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Compliance In Focus
Posted by Shawn Kennedy on Tue, Jul 29, 2014

The Tuskegee Syphilis Study (1932 – 1972)

As we continue to blog about the events that comprise our History of Clinical Research: A Tuskegee Syphilis StudyTimeline, we focus this month on the infamous Tuskegee Syphilis Study.

Perhaps the most notorious example of unethical research practice in modern times, impoverished and illiterate, syphilis positive African American men in Tuskegee, Alabama were lied to and misled in the name of science.  For 40 years, the U.S. Public Health Service conducted the “Study of Untreated Syphilis” on 600 subjects (399 with pre-existing syphilis and 201 without) to study the effects of the disease.  As part of the trial, subjects were not afforded the opportunity to provide informed consent to participate, nor were they treated adequately with antibiotics such as Penicillin which became available as a known treatment during the course of the study in the 1940’s.  Instead, they were provided a placebo and led to believe they were receiving free health care from the U.S. Government.  As a result, many of these men died from Syphilis or complications related to it, infected others with the disease, and passed congenital syphilis on to their children.

As unforgivable as this may be, some good eventually did come out of this unfortunate series of events.  In 1974, Congress passed the National Research Act, which led to the establishment of The Belmont Report and the creation of the Office for Human Research Protection (OHRP).

On May 16, 1997, twenty-five years after the termination of the study, then current President Clinton issued the following Presidential Apology:  “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.”

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

With many of our blogs, we seek your response on the topic.  In the case of Tuskegee, we feel that everyone involved in the clinical research process likely shares our similar sentiments.  Perhaps instead, we can all take a moment to reflect on this and consider whether any injustices, large or small, possibly exist with any of the projects we currently touch?

Image Credit: Nicolette Capuano

The History of Clinical Research

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

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