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Compliance In Focus
Posted by John Lehmann on Tue, Mar 9, 2021

The Tuskegee Syphilis Study (1932 – 1972)

A recent Kaiser Family Foundation poll found over a third of Black Americans (35%) said they would probably or definitely not receive the coronavirus vaccine, compared to 27% of the general public.

Tuskegee-syphilis-study

Many have pointed out that this skepticism is rooted in unethical events in the history of clinical research, including the infamous Tuskegee syphilis study.

We're taking a closer look at what went wrong, the lasting impact it had, and what we can learn from it.

What Was The Tuskegee Syphilis Study?

When the Tuskegee syphilis study began in 1932, there was no known cure for syphilis. This highly contagious venereal disease wreaks havoc on the body, starting with minor symptoms like swelling near the groin, but progressively getting worse. Patients develop sores, begin to lose weight, suffer from hair loss, and develop chronic fatigue. If left untreated, the disease can permanently damage vital organs, causing blindness, deafness, paralysis, and potentially death in the most advanced cases.

To better understand the disease, the U.S. Public Health Service and the Tuskegee Institute promised free medical care to 600 African American men in Macon County, Georgia. The goal of the study was to document the full progression of the disease and learn as much as possible about its effects on the body. Of the 600 men, 399 of them had the disease and 201 served as a control group. 

The PHS told the men they would receive free medical care, but never told them they were part of an experiment to study the venereal disease. 

By 1947, penicillin had become standard treatment for syphilis. The Tuskegee syphilis study continued and researchers knowingly withheld treatment from the patients. 

Many experienced symptoms that gradually worsened, and they were unknowingly spreading it to their partners and children. 

In 1972, an Associated Press story about the Tuskegee syphilis study led the Assistant Secretary for Health and Scientific Affairs to appoint an ad hoc advisory panel to investigate it further. The advisory panel found no evidence that the men who participated in the study had given informed consent or had the option to quit the study. 

By the time the study was shut down, 128 of the 399 men who had syphilis had died, either directly from the disease or from complications related to it. Forty had passed the disease onto their spouses, and 19 children were born with it. 

What Ethical Issues Did The Tuskegee Syphilis Study Violate?

In the 1972 AP article, Senator William Proxmire, who oversaw the Public Health Services budget at the time, called the Tuskegee syphilis study “a moral and ethical nightmare.” 

First, it violated the basic principle of informed consent. Informed consent requires participates to be given sufficient information about the research and risks they are undertaking. They should have the ability to comprehend what the study involves, be given opportunities to ask questions, and be permitted to withdraw from the study at any time.

The agency didn't inform men of the purpose of their study and ask for willing participants. Instead, they went into a community with a vulnerable population and lied to them to get them to participate. Many of the men were unable to afford medical care and agreed to participate with the promise of free doctor’s visits, hot lunches and ongoing treatment.

The study also knowingly withheld treatment — a clear ethical violation of the Hippocratic Oath’s principles to “first, do no harm.”

On May 16, 1997, 25 years after the termination of the study, President Clinton issued a Presidential Apology, stating

“The United States government did something that was wrong—deeply, profoundly, morally wrong.  It was an outrage to our commitment to integrity and equality for all our citizens.  To the survivors, to the wives and family members, the children and the grandchildren, I say what you know: No power on Earth can give you back the lives lost, the pain suffered, the years of internal torment and anguish. What was done cannot be undone. But we can end the silence. We can stop turning our heads away. We can look at you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry.”

What Were The Consequences?

Following the Tuskegee syphilis study, Congress passed the National Research Act in 1974. They formed a committee to create guidelines for ethical research, which resulted in the Belmont Report. 

This report summarized three ethical principles: 

  • Respect for persons - All individuals are entitled to protection
  • Beneficence - Researchers should maximize possible benefits and minimize potential harm
  • Justice - All persons should be treated equally, and research subjects should not be selected on the basis of race, ethnicity, class, or other factors

Although clinical research has come a long way since the Tuskegee syphilis study, it caused a deep-seated distrust of the medical community for many that remains to this day. 

In Macon County, Georgia, where the experiments took place, vaccine skepticism is all too prevalent.

For researchers today, the Tuskegee syphilis study is a troubling reminder of the tremendous responsibilities we have to protect human subjects. It’s why our team at IMARC is so focused on helping study sponsors follow Good Clinical Practice and comply with all applicable regulations — not just because it’s what’s required for approval, but because the stakes are so high. 

Our history of clinical research timeline documents the Tuskegee syphilis study and many other milestones that have shaped research, for better or for worse. 

The image shows the outline of the state of Alabama, and the X indicates the location of Tuskegee where the study took place.

The History of Clinical Research

Topics: History of Clinical Research Timeline, The Tuskegee Syphilis Study, IMARC Research

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