The Ethics of Clinical Trials

Paul Ballas Health Guide
  • There is a lot of controversy surrounding research trials using human subjects to investigate new psychiatric medications. Maybe it's just because I work in psychiatry, but lately, almost every other day I see advertisements on TV asking for volunteers to participate in clinical trials investigating medications used to treat bipolar disorder, schizophrenia, and depression. Many patients with schizophrenia see these advertisements and have questions about how these trials work, in part because many offer substantial financial incentives to participate in these studies. In particular, patients have concerns that their rights will be protected and are worried that if they sign up for a study, they may cease to be treated like patients and be treated more like lab mice. I've decided to write two entries on the subject of clinical trials to give a brief overview of the process and how research is ethically done on people in the United States. To this end, I'll talk about the infamous Tuskegee Study and the ensuing Belmont Report which has framed how research is carried out on people. 

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    The Tuskegee Syphilis Study was conducted to evaluate the efficacy of treatments of syphilis. It ran from 1932 to 1972 and involved 600 participants (299 who had syphilis, and 201 control participants who did not). The participants were primarily impoverished African Americans. There were many things wrong with this study, from beginning to end. Many, if not all participants, did not have informed consent, and many of the patients were not given all the facts about their illness nor were they told what treatments were available. In fact, there is little evidence that any of the 299 subjects with syphilis were explicitly told they had this disease. Instead, they were told that they had ‘bad blood'.  To make matters worse, in 1947 the medication penicillin became the drug of choice to treat syphilis, however none of the participants were given a choice to take this medication once it became available and none were treated with penicillin even after the United States Public Health Service established treatment centers nationwide to treat syphilis.    


    A news story about this study came out in 1972, resulting in widespread concern about the ethics behind the study. The public outrage let to the creation of an Ad Hoc Advisory Panel by the Assistant Secretary for Health and Scientific Affairs to examine this study more closely. The panel concluded that the participants had never been fully informed of the real goals of the project and hadn't been given the option of leaving. The panel deemed the Tuskegee Syphilis Study "ethically unjustified" and advised that it be stopped, which is was late in 1972. The following year, a class action lawsuit was filed on behalf of participants of the study and their families, which was settled in 1974 for $10 million dollars and the creation of program to offer benefits to the participants and their families. 


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    The public awareness of the details of the Tuskegee Syphilis Study led to widespread concern about how research was conducted in the United States. The concerns of the ethical lapses that occurred led to changes in how modern research is conducted on people, specifically the release of the Belmont report, the establishment of Institutional Review Boards, and The National Human Investigation Board.  My next entry will discuss the ways in which these changes influence research today. 

Published On: April 15, 2008