Restoring trust in medical research among African-Americans

When it comes to medical research, informed consent is a touchy subject among African-Americans. This essential component of research, which basically says, “I understand the work you are doing and agree to take part in it,” was long ignored for African-Americans. Many in the research community have worked tirelessly to make medical research less suspicious and more engaging for this community.

That’s why a new Harvard study of 41 “exception from informed consent” trials conducted over the past 20 years came as a huge step backward.

The Food and Drug Administration allows these trials only to investigate therapies for people incapacitated by life-threatening conditions, such as cardiac arrest or exsanguination. These people need treatment immediately, before a surrogate can be contacted for consent. That means the “participants” are unable to acknowledge they either do or don’t want to take part in the trial.

What was shocking to me, and to many others, was that nearly one-third (29 percent) of the patients in these trials were African-Americans, despite the fact that they make up only 13 percent of the U.S. population. Equally alarming, only 8 percent of the trials showed that the experimental intervention was beneficial, while many of the interventions caused adverse effects, including an increased risk of dying soon after the intervention, neurological deficits, and heart attacks.

The Harvard findings are appalling, and will continue to diminish black people’s lack of trust in the medical community.

That distrust has deep roots. Men and women of color have been subjected to inequitable health care practices for centuries. In the mid-1800s, black bodies were illegally used as cadavers for teaching purposes. In the 1900s, the U.S. Public Health Service launched what would become known as the Tuskegee syphilis study, in which black men with syphilis were systematically and intentionally denied treatment and known cures for the disease for four decades so investigators could explore its “natural history.”

This context helps explain the long-standing distrust of the medical establishment among African-Americans that still permeates our communities. It has led to African-Americans being underrepresented in biomedical research studies that inform treatment decisions for themselves and all Americans.

In commenting on the consent-exempt research, Jennifer Miller, an assistant professor at Yale University School of Medicine, pointed out that we lack the data that could provide us with the demographic breakdowns of a range of diseases. That makes it difficult to know if the right types of patients are being enrolled in clinical trials. With no concrete data to inform these trial decisions, people of color have unknowingly been exposed to potentially high-risk procedures at disproportionate rates.

My colleagues and I at the W. Montague Cobb/National Medical Association Health Institute (Cobb Institute), an organization dedicated to eliminating health disparities and racism in medicine, believe that consent-free clinical trials undermine all of our work to date and have no place in our society.

Our team has made great progress in building trust among the community of black doctors and other medical professionals. One of our key goals is to increase representation by blacks in biomedical research studies that seek to identify treatments for members of every ethnic and socioeconomic community in the United States.

To further this work, we have partnered with the national All of Us Research Program currently being conducted by the National Institutes of Health. It was designed to advance precision medicine in the U.S. and ensure that health care providers have the data and information they need to make well-informed, individualized treatment decisions. One million or more participants are being asked to share their health data, creating a research database that will help medical professionals administer care based on a patient’s background, lifestyle, environment, and genetic makeup.

Our team is working to engage African-Americans across the country to participate in All of Us. We regularly publish information about the project in our medical journals and across our platforms. We have also developed informational materials for our network of more than 50,000 African-American physicians so they can talk with the patients they care for about the benefits of participating in the program.

All of Us requires informed consent. That means participants are able to learn all of the details of the program before deciding to join. This process was designed to encourage transparency and make the aims of the program clear. Enrollees can also withdraw from the research pool at any time.

We believe that this model of informed consent, combined with sharing information about the program’s goals and recruiting more black participants, will help change negative perceptions in our community, one physician and one patient at a time, while also contributing to groundbreaking medical research that will benefit our society for generations.

One of the many benefits of the All of Us database will be access to more specific demographic data that will identify the percentage of a population or subgroup affected by a particular disease. It’s our hope that, over time, African-Americans will be less represented in consent-exempt clinical trials and more equally represented in informed consent studies and trials.

I’ve devoted my professional life to helping improve African-Americans’ trust in the medical establishment. All of Us is the kind of research that will drive that and other essential health advancements — research that will force us to be better and to strip away racially inequitable health practices from our society one at a time.

Randall C. Morgan Jr., M.D., is executive director of the W. Montague Cobb/NMA Health Institute.