Restoring trust in medical research among African-Americans

By Randall C. Morgan, Jr., STAT

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.

“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., MD

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. Read more …