he is one of few clinicians in Minnesota who evaluates patients for environmental toxicologic exposures. He is also a faculty physician in the HealthPartners OEM Residency where he trained and an affiliate assistant professor at the University of Minnesota School of Public Health.