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The Bad Blood Study And The Ethics of Human Subjects Based Research

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Ever wondered what gruesome acts were committed against humanity to push for international laws and regulations for research involving human subjects?

The Syphilis Study at Tuskegee, Alabama 1930-1972 was one of the most notorious examples in the United States that caught the public eye to the importance of setting laws and regulations to monitor human subjects based biomedical and behavioral research

                                     

 

During the course of this study 600 African-American men were recruited, 399 of which had syphilis while the rest were used as controls. These men were recruited without informed consent and, in fact, were led to believe that some of the procedures done in the interest of research (e.g, spinal taps) were actually “special free treatments”. The subjects were told that the study would last for six months and instead it continued for 40 years. None of the men infected were ever told they had Syphilis, but instead, they were treated to what was referred to as “Bad Blood” a local term that could mean anything from syphilis to anemia or fatigue.

 

      

 

The main objective of this study was to observe the natural progression of the disease in individuals from an African-American descent since the natural course in Europeans was already well described by that time. As a consequence, none of these men ever received treatment even after penicillin was proven effective against Treponema pallidum the spirochaete causing the disease, and approved as the main management in the 1940s.

The victims of the study, all African American, included numerous men who died of syphilis, 40 wives who contracted the disease, and 19 children born with congenital syphilis.

 

                             

 

Upon the public outrage following the discovery of what was really going on at the Tuskegee study sponsored by the U.S government, the importance of ethical concepts such as informed consent was highlighted.

 

In 1979 the Balmont Report was established, by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which set the cornerstone for the regulations in human subjects research protection used today.

What feelings do you have about this? What thoughts do you have on using prejudiced minorities for the “greater good”? What other human research subjects violations have you heard of?

Suggestions for further read on ethics, clinical researches and historical events that motivated it we recommend Ethics And Clinical Research by Henry Beecher.
References:
 Centers for Disease Control. The Tuskegee Syphilis Story: A Hard Lesson Learned. Atlanta:Centers for Disease Control, 2004. http://www.cdc.gov/nchstp/od/tuskegee/time.htm. Accessed Nov. 5, 2004.

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